Patent Law Weblog

recent posts

about

  • President’s Budget Proposal Increases Funding for Basic Research But Seeks to “Trim” Data Exclusivity Period and Pay-for-Delay Agreements

    By Donald Zuhn —

    Presidential Seal President Obama unveiled his 2012 budget last week, and while the President's budget calls for cuts in many areas of government, he would like to raise investment in basic research.  As a result, under the President's budget proposal, funding for the National Institutes of Health (NIH) would rise from the current $31.3 billion to $32.3 billion in fiscal 2012, and the National Science Foundation would get $7.77 billion in 2012, or 13% more than it did in 2010.  In a statement on the White House website entitled "Winning the Future through Innovation," the Office of Management and Budget (OMB) states that "[h]aving emerged from the worst recession in generations, the President has put forward a plan to rebuild our economy and win the future by out-innovating, out-educating, and out-building our global competitors and creating the jobs and industries of tomorrow."  The OMB outlines a number of ways in which the budget will "spur innovation," including:

    Increase Investment in Research and Development and Create Transformational Technologies.  For many years, the United States has been a world leader in research and development (R&D) spending, as well as in the quality and impact of that spending.  The challenge is for the Nation to make private and public investments in science, research and development that will keep the U.S. as the world's leader in innovation for decades to come.  The 2012 Budget does that by providing $148 billion for R&D overall, while targeting resources to those areas most likely to directly contribute to the creation of transformational technologies that can create the businesses and jobs of the future.  The Budget makes progress toward the President's commitment to double funding for key basic research agencies:  the National Science Foundation (NSF), the Department of Energy's Office of Science, and the National Institute of Standards and Technology (NIST) laboratories.  These funds will be directed at priority areas, such as clean energy technologies, advanced manufacturing technologies, and cyber security.  In addition, the Budget provides $12 million in NIST for the Advanced Manufacturing Technology Consortia program, a new public-private partnership that will develop road maps for long-term industrial research needs and fund research at universities, government laboratories, and businesses directed at meeting those needs.  The Budget also funds research at the National Institutes of Health with an increased focus on translating research discovering into clinical trials.

    Support Biomedical Research at the National Institutes of Health.  The Budget includes $32 billion for basic and applied biomedical research supported by the National Institutes of Health (NIH).  Innovation in this field creates and sustains companies, products, and jobs.  Through implementation of the National Center for Advancing Translational Sciences and the Cures Acceleration Network, NIH will increase its focus on bridging the translational divide between basic science and therapeutic applications.  By fostering novel collaborations among government, academia, and industry, NIH will accelerate the development of treatments for diseases and disorders that affect millions of Americans.  NIH will continue to pursue the leading edge of discovery in basic cancer science, development of new cancer treatments, and prevention and early detection of cancer, focusing on recent discoveries regarding cancer genomes.  For Alzheimer's disease, NIH is partnering with the private sector to find new methods for early diagnosis and to support early drug discovery and preclinical drug development.  Ongoing research into environmental factors, early detection, and novel treatments will transform our understanding and care for those with autism spectrum disorders.

    The OMB also notes that the budget will:

    Improve the Patent System and Protect Intellectual Property.  The Budget proposes to give the U.S. Patent and Trademark Office (USPTO) full access to its fee collections and strengthen USPTO's efforts to improve the speed and quality of patent examinations through a temporary fee surcharge and regulatory and legislative reforms.  The surcharge will better align application fees with processing costs.  In total, this will provide USPTO with over $2.7 billion of resources in 2012, or more than 34 percent more than in 2010.

    In announcing the budget proposal, the President declared that it was important "to invest in those things that are absolutely critical to preparing our people and our Nation for the economic competition of our time," which could be accomplished in part "by encouraging American innovation and investing in research and development — especially in the job-creating industries of tomorrow such as clean energy."  The President noted that:

    [S]ince many companies do not invest in basic research that does not have an immediate pay off, we — as a Nation — must devote our resources to these fundamental areas of scientific inquiry.  In this Budget, we are increasing our investment in research and development that contributes to fields as varied as biomedicine, cyber-security, nano-technology, and advanced manufacturing.

