Patent Docs: District Court

District Court

January 05, 2011

August 06, 2010

USPTO Acts Quickly to Comply with Court Order

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

Posted at 10:33 AM in District Court, Food and Drug Administration, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

August 04, 2010

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).

Posted at 06:27 PM in District Court, Food and Drug Administration | Permalink | Comments (8) | TrackBack (0)

July 12, 2010

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)").

Posted at 11:59 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (11) | TrackBack (0)

June 16, 2010

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

Posted at 07:58 PM in District Court, Federal Circuit, Patentable Subject Matter | Permalink | Comments (5) | TrackBack (0)

April 01, 2010

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."

Posted at 11:58 PM in District Court, Patentable Subject Matter | Permalink | Comments (11) | TrackBack (0)

March 29, 2010

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

Posted at 11:59 PM in District Court, Patentable Subject Matter | Permalink | Comments (22) | TrackBack (1)

January 19, 2010

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

Posted at 11:51 PM in District Court, Patentable Subject Matter | Permalink | Comments (10) | TrackBack (0)

November 02, 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

Posted at 10:29 PM in District Court, Patentable Subject Matter | Permalink | Comments (4) | TrackBack (0)

February 08, 2009

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

Posted at 11:57 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

January 12, 2009

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

Posted at 11:57 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

January 05, 2009

December 03, 2008

More Patentees Follow Wyeth's Lead in Seeking Additional PTA

By Donald Zuhn --

As we reported yesterday, Director Jon Dudas of the U.S. Patent and Trademark Office filed a Notice of Appeal in the District Court for the District of Columbia on November 28th, appealing the Court's decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit (see "USPTO to Appeal Wyeth v. Dudas"). As we noted earlier this fall in our summary of the Wyeth case, the decision could significantly impact the manner in which the Patent Office makes Patent Term Adjustment (PTA) determinations (see "Wyeth v. Dudas (D.D.C. 2008)").

The Wyeth decision, however, has already had a significant impact in that a number of suits have been filed against Director Dudas asserting improper PTA determinations. In November, we reported on the first two patentees to follow in Wyeth's footsteps by filing complaints against Director Jon Dudas for similar PTA "miscalculations" (see "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA"). In particular, on September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint in the District Court for the District of Columbia, asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) should be 1007 days rather than the 453-day period calculated by the Patent Office. On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) should be 702 days rather than the 411-day period determined by the Office.

Recently, four more patentees filed complaints against USPTO Director Jon Dudas contending that the Patent Office's PTA determinations were incorrect. On the same day that Director Dudas filed his Notice of Appeal, Solvay Pharmaceuticals GmbH of Hannover, Germany, filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,729 (issued June 3, 2008) should be 633 days rather than the 534-day period calculated by the Patent Office (see complaint). And on Monday, three more patentees followed suit. These patentees include:

• Biogen Idec Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,560 (which issued June 3, 2008) should be 2,058 days rather than the 1,409-day period determined by the Office (see complaint);

• Purac Biochem B.V. of the Netherlands, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,410,556 (which issued August 12, 2008) should be 949 days rather than the 386-day period determined by the Office (see complaint); and

• Molecular Insight Pharmaceuticals, Inc. of Cambridge, MA, which filed a complaint asserting that the correct PTA for U.S. Patent No. 7,381,399 (which issued June 3, 2008) should be 1303 days rather than the 634-day period determined by the Office (see complaint).

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," three of the four patentees above had little choice but to file complaints seeking additional PTA (while Purac had until February 8, 2009 to file its complaint, the other three patentees had until Sunday, November 30th to file their complaints). And now that the Patent Office has decided to fight Judge Robertson's decision in Wyeth, patentees facing similar situations will be forced to file complaints to obtain additional PTA. 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 additional information regarding this and other related topics, please see:

• "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

Posted at 05:24 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (5) | TrackBack (0)

December 02, 2008

USPTO to Appeal Wyeth v. Dudas

By Donald Zuhn --

Last Friday, U.S. Patent and Trademark Office Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's September 30th decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit. Director Dudas challenges District Judge James Robertson's grant of summary judgment to plaintiffs Wyeth and Elan Pharma International Ltd. and denial of summary judgment to Director Dudas.

As we reported in October, the Wyeth decision could have a significant impact on the manner in which Patent Term Adjustment (PTA) determinations are made. In particular, the Wyeth Court determined that the U.S. Patent and Trademark Office 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 the case 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 plus B delay less A delay that overlaps with B delay less applicant's delay

In November, we reported that two patentees had followed in Wyeth's footsteps by filing complaints in the District Court for the District of Columbia against Director Jon Dudas for similar PTA "miscalculations." On September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) is 1007 days rather than the 453-day period calculated by the Patent Office. On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) is 702 days rather than the 411-day period determined by the Office. Both complaints question the Office's interpretation that the B delay period begins on the date of an application's filing.

We thank the Patent Docs reader who brought the Director's Notice of Appeal to our attention.

For additional information regarding this and other related topics, please see:
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008

Posted at 11:38 PM in District Court, Patent Litigation, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

October 16, 2008

Wyeth v. Dudas (D.D.C. 2008)

District Court Decision Impacts PTA Determinations

By Donald Zuhn --

On September 30th, the District Court for the District of Columbia granted summary judgment in favor of Wyeth, determining that the U.S. Patent and Trademark Office 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 (see Memorandum Opinion and Order). The case, which was decided by Judge James Robertson, should be of interest to patent practitioners, patentees, and assignees for at least two reasons. First, Judge Robertson's decision impacts the manner in which Patent Term Adjustment (PTA) is calculated, and thus, potentially affects the patent terms of numerous patents. Second, Judge Robertson's opinion includes an interesting analysis of the type of deference the USPTO is owed for its interpretations of provisions of Title 35.

At issue in Wyeth was the interplay between two of the patent term guarantee provisions of § 154(b)(1). According to the Court, these provisions provide "a one-day extension of patent term for every day that issuance of a patent is delayed by a failure of the PTO to comply with various enumerated statutory deadlines: fourteen months for a first office action; four months to respond to a reply; four months to issue a patent after the fee is paid; and the like" (see § 154(b)(1)(A)) and "a one-day term extension . . . for every day greater than three years after the filing date that it takes for the patent to issue, regardless of whether the delay is the fault of the PTO" (see § 154(b)(1)(B)). The Court labeled the periods of delay encompassed by § 154(b)(1)(A) as "A delays" or "A periods," and the "[t]he period that begins after the three-year window has closed . . . as the 'B delay' or the 'B period.'" The above delays are subject to the limitations of § 154(b)(2)(A), which states that:

To the extent that periods of delay attributable to grounds specified in paragraph (1) overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed.

The Court described the above provision as being "manifestly intended to prevent double-counting of periods of delay," explaining that "[p]roper interpretation of this proscription against windfall extensions requires an assessment of what it means for 'periods of delay' to 'overlap.'" In a Federal register Notice entitled "Explanation of 37 CFR 1.703(f) and of the United States Patent and Trademark Office Interpretation of 35 U.S.C. 154(b)(2)(A)" (69 Fed. Reg. 34238), the Office states that:

If an application is entitled to an adjustment under 35 U.S.C. 154(b)(1)(B), the entire period during which the application was pending before the Office (except for periods excluded under 35 U.S.C. 154(b)(1)(B)(i)-(iii)), and not just the period beginning three years after the actual filing date of the application, is the period of delay under 35 U.S.C. 154(b)(1)(B) in determining whether periods of delay overlap under 35 U.S.C. 154(b)(2)(A).

