Patent Docs

Audioconference on the Future of Biomedical Patenting

Technology Transfer Tactics will be offering an audioconference entitled "The Future of Patenting in Biomedicine" on August 26, 2010 from 1:00 - 2:30 PM (EDT).  Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP and Professor Chris Holman of the University of Missouri-Kansas City School of Law will take an in-depth look at the effect of the Myriad case on gene patenting and genetic diagnostics and address strategies that universities and innovators can employ to ensure sufficient patent protection and maximize investment opportunities.  The speakers will cover the following topics:

"Detect and infer" claims:
• All diagnostic claims have this format, no matter what is being diagnosed -- how should they be analyzed?
• What is the significance of the "detecting" step with regard to novelty?
• Does patent eligibility depend on the nature of what is detected (metabolites? proteins? genes?)
• Should there be a physician exception from infringement (as there is for medical procedure claims)?
• What is the relevance of any "mental steps" involved in the claims?
• Justice Breyer: the impact of merely reading numbers in light of medical knowledge
• Should a medical degree be enough to distinguish (versus an auto mechanic, for example)?

The impact of recent case law:
• Bilski and what it says about medical diagnostic claims
• What can we expect from the Federal Circuit?
• Lessons learned and hints from other recent cases: Classen, Prometheus, Myriad
• The significance of genetic methods as a subset of medical diagnostic claims

Genetic information
• Relationship between information per se and methods of obtaining information
• Consequences of an outright ban:  Hiding information as trade secret
• Gene patenting bills in Congress
• Is there a middle ground?

The registration fee for the audioconference is $197 ($247 for registration plus CLE processing).  Those interested in registering for the audioconference, can do so here, by calling 877-729-0959 or 239-263-0605, or by faxing or e-mailing this form to 404-381-1354 or info@technologytransfertactics.com.

Patent Term Adjustment CLE

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Patent Term Extension: The Next Chapter" on Thursday, August 5, 2010 beginning at 2:00 PM (EDT).  The IPO webinar will present a panel of experts -- including the patent prosecutor who first discovered a separate calculation error by the U.S. Patent and Trademark Office, another patent expert with extensive experience at the USPTO, and the litigator who successfully argued the Wyeth case at the district court and the Federal Circuit -- who will discuss the recent suit filed by Novartis seeking review of the USPTO's patent term adjustment (PTA) determinations for eleven its patents.  Novartis' action is the first to question the USPTO’s interim procedures for requesting PTA recalculation in light of the Federal Circuit’s decision in Wyeth v. Kappos.  The speakers include Jack Brennan of Fish & Richardson, PC; Charles Van Horn of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; and Patricia Carson of Kaye Scholer, LLP.  The registration fee for the webinar is $100 (government and academic rates are available upon request).  Those interested in registering for the webinar, can do so here.

Audioconference on the Impact of Bilski

Technology Transfer Tactics will be offering an audioconference entitled "Bilski: The Impact of the Final Decision on University TTOs" on August 17, 2010 from 1:00 - 2:30 PM (EDT).  Charles Macedo of Amster, Rothstein and Ebenstein, LLP; Scott Alter of Faegre & Benson; and Dr. Ronald Kudla, the executive director of intellectual property, technology transfer, and new ventures at Rensselaer Polytechnic Institute, will examine the impact of the Supreme Court's decision in Bilski v. Kappos on university technology transfer practitioners and their patenting practices, including the following questions:

• How will inventions of an "abstract" nature be defined?
• How with the "machine or transformation" test continue to influence PTO examiners?
• How should patent prosecution change to help ensure validity?
• How does the decision affect plans for appeals/reconsiderations?
• How does the decision affect existing method patents, and the impact on both value and infringement?

The speakers will also address the following topics:

• The Federal Circuit's "machine or transformation" test
• The Supreme Court's "affirmance"
• The effect of Bilski v. Kappos on patent prosecution efforts, patent licensing in/out, litigation (current and future), and patent reform
• What's next?
• Review upcoming opportunities for further guidance from the Federal Circuit

The registration fee for the audioconference is $197 ($247 for registration plus CLE processing).  Those interested in registering for the audioconference, can do so here, by calling 877-729-0959 or 239-263-0605, or by faxing or e-mailing this form to 404-381-1354 or info@technologytransfertactics.com.

Summit on Biosimilars and Follow-on Biologics

The Center for Business Intelligence (CBI) will be holding its 5th Summit on Biosimilars and Follow-on Biologics on October 18-19, 2010 in Washington, DC.  At the Summit, CBI's faculty will offer presentations on the following topics:

• FDA's implementation of the biosimilar approval pathway -- What to anticipate and how to be prepared (keynote panel discussion);
• Analysis of exclusivities and pre-launch patent dispute mechanisms created by the PPACA;
• FTC address -- Follow-on biologics -- FTC perspective on market competition;
• Follow the money -- How capital will shape the challenges and opportunities for the U.S. biosimilars market (panel discussion);
• Biosimilar innovation -- Differentiated biosimilars and biobetters;
• Evolution of the global biosimilar competitive landscape;
• Operational lessons learned from the approved biosimilars in the EU;
• Differences in clinical trial requirements for biosimilars;
• Fc enhanced antibody biosuperiors versus true biosimilars; and
• Informing the payer and prescriber -- How to assure clinical safety and efficacy to overcome challenges to market penetration.

A pre-conference workshop entitled "Develop a Manufacturing, Preclinical and Clinical Plan for Protein Therapeutic Biosimilars" will be offered on October 18, 2010.  The workshop will address the following questions:

• What are the biggest challenges with biosimilar development?
• How to develop an adequate manufacturing, preclinical and clinical plan?
• What strategies can be implemented to ensure target safety and efficacy qualities are achieved?

A complete agenda for the Summit on Biosimilars and Follow-on Biologics can be found here (Day One) and here (Day Two).  A brochure for this conference can be requested here.

The standard registration rate for the conference is $1,695 (conference alone) or $1,995 (conference plus workshop), and the academic/government/non-profit rate is $995 (conference alone) or $1,195 (conference plus workshop).  Attendees (standard rate only) registering by August 20, 2010 will receive a $300 discount off the registration fee, and attendees registering a group of three individuals will receive a fourth registration for free.  Those interested in registering for the conference can do so here, by calling 1-800-817-8601, or by e-mail at cbireg@cbinet.com.

Patent Docs is a media partner of CBI's Summit on Biosimilars and Follow-on Biologics.

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. (Fed. Cir. 2010)

By Andrew Williams --

On Wednesday, in Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., the Federal Circuit affirmed a finding that claims of Lilly's U.S. Patent No. 5,464,826 ("the '826 patent) were invalid for obviousness-type double patenting over U.S. Patent No. 4,808,614 ("the '614 patent").  The '614 patent claims gemcitabine, and methods of using gemcitabine to treat viral infections, while the '826 patent claims methods of using gemcitabine for treating cancer.  Lilly markets the drug GEMZAR, which contains gemcitabine as the active ingredient, for the treatment of various forms of cancer.  Correspondingly, both the '614 patent and the '826 patent were listed in the Orange Book with respect to GEMZAR.  Sun filed an ANDA in 2006 to market a generic version of GEMZAR, and filed a declaratory judgment action in 2007, asserting, among other things, that the '826 patent was invalid.  Ultimately, the U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment because the asserted claims of the '826 were invalid based on obviousness-type double patenting.

Lilly's '614 patent was a continuation-in-part ("CIP") application of U.S. Application No. 06/473,883 ("the '833 application").  The original '833 application only described gemcitabine's antiviral activity.  However, when the CIP application was filed, the specification was amended to include the observation that "certain compounds of the present invention have also demonstrated excellent oncolytic activity in standard cancer screens" ('614 patent, col. 17, ln. 54-56).  Nevertheless, the '614 patent did not claim any methods of treating cancer.  In fact, Sun and Lilly did not dispute that the '614 patent was entitled to the benefit of the '833 application filing date.  On the same date that Lilly filed the application that resulted in the '614 patent, it also filed an application that gave rise to the '826 patent.  Because both of these applications were filed prior to 1995 (December 4, 1984 to be exact), the patent term was calculated based on the issue date.  Lilly obtained patent term extension for the '614 patent, and as a result, the patent expired on May 15, 2010.  The '826 patent was set to expire two-and-a-half years later, on November 7, 2012.  Lilly did not file a terminal disclaimer.

