Patent Docs

Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)

    By Kevin E. Noonan --

Judge James C. Cacheris, Senior Judge sitting in the U.S. District Court for the Eastern District of Virginia, delivered what is perhaps the most significant ruling in U.S. patent law this year (and this includes the Supreme Court's KSR Int'l Co. v. Teleflex, Inc. opinion).  He granted GlaxoSmithKline's (GSK) motion for temporary restraining order (TRO) and preliminary injunction (PI) to prevent the U.S. Patent and Trademark Office from implementing its new continuation and claims rules entitled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably-indistinct Claims and Examination of Claims in Patent Applications; Final Rule" (New Rules).  The New Rules were set to be implemented tomorrow, November 1st, and the notice on the Patent Office website remained up until well after close of business today (see "USPTO Late to Its Own Party").

The New Rules were opposed in separate lawsuits filed by GSK and earlier by Triantafyllos Tafas, a sole inventor, and supported by amicus curiae briefs from the American Intellectual Property Lawyers Association (AIPLA) (see "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules"); Elan Pharmaceutical Corp.; HEXAS, LLC, The Roskamp Institute, and Tikvah Therapeutics, Inc.; the pharmaceutical manufacturer's trade organization (PhRMA); the Biotechnology Industry Organization (BIO); as well as a letter from Senator Charles Schumer of New York asking Jon Dudas, Undersecretary of Commerce and Director of the Patent and Trademark Office, to delay implementation of the New Rules (see "Senator Schumer Sends a Signal"). GSK's motion was further supported by declarations from Harry F. Manbeck, Jr., Commissioner of Patents during the first Bush Administration (see "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules"); Bert Magen of the Vierra Magen lawfirm; David J. Kappos, Vice President and Assistant General Counsel, Intellectual Property Law, IBM (an early corporate supporter of the New Rules); Joseph F. Hetz of the Brinks Hofer law firm; and Samson Helfgott, a patent attorney formerly employed by the General Electric Co.  These declarants and amici were uniformly opposed to the New Rules, a fact that the Court found important in its determination.

In a thorough and well-reasoned opinion (especially in view of the compressed time frame that saw parties filing briefs as late as yesterday), the Court made some preliminary findings that formed the basis for its decision.  Most important of these is that the Court was persuaded, over vigorous albeit contradictory assertions from Patent Office counsel, that the Office's implementing statute, 35 U.S.C. § 2(b)(2)(A), did not grant the Office substantive rulemaking authority. Particularly persuasive for the Court was the evidence, adduced by GSK, that Congress had included provisions granting the Office just such substantive rulemaking authority in patent "reform" legislation introduced in 2005, and included in legislation recently passed by the House of Representatives (H.R. 1908) (see "Patent 'Reform' Bill Passes House of Representatives"). Not unreasonably, the Court concluded that Congress would not be trying to grant the Patent Office authority it already had.

The Court also voiced "serious concerns" that the New Rules are contrary to the Patent Act, citing In re Henricksen which held that the Patent Office did not have the power to restrict an applicant from filing a continuation application under 35 U.S.C. § 120.  In this regard, the Court was unpersuaded by the Patent Office's reliance on In re Bogese, which dealt with prosecution laches.  The Court cited in particular dicta from the Federal Circuit in Symbol Technologies Inc. v. Lemelson Med. Educ. & Research Found. that prosecution laches should be used sparingly lest it "vitiate" applicant's rights contained in § 120.

The Court applied the law of the Federal Circuit in deciding GSK's TRO/PI motion, although it noted in a footnote that 4th Circuit law was substantially the same.  The Court applied the familiar test for deciding such a motion:

• The likelihood that GSK would prevail on the merits;
• Whether GSK would suffer irreparable harm if the New Rules were implemented;
• The balance of the hardships between the parties; and
• The public interest.

With regard to the question of the likelihood that GSK would prevail on the merits, the Court found that GSK had demonstrated a likelihood of success that:

• The New Rules exceed the Patent Office's statutory authority;
• The New Rules are contrary to the Patent Act;
• Application of the New Rules to pending applications implicates the prohibition on retroactive application of agency regulations; and
• The standards for submitting an examination support document are impermissively vague.

The Court found that neither party demonstrated a likelihood of success on the questions of whether the limitations of requests for continuing examination (RCEs) were contrary to 35 U.S.C. § 132; or that the Patent Office was entitled to Chevron deference with regard to the claims limitations rules.  The Court also held that the Patent Office had demonstrated that promulgation of the New Rules was not arbitrary and capricious, mostly on the basis of Patent Office computer modeling showing that the New Rules would have an impact on the backlog despite the Office's admission that only 2.7% of pending applications (11,000) would be impacted by the New Rules.

The Court also found that GSK had shown sufficient evidence of irreparable harm, despite the Patent Office's argument that GSK had not provided evidence of any particular patent that would be negatively affected.  The Court found the harm to be in the uncertainty that the New Rules would create, and the negative impact on investment that would follow from such uncertainty.

On the question of the balance of the harm, the Patent Office asserted that it would cost "millions" to reconfigure its computer network and to re-train examiners (asserting that the examiner corps could not be relied upon to remember its training on the New Rules should implementation be delayed).  GSK responded, and the Court agreed, that the costs in question were "sunk" costs, already incurred for implementing rules the Office knew might not go into effect.  The Court found that while the costs and harm to the Patent Office were not "nonexistent," the harm to GSK due to "uncertainty and loss of investment suffered immediately" by GSK was the deciding factor in finding this prong of the test in GSK's favor.

Finally, the public interest question pitted the Patent Office's general (and generic) assertion that the public interest was best served by a efficient and timely patenting process against not only GSK's assertions, but the evidence from the amici and declarants that a significant portion of the relevant public did not believe that its interests would be served by implementation of the New Rules.  Patent Office statements regarding the importance of certainty in the patenting process were countered by GSK's assertions of the need for investor certainty that a technology-dependent company like GSK would be able to protect its technology with patents.  The Court was evidently convinced by the argument that such companies relied on the current patent system to protect their interests, and that the changes proposed by the Office "changes those companies' calculus and immediately decreases their ability to pursue costly new innovations." The Court also noted the harm to the public in permitting the New Rules to be implemented while the Court was considering GSK's complaint on the merits, in view of the irrevocable decisions some applicants would have to make under rules that could be later overturned.

Despite its statements on likelihoods, the Court did not address the merits of the parties' positions, and so this decision merely (and thankfully) preserves the status quo.  Before GSK filed its complaint and its case was consolidated with the Tafas action, the Patent Office and Dr. Tafas had agreed on an accelerated briefing schedule for summary judgment motions in exchange for Dr. Tafas withdrawing his request for preliminary injunction.  In view of the Court's decision today, this agreement has been terminated, and the Court asked the parties to submit a briefing schedule in the near future.  Accordingly, the Court's determination on the merits of whether and to what extent the New Rules will ever be implemented has been delayed indefinitely. For most patent prosecutors, however, the important thing is that the New Rules will not go into effect tomorrow.

