Patent Docs

Novartis AG v. Kappos (D.D.C. 2012)

By Donald Zuhn --

In an opinion issued earlier this month, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia determined that Novartis AG and Novartis Vaccines and Diagnostics, Inc. had not satisfied the 180-day limitation of 35 U.S.C. § 154(b)(4)(A) for timely challenging patent term adjustment (PTA) determinations of the U.S. Patent and Trademark Office with respect to nineteen of twenty-three patents at issue, and further, that the 180-day limitation should not be equitably tolled.  For three of the four patents for which Novartis had timely challenged the Office's PTA determinations, the District Court adopted the rationale in Exelixis, Inc. v. Kappos, and for the lone remaining patent, the Court determined that the Office erred in not applying the Federal Circuit's decision in Wyeth v. Kappos.

In July 2010, Novartis brought suit against U.S. Patent and Trademark Office Director David Kappos under 35 U.S.C. § 154 and the Administrative Procedure Act (APA), alleging that the Patent Office improperly determined the amount of patent term adjustment to which eleven of Novartis' patents were entitled (see "Novartis Challenges USPTO's Interim Procedure for Requesting PTA Recalculations").  In its complaint, Novartis argued that the Patent Office improperly refused to apply the Federal Circuit's decision in Wyeth v. Kappos to patents granted prior to September 2, 2009 (which the opinion refers to as the Wyeth claim).  Novartis also challenged the Patent Office's interpretation of the effect of filing a Request for Continued Examination (RCE) on the determination of B Delay (which the opinion refers to as the RCE claim).  The District Court subsequently consolidated the instant case with three other Novartis cases that raise similar issues, bringing the number of Novartis patents at issue in the consolidated action to twenty-three.

With respect to Novartis' Wyeth claim, the opinion notes that the Patent Office's method of determining the extent of any overlap between A Delay (PTA accrued as a result of the Office's failure to take certain specified actions within fixed windows of time) and B Delay (PTA accrued as a result of the Office's failure to issue a patent within three years of the filing of the application) changed in response to the Federal Circuit's decision in Wyeth v. Kappos.  In particular, the Federal Circuit determined that A Delay and B Delay should be aggregated so long as that aggregation did not require counting the same calendar day twice.  Following the Federal Circuit's decision in Wyeth, the Office announced that it would implement the Court's interpretation of A/B Delay overlap for patents issued on or after March 2, 2010, and that it would permit recalculation of PTA for patents issued within 180 days of the Office's announcement.

With respect to Novartis' RCE claim, the opinion notes that the Office has promulgated two rules (37 C.F.R. §§ 1.702(b) and 1.703(b)) interpreting the proper calculation of B Delay under § 154(b)(1)(B).  The effect of these rules is that patentees cannot accrue B Delay for time consumed by an RCE, regardless of when the RCE was filed, and that the "time consumed by" an RCE includes all of the time from the filing of the RCE to the issuance of the patent.

In assessing the Office's determination of PTA for each of the twenty-three Novartis patents at issue, the opinion begins by noting that challenges of the Office's PTA determinations are governed by 35 U.S.C. § 154(b)(4)(A), which provides that:

An applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent.

(In a footnote, the opinion indicates that for complaints filed on or after September 16, 2011, the U.S. District Court for the Eastern District of Virginia now has jurisdiction over actions under 35 U.S.C. § 154(b), a change brought about by passage of the Leahy-Smith America Invents Act.)  For three of the twenty-three Novartis patents at issue (U.S. Patent Nos. 7,807,155; 7,968,518; and 7,973,031), the Office acknowledged that Novartis' complaints were timely filed.  However, the Office argued that for the remaining patents, Novartis' complaints were filed more than 180 days after those patents were issued, and therefore, that Novartis was foreclosed from seeking additional PTA for those patents.  Novartis countered that the 180-day limitation of § 154(b)(4)(A) did not apply to its claims because § 154(b)(4)(A) applies to determinations "under paragraph (3), and therefore only applies to determinations of A Delay.  According to Novartis, determinations of B Delay and A/B overlap can be challenged within the general six-year statute of limitations set forth in the APA (28 U.S.C. § 2401(a)).

In siding with the Patent Office with respect to the 180-day limitation of § 154(b)(4)(A), the District Court states that:

In addition to being consistent with the plain meaning of the statute, [the Patent Office's] interpretation avoids absurd results.  Congress clearly intended to include strict controls on judicial review of PTA determinations.  Under Novartis' interpretation, only Pre-Issuance Determinations [i.e., determinations of A Delay] would be subject to those controls, while the final, complete PTA determinations that accompany an issued patent would not.  Instead, a patentee would have 180 days in which to challenge the calculation of A Delay but six years in which to challenge B Delay and A/B Delay Overlap.

However, while agreeing with the Office on this issue, the District Court disagreed with the Office that Novartis was foreclosed on all of the remaining patents at issue.  In particular, the Court noted that Novartis had filed a petition for PTA reconsideration for U.S. Patent No. 7,470,792 within two months of issuance, as required under 37 C.F.R. § 1.705(d), and had filed a complaint within 180 days of the Office's denial of reconsideration (but more than 180 days after the patent issued).  In response to Novartis' argument that the 180-day limitation period should have been tolled by its filing of a petition for reconsideration, the District Court determined that "[b]ecause the Court holds that the general tolling rule applies, and because Novartis filed its complaint with respect to the ’792 patent within 180 days after the denial of its petition for reconsideration, Novartis' claim with respect to that patent was timely filed."

Novartis next sought equitable tolling of the 180-day limitation of § 154(b)(4)(A) for the remaining nineteen patents at issue.  With respect to its Wyeth claim. Novartis argued that it lacked knowledge of this claim until the Federal Circuit's decision in Wyeth v. Kappos changed the law with respect to A/B Delay overlap, and therefore, that the 180-day limitation should have been equitably tolled until the Office's January 20, 2010 announcement that it would not seek further appellate review of the Federal Circuit's Wyeth decision.  With respect to its RCE claim, Novartis argued that because no court had ruled on the viability of this claim (prior to Exelixis, Inc. v. Kappos), the statute of limitations had not yet begun to run for that claim.

The District Court, however, found Novartis' arguments to be unpersuasive and determined that "the facts in this case do not justify the application of the equitable tolling doctrine to Novartis' nineteen untimely complaints."  Explaining that "[e]quitable tolling is available to a petitioner who has been diligent in pursuing his rights, but for whom some extraordinary circumstance stood in the way and prevented timely filing," the Court noted that "Novartis was free to raise the same issues that Wyeth and Abbott Laboratories raised in their lawsuits within the 180 days after their patents were granted," and stated that "contrary to Novartis' argument, a change in law is not such an extraordinary circumstance as to justify the application of equitable tolling."

Turning to the four patents for which PTA determinations were found to have been timely challenged, the opinion notes that three of the patents concern the same issue decided by the Eastern District of Virginia in Exelixis, Inc. v. Kappos, namely "whether § 154(b)(1)(B) requires that, or even addresses whether, any PTA be reduced by time attributable to an RCE where, as here, the RCE is filed after the expiration of the three year guarantee period specified in that statute."  After discussing the decision in Exelixis, the Court noted that it found "Judge Ellis' well-reasoned opinion to be persuasive," and "therefore adopt[ed] his rationale for concluding that the PTO's interpretation [of the statute] is contrary to the plain and unambiguous language of § 154(b)(1)(B), and that it contravenes the structure and purpose of the statute."

For the lone remaining patent -- the '792 patent -- the District Court determined that the Office "erred in not applying either this Court's or the Federal Circuit's Wyeth decision."  The Court noted that the '792 patent issued on December 30, 2008, two months after the District Court decision in Wyeth, that Novartis sought reconsideration of its PTA determination in February 2009, based in part on the District Court's Wyeth ruling, and that the Office nevertheless declined to apply the Wyeth method of calculating overlap to the '792 patent.  The Court stated that "[t]his was erroneous," and that the Office "abused its discretion by refusing to calculate Novartis' patent consistently with the method adopted in Wyeth"

Novartis AG v. Kappos (D.D.C. 2012)
Memorandum Opinion by Judge Ellen Segal Huvelle

Exelixis, Inc. v. Kappos (E.D. Va. 2012)

Court Overrules PTO Interpretation of B-Delay Calculation

By Kevin E. Noonan --

Judge T.S. Ellis III of the U.S. District Court for the Eastern District of Virginia wrote the latest chapter in the story of judicial review of (and, generally, disagreement with) how the Office has interpreted the patent term adjustment provisions of the 1999 America Inventors Protection Act (AIPA).  This case involves so-called "B delay," corresponding to a date that is three years after an application's filing date and the date on which the Office actually grants a patent pursuant to 35 U.S.C. § 154(b)(1)(B).  The issue was whether the Office had correctly implemented the statute by negating B delay in circumstances where an applicant had responded to a final rejection by filing a request for continued examination (RCE) (also a provision newly added to U.S. patent law by the AIPA).

The case involved an application filed by Exelixis that resulted in grant of U.S. Patent No. 7,989,622 entitled "Phosphatidylinositol 3-Kinase Inhibitors and Methods of their Use."  The application was filed on January 15, 2008 and a first Office Action promulgated by the Office on February 22, 2010, resulting in an "A delay" (the time from the filing date to the first substantive action in a case pursuant to 35 U.S.C. § 154(b)(1)(A)) of 283 days.  The PTO issued Final Rejection on March 9, 2011 (38 months, i.e., 2 months from the three-year date calculated from the filing date), to which the applicants responded on April 11, 2011; this response was filed with an RCE.  "Less than three weeks later" (a time the Court characterized as "commendable, if, with respect to this application, uncharacteristic alacrity"), the Office issued a Notice of Allowance.  Despite payment of the Issue Fee almost immediately (on April 28, 2011), the patent did not grant until August 2, 2011.  At that time, the Office notified Exelixis that the PTA for this patent was a total of 368 days, corresponding to 283 days of A delay, 85 days of B delay, 0 days of C delay under 35 U.S.C. § 154(b)(1)(C) and subtracting 61 days for applicant delay in prosecution ("C reduction" under 35 U.S.C. § 154(b)(2)(C)).  The Office's calculation of the B delay, the issue in the case, credited Exelixis for 85 days from the time between the date that was three years after the application was filed and the date the Final Rejection was mailed; the Office did not give this patent the benefit of another 114 days corresponding from the date the RCE was filed until the grant date, implementing Office policy that filing an RCE stops the accumulation of B delay in the Office's PTA calculation.  These 114 days and the Office's policies that deprived the '622 patent of this additional PTA prompted the lawsuit.  The Court set forth a helpful timeline:

The Court recognized the context of the dispute being based in an assessment of Congressional intent in implementing the provisions of the General Agreement on Tariffs and Trade (GATT), which changed the term of U.S. patents from 17 years from issue to 20 years from the filing (or earliest priority) date, and the provisions of the AIPA apparently aimed at restoring term lost as the result of Patent Office delays in prosecution.  "Taken as a whole," the Court said:

[T]he clear goal and purpose of these provisions is to provide a successful applicant with a patent that can be enforced against putative infringers for approximately 17 years -- 20 years from the date of application less three years for prosecution and examination -- and to reach this goal by providing applicants with day for day patent term extension for delays attributable to the PTO and day for day reductions for the patent term extension for delayed attributable to an applicant's failure to act with alacrity in certain circumstances.

The Court characterizes the provisions of 35 U.S.C. § 154(b) as "guarantees" according to the titles of the three sections of § 154(b) relating to PTO delay, which is significant because the Court notes (in a footnote) that it is permissible for courts to use titles and headings in statutes in interpreting the meaning of the substantive provisions of law.

On summary judgment, the Court ruled against the PTO's interpretation of the statute based on its construction of the statutory provisions and Congressional intent discerned inter alia from how Congress described and characterized those provisions in the statute.  The Court applied the deferential standard that agency action must be upheld unless it is "arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law" under the Administrative Procedures Act (5 U.S.C. § 706(2)(A)), noting that an erroneous interpretation of the law satisfies this standard, citing Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005), and Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).

The Court's opinion begins with the "plain language of the statute," and the Court found that the meaning of the statute was "clear, unambiguous, and in accord with both the statute's structure and purpose."  Section 154(b)(2) clearly and "simply" is intended by its terms to provide a guarantee of no more than a three-year application pendency, according to the Court's opinion, and this goal is accomplished by "(i) starting a three year clock on the date the application is filed, (ii) tolling the running of this clock if, within the three year period, any of three events occur, including an RCE filing, and (iii) adding a day for day PTA to the patent term for any delay in the issuance of a patent after the three year clock, less any tolling, runs out."

In the Court's view, the provisions of the statute involving RCEs have to do solely with tolling the clock with regard to the three-year date.  The opinion states that the portion of the statute concerning RCEs "clearly and unambiguously modifies and pertains to the three year period and does not apply to, or refer to, the day to day PTA remedy."  The Court characterizes as "[e]specially notable" that the statute "does not address the filing of an RCE after the expiration of the three year clock" (emphasis in original).  The statute "makes [it] clear that once the three year clock has run, PTA is to be awarded on a day for day basis regardless of subsequent events" in the Court's view.  The Court also notes that the filing of an RCE is not contained in the section setting forth the day to day reduction in PTA occasioned by applicant delay in prosecution, and concludes that the statute does not consider the filing of an RCE to be an action that warrants reduction in PTA under the statute.  The Court concludes that "RCE's gave no impact on the PTA after the three year deadline has passed."

The Court rejected PTO arguments in favor of the Office's interpretation.  Specifically, the opinion swiftly dismissed the argument that the statute must be interpreted as if it included the word "then" in such a way that would support its interpretation by simply noting that the word "then" did not appear in the statute and on the grounds that the Office's interpretation would effectively treat the filing of an RCE as a failure to "engage in reasonable efforts to conclude prosecution of the application," i.e., the grounds for applicant delay where the Court had expressly found RCE filings were not included.  If this is the interpretation the Office wants to apply to RCEs, the Court tartly recommends that the Office should be sure to "issue any notice of rejection prior to the expiration of the three year period" as well as require prompt filing of an RCE.  The Court also rejects the Office's position that it should be accorded deference, saying that "deference is unwarranted when [] the statute is unambiguous."  In this regard the Court notes that the Federal Circuit had rejected this level of deference in the last case decided on PTA issues, Wyeth v. Kappos.  Finally, the Court noted that any disparate treatment that might result one application to the next (depending on whether an RCE was filed before or after the 3-year anniversary date) was something within the Office's power to control or minimize.

It is likely that the government will appeal to the Federal Circuit, and thus that the finality of this interpretation of the statute will remain delayed until that review of complete.  This means that there is time for prudent patent practitioners to review the PTA status of their clients' patents to determine where there are instances where the PTA was "improperly" calculated under the interpretation set forth in this opinion.  But time may be of the essence for some because the statute also imposes a 180-day statute of limitations on filing challenges to Office PTA determinations (see "USPTO Posts Notice Regarding Wyeth Decision"), and while an intervening change in the law may permit challenges outside that period it makes better sense to identify important patents and file a lawsuit based on this interpretation of the B delay statutory provisions to best protect both clients and practitioners.

Exelixis, Inc. v. Kappos (E.D. Va. 2012)
Memorandum Opinion by Judge T.S. Ellis, III

ArQule v. Kappos: Enjoy Your Weekend, or What a Difference a Day (or Two or Three) of PTA Can Make

ArQule, Inc. v. Kappos, 793 F. Supp. 2d 214 (D.D.C. 2011)

By Sherri Oslick --

A few years ago we had provided some cautionary advice relating to the dichotomy between a timely filed response in accordance with 35 U.S.C. § 21(b), and a delayed response pursuant to 37 C.F.R. § 1.704(b).  35 U.S.C. § 21(b) allowed an applicant to take an extra day or two or three (until the next business day) to file a response to a 3-month action without requiring an extension of time fee, yet under 37 C.F.R. § 1.704(b), those extra days would be regarded as applicant delay for patent term adjustment ("PTA") purposes (see "Patent Term Adjustment: 37 C.F.R. § 1.704(b)'s Three-Month Provision").  For example, if the USPTO issued a non-final rejection, and the 3-month response deadline fell on a Saturday, the applicant could still timely file the response on the following Monday, but those extra two days would be counted against any PTA awarded for the patent.  And so, we cautioned that it would be wise to pay close attention to the true 3-month deadline date, and respond by then, in order to maximize patent term adjustment.

Fast forward, and our advice has changed.  Now we recommend that you enjoy your weekend and/or holiday, and not worry about filing the response until the next business day.  Under ArQule v. Kappos, those extra days will not be regarded as applicant delay for the purposes of a patent term adjustment determination.