The Federal Circuit agreed with the District Court in finding that this case was analogous to the prior decisions in Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008).  In Geneva Pharm., an earlier patent claimed the compound potassium clavulanate, and the specification disclosed its utility in inhibiting B-lactamase, while a later patent claimed the method of using the compound to inhibit B-lactamase.  Because the second patent did no more than claim the previously disclosed utility of a previously claimed compound, the two patents were not patentably distinct.  In Pfizer, an earlier patent claimed several COX-2 inhibitors, and disclosed that they could be used to treat both inflammation and inflammation-associated disorders.  A later patent claimed these previously disclosed methods of use.  Again, the Court found that these two patents were not patentably distinct.

Lilly asserted two reasons why the present case was different from both Geneva Pharm. and Pfizer.  First, Lilly pointed out that in the earlier cases, there was only one disclosed utility -- the methods of use that were claimed in the later patents.  In contrast, Lilly's earlier patent disclosed more than one utility -- treating viral infections and cancer.  Because the treatment of cancer was not the "essential utility," Lilly argued, the two patents were patentably distinct.  The Court rejected this argument because the Pfizer case, in fact, did involve more than one essential utility -- the treatment of inflammation, and the treatment of inflammation-associated disorders.  Of course, the Court does not address whether these were results of the same utility, namely, whether the treatment of the inflammation-associated disorders would flow naturally from the treatment of the inflammation.  But, on the other hand, it is not clear from the discussion whether the anti-cancer properties of gemcitabine would not naturally result from the treatment of the viral infections.  Nevertheless, the Court determined that the holdings of Geneva Pharm. and Pfizer extend to any and all uses disclosed in the earlier specification.

The Federal Circuit also rejected Lilly's second argument that the trial court erred in consulting the specification of the issued patent instead of the specification of the priority document, the '833 application.  In support of this argument, Lilly relied on claim construction concepts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).  Specifically, Lilly argued that a claim term should be given its ordinary and customary meaning as understood by one of ordinary skill in the art at the time of invention.  Gemcitabine's anti-cancer properties were unknown at the time the '614 patent was invented.  However, the Federal Circuit pointed out that its claim construction precedent establishes that claim terms must be construed in light of the entire issued patent, and therefore found no support for Lilly's argument.

Ultimately, the Federal Circuit appears to justify its decision on the policy considerations as articulated in both Pfizer and Geneva Pharm.:

It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patent upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1368 n.8; Geneva Pharm., 349 F.3d at 1386.

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co. (Fed. Cir. 2010)
Panel: Circuit Judges Bryson, Gajarsa, and Prost
Opinion by Circuit Judge Prost

Biotech/Pharma Docket

By James DeGiulio --

Medicis Pharmaceuticals Settles Solodyn Litigation with Mylan

Medicis Pharmaceuticals Corporation has reached settlement and license agreements with Mylan, Inc., thus resolving the patent litigation over Solodyn.

In 2009, Medicis brought suit against Mylan and several drug companies in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 5,908,838.  Medicis has since settled with several defendants, and the strength of Medicis' position was given a boost once the U.S. Patent and Trademark Office upheld the validity of the '838 patent (see "Biotech/Pharma Docket," June 17, 2010).

On July 22, Medicis entered into a settlement and license agreement with Mylan, in which Mylan confirmed the validity and infringement of the '838 patent.  According to the terms of the agreement, Mylan agreed to be permanently enjoined from further distributing the generic drug except under the license agreement.  In return, Medicis will release Mylan from any liability related to the prior sales of their product, and Mylan will have the right to market minocycline ER in the U.S., beginning in November 2011.  Medicis will receive royalties based on sales of Mylan's generic products.

Forest and Merz Pharma Settle Namenda Infringment Dispute

Merz Pharma and exclusive patent licensee Forest Laboratories have wrapped up their patent infringement suit over the Alzheimer's drug Namenda after reaching a settlement and licensing agreement with Mylan.

Forest initially brought suit against Mylan, Merz, Orchid, and a number of defendants in January of 2008 in the U.S. District Court for the District of Delaware following the filing of several ANDAs seeking FDA approval to market generic Namenda.  Forest alleged infringement of U.S. Patent No. 5,061,703.

Under the settlement agreements, the first generic versions of memantine would be able to enter the market on January 11, 2015, three months prior to the April 11, 2015 expiration of the '703 patent.  Forest and Merz will provide licenses to each of Amneal, Watson, Dr. Reddy's, Lupin, Mylan, Orchid, Sun, Teva, Upsher-Smith, and Wockhardt.  The terms of its settlement agreements remain subject to review by the Federal Trade Commission.

Teva Agrees to Dismiss Suit with Eisai over Aricept Patent

Teva Pharmaceuticals USA Inc. agreed to suspend and dismiss its litigation with Eisai Co. over the Alzheimer's drug Aricept.

In 2005, Eisai filed suit in the U.S. District Court for the District of New Jersey in response to Teva's ANDA, alleging infringement of Eisai's U.S. Patent No. 4,895,841, which covers Aricept.  Teva initially claimed the patent was invalid due to obviousness, but later changed its defense to inequitable conduct.  Teva stipulated that its proposed generic infringed the claims of the '841 patent, but that those claims were unenforceable.  In December, Magistrate Judge Salas denied Teva's motion to compel discovery of communications between Eisai and the USPTO over several patent applications not related to the suit.  Teva appealed the order to Judge Brown, but agreed that Teva's request was too broad and unduly burdensome.

Judge Garrett Brown Jr. affirmed the settlement agreement, calling for the case to be suspended and eventually dismissed after the '841 patent expires in November 26, 2010.  Teva has effectively given up its bid to manufacture a generic version of Aricept, for Eisai's 2008 preliminary injunction prohibiting Teva from manufacturing the drug remains in effect.

Judge Brown's order can be found here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.

Senate Removes Pay-For-Delay Provision from Appropriations Bill

By Donald Zuhn --

Earlier this month, the House of Representatives passed the "2010 Supplemental Appropriations Act" (H.R. 4899) after tacking an additional $22.8 billion onto the Senate version of the bill, which called for $45.5 billion in discretionary funding for FY 2010.  The bill would provide, inter alia, $37.12 billion for U.S. troops in Iraq and Afghanistan, $13 billion in mandatory funding for Vietnam veterans exposed to Agent Orange, $5.1 billion for FEMA disaster relief, $2.9 billion for Haiti, $162 million for the Gulf Coast oil spill, and over $600 million for other domestic needs.  The extra $22.8 billion in spending was not the only thing the House tacked onto the bill, however.  House legislators also inserted a provision that would allow the Federal Trade Commission (FTC) to "initiate a proceeding . . . against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product," wherein the agreement has "anticompetitive effects" (see "House Slips Pay-For-Delay Provision into Appropriations Bill").

The bill, which was returned to the Senate last week, was cleared for White House approval yesterday, but not before the Senate stripped away the pay-for-delay provision.  Senate Majority Leader Harry Reid (D-NV) moved to adopt the House amendments to the bill, but the Senate disagreed to the House amendments by unanimous consent, after which the bill was returned to the House where that body voted 308-114 to accept the Senate's earlier version of the bill.

Before the Senate had a chance to remove the pay-for-delay provision, the Generic Pharmaceutical Association (GPhA) released a statement saying that the organization was "extremely disappointed that the U.S. House of Representatives adopted language in the War Funding Bill (H.R. 4899) that will delay consumer access to affordable medicines by severely restricting drug patent litigation settlements" (see "House Slips Pay-For-Delay Provision into Appropriations Bill").  The Pharmaceutical Research and Manufacturers of America (PhRMA) provided its own statement days before the House passed its amended version of the appropriations bill.  The trade group, which represents pharmaceutical research and biotechnology companies, said that it "continues to believe that legislation that would impose a blanket ban on certain types of patent settlements or otherwise prevent them could decrease the value of patents and reduce incentives for future innovation of new medicines," and further, that pay-for-delay (or reverse payment) legislation would "discourage pro-consumer settlements that often bring generics to market years before patent expiration."  The PhRMA release concludes by stating that "each settlement between a brand and generic should be judged on its own merit, taking all the facts into account, and the FTC, Department of Justice and the courts are well-equipped to evaluate individual settlements and determine whether they will help or hurt consumers."