For additional information on this topic, please see:

• "USPTO Late to Its Own Party," October 31, 2007
• "GSK Secures Injunction," October 31, 2007 (includes links to Court's Order and Opinion)
• "Senator Schumer Sends a Signal," October 30, 2007
• "GSK TRO/Preliminary Injunction Hearing," October 29, 2007
• "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules," October 25, 2007
• "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
• "Hooray! - (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect," August 30, 2007

USPTO Late to Its Own Party

    By Sherri Oslick --

Trick or treat, USPTO.  An injunction from Eastern District of Virginia for your goodie bag.

Shortly after 12 noon EDT on Halloween day, October 31, Judge James C. Cacheris granted GSK's motion for preliminary injunction, enjoining the USPTO from implementing its new rules.  And yet, throughout the entirety of the afternoon, the PTO's "Reminder: Claims and Continuations Rules Effective Nov. 1" posting remained emblazoned on the front page of the USPTO website.  It took the PTO a full five hours, until shortly after 5 pm EDT, to remove this post from its site.  And it wasn't until a full hour later, shortly after 6 pm EDT, that the PTO posted a notice regarding the injunction.

That makes the USPTO five hours late to its own party.  And in this Patent Docs reporter's opinion, the PTO's failure to at least pull its "Reminder" post shortly after grant of the PI is just plain irresponsible.  The new rules represent, shall we say, a "significant" change in patent practice, and the public should have been timely informed of the return to status quo.  It is almost certainly safe to say that many patent practitioners and applicants were anxiously awaiting the results of the PI hearing; those unaware of the patent blog coverage of the hearing were undoubtedly expecting the PTO to make a timely announcement.  Alas, not only did the PTO fail to make an affirmative statement within a reasonable amount of time, they also left inaccurate information on their website for the entire afternoon.  Insert governmental inefficiency joke of your choice here.

Anyway, for those of you who have not yet seen the PTO announcement, here are the relevant passages:

On October 31, 2007, the United States District Court for the Eastern District Court of Virginia, however, issued a Preliminary Injunction enjoining the USPTO from implementing the changes in the Claims and Continuations Final Rule.  Therefore, the changes to the rules of practice in the Claims and Continuations Final Rule will not go into effect on November 1, 2007.

USPTO employees are to continue processing and examining patent applications under the rules and procedures in effect on October 31, 2007, until further notice.

This Web site will be updated and USPTO employees will be notified with further information as it becomes available.

For the PTO's full announcement, see its "Notice Regarding Claims and Continuations Rules."

Patent Profile: Nventa Biopharmaceuticals Corp. Announces Grant of U.S. Patent 7,262,014 to HPV-Fusion Technology

    By Christopher P. Singer --

Nventa Biopharmaceuticals Corporation announced on October 29, 2007 that U.S. Patent 7,262,014, titled "Immune responses against HPV antigens elicited by compositions comprising an HPV antigen and a stress protein or an expression vector capable of expression of these proteins" has been granted by the U.S. Patent and Trademark Office.  The '014 patent relates to compositions and methods for inducing or enhancing immune response to human papillomavirus (HPV) with or without adjuvant.  According Nventa's press release, the patent provides a method for treating a tumor expressing HPV antigen by administering an effective amount of a composition of an HPV antigen fused to a stress protein, and additionally provides exclusivity for HspE7, an investigational therapeutic vaccine.

The '014 patent issued from U.S. Application No. 10/938,695 (filed September 10, 2004) and claims priority through a number of divisional and continuation applications as well as to a provisional application, filed on August 5, 1997.  The patent contains a total of 15 claims relating to methods of treatment.  Representative independent Claims 1 and 3 recite:

1.  A method of treating a tumor exhibiting an HPV protein antigen, the method comprising administering to a subject having the tumor an effective amount of an expression vector that encodes and is capable of directing expression of a fusion protein comprising the HPV protein antigen fused to a stress protein.

3.  A method of treating a tumor expressing an HPV protein antigen, the method comprising administering to a subject an effective amount of a composition comprising the HPV protein antigen joined to a stress protein.

GSK Secures Injunction

Judge James C. Cacheris of the Eastern District of Virginia has issued his Order, Memorandum and Opinion, and Minute entry for proceedings following today's hearing in the consolidated cases of SmithKline Beecham Corp. v. Dudas and Tafas v. Dudas.  Patent Docs will provide additional coverage of the Court's Order and Opinion later today.

Senator Schumer Sends a Signal

    By Kevin E. Noonan --

As reported earlier today on the PLI Patent Blog, Senator Charles Schumer (D-NY) last Thursday sent a letter to U.S. Patent and Trademark Office Director Jon Dudas (at right), asking the Director to delay implementation of the new continuation and claims rules (see 72 Fed. Reg. 46716).

In his letter, Sen. Schumer (below) cites both the opposition of inventor and other groups, and the pending lawsuit in the Eastern District of Virginia brought by GlaxoSmithKline, as reasons for delaying implementation of the rule.  The Senator's letter cites the potential for disparate impact of the new rules on different technologies, as well as the potential for unintended consequences including harming American innovation.  The Senator also raises the issue that the costs of filing an Examination Support Document (ESD) could require inventors to make choices between financial resources devoted to additional claims necessary to protect their inventions, and the costs of preparing an ESD.  He also noted that ESD practice could undermine "core principles" of candor in making disclosures to the Patent Office and the public.

The significance of the Schumer letter is that the Senator is a co-sponsor of the patent "reform" bill languishing (fortunately) in the Senate.  Some have speculated that the Senator's letter may be merely a signal to the Office that they should wait until the "reform" bill, which contains (in the versions passed by the House of Representatives, H.R. 1908) provisions authorizing the Patent Office to make substantive rules with regard to continuations.  Another possibility is that the Senator (or one of his staffers) listened to constituents like Gene Quinn who have provided the Senator's office with information regarding the new rules.  And it cannot be forgotten that under Senate rules any Senator can put a "hold" on any measure that, while not binding, will frequently be respected and prevent a bill from coming to a vote.  The Senator's belated interest in the inadvisability of the new rules just might be a signal that some on Capitol Hill are beginning to understand that the push for "reform" has less to do with a broken patent system than it has to do with the unenlightened self-interest of certain technology sectors looking to stifle competition (you know who you are).  It may behoove readers to send their own signals to their Senators to derail the disaster of "reform" before there is nothing of any value left in the U.S. patent system.

