•         By Sherri Oslick —

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

    Teijin Ltd. et al. v. Lupin Ltd. et al.
    1:14-cv-00184; filed February 12, 2014 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

    Teijin Ltd. et al. v. Hetero USA Inc. et al.
    1:14-cv-00166; filed February 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendants:  Hetero USA Inc.; Hetero Labs Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the Hetero complaint here.

    Fresenius Kabi USA LLC v. Dr. Reddy's Laboratories Ltd. et al.
    1:14-cv-00160; filed February 6, 2014 in the District Court of Delaware

    • Plaintiff:  Fresenius Kabi USA LLC
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

    Fresenius Kabi USA LLC v. Watson Laboratories Inc. et al.
    1:14-cv-00161; filed February 6, 2014 in the District Court of Delaware

    • Plaintiff:  Fresenius Kabi USA LLC
    • Defendants:  Watson Laboratories Inc.; Actavis Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the Dr. Reddy's complaint here.

    Forest Laboratories Inc. et al. v. Glenmark Generics Inc. USA et al.
    1:14-cv-00159; filed February 6, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
    • Defendants:  Glenmark Generics Inc. USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.

    Infringement of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia," issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011), and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011), all licensed to Forest, following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Forest's Savella® (milnacipran hydrochloride, used in the management of fibromyalgia).  View the complaint here.

    Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
    2:14-cv-00785; filed February 6, 2014 in the District Court of New Jersey

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

    Infringement of U.S. Patent No. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the complaint here.

  • CalendarFebruary 18, 2014 – "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    February 18, 2014 – "When the Dust Settles – What Have We Learned From the First Post-Grant Final Decisions?" (Foley & Lardner) – 1:00 to 2:00 pm (Eastern)

    February 19, 2014 – "Privilege in Patent Disputes: Thorny Issues Involving Patent Agents and Foreign Lawyers" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    February 19-20, 2014 – AIA Post-Grant Patent Practice Conference (International Intellectual Property Institute and Bloomberg BNA) – Arlington, VA

    February 20, 2014 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; and Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EST)

    February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    February 27, 2014 – "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" (Strafford) – 1:00 to 2:30 pm (EST)

    February 27-28, 2014 – Ninth Annual Symposium (Northwestern Journal of Technology & Intellectual Property and The Searle Center on Law, Regulation, and Economic Growth) – Chicago, IL

    February 28, 2014 – 58th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Privilege in Patent Disputes: Thorny Issues Involving Patent Agents and Foreign Lawyers" on February 19, 2014 beginning at 2:00 pm (ET).  A panel consisting of Anthony Tridico of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Heather Repicky of Nutter McClennen & Fish LLP; and Buckmaster De Wolf, General Counsel of GE Global Research will discuss the case law that governs situations involving patent agents and foreign lawyers, and what internal procedures companies and law firms should rely on to maintain privilege whenever possible.

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Northwestern University LogoThe Northwestern Journal of Technology & Intellectual Property, in conjunction with The Searle Center on Law, Regulation, and Economic Growth, will be holding its Ninth Annual Symposium on February 27-28, 2014 on the Chicago Campus of Northwestern University.  The Symposium will consist of the following sessions:

    Thursday, February 27, 2014

    • Dinner and Keynote Speech by Commissioner F. Scott Kieff, International Trade Commission

    Friday, February 28, 2014

    • Patent Assertion and Non-Practicing Entities Panel — including Patent Docs contributor Dr. Andrew Williams of McDonnell Boehnen Hulbert & Berghoff, LLP

    • Gene Patenting Panel — including Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff, LLP

    • Special Luncheon Lecture on Innovation Economics by Professor Daniel Spulber of the Searle Center on Law, Regulation, and Economic Growth

    The Thursday keynote will be preceded by a welcome reception, and a networking reception will follow the sessions on Friday.

    Additional information about the Symposium, including a complete schedule of the sessions, list of speakers, and directions can be found at the Symposium's website.  Those interested in registering for the conference can do so here.

    The Symposium is sponsored in part by McDonnell Boehnen Hulbert & Berghoff LLP.

