• IPLACThe Intellectual Property Law Association of Chicago (IPLAC) Biotech Committee will be offering a seminar on "Recent Developments in Biotech Patent Law Practice" on November 18, 2011 from 11:45 am to 1:30 pm (Central) at the offices of Quarles & Brady in Chicago, IL.  The seminar will offer presentations on the following topics:

    • AIA's Impact on the Biotech/Chemical Prosecution Practice — Alisha Bull of Whyte Hirschboeck Dudek
    • Joint Direct Infringement and the Biotech Practice — Adam Kelly of Loeb & Loeb
    • An Examination and Discussion of Centocor v Abbott — Aaron Barkoff of McAndrews Held & Malloy
    • The University Perspective of It All — Nancy Sullivan of the University of Illinois Tech Transfer Office

    The registration fee for the seminar is $10 (students), $20 (IPLAC members), or $30 (non-IPLAC members).  IPLAC is an Accredited CLE Provider, and it is anticipated that the program will be eligible for 1.5 hours of CLE credit.  In addition, Quarles & Brady will be providing lunch for attendees.  Those interested in registering for the panel discussion should contact Paul Reinfelds at PREI@Lundbeck.com or Donald Zuhn at zuhn@mbhb.com to reserve a spot.

  • World BankAs part of Law, Justice and Development (LJD) Week 2011, which is being co-sponsored by the World Bank's Legal Vice Presidency, International Finance Corporation (IFC), Multilateral Investment Guarantee Agency (MIGA), and International Centre for the Settlement of Investment Disputes (ICSID), the World Bank Group will be hosting a presentation and panel discussion on "Global Perspectives on the Role of Intellectual Property Rights in Innovation and Development" on November 14, 2011 from 10:45 am to 12:15 pm in Washington, DC.

    The session will be devoted to a discussion of intellectual property rights and their role in development, how such rights figure in decisions for multilateral financing, promote innovation and creativity, and yield tangible development results.  The agenda for the session is as follows:

    • 10:45 – 10:55 am — Opening Remarks and Introduction of the Panelists — Prof. Shyam Balganesh, University of Pennsylvania Law School

    • 10:55 – 11:45 am — Presentations by the Panelists:
    Dr. Edward Kwakwa, Legal Counsel, World Intellectual Property Organization
    Mr. David Snively, Executive Vice President and General Counsel, Monsanto Co.
    Dr. Rita Khanna, General Counsel, Aeras Global TB Vaccine Foundation
    Mr. Roy Waldron, Senior Vice President and Associate General Counsel, Pfizer
    Professor Katsuya Tamai, University of Tokyo

    • 11:45 am – 12:15 pm — Moderated panel discussion and Q&A

    Additional information regarding the session can be obtained here.  Those interested in attending the session can contact LJDevelopment@worldbank.org.

    LJDLJD Week 2011 is a forum to explore how legal innovation and empowerment contribute to development, and will take place at the World Bank headquarters in Washington, DC from November 14-17.  A full agenda for LJD Week 2011 can be obtained here.  Those interested in registering for the forum can do so here.

  • Strafford #1Strafford will be offering a webinar entitled "Biosimilars: Emerging Legal Challenges" on December 6, 2011 from 1:00 – 2:30 PM (EST).  Anthony Fitzpatrick of Duane Morris and Daniel Kracov of Arnold & Porter will provide a review of the complex standards of the Biosimilar Approval Pathway and address patent and exclusivity concerns around the development and marketing of biosimilars including information exchanges, infringement issues, and sameness and interchangeability questions.  The webinar will review the following questions:

    • What are the FDA's definitions for "highly similar" and "interchangeability"?
    • What are the market protection issues raised by patent exchange procedures for biopharmaceuticals?
    • What is the criteria for the 12-year exclusivity period?

    An interactive Q&A session will follow the presentation.