In ArQule, the plaintiff had been awarded a PTA of 1,127 days for U.S. Patent No. 7,713,969 ("the '969 patent," entitled "Compositions and Methods for Treatment of Cancer") due to USPTO delay.  The total of "A" + "B" delay, less overlap, was 1,128 days, but ArQule was charged with one day of applicant delay, based on a response that was filed 3 months and 1 day after its mailing date, the 3-month deadline falling on Veterans Day (with the response being timely filed the next day).  At that time, the USPTO, in calculating PTA, followed the literal language 37 C.F.R. § 1.704(b), which incorporates the language of 35 U.S.C. § 154(b)(2)(C)(ii) and states that "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request" (emphasis added).

Its petitions with the USPTO to correct the PTA (to remove the one-day applicant delay) having been denied, ArQule filed suit in the District Court of the District of Columbia (the appropriate court under 35 U.S.C. § 154 as it stood at the time).  On cross motions for summary judgment, ArQule argued that the provisions of 35 U.S.C. § 21(b) ("[w]hen the day, or the last day, for taking any action or paying any fee in the United States Patent and Trademark Office falls on Saturday, Sunday, or a Federal holiday within the District of Columbia, the action may be taken, or fee paid, on the next succeeding secular or business day") were to be applied to 35 U.S.C. § 154(b)(2)(C)(ii), and the USPTO took the opposite position.  The Court granted ArQule's motion for summary judgment and denied the USPTO's, finding the meaning of 35 U.S.C. § 154(b)(2)(C)(ii) to be plain and clear in referring to an action that applicants must take, and as such, the "any action taken" provision of 35 U.S.C. § 21(b) applied to this aspect of PTA calculations.  The USPTO did not appeal the District Court's finding.

For its part, the USPTO has been largely silent on the implications of this case (the sole reference to the ArQule case on the USPTO website is within a recent Federal Register publication on the revision of PTA provisions relating to appellate review), which indicates that ArQule will be followed for those provisions.  However, a discussion had by this Patent Docs contributor with a representative from the Office of Patent Legal Administration (OPLA) confirmed that the Office is indeed applying ArQule to its PTA determinations -- sort of.  The OPLA representative was not sure if the software used by the USPTO to calculate PTA had been updated to reflect the ArQule holding, and a cursory review of a small sampling of recently issued patents suggests that is has not.  Therefore, in the example noted at the start of this post, the applicant would likely receive a PTA calculation that reflected a deduction of 2 days of PTA due to applicant delay.  In order to have those days of PTA rightfully reinstated, it would be necessary to file a petition for reconsideration of the patent term adjustment, citing the ArQule case.  The OPLA representative advised that such a petition would be granted.

In some instances, it may not be worth the effort and expense to petition for the additional one or two or three days of patent term.  But in others, recapturing those days could translate into significant revenue.  For example, according to an IMS Health report entitled "Top U.S Pharmaceutical Products by Spending," sales of Pfizer's Lipitor® in the U.S. amounted to $7.7 billion dollars in 2011.  Doing some simple math, that translates to approximately $21M in sales daily.  When viewed in that light, one or two or three days of additional patent term would have a significant impact, and would be well worth the pursuing.

Hatch-Waxman Watch

Valeant International (Barbados) SRL v. Watson Pharmaceuticals, Inc.

By Andrew Williams --

On Monday, the Southern District of Florida denied Valeant International (Barbados) SRL's motion for a permanent injunction to prevent Watson Pharmaceuticals, Inc. from commercially manufacturing or selling its generic version of Aplenzin® (see Order Denying Motion for Injunctive Relief).  Valeant had been successful in the District Court in fending off Watson's validity challenges of four Orange Book-listed patents related to bupropion hydrobromide, the active ingredient of Aplenzin®, after Watson had filed its ANDA and conceded infringement in the subsequently filed 35 U.S.C. § 271(e)(2) action.  After final judgment was entered, Valeant filed a motion to amend the judgment to, among other things, enjoin Watson from any commercial activity before the expiration of the patents.  The Court found that Valeant had not met the standard for injunctive relief because it didn't establish irreparable harm, and injunctive relief would be unnecessary (because the entered judgment prohibits Watson from marketing its generic version prior to the expiration of the patents).

To understand Valeant's motion, it is important to note that in addition to allowing a court to delay the approval of a generic drug until the date of expiration of any infringed patent, the Hatch-Waxman statute also provides that injunctive relief may be granted.  See 35 U.S.C. § 271(e)(4)(B).  The Court's order in this case does not explain why Valeant was seeking a permanent injunction, but it did point out that violation of an injunction can result in contempt proceedings against the infringer.  The standard for injunctive relief in a patent case was established by the Supreme Court in eBay, Inc. v. MercExchange, LLC, 547 U.S. 388 (2006):

A plaintiff must demonstrate: (1) that it has suffered irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.

Id. at 391.  Valeant argued that all Hatch-Waxman cases involve direct competition that attempt to take market share from the NDA holder, which always results in irreparable harm.  However, the Court noted that the Federal Circuit has repeatedly required that such evidence to be presented before an injunction can issue, including pharmaceutical cases, citing Abbott v. Labs. v. Andrx Pharms., Inc., 452 F.3d 1331 (Fed. Cir. 2006).  The Abbott case did indicate that generic competition "alone does not establish that [the patent holder's] harm will be irreparable, id. at 1348, but Abbott was seeking a preliminary injunction and was more importantly unable to show a likelihood of success on the merits sufficient to meet that prong of the analysis.  Nevertheless, the important point that the District Court took from the Abbott case was that the insufficiency of monetary damages needs to be established.  It is not clear whether Valeant presented any such evidence.

Moreover, the Court pointed out that even if there was evidence of irreparable harm, Valeant still did not meet the standard for injunctive relief, because the entered judgment prevents Watson from marketing its generic bupropion hydrobromide before the expiration of the patents at issue, and thus Watson is prevented from competing directly with Valeant.  This is true, however, in every 271(e)(2) action, and yet Congress provided for injunctive relief.  It is possible that the District Court could have been persuaded by the procedural posture of this case, and that if Valeant were not seeking an amendment to the final judgment, the outcome may have been different.  Or the Court could have been making clear that, after eBay, if you want injunctive relief, you better provide evidence to support it.  Finally, the Court did note that if Watson violated the final judgment, another case could be filed in the Southern District of Florida (which presumably would satisfy any concern over the inability to seek sanctions).

Importantly, the Court relied on the Delaware case of Alcon, Inc. v. TEVA Pharms. USA, Inc. (D. Del. Aug. 5 2010) in reaching its decision.  In that case, the court also denied Alcon's request for a permanent injunction because, in part, it failed to prove that it had suffered irreparable harm.  Alcon had argued that any deprivation of its right to exclude other constitutes irreparable harm.  However, similar to the present case, the Delaware court found that because Teva would be unable to market its generic product before the expiration of the product, it was necessarily prevented from "usurping any market share or goodwill from Alcon."

SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012)

By James DeGiulio --

In an opinion issued only ten days after the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. ("Prometheus"), the District Court for the District of Columbia is believed to be the first to apply the Prometheus decision to invalidate diagnostic method patents.  In finding the claims-at-issue in two patents held by Advanced Biological Laboratories, SA ("ABL") to be directed to unpatentable subject matter, District Court Judge Beryl A. Howell provides an analysis under Prometheus, but also provides an invalidation analysis applying other tests, including the machine-or-transformation ("MOT") test.  While Prometheus is cited throughout Judge Howell's opinion, that case is treated more as a "guidepost" in applying previous tests, as are other touchstone decisions in Benson, Flook, Diehr, and Bilski.  By comparing and contrasting the claims at issue in these cases, as well as others from the Federal Circuit, Judge Howell provides an early roadmap for § 101 analysis, although at times it is unclear precisely what lends the ABL claims to one case rather than another.  However, what is clear from Prometheus according to Judge Howell is that the Supreme Court has fully endorsed the performing of a "threshold test" by the district court as to patentable subject matter, confirming that a ruling of unpatentable subject matter under § 101 is appropriate, and preferred, in total isolation from the other provisions of the Patent Act.

The dispute between SmartGene and ABL began in 2007 when ABL brought a patent infringement suit against SmartGene in the Eastern District of Texas.  That suit was dismissed for lack of personal jurisdiction in 2008, and within a month, SmartGene responded by filing the instant declaratory judgment suit, requesting a finding of non-infringement, invalidity, and unenforceability as to U.S. Patent Nos. 6,081,786 and 6,188,988.  In February 2009, the suit was stayed pending a series of six reexaminations, but restarted in October 2011, after the parties filed a joint motion to lift the stay.  SmartGene filed a motion for partial summary judgment in December 2011, alleging that the '786 and '988 patents encompassed patent ineligible subject matter under 35 U.S.C. § 101 and Bilksi v. Kappos.  A hearing on the pending motion, as well as claim construction, was held in March.

Both the '786 and '988 patents relate "to a system, method, and computer program for guiding the selection of therapeutic treatment regimens for complex disorders . . . by ranking available treatment regimens and providing advisory information," as defined by the patentee.  Both patents are based on the same specification and disclosure, and relate to methods (i.e., processes) and systems for an interactive, computerized program for guiding the selection of therapeutic treatment regimens for a patient based on input provided by a physician.  Claim 1 of the '786 patent is representative of the subject matter at issue:

1.  A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising:
    (a)  providing patient information to a computing device comprising:
        a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition;
        a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition;
        a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and
    (b)  generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient; and
    (c)  generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules.

SmartGene contended that the '786 and '988 patents are directed to patent ineligible subject matter, and thus invalid, because they are directed to abstract ideas and mental processes, and fail the MOT test articulated in Bilski.  ABL responded that the claims at issue are not directed to an abstract idea, and while the MOT test is "not the sole test for patentability," the '786 and '988 patents satisfy that test.  In its opposition motion, ABL summarized the invention as follows:

Element (a) specifies that the physician provide patient information to the computing device which includes prior therapeutic treatment regimen information.  This information is then processed against a first knowledge base that contains different treatment regimens and a second knowledge base of expert rules.  The computing device then generates available treatments along with advisory information for those treatments.  By providing the patient information to the system and allowing interaction with the physician, the Patents describe how therapeutic treatment regimens can be listed with corresponding advisory information.

The patents also contain "system" claims, which ABL sought to have read as means-plus-function claims, in an effort to tie the claimed methods to the disclosed "computing device" structures in the specification.  Following ABL's claim construction, Judge Howell found (in a footnote) that the distinction between the claim type has no bearing on the standard of review for patentable subject matter, citing In re Meyer (CCPA 1982).

The legal standard section of the opinion cites only Supreme Court decisions weighing patentability under § 101, including Diehr, Bilski, Benson, and finally Prometheus.  Judge Howell latches onto the unpatentability of Einstein and Newton's theories, but closes the section with the policy justification that "too broad an interpretation of this exclusionary principle could eviscerate patent law.  For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."

Judge Howell takes a stepwise and comprehensive approach to evaluating the patentability of the claims under § 101, with the analysis comprising:  (A) examining § 101 as a "threshold" inquiry into patent validity; (B) reviewing Supreme Court caselaw "guideposts" on the subject of patent subject matter eligibility; (C) examining whether the '786 and '988 patents satisfy the MOT test; (D) determining whether the patents constitute eligible subject matter irrespective of the MOT test; and finally (E) examining the parties' claim construction proposals to inform its § 101 analysis.  According to the District Court, ABL's patent claims fail to show patentable subject matter under all five analyses.

As an initial matter, Judge Howell decided that it was appropriate to rule on the patentability of ABL's claims before first construing the claims.  In reaching this conclusion, Judge Howell noted the cases favoring this approach, including Bilski and CLS Bank v. Alice Corp. Pty. Ltd. (D.D.C. 2011), but also recognized the Federal Circuit's recent hostility toward the application of this "threshold" test in isolation by district courts, as embodied in MySpace and Classen.  Judge Howell found the answer in Prometheus, where the Supreme Court "explicitly rejected" the ability of §§ 102, 103, and 112 to provide any "screening function" with regard to the patentability of subject matter.  As such, she holds that "this Court treats the § 101 subject matter patentability inquiry as the threshold inquiry for patent validity."

Following the lead of Bilski and Prometheus, Judge Howell evaluates the Benson, Flook, and Diehr trilogy of opinions as "guideposts" provided by the Supreme Court in considering exceptions to patent subject matter eligibility under § 101.  After summarizing the relevant holdings from each case, Judge Howell provides her interpretation of the Prometheus Court, which "distilled the guideposts from its earlier section 101 cases" into warnings about "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art,'" "upholding patents that claim processes that too broadly preempt the use of a natural law," and the requirement of an "inventive concept" comprising other elements "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

The "mental process" characteristics of the instant claims are determinative of unpatentable subject matter, according to Judge Howell.  She finds that the "patents-in-dispute do no more than describe just such an abstract mental process engaged in routinely, either entirely within a physician's mind, or potentially aided by other resources in the treatment of patients."  Judge Howell contrasts Diehr, stating that these claims "involves no 'transformation of an article' nor a 'step-by-step method for accomplishing such [transformation],'" instead noting similarities with Flook as a mere a recitation of abstract steps.  The District Court is seemingly most persuaded by the analogous case In re Meyer, where claims directed to gathering neurological testing data, imputing it into a computer, and using a formula to evaluate certain neurological functions were found to be an "attempt to patent a mathematical algorithm rather than a process for producing a product as in [Diehr]."  ABL could not distinguish its claims from Meyer, instead stating that the purpose of the invention is to provide a doctor with more information than the physician could have in his or her mind, leading the District Court to find these claims even more abstract than in Meyer, which "at least involved a mathematical algorithm."

The opinion proceeds to evaluate each step of the method in the context of precedent, as was done in Prometheus.  The District Court notes that all of the claim steps are typically conducted as mental steps by a doctor, including "guiding the selection of a therapeutic treatment regimen for a patient" (when a patient describes his/her ailments to the doctor), "providing patient information to a computing device comprising [three knowledge databases]" (documenting the patient's symptoms and medical history in a medical chart, and consulting literature), and "generating in said computing device a ranked listing of available therapeutic treatment regimens" (mentally evaluating the benefits and counter-indicators of each treatment option).  The last step, "generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules," is interpreted as a doctor generating a treatment plan for a patient.  Thus, the claim was found to add nothing to the process that doctors do not already regularly engage in mentally when evaluating and treating patients.  The District Court finally evaluates claim 1 as a whole, finding the four steps as abstract ideas that are commonly performed by medical professionals in evaluating, considering, and constructing treatment options for a patient presenting a specific medical condition.  Following Prometheus, the claim consists of "well understood, routine, conventional activity already engaged in by the scientific community," and is thus lacking the "inventive concept" required to transform unpatentable abstract ideas into patentable applications.

After finding ABL's claims unpatentable under Prometheus, the District Court confirms the unpatentability of the claims under the MOT test.  Judge Howell addresses the Supreme Court's negative treatment of the MOT test in Prometheus, finding that it was only the "Federal Circuit's application of that test" that was rejected in Prometheus, not the test itself, and it remains a "useful investigative tool."  According to the District Court, to satisfy the MOT test under the Supreme Court's application, the "transformation" itself must require the claimed process.  The transformation in Prometheus, which satisfied the MOT test according to the Federal Circuit, transformed the human body (by thiopurine treatment) and the blood (by analyzing metabolite levels), but neither transformation required the claimed process, and thus was deemed "irrelevant" by the Supreme Court.  ABL's argument that its claims "transform the patient's body" suffer the same fate, and cannot be saved by reciting a generic "computing device."  The ABL "computing device" is not a "particular machine" with any specific programming or algorithms, and in no way limits the claims, leading to the conclusion that it is merely extra-solution activity.  The District Court finds that Federal Circuit case law such as Dealertrack and Cybersource "is clear that allowing a process to become patentable simply because it is computer aided and constitutes a practical application would render the subject-matter eligibility criteria contained in section 101 meaningless."

