• Calendar

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

    September 8, 2010 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting – 10:00 am – 4:15 pm

    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, 2010 – Patentable Subject Matter: 35 USC § 101 (George Washington University Law School Intellectual Property Law Program) – Washington, DC

    September 20-21, 2010 – Patent Litigation 2010 (Practising Law Institute) – San Francisco, CA

    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

    September 30, 2010 – Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) – Chicago, IL

    October 1, 2010 – Patent Law Symposium 2010 (Intellectual Property Law Association of Chicago) – Chicago, IL

    October 4-5, 2010 – Patent Litigation 2010 (Practising Law Institute) – McLean, VA

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

    October 6-7, 2010 – Forum on Biotech Patenting (C5) – London, England

    October 14-15, 2010 – Patent Litigation 2010 (Practising Law Institute) – Chicago, IL

    October 18-19, 2010 – 5th Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) – Washington, DC

    October 18-19, 2010 – Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Alexandria, VA

    October 25, 2010 – Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) – San Francisco, CA

    November 8, 2010 – Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) – New York, NY (Groupcasts to be held in Atlanta, Philadelphia, Pittsburgh, and Mechanicsburg, PA)

    November 8-9, 2010 – Patent Litigation 2010 (Practising Law Institute) – Atlanta, GA

    November 15-16, 2010 – Patent Litigation 2010 (Practising Law Institute) – New York, NY (Groupcasts to be held in Philadelphia, Pittsburgh, and Mechanicsburg, PA)

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

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

  • IPLAC The Intellectual Property Law Association of Chicago will be holding its Patent Law Symposium 2010 from 8:45 am to 5:00 pm on October 1, 2010 at the Union League Club of Chicago.  The Symposium will offer presentations on the following topics:

    • Life Under the N.D. of Illinois Local Patent Rules and Jury Instructions — Hon. James Holderman, Chief Judge of the N.D. of Illinois; Hon. Sidney Schenkier, Presiding Magistrate Judge of the N.D. of Illinois; and Allan Sternstein of Dykema Gossett

    • Recent Developments In IP Law:  The Year In Review — Edward D. Manzo of Husch Blackwell Sanders Welsh & Katz

    • Mock Deposition of an Inventor — Timothy Q. Delaney of Brinks Hofer Gilson & Lione and Paul K. Vickrey of Niro, Haller & Niro

    • Best Practices:  Attorney-Client Privilege and Ethical Considerations in IP Transactions — Glen Belvis of Foroenergy

    • Reexamination:  Ex Parte and Inter Partes — Janet Garetto of Nixon Peabody (moderator); Joseph Berghammer of Banner & Witcoff; and Jessica Harrison, Central Reexamination Unit, U.S. Patent and Trademark Office

    • Patent Damages — Garret Leach of Kirkland & Ellis and Raymond Sims, Vice-President of CRA International

    • Common Mistakes in Briefs and Arguments before the Federal Circuit and How to Avoid Them — Olivia Luk of Jenner & Block (moderator); Hon. Randall Rader, Chief Judge of the Court of Appeals for the Federal Circuit; John Whealan, Dean at the George Washington University Law School; and Emily Johnson, Federal Circuit Law Clerk

    A program schedule for the Symposium can be found here.  A cocktail reception will take place following the Symposium.

    The registration fee for the Symposium is $275 (IPLAC members) or $425 (non-members).  Those registering on or before September 26, 2010 will receive a $50 discount off the registration fee.  The registration fee includes Continental breakfast, lunch buffet, coffee breaks, and the cocktail reception.  A registration form can be obtained here.

  • George Washington University Law School The George Washington University Law School Intellectual Property Law Program will be holding a seminar on "Patentable Subject Matter: 35 USC § 101" from 9:30 am to 12:45 pm (EDT) on September 20, 2010 at The George Washington University Law School, 716 20th Street NW in Washington, DC.  The seminar will offer presentations on the following topics:

    • Keynote Address — Hon. Paul R. Michel, former Chief Judge for the U.S. Court of Appeals for the Federal Circuit

    Bilski's Aftermath:  Software, Business Methods and Abstract Ideas (panel discussion) — Robert W. Bahr, Senior Patent Attorney, Office of the Deputy Commissioner for Patent Examination Policy, U.S. Patent and Trademark Office (invited); Professor John Duffy, George Washington University Law School; Assistant Professor David Olson, Boston College Law School; and Richard Wilder, Associate General Counsel for Microsoft

    • Natural Laws and Phenomena in the Life Sciences:  Prometheus & Myriad (panel discussion) — Professor F. Scott Kieff, George Washington University Law School; Dan Ravicher, Executive Director for the Public Patent Foundation and Lecturer of Law at the Cardozo School of Law; Hans Sauer, Associate General Counsel for the Biotechnology Industry Organization; and John M. Whealan, Associate Dean of IP, George Washington University Law School

    The event is free and open to the public.  Those interested in attending for the seminar should RSVP by September 15th to iplaw@law.gwu.edu.  Additional information about the event can obtained here.