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by November 11, 2011 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • By Kevin E. Noonan

    Retractable TechnologiesSometimes it is what a court doesn't do that points to what needs to be done.  That appears to be the case for claim construction and the Federal Circuit's standard, since Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998), that the appellate court should review claim construction de novo with no deference to the factual determinations underlying claim construction by a district court.  Even Cybor (decided en banc in the days just after the Supreme Court's decision in Markman v.Westview Instruments, Inc.), holding that claim construction was a question for a judge rather than a Seventh Amendment right to trial by jury, had its detractors (including Chief Judge Rader) and its skeptics (including Judge Plager, who suggested that the consequences of the court's "no deference" standard would need time to be appreciated).  Now, in a decision by the court not to review this policy en banc in Retractable Techs., Inc. v. Becton, Dickinson & Co., the dissents by three judges illustrate most clearly the deficiencies of the policy decision by the court not to permit any deference in its claim construction jurisprudence.

    Becton DickinsonThe panel decision, by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader, reversed the District Court's claim construction as to one claim term and affirmed as to another, remanding for consideration of infringement under the Doctrine of Equivalents.  The claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury.  The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments.  The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

    The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure.  The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece construction.  The specification described the claimed invention as comprising a one-piece body, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies.  Moreover, there was no disclosure of a multiple piece syringe body in specification.  In reversing the District Court's construction, the majority said:

    There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  See Phillips, 415 F.3d at 1323.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.  Id. at 1323–24.

    Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."  Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

    Federal Circuit SealThere were two dissents filed in the court's decision not to hear the claim construction decision en banc:  one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterizes claim construction as "the single most important event in the course of a patent litigation."  However, the Federal Circuit's rules for making claim construction determinations are "still ill-defined and inconsistently applied," even by the Court.  While citing commentators to support this conclusion, the dissent focuses on the question at issue in Retractable Technologies and, according to Judge Moore, comprising generally a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  The dissent contends that this is the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

    Judge Moore relies principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude."  She discounts the concerns voiced by the majority in Retractable Technologies, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question is one of validity rather than claim construction, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, the dissent relies once again on the mantra that the "plain meaning" of the clams controls (and the dissent voices surprise that this question was not resolved in Phillips).  Judge Moore states her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term — to deviate from the plain and ordinary meaning — unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).  Any deviation from this procedure should be applied narrowly, and specifically, the dissent opines that the choice of an overbroad term may affect validity but should not be considered for claim construction.  Tellingly, she recites that "[w]e [the court] are not lexicographers."  Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent here contrasts the majority decision in Phillips with the panel decision here:  in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied.  And the evidence, according to the dissent, fails to support a claim limited to single-body embodiments.

    Judge Moore identifies the problem with the panel decision with particularlty:

    The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

    While the dissent then explicates why Judge Moore believes that this construction isn't supported by the specification, more particularly she illustrates the subjectivity and difficulty an appellate court can be expected to encounter in reviewing claim construction without deference to a district court's fact finding.  And "[c]hanging the plain meaning of a claim term to tailor its scope to what the panel believes was the 'actual invention' is not consistent with the standard enunciated by Phillips."  While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, the dissent states simply that the Court "does not rewrite claims"; this is not a case, Judge Moore contends, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification."  Rather, this case is illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation."  That is enough to convince Judge Moore and Chief Judge Rader that claim construction requires reconsideration by the court en banc.  Judge Moore also writes that this case has a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction permits or requires deference to a district court's factual determinations under Markman v. Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

    Judge O'Malley dissents separately, a posture reflecting her singular experience as a district court judge tasked with performing factual determinations in support of claim construction decisions.  She is forthright:  "[i]t is time to revisit and reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)," if only because "the court's decision necessarily would change if even minimal deference were afforded to the trial judge's claim construction."  Her dissent notes that the Court's decision to give no deference to district court factual determinations is not required by the Supreme Court in Markman, and indeed the High Court "did not affirm this court's earlier conclusion that resort to a jury was unnecessary because claim construction is a pure question of law."  She sees the appellate court's decision to be "ill considered" when it was enunciated thirteen years ago and that it has not proven "beneficial" to patent jurisprudence "in the long run."