Summarizing the USPTO's take on § 154(b)(2)(A), the Court states that "the PTO's view is that any administrative delay under § 154(b)(1)(A) overlaps any 3-year maximum pendency delay under § 154(b)(1)(B): the applicant gets credit for 'A delay' or for 'B delay,' whichever is larger, but never A + B." Wyeth, however, argued that the "A period" and "B period" overlap only if they occur on the same calendar day or days. The parties' different perspectives on an exemplary PTA calculation can be represented schematically as follows (using the example presented in Judge Robertson's opinion):

The USPTO's view (shown above): the patentee is entitled to three years of PTA.

Wyeth's view (shown above): the patentee is entitled to four years of PTA.

The Court determined that Wyeth's construction of § 154(b)(2)(B) was correct, stating that "[t]he only way that [A and B] periods of time can 'overlap' is if they occur on the same day." Thus, in the example shown above, Wyeth's calculation is the correct one. According to the Court, "[t]he problem with the PTO's construction is that it considers the application delayed under § 154(b)(1)(B) during the period before it has been delayed" (original emphasis).

Judge Robertson acknowledged the reasonableness of the Office's argument that "'A delays' during the first three years of an applications' pendency inevitably lead to 'B delays' in later years," and thus "if plaintiffs' construction is adopted, one cause of delay will be counted twice: once because the PTO has failed to meet and administrative deadline, and again because that failure has pushed back the entire processing of the application into the 'B period.'" However, the Court concluded that while the Patent Office's efforts to prevent "windfall extensions" may be reasonable, and were maybe even consistent with Congress' intent, the Office's interpretation "must square with Congress's words. If the outcome commanded by that text is an unintended result, the problem is for Congress to remedy, not the agency."

In view of the pending appeal in Tafas v. Dudas (see "PTO Files Reply Brief in Tafas v. Dudas Appeal"), the opinion in Wyeth is also intriguing for what it says about the deference owed the Patent Office for its interpretations of provisions of Title 35. The Court first determined that the Office's interpretation was not entitled to deference under Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). Citing Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996), the Court noted that "the Federal Circuit has held that the PTO is not afforded Chevron deference because it does not have the authority to issue substantive rules, only procedural regulations regarding the conduct of proceedings before the agency." Moreover, the Court found that under 35 U.S.C. § 154(b)(3)(A), "the authority of the PTO is limited to prescribing 'regulations establishing procedures for the application for and determination of patent term adjustments under this subsection'" (emphasis added by District Court). Comparing the rulemaking authority set forth by this provision with the rulemaking authority set forth in § 154(b)(2)(C)(iii), the Court concluded that it was "clear that the PTO's authority to interpret the overlap provision is quite limited," and therefore, that "Chevron deference does not apply to the interpretation at issue here." The Court further explained, however, that even if the Office was entitled to Chevron deference with respect to its interpretation of § 154(b)(2)(B), such deference "would not save the PTO's interpretation . . . because it cannot be reconciled with the plain text of the statute" (as discussed above).

While the Wyeth decision impacts the manner in which patent practitioners, patentees, and assignees will calculate PTA for patents that will soon be issuing, Wyeth also impacts the proper PTA for patents that have already issued -- up to a point. That "point" is specified in 37 C.F.R. § 1.705(d), which states that:

If the patent indicates or should have indicated a revised patent term adjustment, request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued and must comply with the requirements of paragraphs (b)(1) and (b)(2) of this section. Any request for reconsideration under this section that raises issues that were raised, or could have been raised, in an application for patent term adjustment under paragraph (b) of this section shall be dismissed as untimely as to those issues.

(Emphasis added.) Thus, if a patent is entitled to more PTA under Wyeth, but that patent issued on or before August 12, 2008 (the selection of a cut-off date is based on the fact that patents issue on Tuesdays), § 1.705(d) would preclude a patentee from requesting reconsideration of the PTA determination (unless, of course, the patentee was willing to follow Wyeth's lead and file suit, or alternatively, the USPTO decided to suspend the provisions of § 1.705(d)). As a point of reference, a simple search of the USPTO Patent Full-text and Image Database identified 15,266 patents issuing between August 16, 2008 and October 16, 2008 (from applications filed between May 29, 2000 and October 16, 2005) that might be entitled to more PTA. A second search of the patent database identified 3,738 patents issued between July 30, 2008 (two months prior to the Wyeth decision) and August 15, 2008 (from applications filed between May 29, 2000 and October 16, 2005) in which requests for reconsideration would be precluded under § 1.705(d). And of course, one would expect that an even greater number of patents issued prior to July 30, 2008 would be entitled to greater PTA periods under Wyeth. In view of the latter two categories, the patent community will anxiously await the Patent Office's response to Wyeth.

We wish to thank the Patent Docs reader (who has asked not to be named) for bringing this case to our attention.

Posted at 11:50 PM in District Court, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)

October 13, 2008

Amgen v. Hoffmann-LaRoche: Remaining Issues

By Kevin E. Noonan --

District_court_for_the_district_of_ On October 2, 2008, Judge William Young of the District Court of the District of Massachusetts issued his 150-page opinion in Amgen Inc. v. F. Hoffmann-La Roche Ltd. , Amgen's patent infringement suit over Roche's Mircera® drug product (see "Victory for Amgen in District Court Decision - Part I"). On October 23, 2007, Amgen received a jury verdict that Amgen's patents-in-suit (U.S. Patent Nos. 5,547,933; 5,441,868; 5,618,698; 5,955,422; and 5,756,349) were not invalid and Mircera® infringed the claims of the '933, '868 and '698 patents (see "Amgen Survives Another EPO Challenge"). Thereafter, Judge Young entered a preliminary injunction to prevent Roche from putting Mircera® on the market while the Court prepared its opinion. On Friday, the Federal Circuit affirmed the preliminary injunction without an opinion, under Federal Circuit Rule 36 (see "Amgen v. Hoffmann-LaRoche: Back to the District Court").

Federal_circuit_seal The Federal Circuit considered none of Judge Young's findings of fact and conclusions of law, maintaining that none of these issues were before the CAFC since Judge Young was precluded from entering a final judgment until after the Federal Circuit made its decision and returned jurisdiction to the District Court. These decisions by the District Court included: 1) affirming the jury's infringement decision by denying Roche's motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the '422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen's patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims 3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction. Previous Patent Docs posts have discussed the obviousness-type double patenting (Part I) and permanent injunction (Part II) aspects of the District Court's decision. Here, we discuss some of the remaining grounds for the Court's deciding this case in Amgen's favor.

Roche_2 The Court denied Roche's motions for judgment as a matter of law (JMOL) that Amgen's claims were invalid. Although the Court noted that Roche's motion raised issued of invalidity on the grounds of anticipation, obviousness, indefiniteness, and non-enablement, the Court addressed two of these arguments: first, that the claims of the '422 patent were anticipated by the Goldwasser study, and second that the term "human erythropoietin" is indefinite.