The Intellectual Property Owners Association (IPO) reported on Tuesday that it sent a letter to Senate leadership last week (the day before the Senate removed the pay-for-delay provision) noting its strong opposition to the pay-for-delay provision.  In its letter, the IPO argued that "[t]he businesses and valuable patent rights owned by all IPO members, particularly members from the pharmaceutical industry, would be significantly impacted by this amendment if it becomes law."  The group also contends that "the amendment would upset the careful balance of the Hatch-Waxman Act, which provides an expedited approval pathway for generic pharmaceutical manufacturers without undermining the innovator pharmaceutical developer's incentives to continue investment and development for life-saving and life- altering medicines."  The IPO explains that:

The amendment undermines pharmaceutical patents by imposing a presumption that any settlement involving a payment to the generic applicant is to protect an undeserved patent.  This is a false rationale because it disregards the presumption of validity that accompanies a patent issued by the U.S. Patent and Trademark Office and ignores the unequal economic situation of the innovator company and the generic applicant. In typical patent litigations, a competing product is already out on the market, and damages can be more easily determined.  In such cases, when entering into a settlement, a patent holder commonly induces the competitor with something of value, either to reduce or waive damages.  In contrast, under Hatch-Waxman, the patent holder may not yet have the right to recover any damages, so the only thing of value it can offer a generic company may be cash or other assets.  In a Hatch- Waxman case, the innovator company often has significant business at risk, including manufacturing plants, sales and marketing employees, and the need to use current revenue to carry out expensive clinical trials on the next generation of innovative medicines.  By contrast, the generic company has nothing at risk other than the legal fees it pays in order to challenge the patent early.  The Hatch-Waxman Act itself contains no restrictions on settlement of the patent litigation it engenders, permitting the parties to arrive at settlements that make business sense, subject to the limits of the patent at issue in the litigation.

The group asserts that "the courts should be trusted to protect competition against the improper expansion of a patentee's lawful monopoly as a result of a settlement by applying existing antitrust case law to the specific facts relating to a challenged settlement."

It is unlikely that the Senate's removal of the pay-for-delay provision from H.R. 4899 marks the end of this debate -- particularly in view of the President's past support for such legislation (see "President's Health Care Plan Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway") and prior attempts to secure passage of standalone bills (see "Bill to Prohibit Reverse Payments Introduced in the Senate" and "Senate and House Introduce Bills Prohibiting Authorized Generics").  While the industry now awaits the next legislative attack on pay-for-delay agreements, recent statements by the GPhA, PhRMA, and IPO indicate that it will not wait silently.

Abbott Files Brief in Therasense Case

By Kevin E. Noonan --

The idea of a "golden age," almost always some time in the past, is a recurrent theme in history, literature, and myth. It is also the unspoken theme in Abbott's principal brief filed earlier this week in Therasense Inc. v. Becton Dickinson & Co., and that Golden Age has an exact date: right after the Federal Circuit rendered its en banc decision in Kingsdown Medical Consultants, Ltd. v. Hollister Inc., the last time the Court took up the question of inequitable conduct en banc.

In an extensive (59 page) brief, Appellants argue that this case is not about whether the doctrine of inequitable conduct should be reformed, but whether it should be restored, specifically "to its origins in Supreme Court precedent; to the confines Congress intended in the 1952 Patent Act; to the standards this Court articulated en banc in Kingsdown Medical Consultants v. Hollister, Inc., 863 F.2d 867 (Fed. Cir. 1988); and to the standards that govern in other areas of law." This restoration is needed, the brief argues, because the Federal Circuit has "expanded" inequitable conduct "well beyond" the appropriate boundaries established by this earlier precedent and practice, and has resulted in an "'ongoing pandemic' of inequitable conduct charges," citing Judge Gajarsa's dissent in Taltech Ltd. v. Esquel Enterprises Ltd., 604 F.3d 1324, 1335 (Fed. Cir. 2010). Most provocatively, the brief charges that prevailing Federal Circuit precedent "has converted the federal courts into roving commissions to enforce standards of conduct before the PTO without regard to whether the alleged infractions had any impact." (And in an interesting strategic move, the brief cites extensively throughout to (now) Chief Judge Rader's many dissents and other pronouncements critical of the burgeoning expanse of conduct adjudged to be inequitable by the Court in recent years.)

The brief begins it argument by asserting that a court should render a patent unenforceable for inequitable conduct only when the patent has been obtained by fraud (or "conduct tantamount to fraud"). The brief cites the "holy trinity" of Supreme Court cases in this area -- Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238, 250-51 (1944); Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945) -- to support its argument that the inequitable conduct doctrine (that a court should not enforce a patent in equity that was obtained due to inequitable conduct) was developed under fact circumstances that amounted to actual fraud (including perjury, subornation of perjury, bribery and other egregiously prosecution misconduct). The brief contrasts this with "missteps in making the legally and factually complex decisions applicants regularly make (such as whether to submit marginal prior art or potentially cumulative material)" as are commonly used today to support inequitable conduct charges (if not findings). The brief cites analogous trademark (citing In re Bose Corp., 580 F.3d 1240 (Fed. Cir. 2009)) and copyright (Eckes v. Card Prices Update, 736 F.2d 859, 861-62 (2d Cir. 1984)) standards that require similarly egregious misconduct to cancel a mark or strike a registration, which standards include the requirement that a challenger establish a "subjective intent to deceive, however difficult it may be to prove." Appellants argue that patent law should follow this example (particularly in view of the parallels the Supreme Court has drawn between patent and copyright based on the parallel recitation of these forms of protection in the Constitution, citing Sony Corp. of Am. v. Universal City Studios, Inc., 464 U.S. 417, 439 (1984) and eBay Inc. v. MercExchange L.L.C., 547 U.S. 388, 391-93 (2006)). Turning to the statute, the brief argues that the inequitable conduct defense was incorporated into the 1952 Patent Act (codified at 35 U.S.C. 282) "against the immediate backdrop" of Supreme Court precedent equating inequitable conduct with "fraudulent procurement" according to contemporary Supreme Court opinions (the "trinity").  Finally, the brief asserts that the equitable principles underlying the inequitable conduct doctrine are only equitably applied under circumstances when a patent is procured by actual fraud.

Appellants next argue that the Federal Circuit's own precedent -- Kingsdown Medical -- requires "powerful proof of scienter" to support the "intent to deceive" prong of its inequitable conduct analysis:

[T]he involved conduct, in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.  863 F.2d at 876 (emphasis added).

The brief asserts that the intent requirement "cannot be inferred from materiality," and exhorts the Court to 'reinvigorate" the scienter requirement, that an applicant must be shown to have a "specific intent to deceive" the Office to support a finding of inequitable conduct (a standard not fulfilled by even "gross negligence"). Citing Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., the brief sets out precisely what should be required (in Appellants' view) to establish an intent to deceive:

The evidence must establish that, at the time, the applicant (1) knew of the information, (2) knew it was material to issuance of the patent, (3) made a deliberate decision to withhold or misrepresent it, and (4) intended to deceive the PTO.

Deceptive intent must be "'the single most reasonable inference able to drawn from the evidence,'" Appellants argue, citing Orion IP, LLC, v. Hyundai Motor Am., 605 F.3d 967, 979 (Fed. Cir. 2010). This interpretation of the standard for establishing the intent to deceive requirement, Appellants argue, is consistent with both Supreme Court precedent and trademark and copyright law standards, as well as "sound policy considerations," not the least of which is to "restore the inequitable conduct doctrine to its proper bounds" and "stem a 'plague' of inequitable conduct charges" reminiscent of the situation that prevailed before the Federal Circuit rendered its Kingsdown decision. It is the Court's failure to stay true to (or even affirmatively disregard) the standards enunciated in Kingsdown that has resulted in the instant situation according to Appellants' brief. This section of the brief ends with an enumeration of the several, negative consequences of this falling away from the Kingsdown standard, both before the Patent Office (such as citing thousands of pages of documentary prior art) and in the courts.