GAO's Report Regarding USPTO's Hiring Efforts and the Backlog: Another Look as November 1st Approaches

    By Christopher P. Singer --

Back in September, the U.S. Government Accountability Office (GAO) published a report to the Ranking Member of the House Committee on Oversight and Government Reform detailing how current U.S. Patent and Trademark Office hiring efforts are likely insufficient to reduce the current application backlog.  The report identifies that examiner attrition, particularly among examiners with less than five years of experience, along with the USPTO's outdated production goals are key factors that have exacerbated the application backlog.  New examiners are relied on primarily for the initial examination of new applications, and the GAO found that 70 percent of the examiners that had left the USPTO from 2002-2006 had fewer than five years of experience.  While Patent Office management believed that examiners leave the Office primarily for personal reasons (e.g., family reasons), 67 percent of the 1,100+ examiners surveyed believed that the unrealistic production goals were a primary reason for attrition.  From this survey information, the GAO report's sole recommendation was that the "USPTO undertake a comprehensive evaluation of the assumptions that the agency uses to establish its production goals."

The Department of Commerce submitted comments to GAO (attached as Appendix III of the report above) that instead of focusing on efforts to re-evaluate current production goals (established in the 1970's) to curb examiner attrition, chose to leverage the conclusion that hiring efforts alone will not reduce the backlog in order to highlight the Office's "productivity" initiatives (i.e., the continuation and claims rule changes and the proposed changes to IDS and Markush claims practice).  According to the Department's comments, once the effect of these productivity initiatives can be assessed, the PTO will then reconsider the assumptions it makes in establishing examiner production goals.  Seemingly, this was simply a polite way of saying: "GAO, your recommendation has been considered, but determined to be unpersuasive."

There is little debate that these changes will shift much of the current examination burden from examiners to the applicant and prosecuting attorneys, which should allow for a more rapid examination.  However, even with this reapportioned burden, a real and immediate effect on the backlog will likely only be realized if:  (1) the examining corps is prepared to handle the new issues that arise under the new rules, and (2) if there are adequate numbers of examiners to do the work.

Interestingly, several comments published in response to a Patently-O post regarding 35 USC § 120 indicate that the USPTO has not adequately prepared the examining corps to deal with implementation of the new continuation and claims rule changes, which take effect November 1 (tick-tock, tick-tock) (see, e.g., comments from "Examiner X" and "another examiner").  How, then, can Patent Office management assert that it has done its part in preparing the examiners to deal with application processing under the terms of the new rules?  As evidenced by the 100+ pages of commentary in the Federal Register notice attached to the publication of the new rules, the 67 pages of FAQs (which have been modified since their initial publication), and the huge amount of discussion from other sources, these new rules are very complex and difficult to interpret.  Examiners who are not prepared to deal with the mechanics and consequences of these rule changes should probably expect to spend at least the same amount of time on any given application under the new rules as they do now.  It seems that practitioners, applicants, and examiners will all be dealing with the fallout from these rules for the months to come.

So, by the end of the week (assuming GSK is unable to provide us all with a Halloween treat), applicants will be left to deal with a brave new world of patent prosecution under the new rules, and examiners will be expected to maintain the same production goals under a radically new system, with minimal training.  Let the gnashing of teeth continue.

Adang v. Umbeck (Fed. Cir. 2007)

    By Sherri Oslick --

In a nonprecedential opinion, the CAFC has affirmed the decision of the Board of Patent Appeals and Interferences dismissing the interference at issue after finding the appellant's claims invalid for failure to comply with the written description requirement of 35 U.S.C. § 112, first paragraph.

In 1995, Adang and Kemp filed U.S. Patent Application No. 08/461,240, claiming plants containing insecticidal resistance genes.  Later in prosecution, Firoozabady was added as an inventor, and in 2001 the applicants (collectively "Adang") added five new claims, on the basis of which they requested an interference against U.S. Patent Nos. 5,004,863 and 5,159,135, both to Umbeck.  Thereafter, Adang added three additional claims and filed a renewed request for an interference against the Umbeck patents.  The Board declared an interference in November 2005, with the count directed to cotton plants transformed to contain "selected foreign DNA."

Umbeck moved to have Adang's involved claims ruled unpatentable for failure to meet the written description requirement, arguing that Adang's specification only supported plants transformed with insecticidal resistance genes, not plants transformed with "selected foreign DNA" as recited in the count.  The Board granted Umbeck's motion, and because claims must meet the requirements of 35 U.S.C. § 112, first paragraph, in order to be part of an interference, the Board dismissed the interference as Adang no longer had standing to continue.

Adang argued two points on appeal.  First, Adang argued that Umbeck had failed to present any expert testimony on the issue of how one of skill in the art would have interpreted the Adang specification.  Noting that invalidity for failure to meet the written description requirement can be based solely on the language of the specification, and that the Board conducted a thorough review of the Adang specification and carefully documented its factual findings, the CAFC concluded that the Board's position that the application's intrinsic evidence did not provide adequate written description was supported by substantial evidence in the record.

Adang next argued that the Board erred in finding that a particular reference cited in the specification was not incorporated by reference; the reference was Firoozabady's U.S. Patent Application No. 07/076,339.  According to Adang, the teachings of the '339 application, along with the disclosure in the '240 specification, fulfilled the written description requirement of the involved claims.  Umbeck countered by asserting that the Board correctly found that the '240 application did not specifically identify the portions of the '339 application Adang intended to incorporate, and that the reference in the '240 application was insufficient to incorporate the entirety of the '339 application.  The relevant passage read: "[c]otton was transformed essentially as disclosed by Firoozabady, E. et al. (1987) Plant Mol. Biol. 10: 105-116, and Firoozabady, E. U.S. patent application serial no. 076,339."  The CAFC agreed with the Board that it was not clear that Adang intended to incorporate any part of the '339 application, noting that the '240 specification used the phrase "incorporated by reference" eight times, but not with reference to the '339 application.  As such, the CAFC concluded that Adang intended to treat the '339 reference differently than those incorporated by reference using specific incorporation language.

Adang v. Umbeck (Fed. Cir. 2007)
Nonprecedential disposition
Panel: Circuit Judge Bryson, Senior Circuit Judge Friedman, Chief District Judge Keeley
Per curiam

IPO Releases Comments on New Markush Rules

    By Robert Dailey --

The Intellectual Property Owners Association (IPO) has finally weighed in on the new Markush rules that were released this August (see 72 Fed. Reg. 44992 (Aug. 10, 2007); "Patent Office Proposes New Rules for Alternative Claiming").

The comments center on two themes:  (1) that the new rules have the unwanted effect of increasing Examiner workload; and (2) that the rules unduly limit inventors' abilities to define the nature of their inventions.  Specifically, the IPO makes the following comments regarding each proposed rule change.

I. Single invention explanation

The new rules encourage applicants who submit alternative claims to provide an explanation as to why the claim is directed to a single invention.  The PTO suggests that applicants may do this in one of two ways:  (1) explain that the species share a substantial feature of common utility; or (2) explain that the species are prima facie obvious over each other.