Amgen Regarding the anticipation argument, this was ground well-traveled and familiar to the Court. Hoechst Marion Roussel (HMR) used the same prior art study of Goldwasser to support the same anticipation argument in Amgen Inc. v. Hoechst Marion Roussel, Inc., and the court there, as the Court here, found claim 1 of the '422 patent not to be anticipated when the Goldwasser study was applied as a § 102 reference. In this case, the Court gave effect to the limitation "purified from mammalian cells grown in culture" to distinguish over the Goldwasser EPO preparations that were made from urine, as a matter of law based on the Court's claim construction. The Court construed claim 1 of the '422 patent as reciting 5 elements:

A [1] pharmaceutical composition comprising a [2] therapeutically effective amount of [3] human erythropoietin and a [4] pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is [5] purified from mammalian cells grown in culture.

The Court said that Roche tried to improperly shift the invalidity burden to Amgen, by arguing that Amgen was required to show that the "source" limitation "imparts novel structure to an otherwise non-novel product." As for the propriety of finding that the process/source limitation was a substantive limitation, the Court found that it was a well-established way of distinguishing claimed subject matter over the prior art. This conclusion was based, in part, on Dr. Lin's testimony that "'the only way [to] characterize [his claimed] product is by the way they were making [it]'." This claim construction was affirmed by the Federal Circuit in Amgen Inc. v. Hoechst Marion Roussel, Inc. (although in that case the issue was whether the term could be construed to mean that the EPO product was purified from the culture media as opposed to being purified from the cells themselves). The Court also noted that there were "observed distinctions" between "recombinant EPO [rEPO] and the urinary EPO [uEPO] employed by Goldwasser." These included what the Court termed "critical distinctions" in glycosylation and specific activity in vivo, which "may . . . reflect recombinant EPO's resistance to degradation in the human body," which the Court cited as reasons for imbuing the source limitation as a real limitation on the EPO product claim

"It is also significant that the source is what enables mass production and commercial viability," according to the Court. In the Court's view, the simple fact is that the prior art Goldwasser method would require a drug manufacturer to "scour the world" for aplastic anemia patients whose urine could be processed to produce purified uEPO, "transforming the company into a glorified urine collection agency." The "genius," in part, of rEPO is that it frees drug manufacturers from this dependency on urine as a source of EPO, according to the opinion.

Procedurally, the Court also disagreed with whether the issue was a question of fact for the jury, casting the question not as whether Amgen's claim 1 of the '422 patent was anticipated but on the question of claim construction. The Court said that Roche's arguments were contrary to Markman v. Westview Instruments, Inc., wherein the meaning of claims is a question of law solely within the province of the court. According to the District Court, having construed the "purified from mammalian cells grown in culture" limitation as discussed above, no jury could decide that the Goldwasser reference anticipated, since Goldwasser taught uEPO, and the Court cited In re Luck for the principle that process limitations in a product claim "must be given the same consideration as traditional product characteristics."

The Court also based its decision on its conclusion that imposing on Amgen the burden argued by Roche would contravene the statutory presumption of validity. The Court distinguished Roche's authority to the contrary, In re Moeller, 117 F.2d 565 (CCPA 1941), by pointing out that the Moeller case was an appeal from a decision of the PTO Board of Appeals, where the presumption of validity does not apply. The Court was also unpersuaded by Roche's argument that the distinctions between rEPO and uEPO were undefined, and that it was possible that an rEPO preparation could be identical to the uEPO preparation of Goldwasser, saying that any such speculation failed to satisfy Roche's burden of establishing invalidity by clear and convincing evidence.

Finally, the Court noted that its construction, that the source is a substantive limit on the product in the claim, has been twice appealed to the Federal Circuit and twice affirmed:

As to the '422 patent, the limitation "purified from mammalian cells grown in culture" in claim 1 clearly limits the source of the EPO used in the claimed "pharmaceutical composition." The limitation only speaks to the source of the EPO and does not limit the process by which the EPO is expressed. Rather, the claim is broadly drawn to a "pharmaceutical composition" having certain elements, one of those being EPO "purified from mammalian cells in culture." This reading is in line with the district court's construction.

Turning to Roche's allegations that the claims of the '422 patent (claim 1) and '933 patent (claims 3, 7, and 9) were indefinite for reciting "human erythropoietin," the Court said that the "touchstone" of the indefiniteness inquiry is whether the skilled worker would understand what was being claimed. This question, according to the Court, was addressed by competing expert testimony (Dr. Lodish for Amgen and Dr. Flavell for Roche). However, the Court said that its role was not to re-weigh the evidence but to determine whether the evidence provided "a sufficient basis for a reasonable jury to conclude Roche failed to prove indefiniteness by clear and convincing evidence." The Court found that it did, saying that the claims are sufficiently definite even if the specification is unclear on whether it is 165-166 amino acids. Part of the basis for the Court's decision is that "in fields of new and evolving knowledge . . . claims can be no more precise than the knowledge of the field permits" (citing PharmaStem Therapeutics Inc v. Viacell, Inc., 491 F.3d 1342, 1373 (Fed. Cir. 2007)). Roche argued that the disclosure in the specification of undefined "mutants, analogs and allelic variants" as falling within the scope of the term "human erythropoietin" was enough to render the term indefinite, and the Court disagreed. The Court also opined that Roche's "focus on the number of amino acids" (165 or 166) was "misplaced," since the Court's construction of the phrase did not require that the amino acid sequence have a precisely-defined length.

Mircera Finally, the Court denied Roche's motion for JMOL on the question of infringement, based on evidence that Roche's Mircera® drug product contained erythropoietin that fell within the scope of Amgen's claims. In doing so, the Court rejected Roche's theory that Mircera® should be considered as a "single molecule" (i.e., peg-EPO), but rather characterized it as rEPO modified by conjugation with polyethylene glycol. In the Court's view, "[p]egylation merely attaches a sugar, via a single carbon bond, to a recombinant glycoprotein with the patented amino acid sequence; it does not alter the patented properties of EPO." This alteration was not sufficient for the Court to overturn the jury verdict of infringement. In support of its decision, the Court cited testimony, internal Roche documents, and Roche's representations to the FDA to the effect that peglylating rEPO did not change its "amino acid sequence, glycosylation or carbohydrate content," i.e., that Mircera® retained rEPO's biological properties.

For additional information regarding this topic, please see:

• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision - Part III," October 9, 2008
• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007

Posted at 11:55 PM in District Court, Federal Circuit, Injunction | Permalink | Comments (0) | TrackBack (0)

October 09, 2008

Victory for Amgen in District Court Decision - Part III

By Kevin E. Noonan --

District_court_for_the_district_of_ As Patent Docs has reported (see Part I and Part II), last week District Court Judge William G. Young (D. Mass) issued a 150-page decision on post-trial motions and a permanent injunction, and provided his rationale for a number of pretrial summary judgment motion decisions, in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. The District Court was precluded from entering final judgment in the case, however, because Roche had appealed a preliminary injunction entered by the Court on February 28, 2008, a decision that kept Roche from putting Mircera® on the market while the Court prepared its opinion. Instead, the Court ordered the case "administratively closed" until the Federal Circuit renders its decision on the appeal.

Federal_circuit_seal Oral arguments on that appeal occurred yesterday, and the consequences of Judge Young's eleventh hour decision-making were fully appreciated by both the parties and the CAFC (audio of oral arguments on this appeal can be found here). The panel, consisting of Judge Rader, presiding, joined by Judges Gajarsa and Plager, began the proceedings by admonishing counsel that the only issue before the Court was the preliminary injunction; Judge Young's opinion was not in the record and was not at issue in this appeal.