With regard to the materiality prong, the brief argues that "[i]n patent cases, 'materiality' is most properly interpreted to require proof that, 'if the Patent Office had been aware of the complete or true facts, the challenged claims would not have been allowed," citing the CAFC's predecessor court from Norton v. Curtiss, 433 F.2d 779, 794 (C.C.P.A. 1971). The brief argues in favor of a "but for" standard, wherein inequitable conduct should be found only where "the patent would not have issue[d] absent the misconduct." The brief says that Supreme Court precedent requires "but-for causation," citing Corona Cord Tire Co. v. Dovan Chemical Corp., 276 U.S. 358 (1928), where the Court reversed an inequitable conduct finding because the undisclosed information was "not the basis for [granting the patent] or essentially material to its issue."  But-for causation is also required under prevailing trademark and copyright law standards for analogous fraudulent procurement activity, the brief argues. When causation is unproven under this standard, the brief argues that courts (as opposed to the Office) should not render valuable patents unenforceable based on violations of PTO rules (as opposed to statutory requirements). And the brief argues that the court should not use Patent Office standards for assessing materiality, since these standards "serve a distinct purpose," being "necessarily . . . relatively broad" to serve their proper prophylactic function.

The brief also exhorts the Court to "eliminate sliding scale" balancing, which reduces the extent of the proofs required to establish both the materiality and intent prongs of the prevailing standards for proving inequitable conduct. Using the "sliding scale" has permitted courts to use a stronger showing of materiality to "lower the burden for proving intent, and vice-versa," with the result that both the required standards (and burden for establishing) both materiality and intent to deceive are "diluted." Specifically, the brief calls out the "should have known" standard applied in some inequitable conduct cases as particularly problematic, since it substitutes a fraud standard for one that "sounds . . . in negligence" but carries a far higher, fraud-based penalty. Appellants ascribe the recurrent "plague" of inequitable conduct squarely to this diminution of the Kingsdown standards (citing Judge Newman's dissent in McKesson Info. Solutions, Inc. v. Bridge Med., Inc., 487 F.3d 897, 926 (Fed. Cir. 2007), in support). Interestingly, the brief does a little jurisprudential excavating on the origins of the sliding scale, and finds its genesis in American Hoist & Derrick Co. v. Sowa & Sons, Inc., which cited an earlier case, Digital Equipment Corp. v. Diamond, 653 F.2d 701, 716 (1st Cir. 1981), for the proposition:

Questions of "materiality" and "culpability" are often interrelated and intertwined, so that a lesser showing of the materiality of the withheld information may suffice when an intentional scheme to defraud is established, whereas a greater showing of materiality of withheld information would necessarily create an inference that its nondisclosure was "wrongful."  725 F.2d at 1363.

Ironically, this citation to the Digital Equipment case is the only support for this proposition in American Hoist & Derrick Co., and the brief notes that the only support for the assertion in Digital Equipment Corp. is a District of Massachusetts case, United States v. Standard Electric Time Co., 155 F. Supp. 949, 952-53 (D. Mass. 1957), that "contains no suggestion of an intent-materiality balancing test." As an illustration of how far off the rails the Federal Circuit has gone in misapplying the proper standard, the brief cites Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181 (Fed. Cir. 2006), which held that "intent to deceive may be inferred -- indeed, inferred as a matter of law -- where '(1) the applicant knew of the information; (2) the applicant knew or should have known of the materiality of the information; and (3) the applicant has not provided a credible explanation for the withholding.'" Such a standard "eviscerates Kingsdown" according to the brief, as it substitutes a mere negligence (not even a gross negligence) standard "that was expressly rejected in Kingsdown," citing Judge Linn's concurring opinion in Larson Mfg. Co. of S.D., Inc. v. Aluminart Prods. Ltd., 559 F.3d 1317 (Fed. Cir. 2009).

Turning to the merits of the case at bar, the brief argues that the panel erred by substituting evidence of "high" materiality for a "diluted" intent standard. Specifically, the brief argues that the lawyer argument during U.S. prosecution was a reasonable interpretation of the argument made in a corresponding European application. Finally, the brief argues that the decision of the initial panel "abrogates the rule that lawyer argument is not material" evidence for (or against) patentability. In its analysis, the brief dissects the five reasons the District Court (and the initial CAFC panel) gave for supporting the determination of an intent to deceive, specifically arguing that at least one of the reasons -- failure to give a credible explanation for non-disclosure -- improperly "inverts the burden of proof" since the accused party "need not offer any explanation" unless the evidence establishes an intent to deceive clearly and convincingly.

Absent any extensions, appellee Becton Dickinson & Co.'s brief is due August 25, and amicus curiae briefs must be filed no later than 7 days (i.e., August 2) after the principal brief of the party being supported is filed, or no later than 7 days after the Plaintiffs-Appellants' principal brief is filed when an amicus curiae does not support either party.

USPTO Celebrates One-Year Anniversary of e-Office Action

    By Sydney Kokjohn --

Last week, the U.S. Patent and Trademark Office celebrated the one-year anniversary of its e-Office Action (e-OA) program.  So far, the program has electronically notified patent applicants on more than 850,000 Office communications and reduced Patent Office paper usage by more than 9.2 million pages. 

A pilot version of the program launched in December 2006 and later expanded to include additional USPTO offices (see "USPTO begins the 'e-Office Action' Pilot Program" and "e-Office Action Pilot Program Expansion").  In February of last year, the USPTO announced the pilot e-Office Action program would be made permanent in March.  There was initially some confusion about whether the program would be mandatory, but the Patent Office clarified that it was optional and that mailed communications would be sent if you were not enrolled (see "Optional e-Office Action Program to Begin in March").  The permanent program actually started on July 21, 2010 (see "USPTO e-Office Action Program Launches").

 

Participation in the e-OA program is available to any registered patent attorney or agent or any pro se inventor, who is prosecuting an application associated with a customer number.  Applicants can opt-in or opt-out at any time.  This program allows applicants to receive notifications several days faster than when paper communications are mailed.  Those who opt-in to the program receive daily email notifications (including on the weekends) that Office communications are available for download through private PAIR.  The email notifications replace the postal mailing of Office communications for these applicants.  Applicants can enroll in the e-OA program through private PAIR by selecting the option to "Receive Correspondence Notification via e-Mail" on the Customer Details for Customer Number screen.  Other beneficial features of the program include:

• Notifications sent to up to three emails addresses; and
• Reminder postcards when a new e-Office Action has not been viewed within seven days and requires a reply.

Some of the top document codes for e-Office Actions include non-final rejections, notices of allowance, and filing receipts (a spreadsheet of top document codes can be found here).  Participants in the e-OA program are invited to share their experiences by emailing PAIR@USPTO.gov.  Additional information about the e-OA program can be found here.

News from Abroad: Argentine Patent Office Issues Regulation Restricting Divisional Filings

    By Ignacio Sanchez Echagüe --

The Argentine Patent Office (Instituto Nacional de la Propiedad Industrial, INPI) has issued Regulation No. 147/2010, which restricts the ability of applicants to file divisional applications once substantive examination has begun.

The regulation, which went into effect on July 16, 2010, allows applicants to file divisional applications until notice of substantive examination has been served.  No divisional applications will be allowed thereafter, unless they are made in response to a request from the Argentine Patent Office.  Once substantive examination has begun, if the examiner finds that the application has more than one object, the applicant will be requested to divide it within 30 days; should the applicant fail to do so, the application will be deemed as having been abandoned.  In all cases, the basic application must be alive and pending.

This new regulation modifies the prior practice of the Argentine Patent Office, which allowed applicants to file divisional applications at any time during prosecution up to the final decision of the main application.

Regulation No. 147/2010 raises concerns as it may unlawfully restrict patent rights, thus providing grounds for challenge.

Ignacio Sanchez Echagüe [IMSE@marval.com.ar] is an attorney with Marval, O'Farrell & Mairal in Buenos Aires, Argentina.

News from Abroad: Mexico to Issue Regulations for Approval of "Biocomparable" Drugs

    By Juan Serrano --

The Mexican General Health Law was reformed on June 11, 2009 to include an article 222 bis, which defined biotechnological drugs, and allowed for the approval of "biocomparables."  The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all specific regulations pertaining to the approval of these biocomparables.