Finally, Judge Howell looks to the ABL's proposed construction for confirmation of her holdings.  Naturally, as the patentee, ABL seeks to have the claim terms construed as broadly as possible, including no limitations on terms such as "database," "patient information," and "knowledge base."  These constructions, akin to Benson, would yield a claim that was "so abstract and sweeping as to cover both known and unknown uses," and would thus foreclose innovation in this area if found valid.  Since ABL's motions and construction were filed before the Supreme Court's opinion in Prometheus was published, ABL's reliance upon the Federal Circuit's previous opinion could certainly explain the relative ease in which Judge Howell was able to find the claims unpatentable.  ABL became an easy target in its choice of claim constructions and characterizations that were effectively overruled by the Supreme Court, which made Judge Howell's ultimate decision much easier.  The patent community has now had some time to digest the "new" criteria from Prometheus, so it remains to be seen how claim construction arguments will be customized to avoid the pitfalls seen in SmartGene.  Regardless, since Prometheus (at least according to one judge) has granted total discretion to the district court to determine patentable subject matter under § 101, it is likely that challenges to subject matter patentability at the district court level will increase in frequency.

SmartGene, Inc. v. Advanced Biological Laboratories, SA (D.D.C. 2012)
Opinion by District Judge Beryl A. Howell

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Medicis Pharmaceutical Corp. et al. v. Stiefel Laboratories, Inc. et al.
2:12-cv-01746; filed March 20, 2012 in the District Court of New Jersey

• Plaintiffs:  Medicis Pharmaceutical Corp.; Dow Pharmaceutical Sciences, Inc.
• Defendants:  Glaxosmithkline PLC; Stiefel Laboratories, Inc.

Infringement of U.S. Patent No. 6,387,383 ("Topical Low-Viscosity Gel Composition," issued May 14, 2002) based on defendants' manufacture and sale of Veltin^TM(antibiotic/retinoid gel, used to treat acne).  View the complaint here.

Alkermes Pharma Ireland Limited v. Actavis Inc. et al.
1:12-cv-00323; filed March 16, 2012 in the District Court of Delaware

• Plaintiff:  Alkermes Pharma Ireland Limited
• Defendants:  Actavis Inc.; Actavis South Atlantic LLC

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Abbott Laboratories et al. v. Watson Pharmaceuticals Inc. et al.
1:12-cv-00324; filed March 16, 2012 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida; Watson Pharma Inc.

Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.

Shire Development LLC et al. v. Osmotica Pharmaceutical Corp.
1:12-cv-00904; filed March 16, 2012 in the Northern District of Georgia

• Plaintiffs:  Shire Development LLC; Shire Pharmaceutical Development Inc.; Cosmo Technologies Ltd.; Giuliani International Ltd.
• Defendant:  Osmotica Pharmaceutical Corp.

Infringement of U.S. Patent No. 6,773,720 ("Mesalazine Controlled Release Oral Pharmaceutical Compositions," issued August 10, 2004) following a Paragraph IV certification as part of Osmotica's filing of an ANDA to manufacture a generic version of Shire's Lialda® (mesalamine, used to induce remission in patients with active, mild to moderate ulcerative colitis).  View the complaint here.

Celgene Corp. et al. v. Actavis South Atlantic LLC
2:12-cv-01688; filed March 16, 2012 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Actavis South Atlantic LLC

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Court Dismisses PubPat's Declaratory Judgment Action against Monsanto

By Kevin E. Noonan --

On Friday, Judge Naomi Reice Buchwald presiding in the Southern District of New York granted Monsanto's motion to dismiss a case brought by the Public Patent Foundation (PubPat) on behalf of "farmers and seed businesses, both organic and non-organic, as well as related membership organizations."  Organic Seed Growers and Trade Assn. et al. v. Monsanto Co.  This puts to an end (for now) PubPat's latest effort to influence U.S. patent policy through the courts (the other instance being, most (in)famously, Association for Molecular Pathology v. U.S. Patent and Trademark Office ("the Myriad case"), although here PubPat was not aided by the American Civil Liberties Union).  The complaint named almost seventy plaintiffs, and the patents at issue were U.S. Patent Nos. 5,322,938 (expired 6/21/2011), 5,532,605 (expired 7/28/2008), 5,362,865 (expired 11/8/2011), 5,378,619 (expired 1/3/2012), 5,424,412 (will expire 6/13/2012), 5,463,175 (will expire 10/31/2012), 5,530,196, 5,554,798, 5,593,874, 5,641,876, 5,659,122, 5,717,084, 5,728,925, 5,750,871, 5,859,347, 6,025,545, 6,040,497, 6,051,753, 6,083,878, 6,753,463, and 6,825,400, and U.S. Reissue Patent Nos. RE38825 and RE39247.

Monsanto asked the Court to dismiss the action for failure to allege a "case or controversy" under the Declaratory Judgments Act as required under Article III of the Constitution.  The District Court began its opinion granting this motion by noting that a court's jurisdiction cannot exceed this Article III requirement under the Declaratory Judgment Act, citing Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1335 (Fed. Cir. 2008).  The Supreme Court's test for determining whether a sufficient case or controversy has been plead requires a plaintiff to establish that "the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment," citing (without apparent irony) Association for Molecular Pathology v. U.S. Patent & Trademark Office ("AMP"), 653 F.3d 1329, 1342-43 (Fed. Cir. 2011) (quoting MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007)).  The Court noted that this test has been "refined" by the Federal Circuit to require "an injury in fact traceable to the patentee," which only exists if plaintiffs have alleged "both (1) an affirmative act by the patentee related to the enforcement of his patent rights, and (2) meaningful preparation to conduct potentially infringing activity."  Id. at 1343 (citing SanDisk Corp. v. STMicroelectronics, Inc., 480 F.3d 1372, 1380-81 (Fed. Cir. 2007).

The opinion notes (in footnote 5) that:

[P]laintiffs attempt to circumvent this test first by arguing that MedImmune confers per se standing on any plaintiff who has purchased a license to a patent.  (Pls.' Mem. 18.)  The argument evinces a lack of understanding of MedImmune's holding, which was that purchasing a patent license does not preclude jurisdiction where the purchase has been coerced.  See 549 U.S. at 129-31.  Plaintiffs, relying on their misreading of MedImmune, next endeavor to extend the argument and contend that standing should be conferred on all parties who are able to purchase a license, whether or not they have done so.  (Pls.' Mem. 19.)  Accepting this suggestion would functionally eliminate the case or controversy requirement and should thus be rejected out of hand.

The Court explained that the first prong of the Federal Circuit's test ensures that the parties have "adverse legal interests," which is established "where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without license."  SanDisk, 480 F.3d at 1381.  (The Court recognized that "it is possible that the first prong of the test may be satisfied upon some lesser showing.")  In any case, there must be "an underlying legal cause of action that the declaratory defendant could have brought or threatened to bring, if not for the fact that the declaratory plaintiff had preempted it," because otherwise "any adverse economic interest that the declaratory plaintiff may have against the declaratory defendant is not a legally cognizable interest sufficient to confer declaratory judgment jurisdiction," citing Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1316 (Fed. Cir. 2011).  The "mere existence of a potentially adverse patent does not cause an injury [or] create an imminent risk of an injury; absent action by the patentee, a potential [infringer] is legally free to market its product in the face of an adversely-held patent," citing Prasco, 537 F.3d at 1338.

As to the second prong, the Federal Circuit's test requires that the declaratory judgment plaintiff has taken "significant, concrete steps to conduct infringing activity"; otherwise, "the dispute is neither 'immediate' nor 'real' and the requirements for justiciability have not been met," citing Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 880 (Fed. Cir. 2008).  The Court notes that "the greater the length of time before potentially infringing activity is expected to occur" is "significant" and impacts the immediacy of the cause of action.

Here, the Court held that plaintiffs failed to assert a "case or controversy" that supported Article III jurisdiction.  The facts supporting the Court's conclusion were that there was no evidence that Monsanto "ever demanded royalty payments from plaintiffs, identified any of plaintiffs' conduct as potentially infringing, or even initiated any contact with plaintiffs whatsoever."  Plaintiffs only support for there being a "case or controversy," according to the Court, was "(1) defendants' pattern of enforcing their patent rights against non-plaintiff farmers through litigation or threats of litigation; (2) plaintiffs' assertion of the 'implicit threat' in defendants' statement that it is not their policy to enforce their patent rights against farmers whose crops inadvertently acquire trace amounts of patented seeds or traits; and (3) defendants' refusal to provide plaintiffs with a blanket covenant not to sue."

These reasons were not sufficient in the Court's opinion.  The first reason, that Monsanto has a pattern of enforcing its patent rights through litigation or threat of litigation, was rejected by the Court because it did not include evidence that Monsanto had exercised its patent rights against the plaintiffs.  While conceding that suits against third parties could support declaratory judgment jurisdiction, the Court noted that these circumstances required that suits against such third parties must be "sufficiently similar" to one that a patentee "may bring" against the plaintiffs (put another way, against "similarly situated parties").  The reason, according to the opinion, is that "a fear of future harm that is only subjective is not an injury or threat of injury caused by the defendant that can be the basis of an Article III case or controversy," citing Prasco, 537 F.3d at 1338.  This is evaluated objectively, wherein "it is the reality of the threat of injury that is relevant to the standing inquiry, not the plaintiff's subjective apprehensions."  Id. at 1338-39 and Hewlett-Packard Co. v. Acceleron LLC, 587 F.3d 1358, 1363 (Fed. Cir. 2009).  Specifically, the Court determined that the 144 patent infringement suits filed by Monsanto between 1997 and 2010 were not excessive, comparing the frequency of thirteen lawsuits a year with the "approximately two million" farms in America.  In addition, these suits were not against "similarly situated plaintiffs" in the Court's view, since the declaratory judgment plaintiffs here averred that they had no interest in having their seed "contaminated by transgenic seed"; the defendants in Monsanto's other actions were farmers who infringed Monsanto's patents by replanting seeds or breaching their contractual obligations.  There was "no evidence that defendants have commenced litigation against anyone standing in similar stead to plaintiffs and thus the evidence did not support the 'affirmative acts' prong of the Federal Circuit's test for declaratory judgment jurisdiction" according to the opinion.  And any allegations by plaintiffs that Monsanto had threatened "similarly situated" farmers who wished to avoid inadvertent use of Monsanto's patented seed were, according to the Court, "equally lame" because "not one single plaintiff claims to have been so threatened."

The Court also rejected plaintiffs' argument that Monsanto's actions contained an "implicit" threat of litigation.  This allegation stemmed from Monsanto's statements.  In response to a post-filing letter from PubPat demanding a covenant not to sue in order to dismiss the lawsuit, and similar statements on Monsanto's website.  The "purportedly threatening languages reads (in its entirety)":

It has never been, nor will it be[,] Monsanto policy to exercise its patent rights where trace amounts of our patented seeds or traits are present in [a] farmer's fields as a result of inadvertent means.

The Court found plaintiffs' characterization of this language as threatening to be "objectively unreasonable."  This determination is based on plaintiffs' avowed intention to not "use or sell transgenic seeds," and that plaintiffs' intention was "specifically communicated" to Monsanto.  If these intentions were true, "the presence of patented traits in plaintiffs' seeds could only be inadvertent," according to the Court, and the possibility that plaintiffs could somehow "find themselves unknowingly utilizing it in significant quantities strains credulity."  The Court finds the "plain meaning" of Monsanto's statement to be clear, and that the Court would not adopt plaintiffs' "deliberate misreading" thereof.  Further:

Indeed, plaintiffs' letter to defendants seems to have been nothing more than an attempt to create a controversy where none exists.  This effort to convert a statement that defendants have no intention of bringing suit into grounds for maintaining a case, if accepted, would disincentivize patentees from ever attempting to provide comfort to those whom they do not intend to sue, behavior which should be countenanced and encouraged.  In contrast, plaintiffs' argument is baseless and their tactics not to be tolerated.

Remarkably, the Court noted that these statements were made after filing the initial complaint, in view of the fact that it is impermissible for the Court to consider such conduct in evaluating whether declaratory judgment jurisdiction exists.  The policy reason for this rule is that it would "invite a declaratory judgment plaintiff in a patent case to file suit at the earliest moment it conceives of any potential benefit to doing so" in an attempt to "draw an infringement suit in response (thereby retroactively establishing jurisdiction over their first-filed declaratory judgment suit)," said the Court, citing Innovative Therapies, Inc. v. Kinetic Concepts, Inc., 599 F.3d 1377, 1384 (Fed. Cir. 2010).  This is exactly what plaintiffs are attempting here, according to the opinion, which is "a further reason to discount their argument."

Finally, the Court deigned not to credit any effect of Monsanto's refusal to execute a covenant not to sue in plaintiffs' favor.  Calling it a request for a "blanket waiver," the Court found it "unsurprising" that Monsanto declined plaintiffs' invitation to enter into such an agreement.  Plaintiffs' argument was "groundless and their tactics unacceptable," the Court held.  Monsanto's refusal to enter into the covenant was but one factor to be considered under Federal Circuit precedent and here "does not meaningfully add to plaintiffs' case."  According to the opinion, "plaintiffs' letter was clearly intended to be used as a prop in this litigation, and the failure to sign a covenant not to sue borders on the wholly irrelevant."

The Court also found no evidence of the required "preparatory conduct" needed under the second prong of the Federal Circuit test.  In this case, plaintiffs contended that there was no requirement for them to take affirmative action to infringe, since "defendants' patented seeds will spread with no action on plaintiffs' part and are self-replicating."  Regardless of the accuracy of these allegations, the Court said that the "potential infringement " must be "a matter of immediate concern," and that plaintiffs' allegations fail in this regard.  The opinion notes that not only have plaintiffs not alleged that any of them have "actually grown or sold contaminated seed," they have maintained their intention to "specifically avoid any such use."  They do, however, allege that they "could . . . be accused of patent infringement" due to contamination of their seed with Monsanto's seed.  The Court characterized this allegation as the sort of "intangible worry, unanchored in time" that the Federal Circuit has found "insufficient to support an 'actual or imminent' injury for standing without any specification of when the some day will be," citing AMP, 653 F.3d at 1346.  Addressing plaintiffs' allegation that they are suffering injury because some of them have stopped planting certain crops due to fear of a lawsuit, the Court called this an injury of their own making that did not support declaratory judgment jurisdiction.

Finally, considering all the circumstances, the Court granted Monsanto's motion to dismiss, calling plaintiffs' allegations "diaphanous" and the complaint "a transparent effort to create a controversy where none exists."

Hatch-Waxman Watch: AstraZeneca Pharmaceutical LP v. Intellipharmaceutics Corp. (D.N.J. 2012)

By Andrew Williams --

Last week, in AstraZeneca Pharmaceutical LP v. Intellipharmaceutics Corp., Civil Action No. 11-2973 (JAP), Judge Pisano of the U.S. District Court for the District of New Jersey dismissed a Hatch-Waxman Act patent infringement action based on a lack of personal jurisdiction because the ANDA filer did not have the requisite minimum contacts with the state to establish either general or specific jurisdiction.  In this particular case, AstraZeneca Pharmaceutical LP and AstraZeneca UK Limited (together, "Astra") had filed suit against Intellipharmaceutics Corp. ("IPC") and Intellipharmaceutics International Inc. ("IPCI") in New Jersey because IPC had filed an ANDA to seek approval to market a generic version of Astra's Seroquel XR product.  Both IPC and IPCI are Canadian companies.  IPC and IPCI subsequently filed their motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(2) (lack of personal jurisdiction), or in the alternative, pursuant to 28 U.S.C. § 1406(a) to transfer to the Southern District of New York.  Astra followed-up by also filing suit in New York to preserve its right to the statutory 30-month stay, but that action was stayed pending the outcome in the New Jersey Court.

For those readers who have not had the pleasure of a first-year Civil Procedure course, due process requires that a defendant have minimum contacts with a state before that state can exercise jurisdiction over them.  This is because "traditional notions of fair play and substantial justice" prevent a plaintiff from hauling a defendant to court in a state in which that defendant does not have at least minimum contacts.  There are two types of jurisdiction -- (1) general jurisdiction, in which the defendant has "continuous and systematic" contacts with a state such that a court can exercise jurisdiction for any action, and (2) specific jurisdiction, for cases in which general jurisdiction cannot be established, but there are sufficient limited contacts with the state that relate to the claims of the suit.

In the present case, the Judge first looked to whether IPC and IPCI were subject to general jurisdiction in New Jersey.  Astra had claimed that IPC and IPCI had continuous and systematic contacts with New Jersey because they (1) had "repeatedly partnered" with New Jersey companies to develop pharmaceuticals, (2) had engaged a consultant in the state, (3) had used a New Jersey Transfer Agent, (4) had sourced materials and equipment from the state, (5) had paid more taxes in New Jersey than most, if not all, other states, (6) had entered into confidentiality agreements with entities in the state, and (7) had asserted counterclaims in the New Jersey Court in an unrelated matter.  After jurisdictional discovery, the Court concluded that these contacts were not sufficient to establish general jurisdictional.  IPC had in fact entered into drug development agreements in the past with New Jersey companies, but these were found to be inadequate to support jurisdiction.  One of these agreements was with Elite Laboratories and Elite Pharmaceuticals to develop a generic Prevacid product.  However, this agreement was in 2005, and no drug development actually commenced.  IPC also entered into three agreements with Par Pharmaceuticals, Inc. ("Par") to develop generic Focalin XR, generic Coreg CR, and a third undisclosed generic product.  The work for these agreements, however, was performed primarily in Canada.  The Judge did note that all of these agreements were unrelated to the present ANDA product, but such a fact should be irrelevant to general jurisdiction analysis.