Roche The Court asked Roche's attorney, Leora Ben-Ami, what Roche wanted them to do, and she responded by saying the Court should consolidate the appeal of the preliminary injunction with Roche's appeal of Judge Young's decision(s) below. The Court aggressively challenged the idea of consolidating -- there was "nothing to consolidate." Ms. Ben-Ami responded that in Roche's view, the District Court had come to a final judgment, but the panel told her "[w]e do not have a paper that says 'Judgment?'" They said they don't have it, and (facetiously) asked her to forward it to the bench. The panel said they have an opinion, but not a judgment, and the rules require a judgment.

Ms. Ben-Ami conceded that it was "an unusual circumstance," and while the Court agreed, and agreed that they could take judicial notice of the existence of the opinion (but not taking judicial notice of its contents), they could not take judicial notice "of a judgment that doesn't exist."

Ms. Ben-Ami also asked the Court to find on the merits that Amgen's patents were invalid for obviousness-type double patenting, which produced (amongst a gale of laughter from the bench) the admonition that the Court needed a record and they did not have it. Ms. Ben-Ami persisted that they did have a sufficient record to decide substantive issues. In this case, she asserted, unlike the typical preliminary injunction case, the Court had a complete trial record. Yes, the Court agreed, but they did not have the judge's findings of fact and conclusions of law. How were they to proceed without that, the Court asked her? Ms. Ben-Ami responded that Roche had been very careful to only ask the Court to decide questions of law, for which they need give no deference to Judge Young's decision below, and so didn't need anything more from Judge Young.

The panel persisted, asking her how they could address these issues on the procedural posture of the case. She said they could vacate the preliminary injunction and require the District Court to enter judgment and move the case back up to the Federal Circuit. This suggestion was also not well-received by the panel, who asked her what basis would they have to vacate the injunction? When Ms. Ben-Ami responded with the "likelihood of success" prong of the standard, the Court countered that they have a trial verdict that Judge Young agreed with, giving them no basis for vacating the injunction on that ground.

In response to a (seemingly sincere) question of whether Roche was merely being frugal in asking the Court to get to the merits here, Ms. Ben-Ami asserted that this wasn't a case about "ball-bearings or widgets," but was a case where the proceedings were keeping a drug from patients who needed it. She reminded the Court that the FDA had approved Mircera® as a new drug with a different label than Amgen's EPO products, and that Mircera® was approved and being sold in Europe. When she brought up Judge Young's evidentiary rulings that prevented the jury from being told about FDA's determination that Mircera® is a "new chemical entity" and that it was being sold in Europe, the panel reminded her that the jury wasn't being asked to decide that question: the issue before the jury was "something called patent infringement . . . it's a little different."

The Court returned to the question of what they could do to expedite the case towards resolution. Ms. Ben-Ami repeated the idea that they vacate the preliminary injunction, based on the likelihood of success. Faced with the panel's resistance to this suggestion, Ms. Ben-Ami argued that the questions Roche asked the Court to decide -- whether continuation applications fell within the ambit of 35 U.S.C. § 121, how should the statute be construed, and the issue of claim construction -- were all questions of law. She told the panel that they had the views of the trial judge from the Markman hearing and jury instructions. Ms. Ben-Ami also contended, in answer to a question from the panel, that Roche would agree to an expedited briefing schedule should the panel give her the relief Roche sought by vacating the injunction.

Amgen The Court next heard from Amgen, represented by Rusty Day. He told the panel he had an answer to the question of what they should do. The answer was either to affirm the preliminary injunction, or dismiss the appeal and remand so Judge Young could enter judgment. Either resolution would get the case to final judgment and ready for a merits panel to address the substantive issues, he said. Consolidation would not achieve that result, Mr. Day asserted, reminding the panel that consolidation disregards Amgen's right to appeal. (To which the panel responded that there was nothing to consolidate.) Mr. Day suggested that entry of a permanent injunction would moot the appeal, but the panel disagreed -- on the record before them there was no basis for mooting the appeal. The panel also said they would be "hard-pressed" to find grounds to dismiss.

The Court then asked Mr. Day, what would be the implications if they affirmed (without deciding the substantive issues)? What would Amgen argue was the precedential effect of an affirmance? Mr. Day responded that the District Court had entered the preliminary injunction as a way to preserve the status quo, preventing Roche from launching Mircera®, while Judge Young was writing his opinion. Under these circumstances, Mr. Day said, the only question the panel needed to answer was whether it was an abuse of discretion for Judge Young to enter the preliminary injunction under these circumstances.

The panel asked Mr. Day whether he was ready to agree to an expedited briefing schedule, and while he didn't refuse, he did remind the Court that Roche had filed its notice of appeal with 26 issues to be appealed, and whether briefing could be expedited would depend on what was being appealed. He did respond to the panel that the Federal Circuit could expect that Amgen would file a notice of appeal once the District Court entered final judgment. And he reminded the panel that, although Roche had filed its notice of appeal either last Friday or Monday and it was a valid notice, it did not take effect until the District Court entered final judgment, so merely filing the notice did not "move the case forward."

In her rebuttal time, Ms. Ben-Ami again argued the equities, that Roche had been precluded from putting its FDA-approved drug on the market, and that any procedural scenario the Court was considering would result in further delay. The panel posed a hypothetical, wherein the Court did reach the merits, and found some issues in favor of Roche and some in favor of Amgen. They would have to remand, asking whether that wouldn't also result in delay, since the District Court would then have another trial and have to write another opinion, even without an injunction, that would return the case to the Federal Circuit in a year or so? What have we achieved, asked the panel? Ms. Ben-Ami argued a result expediting resolution of the case could occur from the Court deciding dispositive issues now, but the panel resisted the idea of "piecemealing" the record to reach a decision on the issues. The panel said they understood the importance of these issues, that they "don't want people dying," but that they cannot see a way to shorten the time it will take to reach a resolution on the procedural posture of the case. Ms. Ben-Ami's final argument to the Court was that they could order Judge Young to enter final judgment immediately, which raised another chuckle; the panel asked, don't you think Judge Young is waiting by his telephone for their opinion? Ms. Ben-Ami's final request, that the Court also order Judge Young to expedite his decision on any post-judgment motions Amgen might file, met with little sympathy: "They [Amgen] have their rights," said the Court, and "you have yours."

The Court's decision should be available in the next few months.

For additional information regarding this topic, please see:

• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007

Posted at 11:28 PM in District Court, Federal Circuit, Injunction | Permalink | Comments (0) | TrackBack (0)

October 08, 2008

Victory for Amgen in District Court Decision - Part II

By Kevin E. Noonan --

District_court_for_the_district_o_2 On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. In a 150-page opinion, Judge Young handed Amgen nothing less than a complete victory.