Even though the 180-day period expired on March 8, 2010, work on the project of regulations has continued, with input being provided by both the Mexican Association of Pharmaceutical Research (AMIIF) and the National Association of Drug Manufacturers (ANAFAM).

This past week, COFEPRIS (the Mexican regulatory authority) made the project of regulations available to the public, through the official website of the Federal Commission for Regulatory Improvement (COFEMER).

At this point, a period of 30 working days has been given to any interested party that wishes to provide comments to this project through COFEMER's website, after which the project can be either published or further analyzed.

The main items in this project are:

• A definition of comparability tests between an innovator and a biocomparable drug.

• An indication that biocomparable drugs will use the same name for the active ingredient as the innovator.

• The Health law regulations currently contain a 3-year period Roche-Bolar-like research exemption (related to the possibility of submitting an application for a marketing authorization before patent expiration, with intent to launch after the date of expiry).  This 3-year period is eliminated, and the submission can now be made at any time.  The modification in the corresponding article will also be applicable to chemical drugs.

• The timelines that COFEPRIS will have for approval of both innovator and biocomparable drugs are established.

A copy of this document can be found here.

Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs.  He can be contacted at jls@olivares.com.mx.

USPTO Provides Clarification Regarding Treatment of PTA Letters

    By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (75 Fed. Reg. 42079) to clarify how the Office will treat certain letters submitted by applicants and patentees regarding the Office's patent term adjustment (PTA) determinations.  In particular, the notice addresses situations in which an applicant or patentee submits a letter (other than requests for reconsideration under 37 C.F.R. § 1.705) stating that the Office's PTA determination is greater than what the applicant or patentee believes is appropriate.  In such situations, the notice states that the Office will no longer review the letter or issue a certificate of correction, but instead will place the letter in the application file without further review.

When reconsideration of a PTA determination is desired, the notice reminds applicants and patentees that the procedures set forth in 37 C.F.R. § 1.705 for requesting reconsideration must be used.  Alternatively, a patentee may file a terminal disclaimer disclaiming any period considered in excess of the appropriate PTA.  The notice states, however, that "the USPTO does not require an applicant or patentee to file either a request for reconsideration under 37 CFR 1.705 or a terminal disclaimer when the patent term adjustment indicated on a notice of allowance, issue notification, or patent is greater than what the applicant or patentee believes is appropriate."

The Office notes that a 2004 revision to the M.P.E.P. permitted applicants and patentees to wait until a patent issues and then request a certificate of correction if a notice of allowance or patent specified a PTA that was longer than expected (M.P.E.P. § 2733).  Despite this revision to the M.P.E.P., however, the notice declares that "the USPTO has long maintained that a request for a certificate of correction under either 35 U.S.C. 254 or 255 is not an appropriate venue for seeking a change to the patent term adjustment indicated on a patent," because "[i]t would render the provisions of 35 U.S.C. 154(b)(3) superfluous if patent term adjustment determinations could be revised at any time during the life of the patent via a certificate of correction under 35 U.S.C. 254 or 255."

The notice does offer two circumstances in which it would be appropriate to issue a certificate of correction to revise a PTA determination:  to make the PTA determination consistent with (1) the PTA determined in a decision on a request for reconsideration under 37 C.F.R. § 1.705, or (2) "the total patent term adjustment indicated on the Patent Application Information Retrieval (PAIR) screen that displays the patent term adjustment calculation for the patent."  According to the notice, the Office will issue certificate of corrections to revise a PTA determination only under the two circumstances described above.  As a result:

If the applicant or patentee wants the USPTO to reconsider its patent term adjustment determination, the applicant or patentee must use the procedures set forth in 37 CFR 1.705 for requesting reconsideration of a patent term adjustment determination, whether the USPTO's patent term adjustment determination is greater than or less than the adjustment that the applicant or patentee believes to be appropriate.

The Office notes that the M.P.E.P. will be revised to correct the improper guidance provided in the 2004 revision.

Court Report

    By Sherri Oslick --

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

Roche Palo Alto LLC et al. v. Lupin Pharmaceuticals, Inc. et al.
1:10-cv-01988; filed July 20, 2010 in the District Court of Maryland

• Plaintiffs:  Roche Palo Alto LLC; Gilead Palo Alto, Inc.; Gilead Sciences, Inc.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Roche Palo Alto LLC et al. v. Lupin Pharmaceuticals, Inc. et al.
2:10-cv-03561; filed July 14, 2010 in the District Court of New Jersey

• Plaintiffs:  Roche Palo Alto LLC; Gilead Palo Alto, Inc.; Gilead Sciences, Inc.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,303,607 ("Method for Administering a Sustained Release Ranolazine Formulation," issued October 16, 2001), 6,479,496 ("Methods for Treating Angina with Ranolazine," issued November 12, 2002), 6,503,911 ("Sustained Release Ranolazine Formulations," issued January 7, 2003), 6,525,057 (same title, issued February 25, 2003), 6,562,826 (same title, issued May 13, 2003), 6,617,328 (same title, issued September 9, 2003), 6,620,814 (same title, issued September 16, 2003), 6,852,724 (same title, issued February 8, 2005), and 6,864,258 (same title, issued March 8, 2005), all licensed to Gilead, following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Gilead's Ranexa® (ranolazine, used to treat chronic angina).  View the New Jersey complaint here.

Bayer Schering Pharma AG et al. v. Teva Pharmaceuticals USA Inc. et al.
1:10-cv-00616; filed July 20, 2010 in the District Court of Delaware

• Plaintiffs:  Bayer Schering Pharma AG; Bayer HealthCare Pharmaceuticals Inc.; Schering Corp.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceuticals Industries Ltd.

Infringement of U.S. Patent No. 7,696,206 ("2-phenyl Substituted Imidazotriazinones as Phosphodiesterase Inhibitors," issued April 13, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of plaintiffs' Levitra® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.

Promote Innovation LLC v. K-V Pharmaceutical Co. et al.
2:10-cv-00254; filed July 20, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  K-V Pharmaceutical Co.; Ther-Rx Corp.

False marking based on defendants' marking of their Gynazole-1® products indicating that these products are covered by U.S. Patent Nos. 4,078,071 ("Derivatives of substituted N-alkyl imidazoles," issued March 7, 1978), 4,551,148 ("Vaginal delivery systems and their methods of preparation and use," issued November 5, 1985), and 4,636,202 ("Medicament applicator with plunger assembly and automatically-openable closure therefore," issued January 13, 1987), which are expired.  View the complaint here.

Promote Innovation LLC v. Schering Corp. et al.
2:10-cv-00248; filed July 19, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  Schering Corp.; Merck & Co., Inc.; Cima Labs Inc.

False marking based on defendants' marking of their Clarinex® products indicating that these products are covered by U.S. Patent Nos. 4,659,716 ("Antihistaminic 8-(halo)-substituted 6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridines," issued April 21, 1987) and 4,863,931 ("Antihistaminic fluoro substituted benzocycloheptapyridines," issued September 5, 1989), which are expired.  View the complaint here.

Promote Innovation LLC v. Roche Diagnostics Corp. et al.
2:10-cv-00249; filed July 19, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  Roche Diagnostics Corp.; Roche Diagnostics Operations, Inc.

False marking based on defendants' marking of their Accu-Chek® products indicating that these products are covered by U.S. Patent Nos. RE36,268 ("Method and apparatus for amperometric diagnostic analysis," issued August 17, 1999), 4,999,582 ("Biosensor electrode excitation circuit," issued March 12, 1991), 4,924,879 ("Blood lancet device," issued May 15, 1990), and 5,053,199 ("Electronically readable information carrier," issued October 1, 1991), which are either unenforceable or expired.  View the complaint here.

Promote Innovation LLC v. Gloucester Pharmaceuticals, Inc. et al.
2:10-cv-00241; filed July 16, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  Gloucester Pharmaceuticals, Inc.; Celgene Corp.

False marking based on defendants' marking of their Istodax® products indicating that these products are covered by U.S. Patent No. 4,977,138 ("FR901228 substance and preparation thereof," issued December 11, 1990), which is expired.  View the complaint here.