  • By James DeGiulio —

    Sepracor Settles with Wockhardt in Lunesta Patent Suit

    Sepracor Sepracor has reached a consent agreement with Wockhardt, thus settling its infringement suit over the sleep drug Lunesta.

    In March 2009, Sepracor brought suit in the U.S. District Court for the District of New Jersey against several generic companies who intended to make generic versions of the sleep drug Lunesta (see "Court Report," March 29, 2009).  Sepracor alleged that the generic makers' ANDAs infringed four patents covering the drug:  U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724.  In June 2010, the District Court denied Wockhardt's inequitable conduct claim, rejecting the argument that Sepracor had misled the U.S. Patent and Trademark Office by presenting inaccurate mouse and rat studies.  The USPTO had previously determined that these particular studies were not material to patentability.

    Wockhardt On August 19, Judge Dennis M. Cavanaugh signed off on an agreement that enjoins Wockhardt from manufacturing generic Lunesta until one of the patents expires in November 2013 or May 2014.  The stipulation leaves open the possibility of an earlier date if a licensing agreement can be reached.  The stipulation order can be found here.


    Ranbaxy Settles Patent Dispute with Roche over Valcyte

    Ranbaxy Laboratories has settled its patent dispute with Roche over the anti-viral drug Valcyte.

    Ranbaxy In March 2005, Ranbaxy notified Roche that it had submitted an ANDA seeking FDA approval to manufacture and distribute a generic version of Valcyte.  Roche filed suit in April 2006 in the U.S. District Court for the District of New Jersey, alleging that Ranbaxy infringed Roche's U.S. Patent No. 6,083,953.  Ranbaxy asserted that its proposed drug does not infringe the '953 patent because it contains amorphous, rather than crystalline, valganciclovir hydrochloride.  Roche argued that the amorphous state of the drug is unstable and that it is not usable in pill form, but the District Court rejected this argument and found that there was no infringement by Ranbaxy.  Roche appealed the decision.

    Roche On August 25, the settlement between Roche and Ranbaxy was disclosed in a filing to the Federal Circuit, and the resolution will apply to the patent infringement lawsuit in the District Court.  The terms of the settlement have not been made public.


    Sanofi Denied Preliminary Injunction against FDA Regarding Approval of Sandoz's Generic Lovenox

    Sanofi-Aventis_small In the latest development in Sanofi-Aventis' campaign to defend its anti-coagulant drug Lovenox, Sanofi was denied a preliminary injunction which would have forced the FDA to withdraw its approval of Sandoz's generic version of Lovenox.  The District Court concluded that Sanofi was unlikely to demonstrate that the FDA exceeded its authority when it approved Sanofi's ANDA.

    FDA Leading up to the instant case, Sanofi-Aventis was engaged in a long-running litigation seeking protect its Lovenox patents, U.S. Patent Nos. 5,389,618 and RE38,743 (see "Biotech/Pharma Docket," July 21, 2009.  Following the conclusion of the infringement litigation, Sanofi brought this additional suit in the U.S. District Court for the District of Columbia on July 26 against the FDA, claiming that the FDA exceeded its authority when it approved Sandoz's ANDA, and failed to ensure that Sandoz's generic had the same active ingredient as Sanofi's brand drug.  Sanofi alleges that the approval of Sandoz's ANDA was arbitrary, capricious and unlawful under the Administrative Procedure Act and improper under the Federal Food, Drug and Cosmetic Act.