As for the other factors, the Judge noted that IPC had made "relatively random purchases" from companies located in New Jersey, and that these were insufficient, alone and with other contacts, to confer general jurisdiction (quoting the Supreme Court's 1984 Helicopteros opinion ("mere purchases, even if occurring at regular intervals, are not enough to warrant a State's assertion of in personam jurisdiction over a nonresident corporation in a cause of action not related to those purchase transcations").  As for the tax payments, IPCI did pay $26.95 to New Jersey in 2010 and $10.13 in 2009.  However, even though these amounts "dwarfed" the single penny IPCI paid in taxes in Wyoming in 2009, the Court found that Astra's tax argument was "a bit overstated."  Finally, the confidentiality agreements were with regard to "potential" or "possible" business relationships, with no evidence that they were ever consummated, and the litigation in question in which counterclaims had been filed was controlled by Par, not IPC.  When viewed in their totality, the Court found that these contacts were insufficient to establish the continuous and systematic contacts with New Jersey necessary to establish general jurisdiction.

To establish specific jurisdiction, it is necessary to focus on the relationship between the claims and contacts.  Of course, in a Hatch-Waxman action, the technical act of infringement is the filing of an ANDA.  Astra pointed to three activities related to IPC's ANDA filing that were allegedly "purposefully directed" at New Jersey.  First, Astra alleged that IPC sourced its magnesium stearate for the ANDA product from a New Jersey company.  The evidence was to the contrary, however, showing that the dealings were with a Missouri office, and that the magnesium stearate was produced in St. Louis.  Second, Astra pointed out that the packaging for the ANDA product was obtained from a New Jersey company.  Even if this were true, however, the claim of the litigation arose from the quetiapine tablets themselves, not the packaging.  Finally, Astra claimed that IPC relied on a Drug Master File held by Hetero Labs Ltd., which itself used a New Jersey Company, Pharm Q, Inc., as its U.S. Regulatory agent.  However, the DMF relied upon by IPC in its ANDA filing was from a company located in Massachusetts, not Herero Labs.  The Court, therefore, found that this case had nothing to do with the state of New Jersey, and that therefore Astra could not establish specific jurisdiction.

This brings up the question as to where an NDA holder can bring a Hatch-Waxman action when the ANDA filer conducts most, if not all, of its activities outside the U.S. (other than the filing of the ANDA, of course).  The present opinion had no need to opine on this issue.  In fact, in this case, IPC and IPCI had already consented to personal jurisdiction in New York, and had sought in the alternative a transfer of the New Jersey action to New York.  The reason that IPC and IPCI believed that they were continuously and systematically doing business in New York was because IPCI was listed on the NASDAQ exchange, executives from both companies regularly travelled to New York for business, both companies used numerous New York companies to handle their affairs, and the companies worked with Par in New York.  The problem is that it is the ANDA filing that is the act of infringement, and such a filing seeks approval to market an ANDA product throughout the United States, including New Jersey.  By dismissing the case, the New Jersey Court was essentially allowing IPC and IPCI to select its own forum, thereby depriving Astra, the NDA holder, of one of the benefits of bringing suit.  Nevertheless, IPC and IPCI's contacts with New Jersey were tenuous at best, and Astra could have selected a more appropriate forum in the first place.

AstraZeneca Pharmaceutical LP v. Intellipharmaceutics Corp. (D.N.J. 2012)

Top Stories of 2010: #4 to #1

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its fourth annual list of top biotech/pharma patent stories.  For 2010, we identified a dozen stories that we covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  On Sunday, we counted down stories #12 to #9, and on Monday we covered stories #8 to #5.  Today, we will present our top four stories of 2010.  As with our other lists (2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

#4 -- Gene Patenting Debate Rages On

Gene patenting has been a hotly debated topic for as long as Patent Docs has been covering developments in biotech patent law.  In fact, only two days after Patent Docs began posting new content, Chicago-Kent College of Professor of Law Lori Andrews and the late Michael Critchton published an article in the November 11, 2006 issue of Parade magazine, in which the two advocated for a Genetic Bill of Rights that would have included a prohibition on gene patents (see "Gene Patenting in the News Again").  In response, Patent Docs countered with an article refuting the factual misstatements in the Andrews-Critchton article (see "In Support of Gene Patents").  The debate between gene patenting proponents and opponents has been so heated that the issue has made three of our four top stories lists (coming in at #4 last year and at #12 in 2007).  And this year -- perhaps making up for omitting the story from our 2008 list -- we have given the story two of the top four spots (one for the debate and one for the AMP v. USPTO case).

In 2010, Patent Docs reported on anti-gene patenting articles that appeared in a number of major publications, including the Los Angeles Times, The Boston Globe, Newsweek, Nature Biotechnology, and The Huffington Post.  The gene patenting animus extended to television, where "60 Minutes" took a less than fair and balanced look at the issue only days after the District Court ruled against Myriad in the AMP v. USPTO case.  During the "60 Minutes" segment, which clocked in at just over thirteen and a half minutes, correspondent Morley Safer devoted about three and a half minutes to an interview with Lisbeth Ceriani and Genae Girard (who were recently diagnosed with breast cancer and who are plaintiffs in the AMP v. USPTO case), and about a minute and a half each to Prof. Andrews, Dr. Aubrey Milunsky (Co-Director for the Center for Human Genetics and Professor of Human Genetics, Pediatrics, Pathology, and Obstetrics & Gynecology at the Boston University School of Medicine), Patent Docs author Dr. Kevin Noonan, and Chris Hansen (Senior National Staff Counsel for the American Civil Liberties Union (ACLU) and co-counsel for plaintiffs in AMP v. USPTO).  Only Dr. Noonan represented gene patenting proponents.  A decidedly more balanced examination of the issue was presented on PBS' "Newshour" program, and a piece that may (or may not) have been supportive of Dr. Noonan's position appeared on Comedy Central's "Colbert Report."

Gene patenting opposition was not, however, confined to the Fourth Estate.  A report issued by the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), which was charged with advising the Secretary of Health and Human Services on human health and societal issues raised by the development and use of genetic technologies, determined that gene patents and licensing practices concerning such patents did not have an adverse impact on patient access to genetic tests, but nevertheless included a number of controversial recommendations, including exempting gene patents from infringement liability.  In April, reports indicated that Congressman Xavier Becerra (D-CA) was ready to reintroduce his anti-gene patenting bill (Rep. Becerra introduced a similar bill in 2007).  Rep. Becerra's plans to reintroduce the bill never materialized, perhaps as a result of the District Court's decision in AMP v. USPTO.  Finally, in Intervet v. Merial, which the Federal Circuit decided in August, Judge Dyk took the occasion to sua sponte question the patent-eligibility for isolated DNA molecules.

For information regarding this and other related topics, please see:

• "'At-Home' Testing for BRCA Gene Mutations," October 13, 2010
• "The Financial Times' Take on Gene Patenting," August 30, 2010
• "Uh-oh: It Looks Like Judge Dyk Has Been Drinking the ACLU's Kool-Aid®," August 11, 2010
• "Intervet Inc. v. Merial Ltd. (Fed. Cir. 2010)," August 10, 2010
• "Facts, Perhaps the Antidote to the Anti-gene Patenting Plague," July 18, 2010
• "Huffington Post Provides Latest Anti-gene Patenting Soapbox," July 14, 2010
• "European Gene Patent Scope Limited by Landmark EU Court Ruling," July 8, 2010
• "Australian Senate to Release Gene Patenting Findings Next Week," June 8, 2010
• "Nature Biotechnology and More Anti-gene Patenting Myths," May 31, 2010
• "MPEG LA Announces Formation of Gene Patent Pool," April 21, 2010
• "The Fantastical Economics of the Gene Patenting Debate," April 18, 2010
• "'Colbert Report' Enters Gene Patenting Fray," April 18, 2010
• "He's Baaack!: Congressman Becerra Once Again Tries to Ban Gene Patenting by Statute," April 8, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th -- Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "BIO Sends Letter on SACGHS Report to HHS Secretary Sebelius," February 11, 2010
• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "BIO Comes out Swinging against SACGHS Report," February 4, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "Like Peas in a Pod," January 12, 2010

#3 -- Fate of Diagnostic Method Claims to Be Determined

In June, the Supreme Court issued its long-awaited decision in Bilski v. Kappos, agreeing with the Federal Circuit that Bilski's claims to methods for "hedging" risk in commodities trading are not patent-eligible subject matter.  One day after issuing its decision in Bilski v. Kappos, the Supreme Court granted certiorari, vacated the Federal Circuit's decision below, and remanded to the appellate court two cases concerning medical diagnostic claims:  Prometheus Laboratories, Inc.  v. Mayo Collaborative Services and Classen Immunotherapies, Inc. v. Biogen Idec.  A little more than two weeks ago, the Federal Circuit dispensed with one of these two cases, determining in Prometheus Laboratories, Inc. that the claims at issue were directed to patent-eligible subject matter.  Practitioners and applicants now await the Federal Circuit's decisions in Classen Immunotherapies, Inc. and AMP v. USPTO, which should further explicate the metes and bounds of patent-eligible subject matter with respect to diagnostic method claims.

For information regarding this and other related topics, please see:

• "Patent Eligibility and In re Grams," December 28, 2010
• "Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)," December 20, 2010
• "An Application of the Abstract Idea Exclusion to Patent Eligibility," December 8, 2010
• "Patenting Information," December 1, 2010
• "IPO Submits Commentary on USPTO Bilski Interim Guidance," October 6, 2010
• "Prometheus Labs. v. Mayo Collaborative Services -- Briefing Schedule," September 14, 2010
• "USPTO Issues Memo to Examiners on Bilski Decision," July 15, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Bilski v. Kappos: What Effects on Biotechnology Patents?" July 1, 2010
• "Reaction to Bilski v. Kappos," June 29, 2010
• "Bilski v. Kappos (2010)," June 28, 2010
• "Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. (Fed. Cir. 2010)," March 17, 2010

#2 -- Biosimilar Regulatory Pathway Enacted

The year began with the Obama administration reportedly pushing for a lower data exclusivity period than the 12-year period contained in both the House and Senate versions of the health care reform bill (readers may recall that the Senate bill was passed on Christmas Eve in 2009).  The four-year fight over an appropriate data exclusivity period continued through President Obama's "open, bipartisan" health care reform summit at the White House in February to the House's surprising vote agreeing to the Senate version of the Patient Protection and Affordable Care Act (PPACA) in March.  The bill returned to the Senate before finally landing on the President's desk, where the legislation was signed into law on March 23.  In November, the Food and Drug Administration held two days of public hearings on the approval pathway for biosimilar biological products that was created when President Obama signed the PPACA into law.  With a biosimilar regulatory pathway in place, the question now is who will be the first to take advantage of the pathway.

For information regarding this and other related topics, please see:

• "EMA Publishes Guidelines for Biosimilar Antibodies – Part II," December 2, 2010
• "EMA Publishes Guidelines for Biosimilar Antibodies - Part I," November 30, 2010
• "Wrapping up the Issues from the FDA Hearings on Biosimilars," November 21, 2010
• "Clinical Trial Requirements Are Top Issue at FDA Hearings on Biosimilars," November 10, 2010
• "Pfizer and Biocon Sign Global Commercialization Agreement on Biosimilars," October 27, 2010
• "Guidelines for Biosimilar Antibodies in Europe Due in November," October 3, 2010
• "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway," September 29, 2010
• "Follow-on Biologics News Briefs - No. 13," September 21, 2010
• "House Passes Health Care Reform Bill -- Biosimilar Regulatory Pathway Makes Cut, Pay-for-Delay Ban Does Not," March 22, 2010
• "New York Times Provides Soapbox for Data Exclusivity Critics," March 8, 2010
• "President's Health Care Plan Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway," February 24, 2010
• "PhRMA Representative Questions Follow-on Biologics Paper," February 18, 2010
• "Follow-on Biologics News Briefs - No. 12," January 31, 2010
• "Law Professors Contend that Data Exclusivity Is Secondary Issue in Follow-on Biologics Debate," January 25, 2010
• "Governors Write President in Support of 12-Year Data Exclusivity Period," January 20, 2010
• "Data Exclusivity Follow-up: More of the Same," January 18, 2010
• "Snatching Defeat from the Jaws of Victory?" January 17, 2010

#1 -- District Court Rules in Favor of Plaintiffs in AMP v. USPTO

No story received more attention on Patent Docs in 2010 than the Association of Molecular Pathology v. U.S. Patent and Trademark Office case.  In March, Judge Robert W. Sweet of the Southern District of New York surprised some biotech practitioners and applicants by ruling in favor of the plaintiffs, granting partial summary judgment that the claims of several patents on BRCA1 were invalid as encompassing non-statutory subject matter.  Myriad Genetics and the Directors of the University of Utah Research Foundation appealed the decision to the Federal Circuit in June.  Patent Docs has provided extensive coverage of the briefing in the appeal (and will continue to do so in the coming months).  A total of 29 amicus briefs were filed, fifteen in support of Defendants-Appellants and/or reversal, twelve in support of Plaintiffs-Appellees and/or affirmance, and two which remain to be determined (Patent Docs has not yet obtained copies of the last two briefs).  Regardless of the Federal Circuit's decision in the case, it is almost certain to make our top stories list in 2011.

For information regarding this and other related topics, please see:

• "AMP v. USPTO -- Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO -- Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO -- Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO -- Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying - Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th -- Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010

USPTO Acts Quickly to Comply with Court Order

By Kevin E. Noonan --

The U.S. Patent and Trademark Office has acted promptly to comply with Judge Claude Hilton's Order earlier this week that the Office accept The Medicines Company (MDCO) Patent Term Extension Request for U.S. Patent No. 5,196,404, by granting the patent an interim patent term extension.  In responding to the Order, Director David Kappos noted that the Office had granted two previous interim extensions to accommodate the litigation schedule, the latest lasting until ten days after the District Court rendered a decision.  Accordingly, the latest extension extends from August 13, 2010 until August 13, 2011.  It can be expected that the Office will use that time to examine MDCO's Request and make its determination, in cooperation with the FDA, regarding the length of extension to which the '404 patent is entitled.

Of course, this action has no bearing on whether the Office ultimately decides to appeal Judge Hilton's decision in this case.

For additional information regarding this topic, please see:

• "The Medicines Company Prevails in Patent Term Extension Dispute," August 4, 2010
• "House Passes Patent Term Extension Bill," June 27, 2008

The Medicines Company Prevails in Patent Term Extension Dispute

By Kevin E. Noonan --

Yesterday, Judge Claude M. Hilton, District Court Judge for the Eastern District of Virginia, handed The Medicines Company (MDCO) a victory in its long-standing dispute with the U.S. Patent and Trademark Office over the timeliness vel non of its Patent Term Extension Request for its patent on the blockbuster drug Angiomax® (bivalirudin).  In his opinion granting summary judgment to MDCO, it was clear that the judge was not happy with the Office's response to his earlier Order mandating reconsideration of its decision that the Request was not timely filed; judicial displeasure, if not pique, seems reasonable in view of the seemingly summary way the Office "complied" with the earlier Order.

The tale has been often told on the circumstances surrounding MDCO's PTE Request.  Pursuant to 35 U.S.C. § 156, MDCO had 60 days from the date that Angiomax® received regulatory (FDA) marketing approval to file its PTE Request (35 U.S.C. § 156(d)(1)).  The approval letter was sent by FDA to MDCO by facsimile transmission at 6:17 pm on Friday, December 15, 2000.  The FDA subsequently published the approval date for Angiomax® on its website as being December 19, 2000.  MDCO filed its PTE Request on February 14, 2001, a date that is 61 days after December 15, 2000, 58 days after December 18, 2000 (the Monday following the date of the Friday night fax) and 57 days after the approval date FDA posted on its website for Angiomax®.  These calculations were complicated by a later-issued directive by the PTO that, for purposes of calculating the time period for filing a PTE Request, the Office would consider the day FDA mailed its approval letter in the calculation (i.e., the times above are each increased by one day) (In re Patent Term Extension Application for U.S. Patent No. 5,817,338, 2008 WL 5477276 (Comm'r. Pat. Dec. December 16, 2008)).  In any case, the PTO, relying on a certification from FDA that the approval date was Friday, December 15, 2000, refused MDCO's Request, costing the company to lose 4.5 years (about 1773 days) of extension for its U.S. Patent No. 5,196,404 (which nominally expired on March 23, 2010).