    Reflecting her own experience, Judge O'Malley opines that:

    [D]istrict judges have been trained to — and do — engage in detailed and thoughtful analysis of the claim construction issues presented to them.  They conduct live hearings with argument and testimony, sometimes covering several days, and certainly always extending beyond the mere minutes that courts of appeals have to devote to live exchanges with counsel.  Simply, "the trial court has tools to acquire and evaluate evidence that this court lacks."  Cybor, 138 F.3d at 1477 (Rader, J., dissenting).

    She goes on to say that "[w]hile no one would urge deference to cryptic, unthinking rulings born of little or no real inquiry, where, as here, the trial court has thoroughly vetted all relevant aspects of the claim constructions at issue, 'careful consideration of the institutional advantages of the district court would counsel deference.'"  Reciting the history of the case, she notes that these claims had been construed by two separate district court judges and that the asserted "wrongdoing" reversed by the panel decision "did not promote the consistency and uniformity in patent law that Cybor was intended to foster; the decision here accomplished the opposite."

    In Judge O'Malley's view, the panel did not misapply the claim construction canons in Phillips; more pedestrianly, she states that she merely disagrees with their application.  But this fact, and the experience of the panel members that they "could not agree on the proper claim construction in this case, despite careful consideration of their respective obligations under Phillips," strongly suggests to Judge O'Malley that the "complicated and fact-intensive nature of claim construction" mandates "the need to rethink our approach to it."  For her, the "review of extensive documentary evidence" and possibly expert testimony suggest factual, not legal questions are being posed to the Court.  And:

    Where, as here, there is fair debate about the scope of the invention after application of Phillips's principles, we should defer to reasoned district court choices.  Reasonable minds can — and do — differ over the correct interpretation of the term "body" as used in the patent in suit.  These are not the circumstances under which we should be reversing carefully reasoned claim constructions and putting aside years of litigation in the process.

    Taking into account the five "active" judges who voted to grant rehearing in Amgen Inc. v. Hoechst Marion Rousell, Inc., 469 F.3d 1039 (Fed. Cir. 2006), Judge O'Malley's dissent suggests that the active members of the Court are almost evenly split on the question of whether to grand en banc review.  Although her call to arms ("[i]t is time we stop talking about whether we should reconsider the standard of review we employ when reviewing claim construction decisions from district courts; it is time we do so") is stirring, the question won't be put to the en banc Court until either its composition changes or an even more compelling case is presented to it.

  • By Donald Zuhn

    USPTO SealLast week, the U.S. Patent and Trademark Office announced the establishment of a new Patent Prosecution Highway (PPH) pilot program with the Norwegian Industrial Property Office (NIPO).  As with other PPH programs, the USPTO-NIPO PPH will permit an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or NIPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.

    NIPOThe USPTO-NIPO PPH pilot program, which began on November 1, 2011, is scheduled to expire on October 31, 2012, but may be extended for up to one year or terminated earlier depending on volume of activity and other factors.  USPTO requirements for participation in the USPTO-NIPO PPH pilot program can be found here, and NIPO requirements can be here.

    Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of twenty PPH programs with other patent offices.  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), the Swedish Patent and Registration Office (PRV), Nordic Patent Institute (NPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), and the Norwegian Industrial Property Office (NIPO).

  • By Donald Zuhn

    WIPOLast week, the World Intellectual Property Organization (WIPO) announced the launch of WIPO Re:Search, a consortium of public and private sector organizations sharing intellectual property (IP) and expertise with the global health research community to promote the development of new drugs, vaccines, and diagnostics for the treatment of neglected tropical diseases, malaria, and tuberculosis.  In addition to WIPO, the collaboration involves BIO Ventures for Global Health (BVGH), a non-profit organization that seeks to accelerate the development of novel drugs, vaccines, and diagnostics addressing the unmet medical needs of the developing world, the U.S. National Institutes of Health (NIH), and eight pharmaceutical companies:  Alnylam Pharmaceuticals, AstraZeneca, Eisai, GlaxoSmithKline, MSD1, Novartis, Pfizer, and Sanofi.  Among the non-profit organizations participating in the project are the California Institute of Technology, the Center for World Health & Medicine, the Drugs for Neglected Diseases initiative, Fundação Oswaldo Cruz (Fiocruz), Massachusetts Institute of Technology, Medicines for Malaria Venture, PATH, the South African Medical Research Council, the Swiss Tropical and Public Health Institute, the University of California, Berkeley, and the University of Dundee (UK).