  • JMLSThe John Marshall Law School Center for Intellectual Property Law will be holding its 58th Annual Intellectual Property Law Conference on February 28, 2014 in Chicago, IL.  The conference will consist of the following sessions:

    • Recent Developments in Intellectual Property Law
    • Keynote speaker — Hon. Maria A. Pallante, U.S. Register of Copyrights

    The conference's afternoon patent track will consist of sessions on:

    • One Man's "Patent Troll" Is Another's "NPE"
    • Making Sense of Prior Art Under the AIA — to be presented by Robert A. Armitage of IP Strategy and Policy
    • Post-Grant Trial Proceedings in the Patent Office
    • Transforming European Patent Litigation: What U.S. Patent Prosecutors, Litigators, and Corporate Counsel Need to Know About the Unified Patent Court

    Additional information about the conference, including an agenda and complete list of speakers, can be found here.  Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).

    Patent Docs is a sponsor of the 58th Annual Intellectual Property Law Conference.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" on March 13, 2014 from 1:00 to 2:30 pm (EST).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, and Donna M. Meuth, Associate General Counsel for Eisai will provide guidance to IP counsel for calculating patent term adjustments, interplay with patent term extensions, examine recent court treatment and proposed legislative changes, and offer approaches for preserving rights and maximizing patent term adjustments and patent term extensions.  The webinar will review the following questions:

    • Is Exelixis I gone forever?
    • What impact could the proposed patent reform bill have?
    • How will the recent changes for the USPTO alter the landscape for PTA and PTE practice?
    • What best practices should patent applicants take to preserve rights and maximize PTA and PTE?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" on March 20, 2014 from 1:00 to 2:30 pm (EST).  Michael L. Kiklis and Eric W. Schweibenz of Oblon Spivak McClelland Maier & Neustadt will provide guidance to patent counsel involved in challenging or defending patent validity on the impact of concurrent proceedings at the USPTO and in the courts on stays, discovery, and settlements, and offer best practices for dealing with concurrent litigation and USPTO proceedings.  The webinar will review the following questions:

    • What litigation tactics can counsel employ to challenge or defend patent validity?
    • What are the implications for discovery and settlement when patents are challenged in concurrent proceedings?
    • What challenges do counsel face when challenging or defending patent validity in concurrent proceedings?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by February 21, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • Foley & LardnerFoley & Lardner will be offering a web conference entitled "When the Dust Settles – What Have We Learned From the First Post-Grant Final Decisions?" on February 18, 2014 from 1:00 to 2:00 pm (Eastern).  Speakers for the web conference will include Howard Shipley and Allen Arntsen of Foley & Lardner LLP, and Robert Hopton, President and CEO of Idle Free Systems, Inc.  Topics to be covered in the web conference will include:

    • What a company should consider before initiating post-grant proceedings
    • Best practices for drafting an IPR or CBM
    • Post-grant proceedings where parallel litigation is involved
    • Motions practice and evidentiary issues in post-grant proceedings
    • Precedent established by the first final decisions

    While there is no cost to participate in the program, pre-registration is required.  Those interested in attending the webinar can register here.

  • By Andrew Williams —

    Supreme Court Building #1In less than two weeks, the Supreme Court will hear arguments in two cases involving the Attorney Fees provision of 35 U.S.C. § 285.  Both of these cases have garnered a lot of attention from the patent community, because many commentators have cited to this section as contributing to the so-called "patent troll" problem.  The statute provides for attorney fees in "exceptional" cases ("The court in exceptional cases may award reasonable attorney fees to the prevailing party"), but the Federal Circuit has held that a case is only exceptional when "both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless," absent misconduct in litigation or in securing the patent.  See Brooks Furniture Mfg. v. Dutailier, Inc., 393 F.3d 1378 (Fed. Cir. 2005).  Even Chief Judge Rader has spoken out about this fee-shifting provision, complaining that federal judges were not using § 285 with sufficient regularity to discourage "troll"-like behavior.  Randall R. Rader, Colleen V. Chien, and David Hricik, Op-Ed, Make Patent Trolls Pay in Court, N.Y. Times (June 4, 2013).  Perhaps it is not surprising that that he recently argued that the "court should return to the rule that a district court may shift fees when, based on the totality of the circumstances, it is necessary to prevent a gross injustice," thereby eliminating the need to parse evidence into subjective and objective categories.  The White House has called for reform to this provision last year, when it recommended that Congress establish legislation that permitted "more discretion in awarding fees to prevailing parties in patent cases," specifically by removing the "exceptional case" requirement.  Press Release, The White House, FACT SHEET: White House Task Force on High-Tech Patent Issues (June 4, 2013).  The House of Representatives took it a step further, making the shifting of attorney fees the default in patent cases in the newly passed Innovation Act, unless "the position and conduct of the nonprevailing party or parties were reasonably justified in law and fact or that special circumstances . . . make an award unjust."  Innovation Act § 3.  The pending Senate version has an even higher standard, requiring the conduct to be "substantially justified."  Patent Litigation Integrity Act of 201, S. 1612, 113th Cong. (2013).