    Lost in the initial discussion of the President's 2012 budget were two proposals that would have a significant impact on drugmakers.  With respect to the $79.9 billion of the budget targeted for the Department of Health and Human Services (HHS), the Administration notes that the 2012 budget:

    Increases Affordability and Reduces Costs for Prescription Drugs Across Federal Programs.  The high cost of prescription drugs is a burden for many Americans.  The Administration will accelerate access to more affordable pharmaceuticals that will lead to cost savings for consumers and health programs across the Federal Government.  The President's Budget includes two proposals to increase availability of generic drugs by providing the Federal Trade Commission authority to stop drug companies from entering into anticompetitive agreements intended to block consumer access to safe and effective generics, and hastening availability of generic biologics while retaining the appropriate incentives for research and development for the innovation of breakthrough products.

    A Reuters report noted that the President would accomplish the goal of "hastening availability of generic biologics while retaining the appropriate incentives for research and development for the innovation of breakthrough products" by trimming the data exclusivity provision of the Approval Pathway for Biosimilar Biological Products section of the Patient Protection and Affordable Care Act (PPACA) from 12 years to 7 years.  In an article in the San Francisco Business Times, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said that the budget proposal to reduce the exclusivity period "flies in the face of President Obama's own call for the U.S. to 'win the future' and maintain our nation's leadership in research and technology."

    In a document entitled "Terminations, Reductions and Savings" on the President's website, the White House states that:

    The Administration is proposing to give consumers more access to affordable pharmaceuticals by: 1) reducing the exclusivity period for brand biologics to encourage faster development of generic biologics; and 2) giving the Federal Trade Commission the authority to prohibit brand and generic drug companies from entering into anticompetitive or "pay-for-delay" agreements intended to keep more generics off the market.

    The Administration attempts to justify both proposals by explaining that:

    Generic Biologics.  Under current law, innovator brand biologics have 12 years of exclusivity and broad "evergreening" authority, whereby innovator manufacturers are able to make relatively minor changes to the "potency, purity, and safety" of their products to receive an additional 12 years of exclusivity.

    Under the Administration proposal, beginning in 2012, innovator brand biologic manufacturers would have 7 years of exclusivity and would be prohibited from receiving additional exclusivity by "evergreening" their products.  According to the Federal Trade Commission, 12-year exclusivity is unnecessary to promote innovation by brand biologic drug manufacturers and can potentially harm consumers by directing scarce research and development funding toward developing low-risk clinical data for drug products with proven mechanisms of action rather than toward new products to address unmet medical needs.  The Administration policy strikes a balance between promoting affordable access to medication while at the same time encouraging innovation to develop needed therapies.

    Pay-for-Delay.  In these agreements, a brand name company settles its patent law suit by paying the generic firm to delay entering the market.  Such deals can cost consumers billions of dollars because generic drugs are typically priced significantly less than their branded counterparts.  The Administration proposal would give the Federal Trade Commission the authority to prohibit pay-for-delay agreements in order to facilitate access to lower-cost generics.

    As for the savings derived from each proposal, the Administration asserts that shortening the exclusivity period will produce $330 million in savings between 2012 and 2016 (but no savings between 2012 and 2014) and $2.34 billion in savings between 2012 and 2021.  The Administration estimates that the pay-for-delay ban will produce $3.42 billion in savings between 2012 and 2016 and $8.79 billion between 2012 and 2021.

    While the means of accomplishing both goals may be surprising, the Administration's positions on both are not.  Before signing the PPACA last March, the President pushed hard for a reduction of the 12-year period (see "Snatching Defeat from the Jaws of Victory?").  Moreover, the Administration's support for a 7-year exclusivity period can be traced back to a letter the White House sent in June 2009 to Rep. Henry Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, stating that a biosimilars regulatory pathway providing a 7-year data exclusivity period would "strike[] the appropriate balance between innovation and competition" (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics").  In addition, little is new about the Administration's proposal "to stop drug companies from entering into anticompetitive agreements intended to block consumer access to safe and effective generics."  Prior to the February 2010 health care meeting at the White House, the President outlined 34 key improvements to reform health care, including a ban of pay-for-delay settlements, wherein a brand-name pharmaceutical company can delay generic competition through an agreement to pay a generic company to keep its drug off the market for a period of time (see "President's Health Care Plan Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway").  Nevertheless, when coupled with the Administration's decision to send the Acting Solicitor General to argue in support of the Justice Department's amicus curiae brief in the Association of Molecular Pathology v. U.S. Patent and Trademark Office appeal (see "Curiouser and Curiouser"), the President's budget proposals leave many of his supporters to question whether the biotech industry will have a role in helping the nation "win the future."