    On August 25, Judge Emmet G. Sullivan issued a memorandum opinion and order that denied Sanofi's motion for a temporary restraining order and preliminary injunction, finding Sanofi unlikely to succeed on the merits.  Sanofi argued that the FDA improperly asked Sandoz for additional information on manufacturing processes, because the FDCA prohibits the FDA from requesting such supplemental documents.  Judge Sullivan rejected this argument, and instead ruled that the statute does not specify which kinds of studies may be used to fulfill the FDA's assessment requirements.  The judge also found that the FDA provided legitimate reasons as to why it was treating this drug differently than it had other drugs cited by the plaintiff.  Finally, Judge Sullivan noted that an ANDA applicant need not use the same manufacturing process as the brand company in order to include the same ingredient.  The judge also rejected Sanofi's argument that an injunction was necessary because sales of the generic version of Lovenox were causing irreparable financial harm.  Judge Sullivan's memorandum opinion can be found here.


    Novartis Drops One of Three Patents from ReFacto/Xyntha Suit against Wyeth

    Novartis Novartis has agreed to drop one of three patents asserted against Wyeth in an infringement suit over the hemophilia drugs ReFacto and Xyntha.

    Wyeth Novartis initially brought suit against Wyeth in the Eastern District of Texas in February 2008, asserting that Wyeth was infringing U.S. Patent Nos. 6,060,447 and 6,228,620 (see "Court Report," February 24, 2008).  In October 2008, Novartis amended its complaint, additionally accusing Wyeth of willful and deliberate infringement of both patents and requesting treble damages for the continued infringement.  Novartis later amended its complaint to add U.S. Patent No. 7,138,505 to the suit.

    On August 24, Judge T. John Ward approved the dismissal of both parties' claims and counterclaims over the '505 patent.  Novartis and Wyeth agreed to cover their own legal costs with respect to this patent.  The stipulated dismissal 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.

  • By Donald Zuhn

    Lilly The U.S. Court of Appeals for the Federal Circuit issued an Order today in Eli Lilly & Co. v. Actavis Elizabeth LLC, granting Lilly's request for an injunction to prevent Defendants-Appellees from launching generic versions of Lilly's ADHD drug Strattera® until Lilly's appeal has been resolved.  On August 25, Lilly filed a notice of appeal seeking review of a decision by the District Court for the District of New Jersey invalidating Lilly's U.S. Patent No. 5,658,590 for lack of enablement, and then immediately moved for an injunction pending disposition of its appeal.  Defendants-Appellees opposed Lilly's request for an injunction in a response that was due Monday.  In granting Lilly's motion, the Court stated that Lilly had met its burden to obtain an injunction pending appeal.

    In addition, two of the Appellees (Aurobindo Phrama and Mylan Pharmaceuticals) moved for clarification of the Court's August 26 Order continuing a 14-day injunction granted by the District Court one week earlier.  The Federal Circuit's August 26 Order also set an expedited briefing schedule in which Lilly's opening brief is due by Thursday, September 9; Defendants-Appelllees' briefs are due by Thursday, September 23; and Lilly's reply brief and the joint appendix are due by Thursday, September 30.  It is the expedited briefing schedule for which Aurobindo and Mylan sought clarification.  In particular, Aurobindo and Mylan asserted that in view of cross-appeals that had been filed, the briefing schedule required revision.  The Court, however, dismissed the cross-appeals for lack of jurisdiction and denied the motion for clarification.

    For additional information regarding this topic, please see:
    • "Federal Circuit Continues Temporary Injunction in Lilly v. Actavis Elizabeth," August 30, 2010
    • "Biotech/Pharma Docket," August 26, 2010
    • "Biotech/Pharma Docket," August 19, 2010

  • By James DeGiulio —

    On June 4, in an effort to address the application backlog and its alleged negative impact on innovation, the U.S. Patent and Trademark Office issued a notice concerning an Enhanced Examination Timing Control Initiative (75 Fed. Reg. 31763).  The initiative would, among other provisions, create three examination tracks:  an accelerated examination track, a traditional examination track, and a delayed examination track (see "USPTO Director Announces New Examination Options").  As part of that initiative, the Office called for input from the patent community regarding the proposal.

    IPO #2 On August 20, the Intellectual Property Owners Association (IPO) answered the call by submitting its comments in a letter written by Douglas K. Norman, president of the IPO.  Mr. Norman's written comments supplement his presentation at the July 20 public hearing on the initiative.  Mr. Norman first addresses several threshold issues, including practical concerns such as hiring enough examiners to support an expedited examination track, retaining newly generated examination fees within the USPTO, and the compatibility of delaying foreign-based applications with TRIPS and the PCT.