    It is with this contentious backdrop that the Supreme Court will hear these two cases.  The question presented in the first of these cases, Octane Fitness v. Icon Health and Fitness, was:

    [W]hether the Federal Circuit's promulgation of a rigid and exclusive two-part test for determining whether a case is 'exceptional' under 35 U.S.C. § 285 improperly appropriates a district court's discretionary authority to award attorney fees to prevailing accused infringers in contravention of statutory intent and this Court's precedent, thereby raising the standard for accused infringers (but not patentees) to recoup fees and encouraging patent plaintiffs to bring spurious patent cases to cause competitive harm or coerce unwarranted settlement from defendants.

    The second case, Highmark Inc. v. Allcare Management Sys., Inc., relates to whether the lower court's determination regarding attorney fees is entitled to deference, and will be detailed in a future post.  It would be surprising if the Supreme Court left the standard for awarding attorney fees articulated by the Federal Circuit unchanged.  Indeed, no amicus curiae came out in support of the respondent, ICON.  In fact, the limited number of amicus curiae briefs filed in support of neither party still advocated changing the standard because the current one is thought to be too difficult to meet.  However, even if the test for determining the award of fees is changed as expected, it is equally likely that the case will be remanded.

    This case involves two companies that are in the exercise equipment industry, and specifically deals with elliptical machines.  According to the briefs of the parties, ICON had invented a specific linkage system that allowed the foot pedals to move in an elliptical path.  Both parties agreed that ICON never commercialized this invention, but they disagree why (Octane alleging that the idea did not work, while ICON claimed that it was because of the cost and other market conditions).  The invention was the subject of U.S. Patent No. 6,019,710 ("the '710 patent"), which issued in February 2000.  Octane was a much smaller competitor that licensed different technology to produce its Q45 and Q47 machines.  According to ICON, Octane was aware of the '710 patent and in addition to obtaining a non-infringement opinion of counsel directed to it, Octane purchased infringement insurance to protect itself.  According to Octane, however, ICON's Vice President of Global Sales stated in an e-mail that ICON was "'[n]ot only coming out with a great product to go after [Octane], but throwing a lawsuit on top of that,' and that I[CON] was asserting a defunct patent because it was 'just looking for royalties'" (emphasis in brief).

    ICON brought the patent infringement lawsuit in 2008 in the United States District Court for the Central District of California, but the case was shortly thereafter transferred to the Minnesota district court.  According to ICON, Octane initially admitted that the accused product had a "stroke rail," one of the elements of the claim.  Nevertheless, months after the parties exchanged claim construction disclosures, Octane raised a dispute with respect to that term, and subsequently moved for summary judgment.  The court adopted Octane's proposed definition, and even though ICON continued to argue doctrine of equivalents, the court granted the summary judgment motion (which the Federal Circuit in a related opinion affirmed).  With regard to attorney fees, according to ICON, the lower court found that its case was neither objectively baseless nor brought in bad faith.  Octane's brief was silent on this point, with its main complaint being that the lower court used the Federal Circuit's two-part test.  The Federal Circuit affirmed, agreeing that this was not an exceptional case.  The Supreme Court granted certiorari.

    In its appeal, Octane attempted to capitalize on the public sentiment regarding patent assertion entities, or "trolls," devoting an entire section of its brief to the public policies related to curbing abusive patent litigation.  Nevertheless, Octane admitted that "[t]his case does not involve a classic 'troll,' but does involve a larger competitor asserting a non-practiced patent against a smaller competitor in a troll-like manner."  Of course, ICON emphasized this potential deception in response.  Moreover, it pointed out that the Supreme Court should not succumb to public pressure, and called into question whether a patent troll crisis actually exists.