  • Court Report

    By Sherri Oslick —

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

    Abbott Laboratories et al. v. Sandoz Inc.
    1:11-cv-00145; filed February 16, 2011 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Sandoz's filing of an amended ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.


    Leo Pharma A/S v. Perrigo Isrel Pharma Ltd.
    1:11-cv-00963; filed February 14, 2011 in the Southern District of New York

    Infringement of U.S. Patent No. 6,753,013 ("Pharmaceutical Composition," issued June 22, 2004) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Leo's Taclones® (betamethasone diproprionate and calcipotriene monohydrate, used to treat psoriasis vulgaris).  View the complaint here.


    Velcera Inc. et al. v. Merial Ltd.
    1:11-cv-00134; filed February 11, 2011 in the District Court of Delaware

    • Plaintiffs:  Velcera Inc.; Fidopharm Inc.
    • Defendant:  Merial Ltd.

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,096,329 ("Insecticidal Combination to Control Mammal Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000), 6,620,943 ("Process for Preparing 4-Trifluoromethylsulfinylpyrazole Derivative," issued September 16, 2003), and 6,881,848 (same title, issued April 19, 2005), all licensed to Merial in the animal health field, based on Plaintiffs' anticipated sale of fipronil-based animal health products.  View the complaint here.


    Novartis Pharmaceuticals Corp. et al. v. Mylan Pharmaceuticals Inc. et al.
    1:11-cv-00015; filed February 11, 2011 in the Northern District of Illinois

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

    Infringement of U.S. Patent No. 6,242,003 ("Organic Compounds," issued June 5, 2001) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Lescol® (fluvastatin sodium, used to treat hypercholesterolemia).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    February 25, 2011 – 55th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    February 25, 2011 – "Navigating the IP Waters of Europe — Understanding and Using the European Patent System" (American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Division, ABA-IPL Young Lawyers Action Group, Section of International Law, and the ABA Center for Continuing Legal Education) – 1:00 – 2:00 PM (Eastern)

    March 4, 2011 – Sixth Annual Symposium, "The Economics of Intellectual Property and Technology" (Northwestern Journal of Technology & Intellectual Property) – Chicago, IL

    March 16-17, 2011 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 31, 2011 – Clinical Biotech Forum West (Institute for International Research) – Phoenix, AZ

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

  • John Marshall Law School 55th Annual IP Law Conference

    JMLS The John Marshall Law School Center for Intellectual Property Law will be holding its 55th Annual Intellectual Property Law Conference on February 25, 2011 in Chicago, IL.  The conference will consist of the following sessions:

    • Recent Developments in Intellectual Property Law
    • The Honorable James F. Holderman, Chief Judge, U.S. District Court for the Northern District of Illinois will present a luncheon keynote on "The Future Challenges of IP Litigation: A Judge's Perspective"

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

    • In re Bilski and what to do about it
    • Apportionment issues in IP damages cases
    • False patent marking
    • Patenting items derived from nature — to be presented by Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP

    Additional information about the conference, including a schedule, list of speakers, and registration form 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).