The IPO points out that the second of these options leads the applicant directly into a trap.  In re Ruff, 118 U.S.P.Q. 340, 347 (C.C.P.A. 1958), states: "[t]o rely on an equivalence known only to the applicant to establish obviousness is to assure that his disclosure is a part of the prior art."  In other words, if applicants admit that their species are prima facie obvious over each other, then they could not excise an anticipated species from the list of alternatives.

II. Long lists of named compounds

The new rules permit Examiners to reject claims directed to large lists of named compounds.  Under such a rejection, the Examiner would reject the claim and ask the applicant to present a common structural feature of the listed compounds.  IPO suggests that applicants may avoid the effect of this rule by claiming lists of structures rather than lists of names.

III. Single invention rule of 37 C.F.R. § 1.75(a)

The new rules would prevent Examiners from examining claims that contain more than one invention.  IPO suggests that the rule should be permissive, allowing Examiners the liberty to examine multi-invention claims if it would pose no undue burden on the PTO.  The rules should not force Examiners to reject claims that can easily be examined.  This would have the unwanted effect of increasing the PTO's workload.

IV. "Difficult to construe" rule of 37 C.F.R. § 1.75(j)(1)

The new rules permit alternative claiming only when "[t]he number and presentation of the alternatives in the claim does not make the claim difficult to construe."  IPO rejects this rule as too vague.  No standard is provided for "difficult," and applicants are given no basis upon which they can rebut a determination that their claims are difficult to construe.

V. Nested alternatives ban of 37 C.F.R. § 1.75(j)(2)

The new rules provide that "no alternative be defined as a set of further alternatives within the claim."  IPO points out that nesting often shortens claim length, and places limits on the manner in which applicants can claim their inventions.  In place of the rigid ban, IPO recommends that Examiners be permitted to review nested claims unless the examination would be unduly burdensome.

VI. Double inclusion ban of 37 C.F.R. § 1.75(j)(3)

The new rules require that no alternative be encompassed by another alternative within the list of alternatives.  IPO accepts this rule as consistent with existing PTO practice.

VII. "Substitutable for one another" rule of 37 C.F.R. § 1.75(j)(4)

The new rules requires that each alternative in a list be substitutable for the other alternatives.  IPO rejects this rule as a contradiction of M.P.E.P. § 2173.05(h):

Where a Markush expression I applied only to a portion of a chemical compound, the propriety of the grouping is determined by consideration of the compound as a whole, and does not depend on there being a community of properties in the members of the Markush expression.

The new rule would encourage the PTO to ignore what one knows about the molecule as a whole.  For example, an R-group at the active site of a drug would be judged no differently than an R-group on a side chain.  IPO suggests that this rule be rejected in favor of the current practice outlined in M.P.E.P. § 2173.05(h).

VIII. Rule 140: "Substantial feature essential for a common utility"

The new rules require that an alternative claim "share a substantial feature essential for a common utility."  Otherwise, the claim is deemed as containing multiple inventions.  Although the PTO purports to rely on In re Harnisch, 631 F.2d 716 (C.C.P.A. 1980) for this rule, IPO points out that Harnisch never recites such a requirement.  Furthermore, IPO sees the rule as vague, and asserts that the rule offers no advantages over current practices for defining a single invention (i.e., that a single invention is one that is independent and distinct).

For additional information on this topic, please see:

• IPO's "Comments on Proposed Rules related to 'Examination of Patent Applications That Include Claims Containing Alternative Language,' 72 Fed. Reg. Reg. 44992 (Aug. 10, 2007)," October 15, 2007

GSK TRO/Preliminary Injunction Hearing

    By Kevin E. Noonan --

The patent blogging team of John White and Eugene Quinn will be doing their part to keep the rest of us informed about the progress of the temporary restraining order/preliminary injunction hearing to be held on Wednesday in GlaxoSmithKline's lawsuit against Jon Dudas and the U.S. Patent and Trademark Office.  As announced last week by White and Quinn, Mr. White will be in the gallery for the hearing, and will be contacting Mr. Quinn by telephone periodically.  Updates will be provided on the pair's website.  The hearing is scheduled to start at 10:00 am on October 31st.

For additional information on this topic, please see:

• "AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules," October 25, 2007
• "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
• "Hooray! - (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007

Patent Profile: Ryogen Announces Issuance of Patent on Soluble Aminopeptidase P Gene

    By Donald Zuhn --

Ryogen LLC announced today that it had been granted U.S. Patent No. 7,273,718.  The '718 patent, which relates to an isolated genomic polynucleotide fragment that encodes human soluble (cytosolic) aminopeptidase P, appears to be the Suffern, New York-based genomics company's second U.S. patent.  According to Ryogen's website, the company, which is a portfolio company of IP Holdings LLC, was formed for the purpose of licensing U.S. Patent No. 6,399,349, which is directed to the human aminopeptidase P gene.

The '718 patent issued from U.S. Application No. 10/457,715, filed June 9, 2003, and claims the benefit of U.S. Provisional Application No. 60/386,941, filed June 7, 2002.  Representative independent claims 1 and 8 of the '718 patent recite:

1.  An isolated genomic polynucleotide, wherein said polynucleotide can be isolated from human chromosome 10 and is selected from the group consisting of:
    (a) a polynucleotide consisting of the nucleic acid sequence set forth in SEQ ID NO:2,
    (b) a polynucleotide consisting of the sequence of nucleotides from position 12803 to position 55760 of SEQ ID NO:2, and
    (c) a polynucleotide which is the complement of a polynucleotide of (a) or (b) and encodes a polypeptide having aminoacyl prolyl peptidyl hydrolase activity.

8.  An isolated polynucleotide consisting of a nucleic acid sequence selected from the group consisting of
    (a) a sequence of at least 5000 contiguous nucleotides within the region consisting of the sequence of nucleotides from position 1 through position 12802 of SEQ ID NO:2,
    (b) a sequence of at least 2000 contiguous nucleotides within the region consisting of the sequence of nucleotides from position 55761 through position 58735 of SEQ ID NO:2,
    (c) a sequence of nucleotides complementary to the nucleotide sequence of (a), and
    (d) a sequence of nucleotides complementary to the nucleotide sequence of (b).

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Purdue Pharma Products LP et al. v. Par Pharmaceutical Inc. et al.
1:07-cv-00666; filed October 24, 2007 in the District Court of Delaware

Infringement of U.S. Patent No. 6,254,887 ("Controlled Release Tramadol," issued July 3, 2001) following a paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of plaintiffs' Ultram® ER (tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the complaint here.  As reported here and here, plaintiffs have previously asserted this patent against Par Pharmaceutical; the present complaint includes an additional dosage included in Par's ANDA.