    The IPO then addresses the prioritized examination track, which the IPO finds to be generally attractive assuming that the USPTO can ensure that normal examinations are not further delayed by the demands of this new priority track.  In this regard, the IPO prompts the USPTO to provide fee estimates and details on how the Office will safeguard against traditional applications being delayed.  The IPO also draws attention to the effect of the prioritized examination on the Patent Prosecution Highway (PPH) in foreign applications, which may force U.S. applicants to elect the more prioritized route to utilize the PPH.  The IPO warns that this may disadvantage U.S. applicants as compared to foreign applicants, who can obtain prompt examination inexpensively in their home country, and then obtain prioritized examination in the U.S., ahead of other U.S. applicants.

    The IPO next turns to the voluntary delayed examination pathway, which the IPO is opposed as contrary to public interest.  The IPO argues that extended time periods for examination leave uncertain the scope of patent protection, which will result in competitor inhibition due to uncertainty of infringement risk, thus negatively affecting competition.  The IPO further argues that mechanisms to delay examination are already in place, such as the 30-month PCT delay or the three-year request for deferral of examination under 37 C.F.R. § 1.103.  The letter suggests that a better alternative would be to issue a refund of the search and examination fees if an application is expressly abandoned prior to examination.

    The IPO is most critical of the provision providing for mandatory delay of examination of foreign-based applications.  Initially, Mr. Norman points out that the system is easily gamed, for applicants wanting quick examination would file first in the U.S., while applicants wanting delayed examination would file first in foreign countries which have a long lag to examination.  Moreover, since foreign-based applications would only be removed from the examination queue temporarily, the resulting backlog relief would be only temporary.  This temporary relief is not worth discouraging foreign application filing in the U.S., and could invite retaliatory procedures in foreign patent offices, which would negatively impact U.S. applicants.  Mr. Norman also prompts the USPTO to disclose details on how the fees would be allocated under this track and more details on when and where foreign-based applications would be placed in the examination queue.

    The IPO next discusses its opposition to any deduction from Patent Term Adjustment (PTA) due to delays that are beyond the applicant's control.  According to the IPO, the USPTO cannot defer examination of foreign-based applications without awarding PTA.  As an example of the flaws with the initiative's overall approach, Mr. Norman notes that it will be extremely difficult for the USPTO to distinguish between applicant delays and foreign patent office delays in the foreign application.  Exactly how PTA will fit with mandatory delay of foreign-based applications is unclear, according to the IPO's letter.

    The IPO questions the proposal to offer a search from an Intellectual Property Granting Organization (IPGO), as the Examiner would still conduct his or her own search.  The IPO predicts that an IPGO search would raise questions about the quality and thoroughness of the USPTO Examiner's own search, which is a fundamental function of the USPTO.

    Mr. Norman concludes the letter by reiterating the concerns the IPO has with the proposed three-track system.  While the application backlog at the USPTO is certainly a problem that requires attention and perhaps reform to address, the IPO is wary of the unintended potential consequences of voluntary delay of original U.S. applications and the mandatory delay of foreign-based applications.

    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.

  • By Donald Zuhn

    USPTO Seal Last month, the U.S. Patent and Trademark Office announced a change in the way registered practitioners can show authorization to participate in an examiner interview.  Under the old procedure, practitioners were required to file a power of attorney or authorization to act in a representative capacity in order to participate in an interview.  Under the new procedure, practitioners need only file an Applicant Initiated Interview Request Form (PTOL-413A).  The instruction sheet for the recently updated form notes that "[t]he Office will accept the signed form as an indication that the registered practitioner not of record is authorized to conduct an interview on behalf of the principal."  In addition, the notice states that "as the interview request form provides for the practitioner to set forth his or her name, signature and registration number, the Office will accept this as an indication that he or she is authorized to conduct an interview on behalf of the principal, which is consistent with the provisions of 37 CFR 1.34."  The notice also indicates that M.P.E.P. §§ 405, 713.04, and 713.05 will be updated to reflect the change set forth in the notice.

  • By Kevin E. Noonan

    Financial Times The staid Financial Times (London) has an article today on the gene patenting debate, and while there are things to criticize in it, the article (perhaps predictably) takes a carefully measured, dispassionate (and welcome) tone ("Who steals the gene from off the common"; free registration required).