MDCO filed a request for reconsideration of this decision, on the grounds that the FDA faxed its letter "after hours" on a Friday, "and that under FDA's practices, facsimiles submitted to FDA after close of business are considered received by the Agency on the next business day" (emphasis added).  Applying this standard, the approval notification date would have been Monday, December 18th, and MDCO's Request would have been timely filed even under an interpretation including the approval date in the 60-day period.  The PTO transmitted the request for reconsideration to FDA (since the dispute involved FDA procedures), which the FDA rejected without comment or support, maintaining that the approval date was Friday, December 15th.

The PTO did not issue a formal denial of MDCO's request, but instead permitted the company to file an amended request for reconsideration and an amended extension application, which were filed on March 13, 2007.  Less than six weeks later, on April 26, 2007, the PTO denied the request, again with no explanation of the inconsistency in the FDA's position on submissions to and notices from the agency.  It was at this time that the Office applied the revised calculation for determining when a PTE Request must be filed, determining in this case that MDCO had filed its Request 2 days late.

MDCO filed a petition for leave to file a second request for reconsideration on the grounds that it had not had an opportunity to address this new interpretation of the deadline date for filing its PTE Request.  In its papers MDCO argued that there was no requirement in the statute that would preclude the Office from adopting its proposed "next business day" rule, and that such an interpretation would "comport with the statute's text and purpose."  While the Office granted leave for filing the second request for reconsideration (based on the "extraordinary situation" occasioned by its change in how days were counted for calculating the filing deadline), it denied the request substantively.  The PTO's position was that the Office did not have the authority under § 156 to adopt the proposed "next business day" rule, at least because there was no basis to distinguish "during business hours" from "after business hours" in the statute, which recites the date (per the PTO, "span[ning] the course of 24 hours").

MDCO brought suit in Judge Hilton's Court, and on March 16, 2010 the judge ordered on remand that the Office reconsider its position on the grounds that "§156(d)(1) was a remedial statute and that it should be liberally construed," and that "the PTO was not bound by statute or case law to reject the business day interpretation of the work date in §156(d)(1)."  Three days later, the Office "without any additional hearings" issued another decision again rejecting the "next business day" interpretation of the statute advanced by MDCO.  The Office went further, holding that the timing provisions of the statute were not remedial in nature, and that the Office was bound by Federal Circuit authority to interpret the word "date" in the statute as the calendar day on the FDA approval letter.  In response, MDCO returned to the District Court under the Administrative Procedures Act, 5 U.S.C. §§ 551-706, arguing that the agency's action was arbitrary and capricious.

The Court began its analysis on the question of what level of deference was owed to the PTO decision, under either Skidmore v. Swift, 323 U.S. 134 (1944), or Chevron U.S.A. Inc. v. National Resource Defense Council, Inc., 467 U.S. 837 (1984), so-called "Chevron deference" being a higher level.  The Court noted that an agency is entitled to Chevron deference generally for its interpretations of law "set forth after notice-and-comment rulemaking or formal adjudication under 5 U.S.C. §§556-557."  Immediately, the Court disqualified the latter grounds for applying Chevron deference to its decision in this case, stating that "[t]he government does not deny that PTE decisions are informal adjudications."  To qualify for Chevron deference regarding the PTE determination, the Court required a "relatively formal administrative procedure," evidence that Congress intended that such decisions be given deferential judicial review, and that the Office itself gives such decisions precedential effect, citing Pesquera Mares Australes Ltda. v. U.S., 266 F.2d 1372 (Fed. Cir. 2001).

The Court found that the circumstances under which the PTO makes PTE determinations (ex parte review, the level of discretion given to the Director to require additional information from applicants, and the absence of formal hearings or administrative review other than requests for reconsideration) are inconsistent with the kinds of "relatively formal process[es] envisioned in Pesquera."  Moreover, the Court cited Federal Circuit precedent that PTO proceedings are not governed by 5 U.S.C. §§ 556-557, citing Brand v. Miller, 487 F.3d 862 (Fed. Cir. 2007).  The Court rejected the PTO's arguments to the contrary; indeed, the Court distinguished the government's citation of Glaxo Operations UK Ld. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990), for the proposition that PTE determinations should be given deference by noting that the Court deferred to the agency's "scientific and technical expertise," but that the Court had "expressly rejected the PTO's claim for deference to its statutory interpretations of PTE proceedings" (expressly, that "we will give . . . little or no deference to the [PTO's] surmise of Congress' intent in framing its definition").  Nor does the Court find that the Office is entitled to Chevron deference under 35 U.S.C. § 2(b)(2), which is limited to procedural rulemaking not statutory interpretation.  The Court also rejected the government's argument that the Office's decision should be given Chevron deference due to consistent application of the calendar day interpretation of the statutory language, in the face of admissions by the Office that it had "never previously considered the choice between calendar day and business day interpretations of §156(d)(1)" (saying that "it cannot claim to give precedential effect to decisions that do not exist"), particularly since the Office is entitled to change its position at any time with no more than a "reasonable explanation" of why it has done so.

The Court then arrived at the heart of the matter:

It is well established that "[d]eviation from [a] court's remand order in . . . subsequent administrative proceedings is itself legal error, subject to reversal on further judicial review."  Sullivan v. Hudson, 490 U.S. 877, 886 (1989).  If an agency is dissatisfied with any part of a district court's order, the remedy is to appeal the case and not, under guise of a hearing, to relitigate a question already finally decided by the district court.  Hooper v. Heckler, 752 F.2d 83, 88 (4th Cir. 1985).  When a case returns to a court for a second time after the court has remanded it with explicit instructions to the agency, the court examines with care the order of the agency to ensure that its earlier decision has been followed.  Guillen-Garcia v. INS, 60 F.3d 340, 344 (7th Cir. 1995).

It is abundantly clear that the Court believed the Office did not comply with this legal standard.  The opinion reviewed its instructions to the Office from its earlier Order, that the statute, being remedial in nature should be given "liberal construction," something that the Office had done in the Synchromed case (In re Patent No. 4,146,029 (Comm'r. Pat. July 12, 1988)).  The Office declined to do so in this case, based on its interpretation that while § 156 may be remedial generally, "the specific timing provision at issue, §156(d)(1), is not."  This decision was in error, according to the Court's opinion, inter alia because "[a]ll of the provisions of a remedial statute . . . should be construed liberally."  "[E]verything is to be done in advancement of the remedy that can be done consistently with any fair construction that can be put upon [the statute]," according to the opinion, citing as an example White v. Cotzhausen, 129 U.S. 329 (1889).  The Court rejected the government's contention that because "Congress did not provide a mechanism for USPTO to prevent the loss of an applicant's patent when the applicant missed a deadline" it was compelled to reject the Court's earlier directive that § 156(d)(1) should be construed liberally.  And the Court further found that "[t]he PTO's failure to acknowledge its prior relevant practices is an independent violation of the Administrative Procedures Act," citing the Synchromed case.  Finally, the Court rejected the government's position that § 156(d)(1) and another part of the statute, § 156(g)(1))B)(ii), must be construed identically, since "[t]he relevant statutory language is different and the provisions serve distinct purposes" (§ 156(d)(1) defines the time for filing the PTE Request, while § 156(g)(1))B)(ii) defines the dates for calculating the time FDA took to review and approve the drug).  The Court discerned a clear distinction between the meaning and purpose of the two portions of the statute, and noted that "the logic that led the FDA to adopt for itself a business day construction [with regard to §156(g)(1))B)(ii)] . . . applies with equal force to the construction of §156(d)(1)."

The Court further took the Office to task for ignoring its earlier instructions:

Even if the PTO were writing on a blank slate without the benefits of the Court's prior opinion, its decision still could not stand.  In numerous respects, the decision violates the APA and advances an interpretation of §156(d)(1) that is unreasonable even under the most deferential standard of review, let alone the more exacting review that applied to the appeal of a remanded order [citing Chamber of Commerce v. SEC, 443 F.3d 890 (D.C. Cir. 2006)].

The Court then addressed the practical consequences of the PTO's asserted interpretation of the rule, to illustrate its unreasonableness.  The Court says that under the Office's interpretation, "the date stamped on the FDA approval letter starts the 60-day period for filing [a PTE Request], even if the FDA never sends the letter, sends it to the wrong address, delays in sending it or sends it by means that would take multiple days to reach the applicant."  (The Court also noted that the Federal Rules of Civil Procedure automatically add three days for a party to act within a specified time after service if service is accomplished by any means other than hand delivery.)  Since the PTO's decision failed to address this issue, "[t]hat failure, by itself, renders the PTO's decision arbitrary and capricious."  The issue is not whether such failures are likely or if there are provisions in place to prevent them, but that "over time mistakes are inevitable . . . .  An interpretation that imposes such drastic consequences when the government errs could not be what Congress intended."

The Court left little to chance in assuring that the Office will understand its Order this time:

The Court finds the proper interpretation of §156(d)(1) is a business day construction of the phrase "beginning on the date."  Of the parties' competing interpretations the business day construction is consistent with the statute's text, structure and purpose.

"[T]he courts are the final authorities on issues of statutory construction" and "must reject administrative constructions of [a] statute . . . that are inconsistent with the statutory mandate or frustrate the policy that Congress sought to implement" [citing Ethicon, Inc. v. Quigg, 849 F.2d 1442 (Fed. Cir. 1988)].

The judge's order was simple:  that the PTO accept MDCO's PTE Request as having been timely filed, and that the Office interpret the meaning of the timing provisions of § 156(d)(1) to include the next business day for notifications received after the close of business.

It remains to be seen whether the Office will challenge this ruling, and if it does not whether it will expedite review of MDCO's PTE Request (and restore the additional term to this expired patent).

Novartis Challenges USPTO's Interim Procedure for Requesting PTA Recalculations

    By Donald Zuhn --

Last week, Novartis AG and Novartis Vaccines and Diagnostics, Inc. filed a complaint against U.S. Patent and Trademark Office Director David Kappos, seeking review of the Office's patent term adjustment (PTA) determinations for eleven Novartis patents (see "Court Report," July 11, 2010).  The eleven patents specified in the complaint are U.S. Patent Nos. 6,656,957, issued December 2, 2003; 6,878,721, issued April 12, 2005; 7,098,325, issued August 29, 2006; 7,112,673, issued September 26, 2006; 7,265,089, issued September 4, 2007; 7,348,353, issued March 25, 2008; 7,423,148, issued September 9, 2008; 7,470,709, issued December 30, 2008; 7,470,792, issued December 30, 2008; 7,534,890, issued May 19, 2009; and 7,576,221, issued August 18, 2009.

In its complaint, Novartis asserts that "[the Director] consistently calculated PTA for utility patent applications filed at least as early as May 29, 2000 that resulted in issued patents at least as late as March 1, 2010 in a manner that incorrectly determined the overlap of A Delay [i.e., one-day extension of patent term for every day that issuance of a patent is delayed by a failure of the USPTO to comply with various enumerated statutory deadlines; see § 154(b)(1)(A)] and B Delay [i.e., one-day extension of patent term for every day greater than three years after the filing date that it takes a patent to issue; see § 154(b)(1)(B)]."  Novartis also asserts that "[the Director] had improperly contended that the period of B Delay began to accrue from the filing date of the patent application, rather than from three years after the filing date of the patent application," and therefore, "had considered the overlap of A Delay and B Delay to include any period of A Delay within the first three years after filing a patent application."  As a result, "[the Director's] policy and practice in calculating PTO delay was to grant PTA amounting to the greater of A Delay or B Delay," which Novartis contends deprived it of patent term to which it was entitled under § 154(b).

Following the Federal Circuit's decision in Wyeth v. Kappos, in which the appellate court determined that "[s]ection 154(b)'s language is clear, unambiguous, and intolerant of the PTO's suggested interpretation," and thus, "accord[ed] no deference to the PTO’s greater-of-A-or-B rubric," the USPTO announced that it would not seek further review of the Wyeth decision (see "USPTO and DOJ Will Not Seek Review of Wyeth v. Kappos").  One week later, the USPTO announced interim procedures for patentees to request PTA recalculation in light of Wyeth (see "USPTO Announces Interim Procedure for Requesting PTA Recalculations").  Novartis notes that "[t]hese interim procedures included an expedited, informal procedure for seeking recalculation of PTA solely on the basis of Wyeth, but extended that remedy only to patents issued on or after September 2, 2009."  (In contrast with Novartis' recitation of a September 2, 2009 cutoff, the Office stated in a Federal Register notice published on February 1, 2010 that it would "deny as untimely any request for recalculation of patent term adjustment indicated on a patent that is not filed within 180 days of the day the patent was granted."  Thus, according to our calculations, the interim procedure for requesting PTA recalculation applied to patents that issued after August 5, 2009 -- i.e., on or after Tuesday, August 11, 2009 -- rather than September 2, 2009 as indicated in Novartis' complaint.).

Regardless of the correct cutoff date, Novartis' action is unique in that it is the first to question the Office's interim procedures for requesting PTA recalculation in light of Wyeth.  In its complaint, Novartis contends that "[the Director's] refusal to accord the benefits of Wyeth to [applications filed by May 29, 2000 and issued on or before September 1, 2009] is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and in excess of statutory jurisdiction, authority or limitation."  Arguing that each of the eleven patents at issue was filed on or after May 29, 2000 and issued on or before September 1, 2009, Novartis asserts that it was deprived of patent term on each patent under Wyeth and that it was precluded from recapturing this patent term under the Office's interim procedure.

With respect to the timeliness of its complaint, Novartis argues that the complaint complies with the filing requirements of 35 U.S.C. § 154(b)(4)(A), or alternatively, is timely under the doctrine of equitable tolling or the discovery rule.  Section 154(b)(4)(A) specifies that that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent."  Thus, for the patents specified in Novartis' complaint, compliance with § 154(b)(4)(A) would have (seemingly) required Novartis to bring suit against the Director by the following dates:

US 6,656,957 -- May 30, 2004
US 6,878,721 -- October 9, 2005
US 7,098,325 -- February 25, 2007
US 7,112,673 -- March 25, 2007
US 7,265,089 -- March 2, 2008
US 7,348,353 -- September 21, 2008
US 7,423,148 -- March 8, 2009
US 7,470,709 -- June 28, 2009
US 7,470,792 -- June 28, 2009
US 7,534,890 -- November 15, 2009
US 7,576,221 -- February 14, 2010

Because Novartis filed its complaint on July 6, 2010, it would appear that the complaint did not comply with § 154(b)(4)(A).  However, Novartis argues that "§ 154(b)(4)(A) applies to a re-determination of PTA by [the Director] under 'paragraph (3),' i.e., 35 U.S.C. § 154(b)(3)," and that "§ 154(b)(3), by its plain terms, governs a PTA determination by [the Director] only in conjunction with a notice of allowance of a patent application," and "does not cover a PTA determination by [the Director] in conjunction with the issuance of a patent."  As a result, Novartis argues that the 180 day time limit is inapplicable to its claim.

Novartis also points to two other ways in which its complaint should be considered timely:  pursuant to the doctrine of equitable tolling or the discovery rule.  In February 2009, we discussed a case in which a patentee tried the first approach (see "More § 154(b)(4)(A) Actions Filed against Director").  In that case, General Hospital Corp. filed a complaint against the Director on January 16, 2009, requesting correction of a PTA determination with respect to U.S. Patent No. 7,367,341, which issued on May 6, 2008.  For a patent issuing on that date, a complaint should have been filed by November 2, 2008.  Thus, General Hospital missed the deadline for filing its complaint by 76 days.  Nevertheless, General Hospital contended in its complaint that "[the District Court for the District of Columbia's] decision in Wyeth v. Dudas constituted a change in the law sufficient to invoke the doctrine of equitable tolling to allow for the filing of this complaint at this time."  The doctrine of equitable tolling preserves a plaintiff's claims when strict application of the statute of limitations would be inequitable. A check of PACER shows that the District Court stayed General Hospital's case on March 30, 2009, pending the outcome of the Wyeth appeal, and that General Hospital voluntarily dismissed the action on April 29, 2010.  As a result, the District Court never addressed the question of whether the doctrine of equitable tolling could be used to bypass the filing deadline set forth in § 154(b)(4)(A).  In the instant case, Novartis contends that it "lacked knowledge and adequate notice of its claim . . . until [the Director's] announcement that the PTO would not appeal the Wyeth decision or, at the earliest, the date of the decision itself."