Amgen_2 Amgen procured a jury judgment on October 23, 2007 that Mircera® infringed several Amgen patents, including U.S. Patent Nos. 5,547,933; 5,441,868; and 5,618,698. In addition, the jury found these and two other patents (U.S. Patent Nos. 5,955,422 and 5,756,349) not to be invalid (see "Amgen Survives Another EPO Challenge"). The District Court entered a preliminary injunction on February 28, 2008, which prevented Roche from launching Mircera® (the FDA approved Mircera® in November 2007). In entering the preliminary injunction, Judge Young assessed whether Amgen was entitled to an injunction using the four-factor test set forth by the Supreme Court in eBay Inc. v. MercExchange, L.L.C. Judge Young found that Amgen satisfied all the eBay requirements except the public interest prong. The District Court expressly did not enter any findings on the fourth prong, but left open the possibility that the injunction could be modified under four conditions. Roche agreed to the Court's conditions (see "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction"), but Amgen did not, and the Court appointed a special master to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared (see "Court Still Cannot Decide on Amgen's Permanent Injunction"). Roche responded by filing its notice of appeal to the Federal Circuit on April 11, 2008 (see "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit"); that appeal was scheduled to be argued today (October 8).

In last Thursday's ruling, the District Court ruled in Amgen's favor on all issues. An earlier post discussed the Court's reasoning on its decision that the claims are not invalid under the judicially-created doctrine of obviousness-type double patenting (ODP) (see "Victory for Amgen in District Court Decision - Part I"). This post will discuss the Court's reasons for granting a permanent injunction to Amgen (subject to Roche's appeal of the preliminary injunction, or a consolidated appeal that Roche may file in response to this decision). The remaining grounds for the Court's decision will be addressed in future posts.

The Court first reiterated its earlier opinion that Amgen fulfilled the first three of the four equitable considerations enunciated by the Supreme Court in eBay: Amgen's asserted claims were infringed and not invalid; Amgen's injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction. The District Court opined that while eBay has made it easier to deny an injunction to a non-practicing entity (aka a "patent troll"), in the Court's view eBay "changed little where a prevailing plaintiff seeks an injunction to keep an infringing competitor out of the market." (The Court stated that, with but two exceptions, district courts have granted permanent injunctions in 26 cases where infringement was found between direct competitors.) The Court also opined that the Supreme Court "does not appear to have intended eBay to be pathbreaking precedent," calling the decision a "barebones majority opinion" that did "little more than remind court[s] that they must exercise discretion in accordance with the framework Congress approved" (i.e., that a court "may" enter an injunction "in accordance with the principles of equity," see 35 U.S.C. § 283).

Mircera The District Court then discussed the factors it considered in determining whether the public interest would favor granting Amgen a permanent injunction. Judge Young conceded that, initially, he was inclined to decide in Roche's favor, on the grounds that introducing Mircera® would increase competition in the pharmaceutical market place and reduce prices accordingly. The Court was not willing to rest on this initial assumption, however, but held "extensive evidentiary hearings" on the effects of permitting Roche to introduce Mircera®, as well as appointing both a special master and a technical advisor to help the Court understand the economics of the pharmaceutical industry. The result was that "[t]he Court's initial impression [did] . . . not withstand a reflective and detailed analysis."

In coming to its decision, the Court identified three factors it balanced in considering the public interest: patient health, Medicare savings, and "the public's interest in a robust patent system." With regard to patient health, the Court found no compelling evidence that the more limited dosing Roche asserted for its Mircera® produce would greatly increase benefits to patients. The Court's conclusion was based to some extent on how erythropoiesis stimulating agents (ESAs) like Mircera® are administered: kidney dialysis patents, for example, receive dialysis three times a week, so more frequent administration of an ESA has no effect on the patient (albeit perhaps incurring additional ancillary administrative costs). The Court also credited expert testimony that more frequent dosing may have beneficial effects in titrating the effect of the drug, leading to more stable and consistent red blood cell levels. The Court also considered the benefits of reducing the "vulnerability" to patients from manufacturing problems stemming from a sole source of approved ESAs, as well as "expanding the armamentarium" available to physicians to treat anemia.

On the other hand, the Court considered testimony that the longer dosing intervals achieved with Mircera® were associated with greater variability in blood hemoglobin levels, and with some evidence from clinical trials that there was a greater mortality rate for patients treated with pegylated erythropoietin. The Court appreciated that the parties' experts would disagree on the relative patient benefits of their respective products. The Court took a slightly longer view of the question, however, in terms of the risks associated with introducing a new product into a treatment regimen:

[O]ne set of facts is clear and warrants particularly strong consideration. Although clinical studies in support of a Biologics License Application at the United States Food and Drug Administration or at the European Medicinal Evaluation Agency frequently involve several thousand patients, it often takes many years before the medical community learns how new therapies are to be used safely and effectively, for what patients and at what doses, and conditions under which their use is not advised. As physician/patient experience accumulates and scientific evidence evolves, the benefit/risk calculation underlying treatment often shifts as well.

The Court noted that even for Amgen's erythropoietin products (Aranesp® and Epogen®) the FDA was continuing to evaluate risks and changing labeling requirements and treatment guidelines (see "FDA Makes Changes in Erythropoietin Labeling"), despite their longevity as approved drugs (Epogen® was launched in 1989 and Aranesp® in 2001).

The Court concluded that:

Given that both the FDA and the European Medicines Agency have approved MIRCERA as safe and effective for the treatment of anemia in patients with chronic renal failure, it seems likely that some patients might well benefit from MIRCERA being on the market as an additional element in the physicians' armamentarium due to clinical, convenience, and quality-of-life concerns. Nevertheless, with major changes in recommended treatment modalities still occurring many years after the initial product launch for currently available ESAs, it is also plausible that, were MIRCERA allowed to be marketed in the United States, information and consensus on its risk/benefit profile relative to those of EPOGEN, Procrit, and Aranesp would also evolve and change, perhaps substantially. . . . Hence, it is difficult if not impossible to predict with any reasonable level of confidence what the net clinical, convenience, and quality-of-life benefits of Mircera will be relative to those of the existing ESAs.

Roche_2 Turning to the second consideration, Medicare savings, the Court set forth a detailed "primer" on drug pricing under Medicare. This factor was an important consideration for the Court because "government purchasers comprised approximately 80% of EPOGEN sales," with 75 of that 80% being incurred under the Medicare Part B program. The Court acknowledged the assistance of "Ernest Berndt, an applied economics professor at the Massachusetts Institute of Technology Sloan School of Business," a court-appointed special master and technical advisor on these matters. (A detailed explication of this analysis would overly burden this post and risk introducing inaccuracies into the Court's careful analysis; thus, only a brief synopsis of the Court's conclusions is provided here.) Simply put, under the complex scheme for calculating reimbursements to drug providers and physicians, the Court found that introducing a new drug into an established market was likely to have the paradoxical effect of causing drug prices to increase. In this case, such increases could arise from Roche charging at least as great a price for Mircera® as Amgen charges for Aranesp® or Epogen®. The Court was clear to acknowledge that this outcome was the result of Medicare's method for calculating reimbursement rates, which provided an incentive to keep ESA prices high. The Court also noted that Amgen's expert testified that there were at least three differences between "textbook" or "plain vanilla" competition and competition between drug providers caused by Medicare reimbursement policies: first, that under Medicare it is the physician rather than the patient that makes drug choice decisions; second, that end-users (i.e., patients) pay only a small fraction of the drug costs, thereby reducing patient incentive for cheaper drugs; and third, "perhaps most important," "providers are drawn to the drugs that offer the largest difference between the amount the provider is reimbursed . . . under Medicare . . . and that the provider actually paid for the drug," a difference the Court said is called "cost recovery" in the industry.