Promote Innovation LLC v. Pfizer Inc. et al.
2:10-cv-00242; filed July 16, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  Pfizer Inc.; Pharmacia & Upjohn Co., Inc.; Bayer Healthcare Pharmaceuticals Inc.

False marking based on defendants' marking of their Glyset® products indicating that these products are covered by U.S. Patent No. 4,639,436 ("Antidiabetic 3,4,5-trihydroxypiperidines," issued January 27, 1987), which is expired.  View the complaint here.

Promote Innovation LLC v. Abbott Laboratories Inc. et al.
2:10-cv-00246; filed July 16, 2010 in the Eastern District of Texas

• Plaintiff:  Promote Innovation LLC
• Defendants:  Abbott Laboratories Inc.; Takeda Pharmaceutical Co. Ltd.

False marking based on defendants' marking of their Lupron® products indicating that these products are covered by U.S. Patent Nos. 4,652,441 ("Prolonged release microcapsule and its production," issued March 24, 1987), 4,677,191 ("Copolymer and method for producing the same," issued June 20. 1987), 4,728,721 ("Polymer, production and use thereof," issued March 1, 1988), 4,849,228 (same title, issued July 18, 1989), 4,917,893 ("Prolonged release microcapsules," issued April 17, 1990), 4,005,063 ("[Des-gly].sup.10 -GnRH nonapeptide anide analogs in position 6 having ovulation-inducing activity," issued January 25, 1977), and 4,005,194 ("Treatment of prostatic hyperplasia," issued January 25, 1977) which are expired.  View the complaint here.

Bayer Schering Pharma AG et al v. Lupin Ltd. et al.
1:10-cv-01914; filed July 15, 2010 in the District Court of Maryland

• Plaintiffs:  Bayer Schering Pharma AG; Bayer Healthcare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. RE37,564 ("Composition for Contraception," issued February 26, 2002), RE37,838 (same title, issued September 10, 2002), RE38,253 (same title, issued September 16, 2003), and 5,569,652 ("Dihydrospirorenone as an antiandrogen," issued October 29, 1996) following a Paragraph IV certification as part of Lupin's filing of ANDAs to manufacture a generic version of Bayer's Yaz® (drospirenone and ethinyl estradiol, used for oral contraception) and Bayer's Yasmin® (drospirenone and ethinyl estradiol, used for oral contraception).  View the complaint here.

Bayer Schering Pharma AG et al v. Lupin Ltd et al.
2:10-cv-01166; filed July 15, 2010 in the District Court of Nevada

• Plaintiffs:  Bayer Schering Pharma AG; Bayer Healthcare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. RE37,564 ("Composition for Contraception," issued February 26, 2002), RE37,838 (same title, issued September 10, 2002), and RE38,253 (same title, issued September 16, 2003) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Bayer's Yaz® (drospirenone and ethinyl estradiol, used for oral contraception).  View the complaint here.

Bayer Schering Pharma AG et al. v. Lupin Ltd. et al.
1:10-cv-05423; filed July 15, 2010 in the Southern District of New York

• Plaintiffs:  Bayer Schering Pharma AG; Bayer Healthcare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone as an antiandrogen," issued October 29, 1996) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Bayer's Yasmin® (drospirenone and ethinyl estradiol, used for oral contraception).  View the complaint here.

King Pharmaceuticals, Inc. et al. v. Sandoz, Inc.
3:10-cv-03568; filed July 14, 2010 in the District Court of New Jersey

• Plaintiffs:  King Pharmaceuticals, Inc.; Meridian Medical Technologies, Inc.
• Defendant:  Sandoz, Inc.

Infringement of U.S. Patent No. 7,449,012 ("Automatic Injector," issued November 11, 2008) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Meridian's EpiPen® Auto-Injector (epinephrine, used to treat anaphylaxis).  View the complaint here.

Genzyme Corp. v. Lupin Ltd. et al.
1:10-cv-01906; filed July 14, 2010 in the District Court of Maryland

• Plaintiff:  Genzyme Corp.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Genzyme Corp. v. Watson Laboratories, Inc.
1:10-cv-01863; filed July 9, 2010 in the District Court of Maryland

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,667,775 ("Phosphate-Binding Polymers for Oral Administration," issued on September 16, 1997) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Genzyme's Renvela® (sevelamer carbonate, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the Watson Laboratories complaint here.

Stiefel Laboratories Inc. et al. v. Perrigo Israel Pharmaceuticals Ltd. et al.
1:10-cv-00592; filed July 12, 2010 in the District Court of Delaware

• Plaintiffs:  Stiefel Laboratories Inc.; Stiefel Research Australia Pty Ltd.
• Defendants:  Perrigo Israel Pharmaceuticals Ltd.; Perrigo Co.

Infringement of U.S. Patent Nos. 6,730,288 ("Mousse Composition," issued May 4, 2004) and 7,029,659 (same title, issued April 18, 2006) following a paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Stiefel's OLUX-E® (clobetasol propionate foam 0.05%, used to treat moderate to severe scalp dermatoses).  View the complaint here.

Siemens Healthcare Diagnostics Inc. v. Enzo Life Sciences, Inc.
4:10-cv-40124; filed July 9, 2010 in the District Court of Massachusetts

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Enzo in the interference between U.S. Patent Application No. 08/479,995 ("Assay Method Utilizing Polynucleotide Sequences," filed June 7, 1995), assigned to Enzo and U.S. Patent No. 5,124,246 ("Nucleic Acid Multimers and Amplified Nucleic Acid Hybridization Assays Using Same," issued June 23, 1992), assigned to Siemens.  View the complaint here.

Elan Pharma International Ltd. et al v. Teva Pharmaceuticals USA, Inc.
2:10-cv-03495; filed July 9, 2010 in the District Court of New Jersey

• Plaintiffs:  Elan Pharma International Ltd.; Fournier Laboratories Ireland Ltd.
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,145,684 ("Surface Modified Drug Nanoparticles," issued September 8, 1992), 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007), and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Abbott Laboratories et al. v. Teva Pharmaceuticals USA, Inc.
2:10-cv-03482; filed July 9, 2010 in the District Court of New Jersey

• Plaintiffs:  Abbott Laboratories; Laboratories Fournier S.A.
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Pfizer, Inc. et al. v. Apotex Inc. et al.
1:10-cv-05272; filed July 9, 2010 in the Southern District of New York

• Plaintiffs:  Pfizer, Inc.; Pfizer Ireland Pharmaceuticals
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,110,940 ("Salts of an Anti-Migraine Indole Derivative," issued August 29, 2000) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Pfizer's Relpax® (eletriptan hydrobromide, used for the acute treatment of migraine with our without aura).  View the complaint here.

AstraZeneca Pharmaceuticals LP et al. v. Torrent Pharmaceuticals Ltd. et al.
1:10-cv-00584; filed July 8, 2010 in the District Court of Delaware

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; IPR Pharmaceuticals Inc.; AstraZeneca AB; Brigham and Women's Hospital Inc.
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

Infringement of U.S. Patent Nos. 6,858,618 ("Use of Rosuvastatin (ZD-4522) in the Treatment of Heterozygous Familial Hypercholesterolemia," issued February 22, 2005) and 7,030,152 ("Systematic Inflammatory Markers as Diagnostic Tools in the Prevention of Atherosclerotic Diseases and as Tools to Aid in the Selection of Agents to be Used for the Prevention and Treatment of Atherosclerotic Disease," issued April 18, 2006) certification as part of Torrent's filing of an amended ANDA to manufacture a generic version of AstraZeneca's Crestor® (rosuvastatin calcium, used to treat high cholesterol).  View the complaint here.