    The paper's conservative bona fides are established on its website:

    First published in 1888 as a four-page newspaper, the Financial Times' initial readership was the financial community of the City of London.  The Financial Times soon established itself as the sober but reliable "stockbroker's Bible", with its only rival being the slightly older and more daring Financial News.  In 1893, the FT turned salmon pink — a masterstroke that made it immediately distinguishable from its competitor.  From their initial rivalry, the two papers merged in 1945 to form a single six-page newspaper.  The Financial Times brought with it a higher circulation, while the Financial News provided enormous editorial talent.

    And it is with a "sober" voice that the article by James Boyle, William Neal Reynolds Professor at Law, Duke Law School addresses a frequently emotional subject.  He cites critics of gene patenting as describing a "'genetic land grab' that promised to privatize the common heritage of mankind," and characterizes their arguments as "frankly moral, protesting the hubris and in some eyes, heresy, of claiming to own the human genome."  He contrasts this with arguments that "patents over genes [are] necessary to spur investment and jump start biotech innovation."  And he includes the third part of the debate, whether gene patents "spur innovation" or slow it, by "introducing a tangle of property rights into the most fundamental building blocks of research science."

    Although evenhanded, the piece suffers from the common misconception that genetic information is patented (Judge Sweet's view), rather than isolated nucleic acids themselves as chemical compounds (which, despite Judge Dyks' recent pronouncements, has been the Federal Circuit's view).  This deficiency also informs the article's discussion of what the author calls a "new consensus," patterned on the recent publicity regarding the Alzheimer's Disease Initiative.  As previously reported in The New York Times, this is an effort by the National Institutes of Health joined with academic and "commercial" researchers "to unlock the secrets of that debilitating disease."  The key development, cited in this article as well as the original Times piece, was that the data from the collaboration would be made public "immediately," and that "no one would own the data" (and no one would file any patent applications, although "private companies would ultimately profit from any drugs or imaging tests developed as a result of the effort").  Professor Boyle hails this development as one where "all parties . . . are better off."  He attributes (without attribution) to private companies "who had watched their drug pipelines dry up" the fear that "the old model of in-house development and jealous guarding of data" would not be able to "unlock such complex biological mysteries" as the motivation for joining the initiative.

    Perhaps.  It is also good to remember that a great deal of the initial research from the Initiative (like much initial research) was unlikely to lead to any patentable subject matter in the first place.  Patents protect inventions, not data.  As the Federal Circuit said in Ariad v. Eli Lilly:

    Ariad complains that the doctrine disadvantages universities to the extent that basic research cannot be patented.  But the patent law has always been directed to the "useful Arts," U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966).  Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered.  That is no failure of the law's interpretation, but its intention.  Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.  "[A] patent is not a hunting license.  It is not a reward for the search, but compensation for its successful conclusion."  Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536).  Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of "invention" — that is, conceive of the complete and final invention with all its claimed limitations — and disclose the fruits of that effort to the public.

    That research hypotheses do not qualify for patent protection possibly results in some loss of incentive, although Ariad presents no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities.  But claims to research plans also impose costs on downstream research, discouraging later invention.  The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not "attempt[s] to preempt the future before it has arrived."  Fiers, 984 F.2d at 1171.  As this court has repeatedly stated, the purpose of the written description requirement is to "ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification."  Rochester, 358 F.3d at 920 (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)).  It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.  Enzo, 323 F.3d at 970.

    And it is also well to remember that the reason for the extensive collaboration between scientists (who heretofore guarded their pre-publication Alzheimer's disease research results just as jealously as any commercial enterprise) is precisely because Alzheimer's disease has proven so intractable.  In today's New York Times is an article bemoaning the lack of progress at developing an effective treatment for the disease, in the face of 30 years effort (and 10 years of that same Alzheimer's Disease Initiative so praised by Professor Boyle).  So while it is evident that at least some of the participants were happy (and self-satisfied) to paraphrase Quincy Jones by proclaiming that they "left their intellectual property at the door," it is less evident that anything of commercial value (or any intellectual property) was put at risk by what was publicly disclosed by the Initiative.  (Recognition of this reality explains as well as the Professor's speculation does why commercial entities were willing to participate in the Initiative.)