Novartis also contends that its complaint is timely in view of the discovery rule.  Under the discovery rule, the statue of limitations specified in § 154(b)(4)(A) would not begin to run until the plaintiff "discovered" the harm.  With respect to PTA determinations based on Wyeth B-delay, the harm would have been "discovered" (at the earliest) on January 7, 2010, when the Federal Circuit decided Wyeth v. Kappos, i.e., on July 6, 2010.

In addition to seeking additional patent term under § 154(b)(4)(A) (count 1), the doctrine of equitable tolling (count 2), and the discovery rule (count 3), Novartis also adds a fourth count alleging that "[the Director's] purposeful and deliberate diminution of the patent term of each of the Novartis Patents constitutes a taking of Novartis' property without just compensation, in violation of the Fifth Amendment of the Constitution of the United States," and a fifth count alleging a violation of the Administrative Procedures Act (i.e., that the USPTO's PTA determinations were "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law within the meaning of 5 U.S.C. § 706(2)(A); contrary to Novartis' constitutional rights within the meaning of 5 U.S.C. § 706(2)(B); and in excess of statutory authority within the meaning of 5 U.S.C. § 706(2)(C)").

Myriad Appeals AMP v. USPTO Decision

    By Kevin E. Noonan --

Myriad Genetics, for itself as well as the named defendant Directors of the University of Utah Research Foundation, filed a Notice of Appeal today in Association for Molecular Pathology v. U.S. Patent and Trademark Office.  As a consequence, the decision by Judge Robert Sweet holding that patents to human genes were not statutory subject matter as being the "physical embodiment of genetic information" will be reviewed by the Federal Circuit, and perhaps ultimately, the U.S. Supreme Court.

The Federal Circuit has not yet set a briefing schedule, which Patent Docs will post when it becomes available.  It can be expected that the Court will be the beneficiaries of several amicus briefs.  It will be interesting to see if amici include universities, whose patent portfolios will be the most harmed by affirmance of the gene patenting ban promulgated by Judge Sweet.

For additional information regarding this and other related topics, please see:

• "AMP v. USPTO: What Everyone Else Is Saying - Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Apporaches to Covering Gene Patenting Story," April 5, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "The USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
• "Top Stories of 2009: #4 to #1," January 4, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009

AMP v. USPTO: What the Parties Are Saying About the Decision

    By Donald Zuhn --

On Monday, the District Court for the Southern District of New York ruled in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims of several patents directed to the BRCA1 and BRCA2 genes invalid as encompassing non-statutory subject matter (see "Round One Goes to the ACLU").  So what are the parties saying about Monday's decision?

The originally named defendants in the case included the U.S. Patent and Trademark Office, Myriad Genetics, and the Directors of the University of Utah Research Foundation.  The District Court's dismissal of claims against the USPTO left Myriad Genetics and the University of Utah Research Foundation as the remaining defendants.

While the University of Utah Research Foundation has not issued a statement regarding the decision, Myriad Genetics released a statement on Tuesday in which the molecular diagnostic company announced that it will appeal the decision to the Federal Circuit and "will continue to vigorously defend this litigation."  Myriad President and CEO Peter Meldrum said that "[w]hile we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation."  Mr. Meldrum added that "[m]ore importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents."  Myriad noted that while the District Court invalidated 15 claims in seven BRCA patents that the company owns or exclusively licenses, there are 164 remaining claims in those seven patents and an additional 16 patents covering Myriad's BRCA tests that were not challenged in the case.

Among the organizational plaintiffs and their counsel, the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, American Civil Liberties Union (ACLU), and Public Patent Foundation (PUBPAT) all issued statements regarding the decision (the College of American Pathologists, Breast Cancer Action, and Boston Women's Health Book Collective did not issue any statements on their respective websites).

In its press release, the ACLU noted that "[t]he precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes." ACLU First Amendment Working Group staff attorney Chris Hansen said the decision was "a victory for the free flow of ideas in scientific research," adding that "[t]he human genome, like the structure of blood, air or water, was discovered, not created.  There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."  With respect to the USPTO's dismissal, the ACLU asserted that "[t]he court found that it was unnecessary to reach the First Amendment claims against the USPTO because it had already ruled in favor of the plaintiffs."  The ACLU release also suggested that "[b]ecause the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes."  ACLU Women's Rights Project staff attorney Sandra Park predicted that the decision was "the beginning of the end to patents that restrict women's access to their own genetic information and interfere with their medical care."

In a statement issued by PUBPAT, Executive Director Daniel Ravicher said that "[t]he court correctly saw that companies should not be able to own the rights to a piece of the human genome."  Mr. Ravicher added that "[n]o one invented genes.  Inventions are specific tests or drugs, which can be patented, but genes are not inventions."

The Association for Molecular Pathology (AMP) applauded the decision in its release.  AMP President Dr. Karen Mann called the outcome "a landmark decision that has the potential to dramatically improve patient access to genetic testing."  Dr. Mann suggested that the decision would also be "a boon to personalized medicine in the purest sense as nothing is more personal than one's genetic makeup."  The AMP noted that it had adopted a Policy Statement on gene patenting in 2008 that "urged an end to the practice of granting patents on single genes, sequences of the genome or correlations between genetic variations and biological states," and "encouraged groups that currently hold gene patents, including higher educational and research institutions, not to grant exclusive licenses to access those patents."  The AMP release contends that the decision is a "significant step forward to eliminating future DNA patents and calls into question the appropriateness of those already in existence."

In its statement, the American College of Medical Genetics (ACMG) "celebrated the US District Court ruling [on Monday] that genes are 'unpatentable.'"  The group's release states that "[t]he outcome of this case is likely to have far-reaching positive implications for physicians, researchers and patients."  ACMG executive director Dr. Michael Watson contended that "[t]he invalidation of gene patents will allow patients to get second opinions on test results, encourage quality improvement of current testing, allow researchers to develop new and better methods of testing and decrease costs of laboratory testing."  ACMG President Dr. Bruce Korn added that "[t]he successful outcome will pave the way towards genome-wide testing, avoiding an obstacle course of patent protection of individual genes that will prevent reporting of a complete set of results."  The group's release notes that the ACMG was the first professional medical association to establish a position against gene patenting (which it did in 1999).

The American Society for Clinical Pathology's (ASCP) release "hailed" the District Court's decision.  ASCP President Dr. Mark Stoler said the ruling "gives patients the right to choose who will perform the test that determines whether they are at greater risk for breast cancer -- a right they never should have been denied."  He added that as a result of the court's decision, "[w]e have won back our natural right to own our own genes."

Round One Goes to the ACLU

Association of Molecular Pathology v. U.S. Patent and Trademark Office

    By Kevin E. Noonan --

Not surprisingly, Judge Robert W. Sweet of the Southern District of New York ruled in favor of the plaintiffs today in Association of Molecular Pathology v. U.S. Patent and Trademark Office, granting partial summary judgment that the claims of several patents on BRCA1 were invalid as encompassing non-statutory subject matter.  In an extensive, 156-page opinion (which will be analyzed more thoroughly in a later post), the District Court entered a narrow ruling that was damaging to the University of Utah and its licensee Myriad Genetics, but not as far-reaching as plaintiffs and their backers, the American Civil Liberties Union and the Public Patent Foundation, undoubtedly hoped.

The Court granted summary judgment on the composition of matter claims, based on its (mis)reading of 19th century Supreme Court precedent as well as several old "product of nature" cases from several district courts and regional circuit Courts of Appeal.  (Ironically, the District Court disregarded the teachings of Learned Hand in this same court, Judge Learned Hand's opinion in Parke-Davis & Co. v. H.K. Mulford Co., 189 F.2d 95 (2d. Cir. 1911)).  The method claims were found invalid under the Federal Circuit's "machine or transformation" test from In re Bilski.  The Supreme Court will rule on the Federal Circuit's decision and adoption of this test (representing another rigid rule like the many the Court has overturned or has voiced its disapproval of), making this portion of the opinion of questionable longevity.

As a reminder, the following U.S. Patents were at issue in this litigation:  U.S. Patent  Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857.  They are assigned to Myriad Genetics, the University of Utah Research Foundation, and the National Institutes of Health (the '282, '001 and '441 patents); Myriad Genetics, Centre de Recherche du Chul, and the Japanese Cancer Institute (the '473 and 999 patents); and Myriad Genetics, Endo Recherche, HCS R&D Ltd. Partnership, and the University of Pennsylvania (the '492 and '857 patents).  All but the '492 and '857 patents claim priority to an application filed August 12, 1994; all but the '473 patent (December 2014) and the '857 patent (March 2017) will expire (upon timely payment of maintenance fees) in 2015.

The following claims have (for now) been invalidated:

For the '282 patent:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

5.  An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6.  An isolated DNA having at least 15 nucleotides of the DNA of claim 2.

7.  An isolated DNA selected from the group consisting of:
    (a)  a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
    (b)  a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
    (c)  a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.

20.  A method for screening potential cancer therapeutics which comprises:  growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

For the '492 patent:

1.  An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

6.  An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.

7.  The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.

For the '473 patent:

1.  An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

For the '999 patent:

1.  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

For the '001 patent:

1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

For the '441 patent:

1.  A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

And for the '857 patent:

1.  A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

2.  A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

Fortunately, the District Court ignored plaintiffs' invitation to rule on several constitutional issues of questionable provenance (see "The USPTO Asks out of Gene Patenting Case (Again)"), dismissing the claims against the U.S. Patent and Trademark Office.  Invoking the principle of constitutional avoidance, i.e., that "federal courts should, where possible, avoid reaching constitutional questions (Allstate Ins. Co. v. Serio, 261 F.3d 143,149-150 (2d Cir. 2001) and Spector Motor Serv. Inc. v. McLaughlin, 323 U.S. 101 (1944)), the Court answered plaintiffs' argument that deciding as it did would not reach the question of whether the Patent Office was improperly granting patents on  genes by saying:

[A] decision by the Federal Circuit or the Supreme Court affirming the holding set forth above would apply to both the issued patents as well as patent applications and would be binding on all patent holders and applicants, as well as the USPTO.

We can only hope not.

As the District Court predicts, however, this case is now headed to the Federal Circuit, which may benefit from amici curiae briefs from those stakeholders, such as major patent bar groups, universities and others, who sat on the sidelines during the District Court case.  The dangers and negative consequences of a ban on gene patenting have been set out before and won't be repeated here.  That doesn't make the outcome any less dangerous, or the consequences any less threatening to the biotechnology industry or our society.

For information regarding this and other related topics, please see:

• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "The USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
• "Top Stories of 2009: #4 to #1," January 4, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009

USPTO Asks out of Gene Patenting Case (Again)

    By Kevin E. Noonan --

Several weeks ago, U.S. District Court Judge Robert W. Sweet denied the U.S. Patent and Trademark Office's motion to dismiss the ACLU-sponsored lawsuit aiming for a human gene patenting ban (see "BRCA Patent Suit to Continue in Southern District of New York").  Just before Christmas, the Office filed another motion with the District Court, for judgment on the pleadings (as well as opposition to Plaintiffs' summary judgment motion).

The brief, by Preet Bharara, U.S. Attorney for the Southern District of New York and Ross E. Morrison, Assistant U.S. Attorney, is broadly based on jurisprudential principles of avoiding a constitutional issue when possible, citing Allstate Ins. Co. v. Serio, 261 F.3d 143, 149-150 (2d Cir. 2001), and Spector Motor Serv. Inc. v. McLaughlin, 323 U.S. 101 (1944) ("'If there is one doctrine more deeply rooted than any other in the process of constitutional adjudication, it is that we ought not to pass on questions of constitutionality . . . unless such adjudication is unavoidable.'")

Accordingly, the brief argues, Plaintiffs' remedy is to prevail against the other defendants on the grounds that the patents-in-suit are invalid.  The Office asserts that the Patent Act gives plaintiffs' a statutory basis for challenging the patents-in-suit, on the grounds that the claims do not recite patent-eligible subject matter under § 101.  Thus, the brief argues, should the District Court find that the Myriad patents were improperly granted under 35 U.S.C. § 101 (as being subject matter not eligible for patenting), there will be no need to address the constitutional aspects of the patent-eligibility issue.  Moreover, the Office contends it cannot be haled into court for granting a patent in contravention of the Patent Act, citing Syntex (USA), Inc. v. U.S. Patent and Trademark Office, 882 F.2d 1570, 1572-1574 (Fed. Cir. 1989).

The office then argues that for the District Court to reach the constitutional issues raised in the complaint, it must first decide that the Patent Office properly applied the relevant provisions of the Patent Act, and thus that the Patent Act itself, not just the Office's implementation of it, is unconstitutional.  With that, the brief turns to the substantive constitutional questions raised in the lawsuit, identifying two:

1.  That granting gene patents are contrary to Article I, section 8, clause 8 (termed "the IP Clause" in the brief); and

2.  That granting gene patents violates the First Amendment.

With regard to the IP Clause argument, the brief points out plaintiffs' unfamiliarity with, or ignorance of, the meaning of the Constitutional language reciting the copyright and patent clause.  Plaintiffs allege in their summary judgment brief that the claims "impede rather than promote the progress of science."  But the language of the Constitution that mentions "science" does not refer to patents but rather to copyrights, since in the 18th Century the term "science" was associated with "learning or knowledge," and what we think of as technology (what is eligible for patenting) was termed "the Useful Arts."  Thus, the brief contends that allegations that the Patent Act does not promote "science" are "not relevant" to the patent system, citing Graham v. John Deere Co., 383 U.S. 1, 5 (1966) (the brief also cites Eldred v. Ashcroft, 537 U.S. 186, 192-92 (2003), which concerned a challenge to revisions to the Copyright Act).

The Office also argues that it is "far from clear" that the preamble to the IP Clause limits the power of Congress in establishing the patent laws.  The brief cites the Eldred case for this proposition, as well as the Supreme Court's Second Amendment decision (District of Columbia v. Heller, 128 S. Ct. 2783, 2789 (2008)), where the Court held that, outside a "clarifying function, a prefatory clause does not limit or expand the scope of the operative clause" in the Second Amendment.

Continuing, the brief further argues that there are limits to the extent of review the District Court can give to the constitutional question even if it were to reach it, saying it is well established that "Congress has the power to establish a patent system as it [sees] fit."  This is essentially an argument for deference, the brief citing in support Graham as well as Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989).  While this power of Congress may not be "absolute," the brief contends that at most Congress' implementation of the IP Clause is subject to rational basis review, again citing Eldred:  "[u]nder that standard," the brief asserts, "courts 'accord great deference to Congress's policy determinations,' and judicial review 'is limited to whether Congress's actions were 'a rational exercise in the legislative authority conferred by the [Patent] Clause,'" citing Figueroa v. United States, 466 F.3d 1023 (Fed. Cir. 2006).

Answering its own question in this regard, the Office contends that there is no doubt that Congress had "a rational basis to believe that a statutory scheme that established broad categories of subject matter eligible for patenting . . . would promote innovation and research."  Further, whether the patents-in-suit were properly granted does not implicate the constitutionality of the Patent Act:  "[t]he fact that some patents issued under the patent system can be argued not to 'promote progress' has no bearing on the question of whether the system as a whole has a rational basis" and is "simply not relevant," citing Eldred ("In sum, we find that the [Copyright Term Extension Act] is a rational enactment; we are not at liberty to second-guess congressional determinations and policy judgments of this order, however debatable or arguably unwise they may be.")

The proper question in this regard, the Office contends, is whether permitting patents on compositions of matter and processes have a rational relationship to "Congress's legitimate objectives under the IP Clause."  Here, the brief asserts, there are "multiple plausible bases" upon which Congress could have enacted § 101.  These include that "[c]hoosing broad categories of subject matter ensured that the Patent Act would not have to be repeatedly amended to accommodate new and emerging technologies," citing Diamond v. Chakrabarty for the proposition that the Supreme Court had "specifically found that broad statutory categories fulfill the constitutional goal."  Even limiting the question to the gene patents at issue, the brief argues that Congress had a rational basis for permitting patenting in "a field of technology [that] can be expected to stimulate investment, research and innovation within this area, all to the benefit of the national economy," citing the House of Representative report on the Hatch-Waxman Act.