    BvghCompanies and organizations participating in the WIPO Re:Search consortium will make selected intellectual property assets available under royalty-free licenses to qualified researchers anywhere in the world for research and development on neglected tropical diseases, malaria, and tuberculosis.  WIPO Director General Francis Gurry noted that "[t]his commitment should accelerate the development of medicines, vaccines, and diagnostics for these diseases," which the World Health Organization (WHO) estimates impair the lives of at least 1 billion people worldwide.  WIPO RE:Search will consist of a searchable, public database of available intellectual property assets, information, and resources.  Participation in the consortium will be open to all organizations that endorse, adhere to, and support the project's Guiding Principles, which include the commitment that IP licensed via WIPO Re:Search will be licensed on a royalty-free basis for research and development on neglected tropical diseases in any country and on a royalty-free basis for sale of neglected tropical disease medicines in, or to, least developed countries.

    For additional information regarding this topic, please see:

    • BVGH press release, October 27, 2011

  • By Kevin E. Noonan

    Obama ChangeDespite achieving a legislative accomplishment that had been frustrated for over a generation (i.e., healthcare reform), the Obama Administration's technology policies have left even the President's supporters perplexed by a fundamental paradox.  Specifically, how could the President (an intelligent man) and his advisors (comprising this generation's "best and brightest") be so seemingly clueless about technology policy?  From promoting the Leahy-Smith America Invents Act as a way to stimulate the economy and create jobs (see "Commerce Secretary Provides Administration's Views on America Invents Act" and "Obama Administration Supports S. 23"), to supporting the Federal Trade Commission's single-minded pursuit of an end to reverse payment agreements between innovator and generic drug companies (despite copious evidence that such agreements actually promote generic drugs to market), to his dogged persistence on trying to limit the data exclusivity provisions of the follow-on biologics portion of the healthcare reform bill from 12 to 7 years (see "President's Deficit Reduction Plan Seeks to Reduce Exclusivity Period for Biologics and Prohibit Pay-for-Delay Deals"), to the spectacularly "simple-minded" nonsense of the "magic microscope" standard for patent eligibility of DNA claims in the Myriad case (see "AMP v. USPTO: Oral Argument at the Federal Circuit"), the President's policies seem disconnected from the reality of promoting innovation in America (and the resulting economic benefits thereof).

    Thus, it may be a sign that the clouds of confusion are clearing in Washington that the President issued the following Memorandum for the heads of all Executive departments and agencies in Friday, October 28th:

    THE WHITE HOUSE

    Office of the Press Secretary

    For Immediate Release October 28, 2011

    October 28, 2011

    MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES

    SUBJECT: Accelerating Technology Transfer and Commercialization of Federal Research in Support of High-Growth Businesses

    Section 1. Policy. Innovation fuels economic growth, the creation of new industries, companies, jobs, products and services, and the global competitiveness of U.S. industries. One driver of successful innovation is technology transfer, in which the private sector adapts Federal research for use in the marketplace. One of the goals of my Administration's "Startup America" initiative, which supports high-growth entrepreneurship, is to foster innovation by increasing the rate of technology transfer and the economic and societal impact from Federal research and development (R&D) investments. This will be accomplished by committing each executive department and agency (agency) that conducts R&D to improve the results from its technology transfer and commercialization activities. The aim is to increase the successful outcomes of these activities significantly over the next 5 years, while simultaneously achieving excellence in our basic and mission-focused research activities.

    I direct that the following actions be taken to establish goals and measure performance, streamline administrative processes, and facilitate local and regional partnerships in order to accelerate technology transfer and support private sector commercialization.