  • Northwestern JTIP Sixth Annual Symposium

    Northwestern University School of Law The Northwestern Journal of Technology & Intellectual Property will be holding its Sixth Annual Symposium on March 4, 2011 on the Chicago Campus of Northwestern University.  The Symposium, entitled "The Economics of Intellectual Property and Technology," will consist of the following sessions:

    • Economics of Biotechnology: The Human Gene Patenting Debate — a panel discussion on the implications of the recent Myriad litigation on the future of gene patents and the development of medical treatments featuring Patent Docs author Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff; Yvonne Cripps of the University of Indiana; and Andrew Robertson of BIO Ventures for Global Health;

    • Economics of Licensing and Intellectual Property Capitalization — a panel discussion examining issues such as how companies are licensing their IP, the potential regulation of IP, and the impact of non-practicing entities featuring Jay Kesan of the University of Illinois (moderator); Emily Miao of McDonnell Boehnen Hulbert & Berghoff; James Gerard Conley of the Kellogg School of Management; and Manny Schecter of IBM;

    • Economics of Telecommunication: The Impact of the Broadband Plan on Competition — a panel discussion debating the current state of broadband competition, disputes between content providers and carriers, and the future of intellectual property protection and control in the developing ecosystem featuring James Speta of the Northwestern University School of Law (moderator); Thomas Hazlett of George Mason University; Daniel Spulber of the Kellogg School of Management; Kevin Martin of Patton Boggs; and Gregory Rosston of the Stanford Institute for Economic Policy Research; and

    • IP & Technology Conversation — John McGinnis of the Northwestern University School of Law will discuss his research and book Accelerating Democracy and lead a discussion with Robert Bennett of the Northwestern University School of Law and Ilya Somin of George Mason University.

    Additional information about the Symposium, including a schedule, list of speakers, and directions can be found at the Symposium's website.  Those interested in registering for the conference can do so here (while registration for the Symposium is free, CLE credit will be available to attendees for a fee of $50 per credit hour).

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

  • Clinical Biotech Forum West

    Brochure The Institute for International Research (IIR) will be holding its Clinical Biotech Forum West on March 31, 2011 in Phoenix, AZ.  The comprehensive one-day meeting delivers content designed for executives from small to midsize biopharmaceutical companies under 500 people looking for tools to execute fast, effective, and compliant clinical trials to achieve ROI and ensure regulatory approval.

    IIR faculty will offer presentations on the following topics:

    • Industry overview — The Avoca Group industry report;
    • Understand the economics of running clinical trials and optimize your financial management;
    • Obtaining funding — How to attract venture capitalists;
    • What every biotech start-up needs to know about IP protection — to be presented by Patent Docs author Donald Zuhn;
    • Explore critical considerations in selecting the right partner — Develop a vendor assessment and selection process;
    • Explore the advantages and disadvantages of partnering with a large CRO vs. a specialty CRO;
    • Smarter outsourcing strategies for biotechs — Best practices for managing your clinical trials;
    • Constructive project management;
    • Regulatory challenges and approaches for interacting with the FDA; and
    • Virtual drug development models.

    An agenda for the Clinical Biotech Forum West can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration information can be obtained on the conference website.

    IIR The registration fee is $795 (the conference is only open to biotech executives).  Those interested in registering for the conference can do so here, by calling 1-888-670-8200, or by e-mail at register@iirusa.com.

  • Webinar on the European Patent System

    ABA The American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Division, ABA-IPL Young Lawyers Action Group, Section of International Law, and the ABA Center for Continuing Legal Education will be offering a webinar and teleconference entitled "Navigating the IP Waters of Europe — Understanding and Using the European Patent System" on February 25, 2011 from 1:00 – 2:00 PM (Eastern).  Brent Jacobs of Brent C. Jacobs, Esq. Attorney at Law and Gwilym Roberts of Kilburn & Strode LLP will present:

    • An overview of IP protection systems in Europe;
    • An understanding of the overlap and interaction between national and international systems;
    • The comparative benefits of using the national vs. EP route for patents;
    • The basic principles of patentability in Europe;
    • Special features — added matter and inventive step;
    • The processes within the EPO and leveraging the system; and
    • The upcoming law changes in the patent arena in Europe.