The result of this economic analysis convinced the Court that Roche was "likely to enter the market at a price higher than that of Amgen's products and to maintain high prices over time." This conclusion was supported by testimony from Roche witnesses that cost recovery was "a major factor" in developing Roche's pricing strategy for Mircera®. The Court also recognized that Roche's pricing behavior would be dependent, in part, on Amgen's reaction to Mircera® entering the market. And on top of these uncertainties, the Court also recognized that Congress and administrative agencies could alter the Medicare drug reimbursement calculation at any time and in unpredictable ways. On balance, the Court concluded that Mircera® market entry was unlikely to reduce Medicare costs for ESA products, saying that "[i]t is simply impossible to predict with certainty the effect that MIRCERA's entry would have on prices and, accordingly, on Medicare expenditures."

Finally, the Court opined that "[p]ermitting Roche to enter the [ESA] market would undermine the incentives for innovation" provided by patenting. The Court relied on testimony from Amgen's CEO on the importance of patents in protecting pharmaceutical innovation, citing statistics on the cost of bringing a successful drug to market, and more importantly, the costs associated with the very many more failures incurred for every successful drug product.

The Court synopsized these considerations, and its ultimate determination, as follows:

If the Court allowed Roche to introduce MIRCERA into the market, perhaps a few patients would benefit, and maybe Medicare would save a few dollars. These arguments, however, could be made for almost any infringing drug. Were courts to refuse injunctions on the basis of such speculation, then pharmaceutical patents would be worth far less than they are today because they would no longer include a right to exclude infringers from the market. The diminishing returns would disincentivize research and development for pathbreaking drugs by lowering the expected value of discovery. By contrast, granting injunctions encourages companies to devote their energies toward developing drugs that
will satisfy unmet medical needs.

As for the equities, as to Roche:

At bottom, Roche attached a sugar to a patented protein. As the jury concluded, this was not innovation. Of course, Roche's efforts to modify Amgen's patented product will not go entirely unrewarded. As it stands, European companies such as Roche can profit from building upon American discoveries by producing and selling infringing products in Europe and throughout the rest of the world. Nevertheless, the fact that Roche "built up its manufacturing facility in [Europe] and prepared to market its product was simply a risk it took with eyes open to the" possibility that it would not be permitted to market MIRCERA in the United States.

And as to Amgen:

The Court has relinquished any notion that the long-suffering or terminally ill among our number may rely upon "the benevolence of" pharmaceutical companies. Companies like Amgen invest in risky research and development to discover drugs like EPO because such drugs are worth tens of billions of dollars, period. If America is to continue to be an engine of medical innovation it will be because we protect the right of inventors to exploit the limited monopoly granted in the Patent Clause.

Accordingly:

[T]he Court cannot conclude with any certainty that MIRCERA will save lives or money. Failure to enter a permanent injunction, however, would risk undermining the incentives for innovation that have produced, and hopefully will continue to produce, medical advances that extend and enhance the value of life. The Court therefore concludes that the public interest will not be disserved by a permanent injunction.

Injunction granted.

For additional information regarding this topic, please see:

• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007

Posted at 10:00 PM in District Court, Injunction | Permalink | Comments (4) | TrackBack (0)

October 06, 2008

Victory for Amgen in District Court Decision - Part I

By Kevin E. Noonan --

District_court_for_the_district_o_3 On October 2nd, District Court Judge William G. Young (D. Mass) issued a decision on post-trial motions and a permanent injunction in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. In a 150-page opinion, Judge Young handed Amgen nothing less than a complete victory.

Amgen_3 Amgen procured a jury judgment on October 23, 2007 that Mircera® infringed several Amgen patents. That verdict found Roche's Mircera® infringed claims 3, 7, and 8 of Amgen's U.S. Patent No. 5,547,933 (claim 12 was found not to be literally infringed but infringed under the Doctrine of Equivalents); claims 1 and 2 of U.S. Patent No. 5,441,868; and claims 6 through 9 of U.S. Patent No. 5,618,698. Two other patents asserted in the litigation were found not invalid: U.S. Patent Nos. 5,955,422 (claim 1) and 5,756,349 (claim 7); and the jury did not reach a determination with respect to infringement and validity for U.S. Patent No. 5,621,080. Amgen's infringed claims were directed to recombinant methods and recombinant EPO protein, and Roche's Mircera® drug product is a form of recombinant EPO that has been covalently linked to polyethylene glycol. In addition, the jury found that Roche had not sustained its burden of establishing that any of Amgen's asserted claims were invalid (see "Amgen Survives Another EPO Challenge ").

Mircera_2 The District Court then entered a preliminary injunction on February 28, 2008 foreclosing Roche from launching Mircera®; Roche had been granted approval by the U.S. Food and Drug Administration to market Mircera® almost a year ago (in November 2007). In entering the preliminary injunction, Judge Young assessed whether Amgen was entitled to an injunction using the four-factor test set forth by the Supreme Court in eBay Inc. v. MercExchange, L.L.C. Judge Young expressly found that Amgen satisfied three of the four requirements (Amgen's asserted claims were infringed and not invalid; Amgen's injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction). However, the Court at that time did not decide in Amgen's favor as to the fourth prong, the public interest, particularly in view of Roche's representations of the advantages of its Mircera® product over Amgen's version of EPO (including inter alia less frequent dosing; see "Long-Acting Drug for Dialysis Anemia Equivalent to Weekly Agent").

Roche_3 The Court left open the possibility that the injunction could be modified under the following four conditions: that Roche would pay Amgen a royalty of 22.5% (Amgen having already rejected an offer for a 20% royalty from Roche; see "Amgen Rejects Roche's Micera [sic] License Payment Offer"); that Roche would introduce Mircera® to the Medicare patient population at a cost no more than the average sales price of Amgen's EPO products (sold under the names Epogen® and Aranesp®); that Roche would have to provide clinical evidence to permit the District Court to determine a "dosage conversion factor" between Mircera® and Epogen®; and that Roche would pay for an independent agency to monitor sales and determine royalty payments owed to Amgen. In addition, Roche would agree to supply Mircera® to any patient needing it, at or below the authorized price. Although Roche ultimately agreed to these conditions (see "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction"), Amgen did not, and the Court appointed a special master to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared (see "Court Still Cannot Decide on Amgen's Permanent Injunction"). Roche responded by filing its notice of appeal to the Federal Circuit on April 11, 2008 (see "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit"); that appeal is scheduled to be argued on October 8th.

In last Thursday's ruling, the Court ruled in Amgen's favor on all issues, including: 1) affirming the jury's infringement decision by denying Roche's motion for judgment as a matter of law (JMOL); 2) reaffirming its pretrial decision to grant summary judgment regarding infringement of claim 1 of the '422 patent; 3) "explaining" its reasoning for ruling, also pretrial, that the claims of Amgen's patents-in-suit are not invalid for obviousness-type double patenting (despite the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.); 4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims 3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting the term "human erythropoietin"; and 5) granting Amgen a permanent injunction barring "Roche, its agents, servants, employees, counsel, and all persons and entities acting in concert therewith" from infringing the claims of the patents-in-suit for the remaining life of those patents.

This post will discuss the Court's reasoning on its decision that the claims are not invalid under the judicially-created doctrine of obviousness-type double patenting (ODP). The remaining grounds for the Court's decision will be addressed in future posts.