Conference & CLE Calendar

July 26-27, 2010 - Advanced Patent Prosecution Workshop 2010: Claim Drafting & Amendment Writing (Practising Law Institute) - New York, NY

July 29-31, 2010 - Intensive Patent Law Training Workshop (Chisum Patent Academy) - Seattle, WA

August 5-10, 2010 - 2010 ABA Annual Meeting (American Bar Association) - San Francisco, CA

August 11, 2010 - "Bilski: Implications of the Supreme Court's Long-Awaited Ruling:  Strategies for Prosecuting or Challenging Patent Process Claims Going Forward" (Strafford) - 1:00 - 2:30 PM (EDT)

August 16-17, 2010 - Advanced Patent Prosecution Workshop 2010: Claim Drafting & Amendment Writing (Practising Law Institute) - San Francisco, CA

August 18-19, 2010 (Postponed to January 26-27, 2011) - The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) - New York, NY

August 25-26, 2010 - FDA Boot Camp*** (American Conference Institute) - San Francisco, CA

September 1-2, 2010 - 7th Annual Pharmaceutical Law Summer School (IBC Legal) - London, UK

September 7-9, 2010 - BioPatent Design (Pharma IQ) - Munich, Germany

September 12-14, 2010 - 2010 Annual Meeting (Intellectual Property Owners Association) - Atlanta, GA

September 15, 2010 - Prior Art & Obviousness 2010: Current Trends in Sections 102 & 103 (Practising Law Institute) - San Francisco, CA

September 16, 2010 - Developments in Pharmaceutical and Biotech Patent Law 2010 (Practising Law Institute) - New York, NY (Groupcasts to be held in Philadelphia, PA; Pittsburgh, PA; Mechanicsburg, PA; New Brunswick, NJ; and Boston, MA)

September 20-22, 2010 - 2nd Annual Business of Biosimilars (Institute for International Research) - Boston, MA

September 22-23, 2010 - Biosimilars & Biobetters: Aligning Business & Science for Success*** (SMi Conferences) - London, UK

September 27-28, 2010 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

October 6-7, 2010 - Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) - New York, NY.

***Patent Docs is a media partner of this conference or CLE

ACI Maximizing Pharmaceutical Patent Lifecycles Conference

American Conference Institute (ACI) will be holding its 11th Maximizing Pharmaceutical Patent Lifecycles conference on October 6-7, 2010 in New York, NY.  The conference will allow attendees to:

• Understand how the introduction of biosimilars has profoundly altered pharmaceutical patent life cycle strategies;
• Appreciate the relationship between life cycle management, brand optimization and new product development;
• See how the Federal Circuit is paving the way for Patent Reform;
• Determine when and how secondary patents -- for both small and large molecules should be pursued;
• Comprehend how the clear delineation between written description and enablement is influencing claims drafting strategies for drugs and biologics via Ariad v. Lilly;
• Assess how the Court's determination in Bilski regarding methods claims may affect areas such as personalized medicine and other new pharmacological technologies;
• Examine the impact of Caraco on skinny labeling, carve-outs and Orange Book listing determinations;
• Identify circumstances under which exclusivity is forfeited; and
• Navigate the boundaries of the safe harbor.

In particular, ACI's faculty will offer presentations on the following topics:

• The remaking of the patent endgame;
• Patent reform revisited:  Pondering its impact on the pharmaceutical industry;
• Understanding the particulars, peculiarities and politics of biosimilars and their impact on pharmaceutical patent life cycle management;
• Of biosimilar applications (BPCIA) and ANDAs (Hatch-Waxman);
• New patent term adjustment and patent term extension decisions and their significance for small and large molecules;
• Obviousness continued:  How KSR and its progeny are impacting the patent life of drug and biological products;
• Ariad v. Lilly:  The reaffirmation of written description and enablement and their collective role in patent life cycle management -- presented in part by Orange Book Blog author Aaron Barkoff;
• Biliski, Prometheus and Myriad:  Understanding the madness over methods claims in the pharmaceutical industry;
• Eye on the CAFC and district courts:  Life cycle lessons derived from Paragraph IV litigation;
• FTC keynote:  Competition considerations for pharmaceutical patent life cycle management -- presented by Markus H. Meier, Assistant Director of the Health Care Division for the Bureau of Competition of the Federal Trade Commission;
• New controversies and concerns associated with Orange Book listing and labeling strategies;
• Exclusivity:  Modes, methods, forfeitures and relinquishments;
• FDA keynote:  Update on FDA activities relative to pharmaceutical patent life cycles for small and large molecules -- Elizabeth Dickinson, Associate Chief Counsel for the Office of the Chief Counsel of the U.S. Food and Drug Administration; and
• Learning to navigate the new limits and boundaries of the safe harbor.

Two pre-conference workshops will be offered on October 5, 2010.  The first, entitled "Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals" will offer presentations on the following topics:

• Understanding pre-commercialization concerns relative to small molecules and biologics;
• The nature of the approval process for drugs and biologics:  What every pharmaceutical patent attorney should know; and
• Patent and IP overview for drugs and biologics:  Hatch-Waxman, trade dress, and more.

A second pre-conference workshop on "Pharmaceutical Patent Life Cycle Strategies for the EU and Emerging Markets" will also be offered on October 5, 2010.

A post-conference workshop, entitled "The Master Class on Patent Term Adjustment and Patent Term Extensions for Pharmaceutical and Biological Patents," will be held on October 8, 2010.  This post-conference workshop will provide practical advice as well as tips and techniques for PTA and PTE, take attendees through the intricacies of the four major ways of getting more time on their patents, and provide the tools that attendees need to accomplish this goal.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fees are $2,295 (conference only), $2,895 (conference plus one workshop), $3,295 (conference plus two workshops), or $3,495 (conference plus all three workshops).  Those registering by September 9, 2010 will receive a $200 discount (for all but the conference plus three workshops), and those registering on or before August 6, 2010 will receive a $300 workshop (for all but the conference plus three workshops).  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Maximizing Pharmaceutical Patent Lifecycles conference.

ACI FDA Boot Camp

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 27-28, 2010 in Boston, MA.  ACI faculty will help attendees:

• Master the complexities of pharmaceutical iP and the regulatory balance between brand name and generic products;
• Analyze the future of follow-on biologics following recent health care reform legislation;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• Comprehend the structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDHR;
• Understand the basics of the approval processes for drugs, biologics and devices, including in-depth discussion of the application, pre-approval and post-approval requirements;
• Evaluate when preemption arguments may offer protection for life sciences companies;
• Assess what marketing activities may constitute off-label promotion;
• Navigate the protocols of adverse events reporting; and
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices.

In particular, ACI's faculty will offer presentations on the following topics:

• The basics:  Understanding and working with the FDA -- Jurisdiction, functions, organization, and operations;
• The nature of the approval process;
• Understanding the clinical trial process for drugs and biologics;
• Patent and IP overview for drugs and biologics:  Hatch-Waxman, trade dress, and more;
• Spotlight on follow-on (comparable or biosimilar) biologics and the 2010 health care reform legislation;
• Drugs and biologics:  Labeling;
• Preemption fundamentals;
• Marketing and promotion;
• Non-patent exclusivity (part of the conference's patent track);
• Bioequivalence:  What patent lawyers need to know (patent track);
• Adverse events monitoring, pharmacovigilance and risk management; and
• Medical device essentials:  Premarket and post-market requirements.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for this conference is $2,195.  Those registering by August 27, 2010 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's FDA Boot Camp conference.

Biotech/Pharma Docket

    By James DeGiulio --

Teva and Novartis Settle Patent Dispute over Zometa

Teva Pharmaceuticals Industries Ltd. and Novartis Corp. have reached an agreement to settle their patent suit over a generic version of Zometa, a drug used to prevent skeletal fractures.

Teva first sent Novartis two Paragraph IV notices on June 10, 2008, claiming that Novartis' U.S. Patent No. 4,939,130 was either invalid, unenforceable, or wouldn't be infringed by Teva's proposed generic.  Novartis claimed that Teva had inappropriately sent the Paragraph IV notices before filing its ANDA (see "Court Report," August 3, 2008).  Thus, Novartis asked the District Court to declare Teva's Paragraph IV notices invalid and require the company to file new notices before the clock on the 30-month stay can start.

The parties subsequently reached an agreement, with Judge Sue Robinson of the U.S. District Court for the District of Delaware signing off on the parties' stipulation of dismissal.  The stipulation dismisses without prejudice all claims, counterclaims, and defenses in the action.  Both Teva and Novartis will pay their own costs and attorneys' fees.  No other details were available.

View Novartis' complaint here.

Judge Robinson's dismissal order can be found here.