Alcon Manufacturing, Ltd et al. v. Barr Laboratories, Inc.
1:07-cv-01377; filed October 23, 2007 in the Southern District of Indiana

Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997) and 5,116,863 ("Dibenz[b,e]oxepin Derivative and Pharmaceutical Compositions Thereof," issued May 26, 1992) following a paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Alcon's Patanol® (an ophthalmic solution containing olopatadine hydrochloride, used to treat allergic conjunctivitis).  View the complaint here.

Sciele Pharma Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:07-cv-00664; filed October 22, 2007 in the District Court of Delaware

Infringement of U.S. Patent No. 4,892,741 ("Press coated DHP tablets," issued January 9, 1990) following a paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Sciele's Sular® (nisoldipine, used to treat hypertension).  View the complaint here.

Schering Corporation v. Dr. Reddy's Laboratories, Inc. et al.
3:07-cv-05062; filed October 19, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).  View the complaint here.

Schering Corporation v. Dr. Reddy's Laboratories, Inc. et al.
3:07-cv-05038; filed October 19, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,100,274 ("8-chloro-6,11-dihydro-11- ] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) following a paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex (desloratidine, used to treat allergies).  View the complaint here.

King Pharmaceuticals Inc. et al. v. Actavis, Inc. et al.
2:07-cv-05041; filed October 18, 2007 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,066,339 ("Oral Morphine Particulate Formulation," issued May 23, 2000) following a paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of King's Avinza® (morphine sulfate extended release capsules, used for the once-daily treatment of moderate-to-severe chronic pain).  View the complaint here.

Sepracor Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.
3:07-cv-05017; filed October 18, 2007 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

Amgen Survives Another EPO Challenge

    By Kevin E. Noonan --

Amgen's recombinant erythropoietin (EPO) franchise (Aranesp® and Epogen®, as well as Johnson & Johnson's Procrit®) survived another challenge last week, when a jury found that Hoffmann-LaRoche's pegylated EPO preparation (Mircera®) infringed three Amgen patents:  U.S. Patent Nos. 5,547,933 (the '933 patent), 5,441,868 (the '868 patent), and 5,618,698 (the '698 patent).  Two other patents asserted in the litigation were found not invalid:  U.S. Patent Nos. 5,955,422 (the '422 patent, claim 1) and 5,756,349 (the '349 patent, claim 7); and the jury did not reach a determination with respect to infringement and validity for U.S. Patent No. 5,621,080 (the '080 patent).

A jury found that the following claims valid and infringed:

The '933 patent:

3.  A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells.

7.  The glycoprotein product according to claim 3 . . .  wherein the host cell is a non-human mammalian cell.

8.  The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.

12.  A pharmaceutical composition comprising an effective amount of a glycoprotein product effective for erythropoietin therapy according to claim 7 and a pharmaceutically acceptable diluent, adjuvant or carrier.  [Infringed under the Doctrine of Equivalents.]

The '868 patent:

1.  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, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
(b) isolating said glycosylated erythropoietin polypeptide therefrom.

2.  The process according to claim 1 wherein said host cells are CHO cells.

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 DNA encoding the mature erythropoietin amino acid sequence of FIG. 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.

Amgen has previously prevailed on these same patents in the same court (and before the same judge, the Honorable William G. Young) against Hoechst Marion Roussel; indeed, the Court had the parties address the precedential effect vel non of Judge Young's prior claim construction (and those portions thereof that had been affirmed by the Federal Circuit) of the asserted claims.  Amgen v. Hoffman LaRoche Ltd., 480 F. Supp. 2d 462 (Fed. Cir. 2007).  Ironically, in view of the ultimate result, the Court noted:

There is more to this motion practice than meets the eye.  Amgen has largely prevailed in an earlier jury-waived action before this session of this Court.  See Amgen, Inc., v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1295-97 (recounting procedural history).  That exhaustive litigation involved the same patents that are here at issue.  It is not surprising therefore, given the permissive venue requirements for patent cases, 28 U.S.C. 1400(b), that Amgen brought the instant declaratory judgment action in the District of Massachusetts and denominated it a "related" case pursuant to Local Rule 40.1(G)(1)-(3) so that it would be assigned to this session of the Court.  Amgen filed a declaratory action seeking only equitable relief, for which there is no right to a trial by jury.

Roche/Hoffmann has a different agenda.  For all the reasons Amgen seeks this judge in this Court, Roche/Hoffmann naturally prefers a fresh fact-finder, to wit, an American jury.  What is more, in a case with both equitable (non-jury) and legal (jury) issues, the jury determination may govern the equitable decree.  Dairy Queen, Inc. v. Wood, 369 U.S. 469, 479, 82 S. Ct. 894, 8 L. Ed. 2d 44 (1962).

These principles markedly change the potential complexion of this case.  No matter how shallow the antitrust claims -- and, while they survive this motion to dismiss, they appear somewhat wanting -- they insure (as long as they remain in the case) that the patent issues (e.g., anticipation, infringement) will be tried to a jury.  This Court will assiduously insure that the jury has presented to it all those issues which it must resolve.  See, e.g., MacNeill Engineering Co., Inc. v. Trisport, Ltd., 126 F. Supp. 2d 51 (D. Mass. 2001) (case tried to a jury); MediaCom Corp. v. Rates Technology, Inc., 34 F. Supp. 2d 76 (D. Mass. 1998) (case for the jury).

The victory at trial comes at a particularly good time for Amgen.  Regulatory concerns, both over risks of long-term EPO administration and the costs incurred by public payors such as Medicare and Medicaid have buffeted the company over the past several months.  Since Amgen's EPO products accounted for about half of Amgen's revenues last year, these events have had negative effects on Amgen's stock price as well as its bottom line.  The loss comes at a particularly bad time for Roche, since the Food and Drug Administration was reportedly ready to approve Mircera® for sale in the U.S. as early as November 14th (the product was approved for sale in Europe in July).

Amgen has indicated that it will ask the Court for a permanent injunction prohibiting sales of Mircera® until the last of the infringed patents expire (which will not occur before 2017); the injunction hearing is scheduled for November 15th.  However, certain purported advantages of Roche's product - specifically, a less-frequent administration schedule due to the longer in vivo persistence of the pegylated version of EPO - may reduce the likelihood that the Court will grant an injunction, or that the injunction will be upheld on appeal, in view of the Supreme Court's proscriptions on granting injunctions in patent cases.  See eBay Inc. v. MercExchange, LLC.  One of the factors Judge Young will be required to balance in deciding whether to grant an injunction is the public interest, which may be weighed against Amgen in the injunction calculus.  For now, however, Amgen's clear victory can be expected to keep Mircera® off the market for the foreseeable future.