The brief also cites numerous academic sources for the proposition that biotechnology required intensive investment and thus patent protection to promote such investment.  The brief then cites the benefits of disclosure as a rational basis for patenting, because "other researchers learn what has been patented, and therefore are able to focus their research dollars on areas that have yet to be explored."  "Under rational basis review, the task of performing the 'careful balance between the need to promote innovation and the recognition that imitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy,' must be left to Congress," the Office asserts, citing Bonito Boats, 489 U.S. at 146.

Finally, the brief reminds the District Court that Congress had recently considered, and did not deign to pass, a bill prohibiting gene patenting, asserting that this constitutes a suggestion "that courts should tread lightly in this area."

Regarding the First Amendment argument, the brief contends that the First Amendment does not provide a substantive limitation on Congress' authority to enact patent laws.  Indeed, the Office argues that the Patent Act actually supports the concerns motivating the First Amendment, since it "promote[s] the dissemination of knowledge."  Citing Kewanee Oil Co. v. Bicron, 416 U.S. 470 (1974) for support, the brief asserts that:

[T]he Patent Act promotes free speech and general dissemination of information because it grants a temporary exclusive right to an invention in exchange for disclosure of information that might otherwise have remained secret.  By making the information about the invention available, it creates the possibility for stimulating further research in a related area as well as for one who wants to practice the invention to seek a license.  If the information were kept secret -- potentially in perpetuity, depending on the nature of the technology -- no such opportunity would arise.

The brief then contends that patents are fully compatible with free speech rights, noting that Congress enacted the first Patent Act "in close proximity" to adoption of the First Amendment.  Indeed, the Office argues, the Framers did not seem to believe there was any "tension" between the IP Clause and the First Amendment, "given the proximity in time between the establishment of the patent system and the ratification of the First Amendment."

The Office also argues that any purported impact on free speech is not unique to the patents-in-suit.  The brief mentions in particular Morse's patent on the telegraph and Bell's patent on the telephone as patents impacting "free" speech, specifically by charging a fee for speech:  "[i]n each case, individuals wishing to use these devices to communicate their thoughts or to gain access to new knowledge could do so only subject to the rights of the patentholder."  In a footnote, the brief makes this point more forcefully:

"Nothing in the First Amendment requires that the exercise of First Amendment rights be cost-free.  Those who wish to publish must pay for the equipment and labor (or internet access) required for publication; indeed, even parade demonstrators may be required to pay to exercise their First Amendment right to march," citing Cox v. New Hampshire, 312 U.S. 569, 576-77 (1941) and, more generally, Eric Neisser, Charging for Free Speech: User Fees and Insurance in the Marketplace of Ideas, 74 Geo. L.J. 257 (1985).

Even the portion of the statutes providing for remedies for infringement could, the brief asserts, "be said to regulate speech and thus, according to plaintiffs' theory, to violate the First Amendment."  Any "incidental limitation" of unfettered speech is just "a temporary burden on the public that Congress has deemed necessary to encourage invention and disclosure of inventions that inure to the public benefit," the brief contends, and it characterizes such limitation as ones on conduct, not speech, thus not implicating the First Amendment.  Making the point more strongly, the Office argues that "[t]here are few restrictions on action which could not be clothed by ingenious argument in the garb of decreased data flow.  For example, the prohibition on unauthorized entry into the White House diminishes the citizen's opportunities to gather information he might find relevant to his opinion of the way the country is being run, but that does not make entry into the White House a First Amendment right.  The right to speak and publish does not carry with it the unrestrained right to gather information," citing Zemel v. Rusk, 381 U.S. 1, 16-17 (1965).

The brief's conclusion is that:

[T]he free-speech interests here -- if any -- are subordinate to the interest in a working patent system that provides complete remedies to patentholders.  The question is not whether any given patent might inhibit more speech than it promotes, but rather whether in establishing a patent system that awarded such a patent, Congress somehow violated the First Amendment.  Because Congress did not, plaintiffs' First Amendment claim should be dismissed.

The Office then goes on the offensive in this regard, stating that the Supreme Court has held the patent statutes to "promote free speech interests," notably by Supreme Court decisions precluding information and abstract ideas from being patent-eligible (citing Gottschalk v. Benson).  Using Eldred as an illustration, the brief illustrates the infirmities of plaintiffs' First Amendment case:  the plaintiffs in Eldred raised similar First Amendment allegations against the 1998 Copyright Term Extension Act, and the Supreme Court held that the Copyright Act and the First Amendment were compatible on historical grounds (closeness in time of adoption).

The brief also rebuts the argument that patenting genes is the same as patenting information, citing Amgen Inc. v. Chugai Pharmacutical Co. ("A gene is a chemical compound"), and reminding the District Court that chemical compounds have been patent-eligible subject matter since the first Patent Act.  "[P]laintiffs attempt to blur the line between genes, which are chemical compounds, and genetic sequences, which are human-created representations that identify one of the gene's properties:  the arrangement of nucleic acids in the gene.  . . .  Plaintiffs fail to cite -- nor is the USPTO aware of -- any case law supporting the notion that a chemical (or machine or any other physical structure) that is capable of conveying information no longer qualifies for patent protection based on the fact that it has informational content."  This distinction between chemistry and information is accommodated by the Office, according to the brief, citing specifically the Utility Guidelines (wherein the Office does not grant patents on the nucleotide sequence but on the chemical), and that use of the sequence per se is not patent infringement.  Regarding Plaintiffs' argument that genes can be represented by "a series of letters" and hence comprise information, the brief also reminds the court that "[a]ll chemicals can be described in letter and number format."

The brief provides a good example of the constitutional and jurisprudential deficiencies in the Plaintiffs' arguments.  The risk, of course, is that Judge Sweet will grant the Office's motion, thus removing any incentive for the Office to weigh in on the substantive question raised in Plaintiffs' summary judgment brief -- that the patents on the BRCA1 and BRCA2 genes were improperly granted.  No matter what decision the parties receive from the Judge, the case will be appealed and eventually reach a petition for certiorari.  At that point, it is likely that the Solicitor General will set out the Administration's position on the patent-eligibility of isolated human DNA.  But it could be helpful to have the Office's arguments before the case gets to that point.

For information regarding this and other related topics, please see:

• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "BIO IP Policy Briefing," May 11, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "The Effects of Intellectual Property Protection on Agricultural Research: Patents Are Not The Problem," February 3, 2009
• "Newsweek Joins the Anti-patent Bandwagon," January 26, 2009

BRCA Patent Suit to Continue in Southern District of New York

    By Kevin E. Noonan --

Judge Robert W. Sweet of the Southern District of New York ruled against the defendants' motions to dismiss in Association for Molecular Pathology v. U.S. Patent and Trademark Office (see Opinion).

The defendants brought these motions under Federal Rules of Civil Procedure 12(b)(1) (for lack of subject matter jurisdiction), (b)(2) (for lack of personal jurisdiction), and (b)(6) (for failure to state a claim).  The judge denied the U.S. Patent and Trademark's motion under Fed. R. Civ. Pro. 12(b)(1) that the plaintiff's claims lacked subject matter jurisdiction, distinguishing the legal precedent asserted by the Office as being limited to instances where there was alleged "a statutory violation for which the Patent Act provided a remedy."  Here, the District Court found that the "novel circumstances presented by this action against the USPTO, the absence of any remedy provided in the Patent Act, and the important constitutional rights the Plaintiffs seek to vindicate establish subject matter jurisdiction over the Plaintiff's claims against the USPTO."  The Court further ruled that the plaintiffs have standing to sue the Patent Office for "constitutional violations" for similar reasons of a lack of statutory remedy.

As for Myriad and the Directors of the Utah University Research Foundation ("UURF," a not-for-profit corporation alleged by Plaintiffs to be "operated, supervised and/or controlled" by patent assignee University of Utah), the District Court found that the plaintiffs had standing to sue arising from the Supreme Court's broad interpretations of the contours of the Declaratory Judgments Act in MedImmune Inc. v. Genentech, Inc.  Like the non-breaching licensee in MedImmune, the District Court found that the Plaintiffs were not required to infringe Myriad's claims in order to challenge their constitutional validity.  The existence of the patent, and Myriad's actions in threatening enforcement, were sufficient to establish standing to sue.  (Although it seems likely that the Court would have found standing even under the Federal Circuit's pre-MedImmune "reasonable apprehension of suit" test, the MedImmune decision enabled the District Court to distinguish precedent asserted by Myriad and its Directors challenging standing.)  Using the Supreme Court's "all the circumstances" test, said the lower court, there was an actual "case or controversy" alleged by Plaintiffs that conferred standing; in particular the District Court found that the "cease and desist" letters and other actions by Myriad and its Directors satisfied the "affirmative acts" prong of the test with regard to two of the named Plaintiffs (Drs. Kazazian and Ganguly) and noted prior litigation against alleged infringers in support of its analysis.  The Plaintiff researchers asserted readiness, willingness, and ability to undertake infringing activity was sufficient for the Court to find that the "meaningful preparations for infringing action" prong was also satisfied.

The personal jurisdictional challenge denied by the District Court relates to the UURF Directors, and the Court's analysis was performed under Federal Circuit law and New York State's "long-arm" statute with regard to both general and specific jurisdiction.  The standard is merely that Plaintiffs have made a prima facie showing, and all uncontroverted facts alleged in the complaint are accepted as true, with factual conflicts being resolved in the plaintiff's favor.  The claims asserted by Plaintiffs were not directed towards the Directors personally, but in their capacity as Utah state officials.  The Court found that the UURF Directors had entered into an exclusive licensing agreement authorizing Myriad to market products in New York protected by UURF patents.  "Because the claims in this case are directly related to that license agreement, the Directors have purposefully availed themselves of the privilege of conducting business in New York," satisfying the specific jurisdiction requirement of New York jurisdictional law.  This conclusion was supported, according to the Court, by continued obligations imposed by the license on the Directors, including agreeing (as patent owner) to join any infringement lawsuit brought by Myriad coupled with Myriad's actions seeking to enforce the patents in New York.

Finally, turning to the failure to state a claim basis for Defendants' motion to dismiss, the District Court found that the Plaintiffs allegations of Constitutional violations were sufficient, specifically holding that the complaint satisfied the higher pleadings requirements imposed by the Supreme Court in Ashcroft v. Iqbal.  These allegations go to the heart of the complaint, that the BRCA mutations are not "inventions" but "exist in nature," and that the correlation between the presence of these mutations and an increased risk of cancer are "nothing more than a naturally-occurring phenomenon."  While noting that the standard is a liberal one, and that a complaint should be dismissed on these grounds only if "it appears beyond doubt that the plaintiff can prove no set of facts in support of its claims that would entitle it to the relief it seeks," the Court found that the allegations regarding the First Amendment violations were enough for the Plaintiffs to withstand Defendants' motion to dismiss on these grounds.

This case will not go to trial; summary judgment motions are next on the agenda, with eventual appeal (ultimately to the Supreme Court) no matter what decision the District Court reached in the merits.  While no longer named in the suit, the American Civil Liberties Union (as well as the Public Patent Foundation) is representing the Plaintiffs.  The ACLU has taken up this cause and is unlikely to not see it through.  While the Court's decision today may dash the hopes that the case would just disappear quietly, the decision provides no evidence that either party will prevail, just that the Court believes that the case has the jurisdictional and substantive competence to go forward.  And a possible silver lining in the District Court's decision is that, in keeping the USPTO in the case, the judge left the government with sufficient skin in the game to motivate a spirited defense of gene patenting as appropriate public policy in fulfillment of the Constitutional mandate to "promote the Progress . . . of the Useful Arts."

For additional information regarding this and other related topics, please see:

• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
• "Science Article Should Help Allay Gene Patenting Fears," December 17, 2008

More § 154(b)(4)(A) Actions Filed against Director

    By Donald Zuhn --

Shortly before leaving the U.S. Patent and Trademark Office, former Director Jon Dudas was served with three last complaints from patentees seeking additional Patent Term Adjustment (PTA) for their patents.  The three complaints bring the number of 35 U.S.C. § 154(b)(4)(A) actions to 14, involving 15 patentees and 21 separate patents (including Wyeth and Elan Pharma International Ltd., which secured a favorable decision against the Director with regard to two of their patents on September 30, 2008).

The most recent additions to the growing list of patentees that have filed complaints under § 154(b)(4)(A) include:

• Bayer Bioscience GmbH and Max-Planck-Gesellschaft zur Foderung der Wissnschaften eV of Berlin, Germany, which filed a complaint on January 15, 2009 asserting that the correct PTA for U.S. Patent No. 7,402,420 (which issued July 22, 2008) should be 667 days rather than the 259-day period determined by the Office (see complaint);

• Syntonix Pharmaceuticals, Inc. of Waltham, MA, which filed a complaint on January 16, 2009 asserting that the correct PTA for U.S. Patent No. 7,404,956 (which issued July 29, 2008) should be 752 days rather than the 423-day period determined by the Office (see complaint); and

• The General Hospital Corporation of Boston, MA, which filed a complaint on January 16, 2009 asserting that the correct PTA for U.S. Patent No. 7,367,341 (which issued May 6, 2008) should be 515 days rather than the 214-day period determined by the Office (see complaint).

As noted in our previous reports regarding complaints filed under § 154(b)(4)(A), this section specifies that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent."  Interestingly, General Hospital Corp. becomes the first patentee to seek additional PTA for a patent that issued more than 180 days prior to the filing of its complaint (the deadline for filing a complaint under § 154(b)(4)(A) for a patent issuing on May 6, 2008 was November 2, 2008).  (While Biogen and Molecular Insight Pharmaceuticals filed § 154(b)(4)(A) actions on December 1, 2008 -- rather than November 30, 2008 -- for patents that issued on June 3, 2008, November 30th was a Sunday, and therefore, their complaints were timely filed under Fed. R. Civ. P. 6(a)(3).)

In its complaint, General Hospital Corp. contends that the complaint was timely filed in view of the doctrine of equitable tolling.  In particular, the complaint states that "[the District Court for the District of Columbia's] decision in Wyeth v. Dudas constituted a change in the law sufficient to invoke the doctrine of equitable tolling to allow for the filing of this complaint at this time."  The doctrine of equitable tolling preserves a plaintiff's claims when strict application of the statute of limitations would be inequitable.

Patentees who were unable to file complaints within the 180-day deadline proscribed by § 154(b)(4)(A) will no doubt be watching with great interest to see whether the District Court permits General Hospital Corp. to move forward with its case despite missing the 180-day deadline by 76 days.  Whether the District Court gives any weight to the fact that Wyeth was decided 34 days before General Hospital Corp.'s 180-day deadline will also be of interest.  Of course, even if the District Court were to refuse to apply the doctrine of equitable tolling in this case, whether the doctrine could be applied in a case involving a patent issuing on or before April 1, 2008 (i.e., more than 180 days before the Court's decision in Wyeth v. Dudas) would remain an open question.  While awaiting the Court's decision in General Hospital Corp. v. Dudas, patentees seeking additional PTA would be wise to file their complaints within the 180-day deadline.

Patent Docs will continue to monitor newly filed actions in the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations.  A recent search of the District Court for the District of Columbia case management electronic case filing system indicated that no complaints have yet been filed against Acting Director John Doll.

For information regarding this topic, please see:
• "Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas," January 12, 2009
• "Top Stories of 2008: #13 to #10," January 1, 2009
• "More Patentees Follow Wyeth's Lead in Seeking Additional PTA," December 3, 2008
• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008

Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas

    By Donald Zuhn --

Last month, Medarex, Inc., Eurand, Inc., and Alexion Pharmaceuticals, Inc. joined the growing list of patentees that have filed complaints against U.S. Patent and Trademark Office Director Jon Dudas alleging that the Patent Office miscalculated the Patent Term Adjustment (PTA) for their patents.  Medarex, Eurand, and Alexion became the eighth, ninth, and tenth patentees to file suit against Director Dudas seeking revised PTA determinations.

As we reported last fall, the District Court for the District of Columbia issued an important decision that impacts the manner in which PTA determinations are made (see "Wyeth v. Dudas (D.D.C. 2008)").  In Wyeth v. Dudas, the District Court determined that the USPTO had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled under U.S. Patent Law.