Teva, Sun Fail to Overturn Jury Verdict Finding Pfizer Protonix Patent Valid

Teva and Sun's allegations that Pfizer's Protonix patent was invalid as obvious and invalid for double patenting were rejected in a recent court decision, which upholds an earlier jury verdict affirming the validity of Pfizer's U.S. Patent No. 4,758,579, covering the heartburn drug.

Wyeth, the licensee of the '579 patent and now part of Pfizer, and Altana Pharma AG, now part of Nycomed, brought a patent infringement suit against Teva in May 2004 following Teva's ANDA filing.  In September 2007, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey found that Teva had raised sufficient issues over the patent's validity, and denied a motion for preliminary injunction to stop Teva from launching generic versions of Protonix.  In April, a jury found the '579 patent valid, disagreeing with allegations by Teva and other generic firms that the patent was invalid based on obviousness and double-patenting (see "Biotech/Pharma Docket," May 10, 2010).

Judge Linares has now affirmed the April 23 jury verdict, finding that all issues regarding validity and infringement of the Protonix patent have been decided in Pfizer's favor.  Pfizer will now pursue its damage claims from the at-risk launch of generic versions of the drug by Teva and Sun.  Teva reiterated its belief the patent was invalid and unenforceable and planned to pursue all available legal remedies, including appeals.

Sandoz Loses Motion for Interlocutory Appeal in Effexor Patent Suit with Wyeth

Sandoz's bid for an interlocutory appeal has been denied following a grant of partial summary judgment for Wyeth in a patent infringement suit over the depression and anxiety drug Effexor.

Wyeth sued Sandoz in 2007, claiming that Sandoz's ANDA infringed three patents, U.S. Patent Nos. 6,419,958, 6,403,120, and 6,274,171 (see "Court Report," July 1, 2007).  Following a Markman hearing, Wyeth moved for summary judgment regarding Sandoz's direct infringement, active inducement of infringement, and contributory infringement of several claims in the three patents.  On March 12, Judge James Denver of the U.S. District Court for the Eastern District of North Carolina granted Wyeth's motion for summary judgment over all the infringement claims against Sandoz.  At the same time, he denied Sandoz's motion for summary judgment for noninfringement and invalidity, finding the defendant's arguments based on inappropriate claim construction.  Following this ruling, Sandoz asked Judge Denver to immediately certify his order granting summary judgment to Wyeth for an interlocutory appeal.

On July 14, Judge James ruled that Sandoz failed to meet the standard necessary for an interlocutory appeal.  Judge Denver had construed the term "extended release formulation" broadly to include a formulation that releases the active ingredient at a slower rate than the original formulation.  Judge Denver found no substantial ground for difference of opinion over the term such that an interlocutory appeal was warranted.  The judge also ruled that because the issues raised by Sandoz were not controlling questions of law, an interlocutory appeal would not materially advance the litigation.

Judge James' order can be found here.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.

NVCA Reports 34% Increase in Venture Funding for Second Quarter

    By Donald Zuhn --

Last week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of 2010.  The NVCA quarterly study, which the NVCA conducts with PriceWaterhouseCoopers using data from Thomson Reuters, indicates that venture capitalists invested $6.5 billion in 906 deals during the second quarter, a 34% increase in dollars and 22% increase in deals as compared to the first quarter of 2010.  After adjusting its first quarter numbers, the NVCA determined that $4.9 billion had been invested in 740 deals, as opposed to its initial determination that $4.7 billion had been invested in 681 deals (see "NVCA Report Shows First Quarter Drop in Venture Funding").  In addition, the NVCA report indicates that the $11.4 billion was invested over the first half of 2010, a 49% increase in dollars over the $7.7 billion that was invested over the first half of 2009.

In contrast with the first quarter of 2010, when the Life Sciences sector (biotechnology and medical devices) led all sectors with $1.3 billion invested in 160 deals, but still suffered through a 26% drop in dollars and a 21% decrease in deals as compared with the fourth quarter of 2009, the news was all good for the industry in the second quarter.  Thus, not only did the Life Sciences sector experience increases of 52% in dollars and 36% in deals ($2.1 billion invested in 234 deals), but the sector ran its string of consecutive quarters as the top sector in terms of dollars invested to five.  Interestingly, the biotech industry received as much funding in the second quarter ($1.3 billion going into 139 deals) as the Life Sciences sector received as a whole in the first quarter.  The biotech numbers constituted a 59% increase in dollars and 34% in deal volume as compared with the first quarter.

Of the seventeen sectors analyzed for the report, the NVCA noted that eleven experienced dollar increases in the second quarter, including the Life Sciences, Computers and Peripherals (48% increase), Consumer Products and Services (44%), and IT Services (28%) sectors.

In a press release issued by the NVCA and PricewaterhouseCoopers, Tracy Lefteroff, global managing partner of the venture capital practice at PricewaterhouseCoopers, noted that the first quarter numbers had venture capitalists feeling more positive about the economic outlook for investment.  She also noted that quarterly investment had topped the $6 billion mark for the first time since the third quarter of 2008.  According to Ms. Lefteroff, the likely driver for the strong rebound in investment was the rise in Life Sciences companies looking to go public in the second quarter.  She added that "[i]f the markets remain positive, we'll likely continue to see robust investment levels for the remainder of the year, with VC funding in 2010 poised to surpass 2009 levels."

USPTO to Streamline Review of Ex Parte Reexamination Appeal Briefs

    By Sarah Fendrick --

The U.S. Patent and Trademark Office recently published a notice in the Federal Register (75 Fed. Reg. 29321) announcing that the Office will streamline procedures for the review of appeal briefs in ex parte reexamination proceeding appeals.  The new procedures were implemented in an effort to increase the efficiency of the appeal process and to reduce the processing time of appeals in ex parte reexamination proceedings.  Under the new streamlined procedure, instead of examiners reviewing appeal briefs to determine if they comply with applicable regulations, the task will be completed by the Chief Judge of the Board of Patent Appeals and Interferences (BPAI) or the Chief Judge's designee.  If the Chief Judge determines the appeal brief complies with the applicable regulations, the appeal brief will be forwarded to the examiner for consideration.  On the other hand, if the appeal brief is found to be noncompliant the Chief Judge will issue a notice of a noncompliant brief and require a corrected appeal brief.  Under the new streamlined procedures, the Chief Judge will also determine compliance of corrected appeal briefs.

By assigning the task to the Chief Judge, the USPTO aims to increase consistency in the determination of compliance of appeal briefs and in turn reducing the filing of corrective appeal briefs in ex parte reexamination proceeding appeals.  The streamlined procedure became effective on May 25, 2010 and to date, is only applicable to appeals in ex parte reexamination proceedings.  However, the USPTO is considering implementing the procedure for inter partes reexamination proceedings as well.

USPTO Seeks Comments Regarding 2010-2015 Strategic Plan

    By Donald Zuhn --

In a notice published in the Federal Register earlier this month (75 Fed. Reg. 39493), the U.S. Patent and Trademark Office announced that its draft strategic plan for FY 2010–2015 has been made available for public review and comment.  The Office notes that the plan is a revision of the FY 2007–2012 strategic plan; both the 2007-2012 and 2010-2015 plans can be viewed here.  The draft plan for 2010-2015, which numbers 76 pages, includes the USPTO's mission statement, vision statement, and a description of the strategic goals, objectives, and significant actions that the USPTO plans to take in order to accomplish its mission and achieve its vision over the next five years.  Among the goals outlined in the draft plan are to optimize patent quality and timeliness and provide domestic and global leadership to improve intellectual property policy, protection, and enforcement worldwide.

The notice states that the Office would like to receive input on the draft strategic plan from a wide range of organizations (both national and international), public bodies, and other stakeholders, and is especially encouraging individuals and entities holding or dealing with intellectual property, and USPTO employees, to provide their views and suggestions.  The deadline for submitting written comments regarding the draft strategic plan was originally July 26th, but in a press release posted on the USPTO website last week, the Office announced that the period for receiving public comments had been extended until August 2nd.  Written comments regarding the draft plan should be sent by e-mail to strategicplan@uspto.gov, or by mail addressed to:  The USPTO Strategic Plan Coordinator, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Candice Goodman.