The relationships between Amgen's various patents-in-suit, and the earlier-filed '008 patent, are set forth in the following diagram:

Roche argued that the claims of the patents-in-suit were invalid for obviousness-type double patenting (ODP) over claim 10 of U.S. Patent No. 4,667,016:

10. A process for the efficient recovery of recombinant erythropoietin from a mammalian cell culture supernatant fluid, said process comprising the following steps in sequence:
(1) subjecting the fluid to ion exchange chromatographic separation at about pH 7.0, thereby to selectively bind erythropoietin in said sample to a DEAE agarose cationic resin;
(2) stabilizing materials bound to said resin against degradation by acid activated proteases through treatment with urea;
(3) selectively eluting bound materials having a pKa greater than that of erythropoietin by treatment with aqueous acid at a pH of about 4.3.
(4) selectively eluting erythropoietin by treatment with an aqueous salt at a pH of about 7.0;
(5) subjecting erythropoietin -containing eluent fractions to reverse phase liquid chromatographic separation involving an immobilized C.sub.4 resin, thereby to selectively bind erythropoietin in said fluid to said resin;
(6) selectively eluting bound erythropoietin from said resin with an aqueous ethanol solution of about 60 percent at a pH of about 7.0; and,
(7) isolating erythropoietin -containing fractions of the eluent.

The Court denied Roche's summary judgment motion based on claim 10 of the '016 patent pretrial, and granted (in part) Amgen's cross-motion for summary judgment that the claims of its patents-in-suit were not invalid for ODP over both the '016 patent and U.S. Patent No. 4,703,008.

In its October 2nd decision, the Court explained that it had made its determination by application of the "two-way" test for ODP. Under the Court's understanding of Federal Circuit precedent, this was a case of a patent on a "follow-on" invention granting before a patent on an earlier-filed application to an "original" invention. Moreover, the order in which the patents were granted was "a function of a restriction requirement imposed by the PTO," and the claims of the patents in suit were "consonant" with this restriction requirement. Thus, according to the Court, "the claims of the '933, '422, and '349 patents are immune from ODP" over the '016 or '008 patents pursuant to 35 U.S.C. § 121.

The Court set forth its legal analysis: "[i]n most cases, courts employ a 'one-way' test where the court compared the claims according to the order in which the patents issued." There are exceptions to this rule under Federal Circuit precedent, according to the Court, citing In re Berg, 140 F.3d 1428 (Fed. Cir. 1998). These circumstances are the result of "the reality that the Patent Office is perennially underfunded and slow." Accordingly, occasionally patents will issue such that "a patent covering a subsequently conceived follow-on invention" will issue "before the patent covering the underlying invention." Using the two-way test prevents the inequity that would arise from applying the one-way test under circumstances where the internal workings of the Patent Office invert the order in which patents are granted on such "underlying" and "follow-on" inventions.

Which test is to be used is, according to the Court, a matter of law, depending on a two-prong test: first, that an applicant could not have filed the claims in the same (i.e., the earlier-filed) application; and second, that the applicant did not cause a delay in prosecution of the earlier-filed application.

The Court found that any delay in the grant of the earlier-filed application was caused by the Patent Office. The application resulting in the '008 patent (USSN 06/675,298; see diagram) was filed November 20, 1984, while the application resulting in the '016 patent (USSN 06/747,119) was filed on June 20, 1985. Claim 10 is clearly directed to a specific 7-part process for purifying erythropoietin. The Court characterized as "undisputed" that the '016 patent inventors did not conceive of their process until after Amgen filed the '298 application. Under these circumstances, the Court found the first prong of the test was satisfied, that the applicants could not have filed claim 10 of the '016 patent in the earlier-filed '298 application because it had not been invented yet.

As to the second prong, the PTO imposed a restriction requirement on the claims of the '298 application as follows:

I. Claims 1-13, 16, 39-41, 47-54 and 59, drawn to polypeptide, classified in Class 260, subclass 112.
II. Claims 14, 15, 17-36, 58 and 61-72, drawn to DNA, classified in Class 536, subclass 27.
III. Claims 37-38, drawn to plasmid, classified in Class 435, subclass 240.
IV. Claims 42-46, drawn to cells, classified in Class 435, subclass 240.
V. Claims 55-57, drawn to pharmaceutical composition, classified in Class 435, subclass 177.
VI. Claim 60, drawn to assay, classified in Class 435, subclass 6.

Amgen elected to pursue claims in Group II in the '298 application, and the granted claims of the '008 patent were confined to claims from that Group. Amgen also filed two divisional applications, USSN 07/113,178 (having claims from Groups I and VI) and USSN 07/113,179 (having claims from Group I) (see diagram). The Court defined the co-pendency period of the applications resulting in the '008 and '016 patents narrowly (between the time the application resulting in the '016 patent was filed on June 20, 1985 and when it granted on May 19, 1987), and found that during that period Amgen did nothing to delay prosecution of the '298 patent application. "[I]t was the PTO, not Amgen, that caused the later-filed '016 patent to issue before Dr. Lin's '298 application" in the Court's estimation.

The Court expressly rejected Roche's contention that recitation of the term "recombinant erythropoietin from a mammalian cell culture supernatant fluid" in claim 10 of the '016 patent was sufficient to satisfy ODP requirements. The decision characterized as "fatally flawed" the assumption (attributed to Roche by the Court) that the disclosure found in the '016 patent specification was relevant to the question of whether the claims of the patents-in-suit were patentably-distinct over claim 10 of the '016 patent. According to the Court, the Federal Circuit had "made clear that '[d]ouble patenting is altogether a matter of what is claimed," citing General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1277 (Fed. Cir. 1992). The Court expressly distinguished the Federal Circuit decision, relied upon by Roche, in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). Roche argued that this case stood for the proposition that a court can rely on disclosure in the parent specification as well as the parent's granted claims in determining whether claims in a later-granted patent are invalid for ODP. According to Judge Young, the reason that the Federal Circuit considered the specification in Geneva was a part of construing the claims to understand their metes and bounds. Reliance on the specification is not only unnecessary but improper where, as here, that scope and meaning are evident from the express language of the claims of the patents-in-suit and claim 10 of the '016 patent, and thus the Court found that Geneva did not support Roche's position.

The Court also noted that Roche had the burden of establishing ODP by clear and convincing evidence, a burden made more difficult in this case because the Patent Office had twice rejected that argument in finding that the claims of the patents-in-suit were not invalid under ODP over the claims of the '016 patent.

Finally, the Court turned to the question of whether the claims of Amgen's patents-in-suit were entitled to the safe harbor of 35 U.S.C. § 121. In addition to "the express requirements" of § 121 (i.e., the plain meaning of the statute), the Court interpreted Federal Circuit precedent to require "consonance": "the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement," citing Pfizer Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1358, 1359 (Fed. Cir. 2008). Consonance thus required the Court to determine whether the patents-in-suit were the product of applications filed in response to a PTO-imposed restriction requirement, and whether the claims in those patents "remained faithful" to the claim groupings that made up the restriction. In answer to the first question, the Court found that the '178 and '179 applications (that resulted ultimately in the '933, '422, and '349 patents-in-suit; see diagram) were filed in response to the restriction requirement imposed on the '298 application. The Court also found that these claims "remained faithful" to the groupings that made up the restriction. In coming to this conclusion, the Court was persuaded by the fact that none of the claims prosecuted in the '178 or '179 applications, or granted in the '933, '422, or '349 patents-in-suit, were members of restriction Group II that had been elected in response to the restriction requirement in the '298 application and comprised the claims granted in the '008 patent.