At issue in Wyeth was the interplay, under § 154(b)(2)(A), between the patent term guarantee provision of § 154(b)(1)(A) that provides a one-day extension of patent term for every day that the issuance of a patent is delayed by the failure of the USPTO to comply with various enumerated statutory deadlines ("A delay") and the patent term guarantee provision of § 154(b)(1)(B) that provides a one-day term extension for every day greater than three years after the filing date that it takes for the patent to issue ("B delay").  According to the Patent Office's interpretation of § 154(b)(2)(A), the start of the B delay period is an application's filing date rather than the date occurring three years after the application's filing date, and as a result, any A delay occurring during the first three years of prosecution would overlap with any B delay the application might accumulate.  Thus, under the USPTO's procedure for determining PTA, "the applicant gets credit for 'A delay' or for 'B delay,' whichever is larger, but never A + B."  The Wyeth Court determined, however, that the proper formula for determining PTA is:

A delay + B delay - A delay that overlaps with B delay - applicant's delay

While the District Court's decision in Wyeth specifically impacts only the two patents that were at issue in that case (U.S. Patent Nos. 7,179,892 and 7,189,819), the decision has had a significant, albeit indirect, impact by raising awareness concerning the Patent Office's flawed interpretation of § 154(b)(2)(A).  In addition, because 35 U.S.C. § 154(b)(4)(A) specifies that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent" (emphasis added), patentees finding themselves in Wyeth's position have had little choice but to file complaints seeking revised PTA determinations or risk waiving the additional patent term.  Prior to the new filings, the list of patentees filing complaints included:

• Complaint filed on August 16, 2007 -- Wyeth seeks additional 294 days of PTA for U.S. Patent No. 7,179,892, and additional 230 days of PTA for U.S. Patent No. 7,189,819;
• September 5, 2008 -- Napo Pharmaceuticals, Inc. seeks additional 554 days of PTA for U.S. Patent No. 7,341,744;
• November 7, 2008 -- Ironwood Pharmaceuticals, Inc. seeks additional 291 days of PTA for U.S. Patent No. 7,371,727;
• November 28, 2008 -- Solvay Pharmaceuticals GmbH seeks additional 99 days of PTA for U.S. Patent No. 7,381,729;
• December 1, 2008 -- Biogen Idec Inc. seeks additional 649 days of PTA for U.S. Patent No. 7,381,560;
• December 1, 2008 -- Purac Biochem B.V. seeks additional 563 days of PTA for U.S. Patent No. 7,410,556;
• December 1, 2008 -- Molecular Insight Pharmaceuticals, Inc. seeks 669 days of PTA for U.S. Patent No. 7,381,399; and
• December 1, 2008 -- Molecular Insight Pharmaceuticals, Inc. seeks 669 days of PTA for U.S. Patent No. 7,381,745.

The most recent additions to the above list include:

• Medarex, Inc. of Princeton, NJ, which filed a complaint on December 12, 2008 asserting that the correct PTA for U.S. Patent No. 7,387,776 (which issued June 17, 2008) should be 521 rather than the 231-day period determined by the Office (see complaint);

• Eurand, Inc. of Vandalia, OH, which filed a complaint on December 12, 2008 asserting that the correct PTA for U.S. Patent No. 7,387,793 (which issued June 17, 2008) should be 655 days rather than the 470-day period determined by the Office (see complaint); and

• Alexion Pharmaceuticals, Inc. of Chesire, CT, which filed a complaint on December 23, 2008 asserting that the correct PTA for:

• U.S. Patent No. 7,393,648 (which issued July 1, 2008) should be 758 days rather than the 462-day period determined by the Office (see complaint);
• U.S. Patent No. 7,396,917 (which issued July 8, 2008) should be 654 days rather than the 413-day period determined by the Office (see complaint);
• U.S. Patent No. 7,399,594 (which issued July 15, 2008) should be 990 days rather than the 512-day period determined by the Office (see complaint);
• U.S. Patent No. 7,408,041 (which issued August 5, 2008) should be 306 days rather than the 258-day period determined by the Office (see complaint);
• U.S. Patent No. 7,414,111 (which issued August 19, 2008) should be 870 days rather than the 549-day period determined by the Office (see complaint);
• U.S. Patent No. 7,427,665 (which issued September 23, 2008) should be 812 days rather than the 379-day period determined by the Office (see complaint); and
• U.S. Patent No. 7,435,412 (which issued October 14, 2008) should be 1,012 days rather than the 343-day period determined by the Office (see complaint).

Patent Docs will continue to monitor newly filed actions in the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations.

For information regarding this topic, please see:

• "Top Stories of 2008: #13 to #10," January 1, 2009
• "More Patentees Follow Wyeth's Lead in Seeking Additional PTA," December 3, 2008
• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008

Top Stories of 2008: #5 to #1

    By Donald Zuhn --

Yesterday, we counted down stories #9 to #6 of the top stories covered at Patent Docs in 2008 (see "Top Stories of 2008: #9 to #6"), and on New Year's Day, we listed stories #13 to #10 (see "Top Stories of 2008: #13 to #10").  Today, we conclude our second annual list of top stories by counting down the top five stories of 2008.  In case you missed the articles the first time around or wish to go back and review them, we have also provided links to our coverage of these stories (as well as a few links to articles on related topics).  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.


#5 -- Examination of Obviousness in Group 1600

Obviousness-related stories took the #5 (obviousness guidelines) and #4 (Supreme Court KSR decision) spots on our 2007 list of top stories.  With respect to the USPTO's issuance of guidelines for making obviousness determinations, we "predicted" that it would take some time for patent practitioners to discover the extent to which the new obviousness guidelines might impact patent prosecution.  For practitioners in the biotech and pharma arts, it didn't take too long.  As we reported in March, Bruce Kisliuk, a former Director with USPTO Technology Center 1600, informed attendees at an American Conference Institute (ACI) conference that most of the rationales set forth in the new obviousness guidelines applied to "classical mechanical situations" rather than biotech and pharma applications.  As a result, TC 1600 examiners were being taught to analyze obviousness using eleven key cases (consisting of seven CAFC, three district court, and one board decision).  One of these cases, the board decision in Ex parte Kubin, is scheduled for oral argument before the Federal Circuit on Thursday.

For information regarding this and other related topics, please see:

• "Docs at BIO: Panel Discusses IP Strategies after KSR," June 26, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "Briefs for In re Kubin filed by Amgen and BIO," June 12, 2008
• "USPTO's Bruce Kisliuk Addresses ACI Conference," March 3, 2008

#4 -- New Written Description Guidelines Issued

Obviousness was not the only requirement for patentability that garnered special attention at the Patent Office last year.  At the end of March, the USPTO released revised training materials for use in the examination of patent applications for compliance with the written description requirement.  The new training materials, which replace the training materials issued by the Office in 1999, provide seventeen examples, of which fourteen are specifically related to biotech inventions.  While many of the examples should be of interest to biotech/pharma practitioners (as shown below, analyses of the majority of these examples were provided on Patent Docs), the most interesting example may be Example 11, which concerns claims reciting a polynucleotide or polypeptide sequence that shares percent identity with another sequence.  The new training materials give the impression that claims reciting both percent identity and functional limitations can create more of a written description problem than claims reciting just a percent identity limitation (while the training materials note that the latter class of claims could present an enablement problem, this advice comes by way of a separate practice note).  During a BIO 2008 presentation, TC 1600 Director Dr. George Elliott explained that the rationale behind Example 11 could be found in Ex parte Porro.  Unfortunately, with respect to Example 11, the training materials appear to neglect case law that allows for the recitation of a genus containing some inoperative species.

For information regarding this and other related topics, please see:

• "In re Alonso (Fed. Cir. 2008)," November 3, 2008
• "The Written Description Training Materials and Ex parte Porro," July 8, 2008
• "Docs at BIO: 'Gotcha' Games Continue at USPTO," June 25, 2008
• "An Analysis of the New Written Description Training Materials – Protein Variants," June 24, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "An Analysis of the New Written Description Training Materials – Antisense," May 13, 2008
• "An Analysis of the New Written Description Training Materials – Antibodies to a Single Protein & Antibodies to a Genus of Proteins," May 12, 2008
• "An Analysis of the New Written Description Training Materials - ESTs & Partial Protein Structures," May 8, 2008
• "An Analysis of the New Written Description Training Materials - DNA Hybridization & Percent Identity," May 6, 2008

#3 -- Patent Reform Stalls in the Senate

No story on this year's list received more coverage on Patent Docs -- as evidenced by the list below -- than the story that moved from #6 on last year's list to #3 on this year's list:  patent reform.  But for the fact that the Senate patent reform bill never reached the floor for a vote (the bill was removed from the Senate calendar last spring), this story might have reached #2 on our list.  The year started out with the release of a draft of the Senate Judiciary Committee's report on the Patent Reform Act of 2007 (S. 1145), saw a better-late-than-never movement by biotech and pharma companies and organizations against biotech/pharma-unfriendly provisions of the bill, and ended with the announcement by Senator Jon Kyl (D-AZ) of a (possibly) more biotech/pharma-friendly patent reform bill to compete with Senator Patrick Leahy's (D-VT) bill.  Both bills are expected to be re-introduced when the 111th Congress gets down to business this month.  As with follow-on biologics legislation, however, whether the new Congress will be able to devote much attention to patent reform in view of the current economic crisis remains to be seen.

For information regarding this and other related topics, please see:

• "BIO Praises Senator Kyl's Patent Reform Bill," September 26, 2008
• "Senator Kyl’s Patent Reform Bill Introduced Today," September 25, 2008
• "BIO Discusses Legislative Accomplishments," September 3, 2008
• "Senate Patent Reform Legislation -- One Old Bill and One New Bill," August 11, 2008
• "Patent Reform Critic Says Legislation Would Be Costly and Counterproductive," July 30, 2008
• "Wall Street Journal: Current Patent System Suppresses Innovation," July 14, 2008
• "Evolution of Inequitable Conduct," May 27, 2008
• "Patent Hypocrisy," May 22, 2008
• "Bush Administration Continues Attempt to Destroy U.S. Patent System," May 18, 2008
• "Senate Patent Reform Bill: R.I.P.?" May 5, 2008
• "New York Times to Innovation: Drop Dead," April 30, 2008
• "No End to Fee Diversion?" April 21, 2008
• "BIO Commends Senator Specter for Patent Reform Stance," April 10, 2008
• "Commerce Secretary 'Entirely Wrong' on Inequitable Conduct Reform," April 8, 2008
• "Last Call to Voice Your Opposition to AQS Provision," April 4, 2008
• "Department of Commerce Sends Senators Second Letter on Patent Reform Bill," April 3, 2008
• "IPO Distributes 'Urgent' Legislative Alert on Applicant Quality Submissions," March 30, 2008
• "Amendments to S. 1145," March 17, 2008
• "Harry Manbeck on Inequitable Conduct," March 13, 2008
• "It's Getting to Be Crunch Time for S. 1145," March 13, 2008
• "U.S Patent 'Reform' Bill Worries Israelis," February 22, 2008
• "Judge Michel Doesn't Think Much of Senate Bill S. 1145, Either," February 20, 2008
• "The (Un)Intended Consequences of the Law," February 18, 2008
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part I," February 14, 2008
• "BIO Report Indicts 'Patent Reform' Proponents," February 13, 2008
• "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008
• "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008
• "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008
• "The Letters Keep Coming Over the Senate Transom," January 30, 2008
• "Draft Report on Senate Patent Reform Bill: Interlocutory Decisions & Venue," January 29, 2008
• "Draft Report on Senate Patent Reform Bill: Damages," January 28, 2008
• "Draft Report on Senate Patent Reform Bill: Applicant Quality Submissions & Micro-Entities," January 25, 2008
• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill: An Update," January 23, 2008
• "Draft Report on Senate Patent Reform Bill: Post-Grant Procedures," January 22, 2008
• "Draft Report on Senate Patent Reform Bill: Inequitable Conduct Provisions," January 21, 2008
• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill," January 18, 2008
• "Draft Report on Senate Patent Reform Bill: First Inventor to File Provisions," January 17, 2008
• "Draft Report on Senate Patent Reform Bill: Assignee Filings, Mandatory Publication, and Third Party Submissions," January 16, 2008
• "Draft Report on Senate Patent Reform Bill: Late Patent Filings," January 15, 2008
• "Draft Report on Senate Patent Reform Bill Circulated," January 14, 2008

#2 -- The Rise and Fall of Other USPTO Rules Packages

The USPTO spent most of 2008 defending four major rules packages:  the claims and continuations, IDS, Markush, and appeal rules.  The enjoinment of the claims and continuations rules is currently at issue in the Tafas v. Dudas appeal.  The other three rules packages, however, have been (at least for now) tabled by the USPTO.  A significant amount of the credit for forcing the USPTO to postpone (perhaps indefinitely) the implementation of these rules packages must go to David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald L.P., and Dr. Richard Belzer, a former civil service staff economist in the Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB).  Mr. Boundy and Dr. Belzer regularly reminded (and encouraged patent practitioners and applicants to remind) the OMB that the Patent Office was not playing by the rules in trying to secure approval for each of the rules packages.  Whether the Obama Administration picks up the rules packages where the Bush Administration left off remains to be seen (as we have noted before, Obama advisor and Duke University School of Law Professor Arti Rai, co-signed one of only two amicus briefs in support of the USPTO in the Tafas v. Dudas appeal).

For information regarding this and other related topics, please see:

• "Patent Office Announces Delay for New Appeals Rules," December 10, 2008
• "Patent Office to Publish Notice Delaying New Appeals Rules," December 9, 2008
• "Patent Office Issues Appeals Rules Clarification," November 21, 2008
• "PTO Announces No IDS or Markush Rules During Bush Administration," October 27, 2008
• "More on Ex parte Appeal Rule," October 10, 2008
• "Unhappy with the Ex parte Appeal Rule? Read This Now -- Updated," October 8, 2008
• "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
• "More on USPTO Rulemaking Practices," July 21, 2008
• "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
• "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting," June 23, 2008
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008
• "USPTO Posts Comments on New Rules for Alternative Claiming," April 23, 2008
• "Cantor Fitzgerald VP Comments on Markush Rules," April 10, 2008
• "You Can't Fight the USPTO -- or Can You?" March 11, 2008
• "Patent Office Publishes Notice Regarding Impact of Proposed Markush Claims Rules on Small Entities," March 10, 2008
• "Federal Register Notice Regarding Markush Claims to Publish on Monday March 10, 2008," March 7, 2008
• "OMB Receives Additional Submission Regarding PTO Rules Packages," February 21, 2008

#1 -- Continuation and Claims Rules Enjoined in GSK/Tafas v. Dudas; USPTO Appeals Injunction

Stories related to the new claims and continuations rules took the #3 (promulgation of new rules), #2 (USPTO clarification of new rules), and #1 (new rules preliminarily enjoined) spots on our 2007 list of top stories.  Not surprisingly, the Tafas case once again takes the top spot on this year's list of top stories.  On April 1st, Judge James C. Cacheris of the District Court for the Eastern District of Virginia granted Dr. Tafas' and GSK's motions for summary judgment and voided the claims and continuation rules as "otherwise not in accordance with law" and "in excess of statutory jurisdiction [and] authority," and thus, in contravention of the Administrative Procedure Act (APA).  The Patent Office responded by appealing the District Court's decision in May, and the Federal Circuit held oral argument on the appeal on December 5th.  In view of the panel's questioning of USPTO General Counsel James Toupin (and the quantity of amicus briefs supporting Dr. Tafas and GSK -- thirteen of the fifteen amicus briefs supported the appellees), one might guess that the Federal Circuit will affirm the District Court's decision.  However, stranger things have happened (and if the CAFC does lift the injunction, the Tafas case will almost certainly take the top spot again next year).  

For information regarding this topic, please see:

• "Federal Circuit Hears Oral Argument on Tafas Appeal," December 8, 2008
• "Law Professors Back USPTO in Tafas v. Dudas Appeal," October 23, 2008
• "PTO Files Reply Brief in Tafas v. Dudas Appeal," October 15, 2008
• "Dr. Tafas Files Brief in New Rules Appeal," September 20, 2008
• "GSK Files Brief in Tafas v. Dudas Appeal," September 25, 2008
• "Tafas v. Dudas Update," September 2, 2008
• "Enjoined Rule Will Not Be Applied Retroactively . . . If PTO Prevails in Tafas v. Dudas," August 7, 2008
• "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal," August 5, 2008
• "USPTO Files Opening Brief in Tafas v. Dudas Appeal," July 22, 2008
• "Save the Date -- Initial Scheduling of the Tafas/GSK v. Dudas Appeal," May 21, 2008
• "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
• "BIO Responds to Events of the Day," April 1, 2008
• "No April Fool's Joke -- Tafas and GSK Win on Summary Judgment," April 1, 2008
• "PLI's John White Discusses Tafas/GSK v. Dudas," February 11, 2008
• "Judge Cacheris Takes GSK Case under Advisement," February 8, 2008
• "GSK Summary Judgment Hearing Set for Friday Morning," February 7, 2008