    Being the Financial Times, the article is quick to point out that "[t]he idea is not to give up property rights," because "these will be essential in the development of therapies down the line."  Rather, Professor Boyle contends that "science — and commerce — will benefit from the establishment of a pre-competitive commons, a pool of information from which all can draw," using the NIH as an "honest broker."  As evidence of a trend, he cites the Bermuda Accords guiding the public prong of the Human Genome Project, the Sage Bionetworks project, as well as the Science Commons (which organization had Professor Boyle as one of its founders).  He suggests that the economic tools exist to ascertain the best ways to "jump-start commercial innovation" while at the same time recognizing that the task of deciding where sharing should end and privatization and property rights begin is complex.  Refreshingly, he says that this enterprise "is not an ideological war but a pragmatic process of design."

    The article charmingly analogizes the gene patenting debate to enclosure of the English commons over 500 years ago, and in doing so returns the analogy from the "anticommons" rhetoric that usually accompanies discussions of this debate.  The article begins and ends with part of a poem regarding this ancient argument:

    The law locks up the man or woman
    Who steals the goose from off the common
    But leaves the greater villain loose
    Who steals the common from off the goose
    And geese will still a common lack,
    Til' they go and steal it back.

    However the gene patenting debate is resolved, it would be well if the same benefits garnered from enclosing the common — providing the greatest benefits to the greatest number — are the result.

  • By Donald Zuhn

    Lilly On Thursday, the U.S. Court of Appeals for the Federal Circuit issued an Order in Eli Lilly & Co. v. Actavis Elizabeth LLC, continuing a temporary injunction that had been granted by the District Court for the District of New Jersey one week earlier.  Lilly moved for the injunction, which prohibits generic versions of its ADHD drug Strattera® from entering the market, after the District Court found Lilly's patent on the drug (U.S. Patent No. 5,658,590) invalid for lack of enablement (see "Biotech/Pharma Docket," August 19, 2010).  Although Lilly sought to enjoin the Defendants for "the period of time it takes for the Federal Circuit to decide Lilly’s appeal of this Court's decision," the District Court granted the company a 14-day injunction, giving it enough time to secure an injunction from the Federal Circuit (see "Biotech/Pharma Docket," August 26, 2010).

    Federal Circuit Seal After filing a notice of appeal, Lilly moved quickly for an injunction to prevent the launch of generic versions of Strattera®, as well as to expedite the briefing and assignment of the case to the calendar.  In addition to continuing the District Court's temporary injunction, pending the Federal Circuit's consideration of Lilly's motion and Defendants-Appelllees' response, the CAFC gave Defendants-Appelllees until noon today (August 30, 2010) to file their (preferably joint) response.  The Court also set an expedited briefing schedule in which Lilly's opening brief is due by Thursday, September 9 (within 14 days of the filing of the Order), Defendants-Appelllees' briefs are due by Thursday, September 23 (within 14 days of service of Lilly's opening brief), and Lilly's reply brief and the joint appendix are due by Thursday, September 30 (within 7 days of service of Defendants-Appelllees' briefs).

  • By Sherri Oslick

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

    Eli Lilly and Company v. Sandoz, Inc.
    1:10-cv-01057; filed August 23, 2010 in the Southern District of Indiana

    Infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued November 7, 1995) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Lilly's Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.


    Schering Corp. et al v. Impax Laboratories, Inc.,

    3:10-cv-03719; filed August 20, 2010 in the Northern District of California

    • Plaintiffs:  Schering Corp.; MSP Singapore Co. LLC
    • Defendant:  Impax Laboratories, Inc.

    Schering Corporation et al v. Impax Laboratories, Inc.
    2:10-cv-04270; filed August 19 in the District Court of New Jersey

    • Plaintiffs:  Schering Corp.; MSP Singapore Co., LLC
    • Defendant:  Impax Laboratories, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. RE37,721 ("Hydroxy-Substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued May 28, 2002) and 5,846,966 ("Combinations of Hydroxy-Aubstituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of MSP's Vytorin® (ezetimibe and simvastatin, used to treat hyperlipidemia).  View the New Jersey complaint here.


    Medicis Pharmaceutical Corp. v. Acella Pharmaceuticals Inc.

    2:10-cv-01780; filed August 19, 2010 in the District Court of Arizona

    Infringement of U.S. Patent No. 7,776,355 ("Delivery System for Topical Medications," issued August 17, 2010) based on Acella's manufacture and sale of benzoyl peroxide foaming cloths, similar to Triaz® Foaming Cloths (benzoyl peroxide foaming cloths, use to treat acne).  View the complaint here.


    Medicines Company v. Hospira Inc.

    1:10-cv-00700; filed August 19, 2010 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Hospira's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.