In reaching this decision, the Court rejected Roche's argument that Amgen had "broken consonance" by including claims from Groups I and V in the '178 application, and similarly rejected Roche's argument that Amgen's combining claims from Groups V and VII had the same effect during prosecution of the '422 patent. The Court held that these arguments were "without legal foundation" because Roche cited no case supporting the proposition that Amgen was required to file a separate divisional for each restriction group to maintain consonance with the original restriction requirement. The Court cited Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 1579 (Fed. Cir. 1991) for the rule that "new or amended claims in a divisional application are entitled to the benefit of [section] 121 if the claims do not cross the line of demarcation drawn around the invention elected in the restriction requirement." In addition, the Court rejected Roche's contention that reciting erythropoietin as a "non-naturally occurring glycoprotein" in the claims of the '933 patent implicated the DNA claims of restriction Group II (based in the premise that such "non-naturally occurring erythropoietin required recombinant DNA for its production). While agreeing that the Examiner's written description of the restriction groupings was consistent with Roche's argument, the Court drew the "relevant line of demarcation" between the claims as "the grouping restriction actually imposed by the examiner (rather than her characterization thereof), citing Texas Instruments Inc. v. ITC, 988 F.2d 1165, 1179 (Fed. Cir. 1993) (which interpretation did not support Roche's argument).

This portion of the opinion was directed towards the Court's grant of partial summary judgment to Amgen prior to trial. However, this did not decide the issue, since Roche was able to convince the Court that there were fact issues remaining to be determined relating to two additional theories (that the Court termed "number 3 and number 4") and that the Court decided in this opinion. These issues were tried to the Court and not to the jury, since the Court held that ODP was related to the metes and bounds of how claims were construed and thus solely within its province.

Roche theory number 3 relates to the claims of the '868 and '698 patents that are clearly outside the scope of the § 121 safe harbor. The asserted claims of the '868 and '698 patents are process claims, and the task for the Court was to determine whether they are patentably distinct from the claims of the '008 patent. Simply put, Roche's argument was that claim 1 of the '868 patent:

1. A process for the production of glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
(a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
(b) isolating said glycosylated erythropoietin polypeptide therefrom.

" . . . simply tells one skilled in the art to 'take the cells that were claimed in the '008 patent and grow them, let[ting] them do what they normally do.'" The Court disagreed, adopting Amgen's argument that the cells claimed in the '008 patent were not required to "actually express any EPO polypeptide" (a rationale that would seem to call into question satisfaction by such a claim of the utility requirement of 35 U.S.C. § 101). The Court opined that "simply having the starting material" (the cells claimed in the '008 patent) was not equivalent to "having an actual process that successfully" produces useful quantities of erythropoietin. This clarity of this reasoning improves when the Court puts it in proper context, that Roche did not carry its burden of establishing by clear and convincing evidence that the claims of the '868 and '008 patents are not patentably distinct and thus invalid for ODP.

The Court came to the same conclusion for claims 6-9 of the '698 patent:

6. A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
(a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified erythropoietin amino acid sequence of [figure] 6, and
(b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.

7. The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.

8. The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.

9. The process according to claims 2, 4, and 6 wherein said cells are mammalian cells.

For these claims, limitations relating to the presence of amplified EPO-encoding DNA provided additional points of patentable distinction supporting the Court's decision.

Finally, Roche's theory number 4 was that the claims of the '933, '422, and '349 patents-in-suit were invalid over the claims of the '868 and '698 patents for ODP. The viability of this argument rested, according to the Court, on whether Amgen could avail itself of the § 121 safe harbor. This, in turn, depended on whether the '933, '422, and '349 patents-in-suit "arose from" an application resulting from a PTO restriction requirement and whether these claims "are consonant with the restriction requirement." The Court relied in its analysis on its decision in granting partial summary judgment that the '933, '422, and '349 patents-in-suit all "arose from" the restriction requirement imposed by the PTO in the '298 application. The Court also determined that, while the issued claims of the '933, '422, and '349 patents-in-suit were not identical to the claims in the two divisional applications (the '178 and '179 applications) as filed, they maintained the required consonance with the restriction requirement imposed in the '298 patent.

In making this determination, the Court directly addressed the question of whether the § 121 safe harbor was available in a continuation application claiming priority to a divisional application that itself was clearly within the § 121 safe harbor. This is because the '698 patent was granted on a continuation application claiming priority to the '179 divisional application. In making its determination, the Court appeared to adopt Amgen's position that Federal Circuit precedent established that such a continuation application would fall within the protection of the § 121 safe harbor. The Court cited in support of its determination Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996) and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991), cases cited by Amgen in its bench brief submitted in response to the Federal Circuit's Pfizer v. Teva Pharmaceuticals decision (see "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin? "). In something of an anticlimax, the Federal Circuit's recent decision in Pfizer v. Teva Pharmaceuticals had little impact; the Court relegated its discussion of the decision to a footnote (no. 8), and limited the Pfizer decision to its facts, that the § 121 safe harbor does not apply to continuation-in-part applications:

Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. does not invalidate this precedent. As an initial matter, Pfizer did not name Symbol Technologies as one of the decisions that was possibly at odds with the Pfizer decision. See Pfizer, 518 F.3d at 1362 (naming other cases). Furthermore, Pfizer addressed the scope of section 121 in the context of a continuation-in-part application filed in lieu of a divisional application when responding directly to a restriction requirement. Id. at 1362. It said nothing about what happens if an applicant files a divisional application – which is eligible for section 121's safe harbor – and then files a continuation application to that divisional application.

For additional information regarding this topic, please see:

• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007

Posted at 11:50 PM in District Court, Injunction | Permalink | Comments (0) | TrackBack (0)

July 07, 2008

AstraZeneca Prevails in Seroquel® Paragraph IV Litigation

By Sherri Oslick --

Late last week, Judge Pisano of the District Court of New Jersey granted summary judgment of no inequitable conduct in favor of AstraZeneca in its consolidated Paragraph IV litigation against Teva Pharmaceuticals and Sandoz, Inc. over AstraZeneca's antipsychotic drug Seroquel®. Because the Defendants previously abandoned their other defenses, no issues remain for trial; AstraZeneca has petitioned for entry of final judgment.

Teva_1_3 The patent-in-suit, U.S. Patent No. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989), covers quetiapine fumarate, the active ingredient in Seroquel®, used to treat schizophrenia and bipolar disorder. The original case, 05-cv-05333 (JAP) was consolidated with later filed cases, including one against Sandoz as reported here, and one against Teva, as reported here.

Sandoz_3 AstraZeneca moved for summary judgment of no inequitable conduct on March 18, 2008. The Defendants had alleged multiple bases for their charge of inequitable conduct, however, Judge Pisano found the alleged omissions to lack sufficient materiality to constitute inequitable conduct. Additionally, the Court found that the Defendants had failed to present evidence of intent. AstraZeneca's motion was granted on July 1, 2008.

For additional information, please see:

• Judge Pisano's opinion
• AstraZeneca's press release
• "Court Report," July 1, 2007
• "Court Report," April 15, 2007

Posted at 11:25 PM in District Court, Inequitable Conduct | Permalink | Comments (0) | TrackBack (0)

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