    The registration fee for the webcast is $60 for Section of Intellectual Property Law members and Section of International Law members, $100 for ABA members, and $120 for the general public (for additional fee options, please visit the event website).  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • PCT and EP Filings on the Rise Again

    By Donald Zuhn —

    WIPO Last week, the World Intellectual Property Organization (WIPO) announced that International patent filings under the Patent Cooperation Treaty (PCT) rose from 155,398 in 2009 to 162,900 in 2010 — an increase of 4.8%.  While the United States ranked first in filings with 44,855 applications, this still marked a 1.7% decline from the 45,618 applications that were filed in 2009.  China saw the strongest growth in PCT filings, with applications up 56.2% to 12,337 in 2010.  Japan, Germany, and South Korea rounded out the remainder of the top five with 32,156; 17,171; and 9,686 applications, respectively.

    When 2010 filings were sorted into 35 technical fields by International Patent Classification (IPC), the top five fields were:

    (1) Electrical machinery, apparatus, energy: 10,581 applications
    (2) Medical technology: 10,465
    (3) Computer technology: 9,540
    (4) Electrical machinery, apparatus, energy: 9,143
    (5) Pharmaceuticals: 7,843

    While the fields of biotechnology and organic fine chemistry each had more than 5,000 filings (with 5,206 and 5,511, respectively), both fields saw filings drop in 2010 (down 1.5% and 2.9%, respectively).  However, only six of 35 technical fields saw filings rise in 2010 (digital communication; semiconductors; materials, metallurgy; electrical machinery, apparatus, energy; thermal processes and apparatus; and medical technology).

    According to WIPO's figures, the top ten corporate PCT filers in 2010 were:

    (1) Panasonic Corp. (Japan) – 2,154 applications
    (2) ZTE Corp. (China): 1,863
    (3) Qualcomm Inc. (U.S.): 1,677
    (4) Huawei Technologies Co., Ltd. (China): 1,528
    (5) Koninklijke Philips Electronics N.V. (Netherlands): 1,435
    (6) Robert Bosch GmbH (Germany): 1,301
    (7) LG Electronics Inc. (South Korea): 1,298
    (8) Sharp Kabushiki Kaisha (Japan): 1,286
    (9) Telefonaktiebolaget LM Ericsson (Sweden): 1,149
    (10) NEC Corp. (Japan): 1,106

    and the top five university filers in 2010 were:

    (1) The Regents of the University of California (U.S.): 306 applications
    (2) Massachusetts Institute of Technology (U.S.): 145
    (3) Board of Regents, The University of Texas System (U.S.): 130
    (4) University of Florida (U.S.): 107
    (5) The University of Tokyo (Japan): 105

    A list of the top corporate and university filers can be found here.

    EPO In January, the European Patent Office (EPO) announced that it had also seen a rise in application filings in 2010.  According to the EPO release, 232,000 European applications were filed in 2010, up 10% from the 211,000 filings in 2009.  The EPO noted that 39% of the applications originated from the 38 member states of the European Patent Organisation, 26% came from the U.S., 18% were from Japan, and 5% were from each of South Korea and China.  The EPO also noted that 58,100 European patents were granted in 2010, up 11% from the 52,400 patents granted in 2009.  More detailed statistics are expected to be released later this year.

  • Biotech/Pharma Docket

    By James DeGiulio —

    Medicis and Q-Med Settle Restylane Dispute with Genzyme

    Genzyme Genzyme has agreed to drop its infringement suit with Medicis regarding the cosmetic injection product Restylane in exchange for a lump sum payment from Q-Med.  In October 2010, Genzyme brought suit in the U.S. District Court for the District of Massachusetts against Medicis, who licenses the product from Q-Med (see "Court Report," October 25, 2010).  Genzyme claimed that importing and selling Restylane, Perlane, Restylane-L, and Perlane-L injection products infringed U.S. Patent No. 5,399,351.  Genzyme alleged that Medicis also actively induced the infringement of the patent by selling these products together with instructions that advised others to infringe the '351 patent.  Q-Med, as licensor, was not named as a defendant in the suit, but Q-Med elected to assume the defense of Genzyme's claim in accordance with its license agreement with Medicis.

    Medicis On February 15, Q-Med announced in a press release that the parties had reached a settlement agreement, and that Genzyme agreed to dismiss the case and release Medicis and Q-Med from any liability related to the suit.  Q-Med did not disclose the exact sum paid to Genzyme.  However, Medicis is not required to make any payments under the terms of the settlement and none of the parties admit any liability related to the lawsuit's claims.