ARYx Therapeutics Inc. Sets Terms of IPO in Regulatory Filing with SEC

    By Christopher P. Singer --

As reported last Tuesday, October 23, 2007, ARYx Therapeutics set its planned initial public offering at 5 million shares for an estimated price of $14 to $16 each.  In the filing, ARYx indicated that Morgan Stanley, CIBC World Markets, Jefferies & Co, and Leerink Swann were underwriting the IPO.  At that price point, the company anticipates to raise about $67.8 million in proceeds after expenses.  The underwriters have the option to buy an additional 750,000 shares to cover over-allotments.  ARYx plans to list its stock on the Nasdaq under the symbol "ARYX".

ARYx has several drug candidates in clinical Phase II testing, which are based on its RetroMetabolic "ARM" technology.  This approach seeks to identify and design an "ideal metabolite" which is non-toxic, water soluble, and pharmacologically inactive and is not metabolized through a typical metabolic pathway.  This strategy avoids any metabolic "bottlenecks" and associated build-up of drug levels.

Conference & CLE Calendar

November 8, 2007 - Trilateral Cooperation: Successes, Opportunities, and Challenges (Intellectual Property Owners Association) - Washington, D.C.

November 13-15, 2007 - Pharma and Biotech Collaborative Agreements (American Conference Institute) - New York, NY***

December 3, 2007 - 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice - PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) - Washington, D.C.

January 30-February 1, 2008 - Pharma/Biotech IP Due Diligence (American Conference Institute) - New York, NY***

***Patent Docs is a media sponsor of this conference or CLE.

House Subcommittee Schedules DNA Patenting Hearing

    By Kevin E. Noonan --

The Subcommittee on Court, the Internet and Intellectual Property of the House of Representative's Judiciary Committee has scheduled a hearing entitled "Stifling or Stimulating - The Role of Gene Patents in Research and Genetic Testing" for Tuesday, October 30, 2007.  While not stating so on the hearing notice, the testimony to be solicited is no doubt intended to be used in deciding whether the House should consider Congressman Becerra's wrong-headed ban on human gene patenting (see "The Continuing Threat to Human Gene Patenting").

Readers of Patent Docs know our position on the bill and the neo-vitalist provocateurs like Michael Crichton that are behind it.  In view of the penchant for this Congress to dabble in patent "reform" (in the absence of the political power or courage to address more pressing national concerns), this hearing and this bill have the potential to seriously injure U.S. biotechnology and pharmaceutical companies, universities, and their ancillary industries, as well as remove a significant American advantage in the development of new drugs and disease diagnosis and treatment methods.

The witness list has not been published on the website as yet, which suggests that Patent Docs readers can do themselves and the country a service.  Set forth below are the names and e-mail addresses of the members of the subcommittee.  Write them, asking that the witness list be a fair representation of the differing points of view on the issue.  People like Michael Crichton and Lori Andrews are, frankly, a waste of time - they have great name recognition and may favor the hearings with extra C-SPAN coverage, but their own views are well-known and they are unlikely to tell the subcommittee anything its members don't already know.  What the subcommittee needs is a dose of reality, provided by the people who have the experience to understand the scope of the problems that exist and the benefits the country has obtained by being at the forefront of allowing genes to be patented freely.  And quoting some of our earlier Patent Docs posts may be an quick and painless way to get this point of view on the members' radar screens.

Set forth below are the names of the members of the subcommittee:

Berman (D-CA, 28th Dist.)
Boucher (D-VA, 9th Dist.)
Cannon (R-UT, 3rd Dist.)
Chabot (R-OH, 1st Dist.)
Coble (R-NC, 6th Dist.)
Cohen (D-TN, 9th Dist.)
Conyers (D-MI, 14th Dist.)
Feeney (R-FL, 24th Dist.)
Gallegly (R-CA, 24th Dist.)
Goodlatte (R-VA, 6th Dist.)
Issa (R-CA, 49th Dist.)
Jackson Lee (D-TX, 18th Dist.)
Johnson (D-GA, 4th Dist.)
Keller (R-FL, 8th Dist.)
Lofgren (D-CA, 16th Dist.)
Pence (R-IN, 6th Dist.)
Schiff (D-CA, 29th Dist.)
Sensenbrenner (R-WI, 5th Dist.)
Sherman (D-CA, 27th Dist.)
Smith (R-TX, 21st Dist.)
Sutton (D-OH, 13th Dist.)
Watt (D-NC, 12th Dist.)
Weiner (D-NY, 9th Dist.)
Wexler (D-FL, 19th Dist.) - co-sponsor of the Becerra bill

If you reside in any of these representatives' Congressional districts, you can contact your representative directly by e-mail or telephone; contact info can be obtained here.  If not, comments to the subcommittee can be submitted here.

This may be the best opportunity to influence whether the Becerra bill will be another patent law mistake visited on American innovation by a motivated group with its own interests at heart.  Let's make some noise.

For additional information on this topic, please see:

• "The Continuing Threat to Human Gene Patenting," October 16, 2007
• "The Anti-Patent Beat Goes on at The New York Times," July 1, 2007
• "The Future of DNA Patenting," February 20, 2007
• "A DNA Patenting Thought Experiment," February 16, 2007
• "Science Fiction in The New York Times," February 13, 2007
• "The Continuing Value of Biotech Patenting," February 4, 2007
• "Anti-Patent (Sullivan?) Malice by The New York Times," January 29, 2007
• "In Support of Gene Patents," December 7, 2006
• "The 'Anti-Commons' Aren't So Tragic After All," October 27, 2006
• "Gene Patenting in the News Again," December 5, 2006

IPO Trilateral Cooperation Conference

The Intellectual Property Owners Association (IPO) will be co-sponsoring a conference entitled: "Trilateral Cooperation: Successes, Opportunities, and Challenges" on November 8, 2007 in Washington, D.C.  The conference, which is being held in conjunction with the 25th Annual Meeting of the Trilateral Patent Offices (U.S. Patent and Trademark Office, Japan Patent Office, and European Patent Office), will seek to foster and expand international collaboration and address the challenges associated with increased use of world patent systems.  The conference will cover the following topics:

• The Business Imperative for Close Trilateral Cooperation in a Global Economy
• Patent Office Insights on the Trilateral Process . . . Past Successes and Future Challenges
• Perspectives of Owners and Advocates on Trilateral Cooperation

Conference speakers will include Jon Dudas, Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office; Masahiro Koezuka, Commissioner of the Japan Patent Office; and Alison Brimelow, President of the European Patent Office.  The program for the conference can be found here.

The registration fee for the conference is $50.  Those interested in registering can do so here.

IPO PTO Day

The Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark Office will be co-sponsoring the 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 3, 2007 in  Washington, D.C.  While a program for the conference is not yet available, the IPO has announced that the conference will include several presentations on the new patent continuation and claims rules.

The registration fee for the conference is $600.  Those interested in registering can do so here.