    Octane argued that the plain language of the statute implies the grant of broad discretion on the part of the lower courts.  It looked to the use of two words in the statute, "may" and "exceptional."  Not even ICON challenged that the word "may" connotes discretion.  However, to support its position regarding "exceptional," Octane pointed to dictionary definitions of the word which suggest that it has an ordinary meaning of "uncommon" or "unusual."  This appears to be a fairly weak argument.  Even the Federal Circuit's two-prong test results in the awarding of fees in "uncommon" or "unusual" circumstances.  Moreover, as ICON pointed out, if the two words mean the same, it would render at least one of the superfluous, contrary to the cannons of statutory construction.

    Somewhat stronger, Octane pointed out how the Federal Circuit's current test was inappropriately transplanted from the "sham" litigation exception to Noerr-Pennington antitrust immunity.  In Brooks, the appeals court adopted the standard as articulated in the Supreme Court's Prof'l Real Estate Investors v. Columbia Pictures Indus., 508 U.S. 49 (1993) ("PRE").  However, as Octane pointed out, PRE implicated the First Amendment freedoms, and therefore "even activity that is subjectively motivated by an improper anticompetitive purpose remains protected as long as there is an 'objectively reasonable' basis for the action."  PRE, 365 U.S. at 57.  Such concerns, according to Octane, are not present "in the context of objectionably weak patent suits or fee-shifting statutes in general."  ICON disagreed, however, pointing out that the ability to bring such suits is also "the exercise of constitutionally protected rights."

    In the end, Octane advocated for, what it referred to as, the "equitable discretion" test.  This was defined as "broad discretion on [the part of] district courts to apply traditional equitable factors, guided by the purposes of patent, to determine whether to award fees to a prevailing accused infringer."  Problematic in this test, however, is that Octane also advocated for keeping the standard "party-neutral."  Not surprising, ICON argued to maintain the test as articulated by the Federal Circuit.  Therefore, if the Supreme Court does change the test for the award of attorney fees under 35 U.S.C. § 285, it will likely either adopt its own or incorporate one or more suggestions from the 14 amicus curie briefs that were filed.  We will highlight some of these proposals in a future post.  And, of course, we will report on the oral argument in a couple weeks and provide an analysis when the Court issues its opinion, which should occur before the end of June, 2014.

  • By Donald Zuhn —

    Washington - Capitol #5Last month, in a letter sent to the U.S. Trade Representative, Ambassador Michael Froman, five Representatives reiterated the importance of incorporating the 2007 Bipartisan Agreement on Trade Policy into the Trans-Pacific Partnership Agreement (TPP).  The TPP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam (Canada, Japan, the Philippines, South Korea, and Taiwan have also expressed interest in participating in the agreement).

    The letter, which was signed by Sander Levin (D-MI), Ranking Member of the Committee on Ways and Means; John Conyers, Jr. (D-MI), Ranking Member of the Committee on the Judiciary; Jim McDermott (D-WA), Ranking Member of the Subcommittee on Health of the Committee on Ways and Means and Co-Chair of the Congressional HIV/AIDS Caucus; Henry Waxman (D-CA), Ranking Member of the Committee on Energy and Commerce; and Charles Rangel (D-NY), Ranking Member of the Subcommittee on Trade of the Committee on Ways and Means, indicated that the Bipartisan Agreement on Trade Policy was aimed at ensuring that developing country free trade agreement partners would be able to achieve an appropriate balance between fostering innovation in, and promoting access to, life-saving medicine.  The letter states that "[a] core objective of [] changes [arising from the Bipartisan Agreement on Trade Policy] was to ensure that FTA obligations do not put patients in poor countries in a position in which they could have to wait longer than patients in the United States to obtain affordable life saving generic medicines."  According to the Representatives, key changes brought about by the Bipartisan Agreement on Trade Policy included the following:

    Exclusive marketing rights based on clinical trial data were limited to one five-year period that could run concurrently with such protection in the United States.  Granting patent term extensions became optional.  Regulatory authorities were given greater freedom to approve generic medicines by having patent disputes resolved through the legal system instead of the drug approval process.

    The letter concludes by declaring that "[o]ur trade agreements should not impede our partners in the developing world from access to these medicines."