    Sec. 2. Establish Goals and Measure Progress. Establishing performance goals, metrics, and evaluation methods, as well as implementing and tracking progress relative to those goals, is critical to improving the returns from Federal R&D investments. Therefore, I direct that:

    (a) Agencies with Federal laboratories shall develop plans that establish performance goals to increase the number and pace of effective technology transfer and commercialization activities in partnership with non-federal entities, including private firms, research organizations, and non-profit entities. These plans shall cover the 5-year period from 2013 through 2017 and shall contain goals, metrics, and methods to evaluate progress relative to the performance goals. These goals, metrics, and evaluation methods may vary by agency as appropriate to that agency's mission and types of research activities, and may include the number and quality of, among other things, invention disclosures, licenses issued on existing patents, Cooperative Research and Development Agreements (CRADAs), industry partnerships, new products, and successful self-sustaining spinoff companies created for such products. Within 180 days of the date of this memorandum, these plans shall be submitted to the Office of Management and Budget (OMB) which, in consultation with the Office of Science and Technology Policy (OSTP) and the Department of Commerce, shall review and monitor implementation of the plans.

    (b) The Interagency Workgroup on Technology Transfer, established pursuant to Executive Order 12591 of April 10, 1987, shall recommend to the Department of Commerce opportunities for improving technology transfer from Federal laboratories, including: (i) current technology transfer programs and standards for assessing the effectiveness of these programs; (ii) new or creative approaches to technology transfer that might serve as model programs for Federal laboratories; (iii) criteria to assess the effectiveness and impact on the Nation's economy of planned or future technology transfer efforts; and (iv) an assessment of cooperative research and development venture programs.

    (c) The Secretary of Commerce, in consultation with other agencies, including the National Center for Science and Engineering Statistics, shall improve and expand, where appropriate, its collection of metrics in the Department of Commerce's annual technology transfer summary report, submitted pursuant to 15 U.S.C. 3710(g)(2).

    (d) The heads of agencies with Federal laboratories are encouraged to include technology transfer efforts in overall laboratory evaluation.

    Sec. 3. Streamline the Federal Government's Technology Transfer and Commercialization Process. Streamlining licensing procedures, improving public availability of federally owned inventions from across the Federal Government, and improving the executive branch's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT) programs based on best practices will accelerate technology transfer from Federal laboratories and other facilities and spur entrepreneurship. Some agencies have already implemented administrative changes to their SBIR and SBTT programs on a pilot basis and achieved significant results, such as reducing award times by 50 percent or more. Over the past year, some agencies have also initiated pilot programs to streamline the SBIR award timeline and licensing process for small businesses. In addition, some agencies have developed new short-term exclusive license agreements for startups to facilitate licensing of inventions to small companies. Therefore:

    (a) Agencies with Federal laboratories shall review their licensing procedures and practices for establishing CRADAs with the goal of reducing the time required to license their technologies and establish CRADAs to the maximum practicable extent.

    (b) The Federal Chief Information Officer and the Assistant to the President and Chief Technology Officer shall, in coordination with other agencies: (i) list all publicly available federally owned inventions and, when available, licensing agreements on a public Government database; (ii) develop strategies to increase the usefulness and accessibility of this data, such as competitions, awards or prizes; and (iii) report their initial progress to OMB and OSTP within 180 days of the date of this memorandum.

    (c) The heads of agencies participating in the SBIR and SBTT programs shall implement administrative practices that reduce the time from grant application to award by the maximum practicable extent; publish performance timelines to increase transparency and accountability; explore award flexibility to encourage high quality submissions; engage private sector scientists and engineers in reviewing grant proposals; encourage private sector co-investment in SBIR grantees; partner with external organizations such as mentoring programs, university proof of concept centers, and regional innovation clusters; and track scientific and economic outcomes. The OMB, OSTP, and the Small Business Administration shall work with agencies to facilitate, to the extent practicable, a common reporting of these performance measures.

    Sec. 4. Facilitate Commercialization through Local and Regional Partnerships. Agencies must take steps to enhance successful technology-innovation networks by fostering increased Federal laboratory engagement with external partners, including universities, industry consortia, economic development entities, and State and local governments. Accordingly:

    (a) I encourage agencies with Federal laboratories to collaborate, consistent with their missions and authorities, with external partners to share the expertise of Federal laboratories with businesses and to participate in regional technology innovation clusters that are in place across the country.