AIPLA Supports GSK's Lawsuit Against the Patent Office's New Rules

    By Kevin E. Noonan --

Like the most popular kid at a high school dance being the first to take the floor, GlaxoSmithKline's (GSK) lawsuit against John Dudas and the U.S. Patent and Trademark Office's new continuation and claims rules entitled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably-indistinct Claims and Examination of Claims in Patent Applications; Final Rule" (New Rules), seems to have broken the ice.  The American Intellectual Property Lawyers Association (AIPLA) has filed an amicus curiae brief with the Court hearing GSK's temporary restraining order and preliminary injunction motion, and it has been joined by some expected and unexpected bedfellows.

The AIPLA brief focuses on two of the requirements for a preliminary injunction:  irreparable harm and the public interest (the other two are the balance of the hardships between the parties and the likelihood of success on the merits).  In doing so, the brief concentrates on the retroactive application of the rules to applications filed prior to the time the rules were promulgated (and, if the Patent Office's backlog statistics can be believed, before the rules were even proposed for the majority of pending applications).  AIPLA states the case for the injunction succinctly:  imposition of the rules would affect great hardship on applicants, while the Court's granting a stay on implementing the new rules "should not adversely impact" the Office.

The brief sets up the argument with regard to contrasting patent protection and trade secret protection.  Patent applicants, rather than disclosing their inventions to the public attendant on applying for patent protection, had the option of holding their inventions as trade secrets.  The decision-making involved in choosing patent protection over keeping the technology as a trade secret was made in reliance on the rules as they existed when the applications were filed, and applying the new rules retroactively frustrates the legitimate expectations patent applications had in reliance thereupon, according to the brief.  The brief argues that the public interest is served by encouraging invention disclosure through patenting, since patent protection is given for only limited times and the technology falls into the public domain upon patent expiry (and earlier should the patent maintenance fees not be paid).

The hardships on patent applicants, according to the brief, will be "immediate, widespread and irreparable" should the new rules be permitted to come into effect on November 1st.  This is an important point made in the brief, since the aim is to convince the Judge that the rules should be stayed pending judicial resolution of the allegations of unlawfulness in GSK's complaint.  The brief asserts that permitting the new rules to come into effect will make it "impossible to return to the status quo . . . important intellectual property rights will be permanently lost."  The brief references case law, treatises, and other reference works to demonstrate that filing patentably-distinct claims for what may be more than a single invention has been both routine and useful for applicants, particularly new business concerns, that are formed to commercialize "emerging technology," a type of technology cited by the Office as intended to benefit from the new rules.  The brief asserts that it is just the applications in these technologies that "almost inevitably" contain more than the 5 independent claims and 25 total claims that are the maxima permitted under the new rules.  Having filed and prosecuted applications under the former rules of practice, implementation of the new rules will, according to the brief, require companies to file a Suggested Restriction Requirement (SRR) document or an Examination Support Document (ESD).  The deficiency of the first option is that the Office is not obliged to grant such requests, and such a failure would cause an applicant to abandon claims to previously-disclosed inventions and lose intellectual property rights as a result.  This is "profoundly unfair" and constitutes a "forfeiture" of rights for inventions disclosed publicly (by publication of an application) and then preclusion from pursuing claims to such invention(s).  ESDs fare no better in the brief's analysis, citing the risks attendant to filing such a document (including "inadvertent misstatements") and the costs, which even the Office now admits can cost over $13,000 in some instances and not the $2,500 it originally estimated the average cost to be.  The brief makes the interesting point that, by shifting the burden from the Examiner to the applicant, the new rules are "at variance with counsel's role as 'an advocate' for her client."  And the alternatives to filing an ESD or cancelling claims and losing valuable intellectual property rights in the process is rightly termed a Hobson's Choice in the brief.

The same can be said, in another portion of the brief, for requiring applicants to make the types of representations regarding patentable-distinctiveness between claims of related, co-pending applications in order to avoid having to cancel claims or entire applications filed under a different regulatory regime.

A portion of the brief is spent exposing the Office's proffer of petitioning for additional claims, RCEs, or continuation applications for what it is -- a red herring, a sham, and a ruse, because according to the Office's own words there are so few situations that would constitute an adequate showing to have a petition granted.  Also noted are the costs attendant upon the filing and rearranging of claims in existing applications, as well as the reporting requirements discussed above.  All these efforts are expected to take "extraordinary amounts of time" and "incur unjustifiably excessive costs" in order to comply.

The AIPLA brief is supported by a declaration from Burt Magen (at right), a partner at the Vierra Magen Marcus & DeNiro firm who represents SanDisk; Mr. Magen testifies on behalf of their interests and the effects he expects the new rules to have on his client's interests.  Not surprisingly, these effects will be bad.  Mr. Magen focuses his testimony on the retroactive application of the rules to pending applications.  He testifies that SanDisk has 235 applications pending for which his firm provides representation in patent prosecution matters and that have not yet received a "first action on the merits" (FAOM).  According to Mr. Magen, there are 142 patent families represented by these 235 applications.  By his calculations, the claims of 174 of the 235 pending applications will need to be combined into 81 patent applications to comply with the rules, requiring SanDisk to abandon 93 of these applications, and another 8 applications where other members of the family have received a FAOM.  Mr. Magen testifies that the cost of abandoning these applications alone amounts to almost $200,000 in wasted filing fees (which, unlike claims fees, are not going to be refunded by the Office).  In addition, adding the claims from these 101 applications will incur an additional cost in excess of $130,000, according to Mr. Magen's calculations.  Mr. Magen then adds the expected costs of the divisional applications that SanDisk will file as a consequence of restriction of the claims (by the Office, or more likely, consistent with a Suggested Restriction Requirement (SRR) submission), which he estimates to be about $150,000.  The grand total is almost half a million dollars.  Mr. Magen then goes on to testify as to the consequences of the Office not granting SanDisk's SRR, which will be irrevocable loss of intellectual property rights.

Anticipating the Office's counterargument regarding the filing of a petition and showing, or an Examination Support Document (ESD), Mr. Magen testifies that this option is "not only expensive, but also provides statements on the record that can potentially be used by an accused infringer" for both invalidity and inequitable conduct defenses.  With regard to Requests for Continued Examination (RCEs), Mr. Magen testifies that the limitation of only one per patent family disrupts the "normal back-and-forth" with an Examiner that occurs during patent prosecution, and also prevents an applicant from complying with the duty of disclosure under Rule 56 in instances where an applicant files international applications, as Mr. Magen testifies SanDisk does routinely, and receives a search report containing relevant prior art that is not known to the applicant nor received in time to be filed in the ordinary course.  RCE practice permits an applicant to submit such art under the current rules, and this procedural avenue is foreclosed under the new rules.  "This situation will create irreparable harm to SanDisk," according to Mr. Magen.

Perhaps most surprising is the declaration of David J. Kappos (at left), Vice President and Assistant General Counsel, Intellectual Property Law, of IBM.  IBM, like many information technology (IT) companies, has been a strong supporter of "patent reform," including the new rules.  Despite previous statements in support of the rules, Mr. Kappos' declaration is filed in support of the AIPLA's amicus brief.

Mr. Kappos' declaration focuses on the retroactive application of the rules to pending applications, and specifically references the "related application" disclosure requirements imposed by new rules 37 C.F.R. §§ 1.78(f)(1) and 1.78(f)(2).  Mr. Kappos testifies that IBM has 25,000 pending applications and, after preliminary review, would need to identify more than 30,000 related patents and patent applications in order to comply with the rules.  Mr. Kappos further testifies that, should the Patent Office refuse to accept IBM's bases for its assertions of patentable distinctiveness, the only remedy would be to cancel claims and thus lose rights to patentable inventions.  (No doubt the Patent Office rejoinder to this assertion will be the Examination Support Document (ESD) option; the lunacy of this course of action is not addressed in Mr. Kappos' declaration.)

The bottom line, according to Mr. Kappos, is a cost of "over 10 million dollars" in legal fees and internal costs, not counting the loss of intellectual property rights that may be occasioned by the rules.  These costs, according to Mr. Kappos, will be incurred to the detriment of IBM's abilities to protect its new intellectual property; this allegation strikes directly at one of the (largely spurious) Patent Office grounds for the new rules, that examination of "old" technology (represented by continuation applications) detracts from the Office's ability to examine "new" technology.

It remains to be seen whether all this activity will be "too little, too late" or whether GSK and its amici will be able to convince the Judge that they satisfy the preliminary injunction standard.  It would be sweet irony if the Judge recognizes the Patent Office's postponement of the hearing to the day before implementation is slated to occur for what it is - an attempt to tie his hands and make it more likely that he will deny the motion.  The brief and declarations submitted today bolster GSK's argument that it has fulfilled the requirements for an injunction.  Let's hope the Judge is listening.

For additional information on this topic, please see:

• "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
• "Hooray! - (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
• Patently-O's coverage

IP Australia Lifts Requirement to Submit Documentary Searches

    By Donald Zuhn --

Over the past week, Patent Docs has reported on two challenges to new IDS rules proposed by the U.S. Patent and Trademark Office ("Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808).  The USPTO's new IDS rules would require applicants to, inter alia, provide detailed explanations of all references when more than 20 references are cited and explain cited references that are at least 25 pages long or in foreign languages.

Interestingly, while the USPTO attempts to force U.S. applicants to jump through even more hoops in complying with their duty to disclose "all information known . . . to be material to patentability" under 37 C.F.R. § 1.56, IP Australia announced on October 18, 2007 that it was "substantially remov[ing] the requirement for applicants and patentees to inform the Commissioner of Patents of the results of documentary searches by, or on behalf of, foreign patent offices" (see "Changes to regulations made under sections 27(1), 45(3) and 101D of the Patents Act 1990).  Thus, as of October 22, 2007, Australian patent applicants will no longer have to inform IP Australia of documentary search results -- with one exception:

if the final date by which an applicant or patentee was required to inform the Commissioner of the results of a search under the regulations was before 22 October 2007, and the Commissioner was not informed of the results of the search by that final date, the results of that search remains outstanding.  The amending legislation does not excuse any past failure to comply with the disclosure obligations.

In a corresponding position paper, IP Australia provided an overview of the feedback it received in response to its May 16, 2007 consultation paper regarding the elimination of the obligation to lodge search results.  In the position paper, IP Australia noted that it received comments indicating:

a general level of consensus that the existing search result disclosure provisions were onerous and costly for applicants and other users of the patent system.  There was also a level of doubt expressed as to the value or the benefits arising from the present provisions.

One can only hope that the USPTO will look to the changes in Australian disclosure requirements, and the reasons offered for such changes by IP Australia, as it continues in its efforts to reshape the U.S. disclosure requirements.

Related reading:

• "More on Second Letter to OMB Criticizing the IDS Rule," October 24, 2007
• "OMB Receives Second Letter Criticizing Proposed IDS Rule," October 23, 2007
• "Cantor Fitzgerald VP Criticizes IDS Rule in Letter to OMB," October 18, 2007

Patent Profile: Epigenomics Awarded Patent Covering DNA Methylation Detection Method

    By Suresh Pillai --

Epigenomics AG of Frankfurt, Germany has been awarded U.S. Patent No. 7,229,759 ("Highly sensitive method for the detection of cytosine methylation patterns," issued June 12, 2007).  The '759 patent, covering a method for the detection of cytosine methylation in genomic DNA samples, is the fourteenth U.S. patent to be awarded to the Frankfurt, Germany-based biotech company.

DNA methylation is a naturally occurring means by which cells regulate gene transcription.  Methylation occurs when cytosine is modified via the addition of a DNA methyl group.  The methyl group subsequently interferes with the binding of transcription factors and allows for chromatin condensation, thereby terminating gene activity.  Specific methylation at cytosines throughout the genome results in the specific targeted reduction for gene transcription.  Methylation patterns also form genetic fingerprints specific to various disease states, including cancer, that correspond to the regulation of genes important in disease pathogenesis.

The newly issued patent covers Epigenomics' HeavyMethyl® and MethyLight® technology (see below) as well as their proprietary line of DNA methylation biomarkers.  Through the use of established real-time quantitative PCR techniques, the technology can differentiate between genomic DNA that is either methylation-modified or unmodified.  This technology can be used for the high-throughput methylation detection of cancer biomarkers, thereby providing a clinical diagnostic tool for the early detection of cancer at the genetic level.

The '759 patent issued from U.S. Application No. 10/229,370, which was filed on August 27, 2002, and which claims the benefit of International Application No. PCT/EP02/02572, filed March 8, 2002.  Independent claim 1 recites:

1.  A method for the detection of cytosine methylation in DNA samples, characterized in that the following steps are conducted:
    a genomic DNA sample, which comprises the DNA to be investigated as well as background DNA, is chemically treated in such a way that all unmethylated cytosine bases are converted to uracil, while 5-methylcytosine bases remain unchanged;
    the chemically treated DNA sample is amplified with the use of at least 2 primer oligonucleotides, as well as a polymerase and at least one blocking oligonucleotide or PNA oligomer which preferentially binds to a 5'-CG-3' dinucleotide or a 5'-TG-3' dinucleotide or a 5'-CA-3' dinucleotide on the background DNA, whereby the DNA to be investigated is preferentially amplified over the background DNA as the template, and
    the amplified products are analyzed and the methylation status in the DNA to be investigated is concluded from the presence of an amplified product and/or from the analysis of the amplified product.

Suresh Pillai, Ph.D., is a molecular biologist and a third-year law student at DePaul University College of Law.  Dr. Pillai was a member of MBHB's 2007 class of summer associates, and is currently working as a law clerk at MBHB.