    (b) I encourage agencies, where appropriate and in accordance with OMB Circular A-11, to use existing authorities, such as Enhanced Use Leasing or Facility Use Agreements, to locate applied research and business support programs, such as incubators and research parks, on or near Federal laboratories and other research facilities to further technology transfer and commercialization.

    (c) I encourage agencies with Federal laboratories and other research facilities to engage in public-private partnerships in those technical areas of importance to the agency's mission with external partners to strengthen the commercialization activities in their local region.

    Sec. 5. General Provisions. (a) For purposes of this memorandum, the term "Federal laboratories" shall have the meaning set forth for that term in 15 U.S.C. 3703(4).

    (b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

    (c) Nothing in this memorandum shall be construed to impair or otherwise affect the functions of the Director of OMB relating to budgetary, administrative, and legislative proposals.

    (d) Independent agencies are strongly encouraged to comply with this memorandum.

    (e) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

    BARACK OBAMA

    It must be acknowledged that this is merely a statement of intentions and policy goals, and that the extent to which it influences or changes the pace and scope of technology transfer from Federal laboratories is uncertain (and perhaps more dependent on the personalities in charge of those laboratories, both administration and scientific).  However, it is refreshing to see the Administration take this tack on innovation policy, particularly in view of the contrary (and contradictory) signals that has characterized the past few years.

  • By Sherri Oslick

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

    Alkermes Pharma Ireland Ltd. et al. v. Torrent Pharmaceuticals Ltd. et al.
    1:11-cv-01009; filed October 21, 2011 in the District Court of Delaware

    • Plaintiffs:  Alkermes Pharma Ireland Ltd.; Jazz Pharmaceuticals Inc.
    • Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

    Infringement of U.S. Patent No. 7,456,462 ("Multiparticulate Controlled Release Selective Serotonin Reuptake Inhibitor Formulations," issued December 16, 2008), licensed to Jazz Pharmaceuticals, following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Jazz's Luvox® CR (fluvoxamine maleate, used to treat social anxiety disorder and obsessive compulsive disorder).  View the complaint here.


    Fred Hutchinson Cancer Research Center et al. v. Branhaven, LLC

    3:11-cv-00710; filed October 21, 2011 in the Eastern District of Virginia

    • Plaintiffs:  Fred Hutchinson Cancer Research Center; Argus Genetics, LLC; Mars, Inc.
    • Defendant:  Branhaven, LLC; Scidera, INC.; Scidera Canine, LLC

    Infringement of U.S. Patent No. 7,729,863 ("Methods and Materials for Canine Breed Identification," issued June 1, 2010) based on defendants' use, sale, and offers to sell its dog breed identification services (Canine Heritage XL Breed Test).  View the complaint here.


    Janssen Pharmaceuticals, Inc. v. Sun Pharma Global FZE et al.

    2:11-cv-06089; filed October 17, 2011 in the District Court of New Jersey

    • Plaintiff:  Janssen Pharmaceuticals, Inc.
    • Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.

    Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception).  View the complaint here.


    Novo Nordisk Inc. et al. v. Sandoz Inc.

    3:11-cv-06106; filed October 14, 2011 in the District Court of New Jersey

    • Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk A/S
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglinide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.


    Alcon Pharmaceuticals, Ltd. vs. Perrigo Co.

    4:11-cv-00732; filed October 14, 2011 in the Northern District of Texas

    • Plaintiff:  Alcon Pharmaceuticals, Ltd.
    • Defendants:  Perrigo Co; Perrigo Israel Pharmaceuticals Ltd.

    Infringement of U.S. Patent No. 7,977,376 ("Olopatadine Formulations for Topical Nasal Administration," issued July 12, 2011) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Alcon's Patanase® (olopatadine hydrochloride, used to treat seasonal allergic rhinitis).  View the complaint here.


    Noven Pharmaceuticals, Inc. v. Watson Laboratories, Inc. et al.

    2:11-cv-05997; filed October 13, 2011 in the District Court of New Jersey

    • Plaintiff:  Noven Pharmaceuticals, Inc.
    • Defendants:  Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.

    Infringement of U.S. Patent Nos. 6,210,705 ("Compositions and Methods For Treatment of Attention Deficit Disorder and Attention Deficit/Hyperactivity Disorder With Methylphenidate," issued April 3, 2001) and 6,348,211 (same title, issued February 19, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Noven's Daytrana® (transdermal methylphenidate delivery system, used to treat attention deficit disorder and attention deficit/hyperactivity disorder).  View the complaint here.


    Schering Corp. et al. v. Actavis Inc. et al.

    2:11-cv-06067; filed October 13, 2011 in the District Court of New Jersey

    • Plaintiffs:  Schering Corp.; MSP Singapore Company LLC
    • Defendants:  Actavis Inc.; Actavis Group HF

    Infringement of U.S. Patent Nos. RE42,461 ("Hydroxy-Substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued June 14, 2011) and 5,846,966 ("Combinations of Hydroxy-Aubstituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998), both licensed to MSP, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of MSP's Vytorin® (ezetimibe and simvastatin, used to treat hyperlipidemia).  View the complaint here.


    Warner Chilcott Co., LLC et al. v. Watson Pharmaceuticals, Inc. et al.

    2:11-cv-05989; filed October 12, 2011 in the District Court of New Jersey

    • Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott (US), LLC
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc. – Florida; Watson Pharma, Inc.

    Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause).  View the complaint here.

  • Calendar

    October 31, 2011 – Leahy-Smith America Invents Act (U.S. Patent and Trademark Office) – 1:00 pm (EDT)

    November 1, 2011 – Patent Reform: Advanced Prior Art under the AIA (Intellectual Property Owners Association) – 2:00 – 3:00 PM (ET)

    November 2-4, 2011 – Intellectual Property Counsels Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) – New York, NY

    November 2-4, 2011 – Biotechnology from the Ground Up (Management Forum and JNB Marketing & Events) – San Diego, CA

    November 4, 2011 – Patent Law Symposium 2011 (Intellectual Property Law Association of Chicago) – Chicago, IL

    November 9, 2011 – Optimizing Relations with the USPTO: All the Questions You Always Wanted to Ask and Could Never Get Answers For (Association of Intellectual Property Firms) – 12:30 – 1:30 PM (EST)

    November 15, 2011 – Patent Reform: First to File Provisions (Strafford) – 1:00 – 2:30 PM (EST)

    November 17, 2011 – The America Invents Act: Key Facts You Need To Know Now About Provisions that Are Already Law (American Bar Association) – 1:00 – 2:30 pm (Eastern)

    November 18, 2011 – The US Patent Reform Congress (IBC Legal Conferences) – London, UK

    November 30 to December 1, 2011 – Advanced Forum on Biotech Patents*** (American Conference Institute) – Boston, MA

    December 1, 2011 – Biotechnology/Chemical/ Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 9:00 am – 5:15 pm

    December 5-7, 2011 – Drug and Medical Device Litigation*** (American Conference Institute) – New York, NY

    December 6-7, 2011 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

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

  • USPTO SealThe U.S. Patent and Trademark Office will be hosting a free public webinar on the Leahy-Smith America Invents Act on October 31, 2011 at 1:00 pm (EDT).  The panel for the webinar will include David Kappos, USPTO Director; Teresa Stanek Rea, USPTO Deputy Director; Robert L. Stoll, Commissioner for Patents; Bernard Knight, USPTO General Counsel; and James D. Smith, BPAI Chief Administrative Patent Judge, who will outline the agency's implementation plans and answer a selection of questions submitted during the session.  Questions should be submitted in advance to aia_townhallquestions@uspto.gov.  The webinar can be accessed here.  Participants should enter their name and e-mail address, if prompted.  If a password is required, participants should enter the meeting password: 123456 and click "Join."  Additional information regarding the webinar, including phone numbers for participating in the audio conference only, can be found here.