    Sun Agrees to Briefly Stop Selling Generic Eloxatin

    Sanofi-Aventis_small As Sun Pharma and Sanofi-Aventis continue to try to close their long-running battle over the cancer drug Eloxatin, Sun has agreed to temporarily halt its sales of oxaliplatin while the parties decide how to proceed with the infringement dispute that appeared to have been settled.  The case has a long history.  In 2007, the dispute between Sun and Sanofi-Aventis began, after Sanofi brought suit against Sun in response to Sun's ANDA filing, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007).  Sanofi also filed suit against other generic drug manufacturers who filed ANDAs for generic oxaliplatin.  In 2009, the parties entered into settlement negotiations, eventually agreeing to a license.  Two days after Sanofi and Sun reached a settlement agreement, the District Court denied summary judgment of invalidity and granted summary judgment of noninfringement of '874 patent.  A series of challenges to the original license agreement followed, eventually reaching the Federal Circuit, which vacated the settlement and remanded the case because the disputed language in the consent judgment was susceptible to two different interpretations (see "Sanofi-Aventis v. Sandoz, Inc. (Fed. Cir. 2010)").  The Federal Circuit denied Sanofi's request for reconsideration of this decision on February 7.

    Sun Pharma On February 9, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey approved the stipulation and proposed order requiring Sun to briefly refrain from selling, attempting to sell, or offering for sale any product containing oxaliplatin until February 17.  In exchange, Sanofi agreed not to seek injunctive relief against Sun or its affiliates until February 15, according to the order.  The agreement was sought to facilitate further negotiation in the action.  This latest agreement can be found here.


    Novozymes' Biofuel Enzyme Patent Survives Danisco Invalidity Challenge

    Novozymes Novozymes' patent covering a modified enzyme for use in ethanol production survived an invalidity challenge in the company's patent dispute with Danisco following the denial of Danisco's motion for summary judgment ofr invalidity.  In May 2010, Novozymes sued Danisco in the U.S. District Court for the Western District of Wisconsin, claiming that Danisco and its U.S. affiliates infringed U.S. Patent No. 7,713,723, covering the modified alpha-amylase enzyme (see "Court Report," May 23, 2010).  Novozymes moved for a preliminary injunction in September, asking the District Court to stop Danisco and its subsidiaries from selling GC358 and the more recent GC980 enzymes.  However, that bid was denied.  The Court concluded that Novozymes had failed to demonstrate that it would be irreparably harmed without an injunction, and questioned whether the patent-in-suit was actually valid, criticizing its written description.  Following this ruling, Danisco moved for summary judgment of invalidity of the '723 patent.

    Danisco On February 4, Judge Barbara B. Crabb denied Danisco's motion for summary judgment, rejecting the argument that the patent's written description does not convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.  Judge Crabb ruled that Danisco had not met its burden to prove invalidity by clear and convincing evidence.  However, she also stated in her opinion that lack of enablement might be a better argument for the defendants, hinting that the specification may require undue experimentation.  Judge Crabb's opinion can be found here.

  • Curiouser and Curiouser

    By Kevin E. Noonan —

    Alice in Wonderland The rift that has arisen between the U.S. Patent and Trademark Office and the Justice Department over the question of patent-eligibility for isolated genes seems to be continuing.  Last Thursday, the Acting Solicitor General sent a letter to the Federal Circuit, requesting to opportunity to present oral argument to the Court in support of the Justice Department's amicus curiae brief in Association of Molecular Pathology v. U.S. Patent and Trademark Office (aka the Myriad case).  This brief has already exposed deep divisions between the two Cabinet departments (Justice and Commerce), with the patent solicitor evidently being completely excluded from any participation in preparing the "government's" brief.  Now, the specter is raised of one part of the Executive Branch arguing to the Court that the considered judgment and almost three-decade history of practice of another department of that same government has been (and continues to be) wrong in granting patents not only on isolated human genes but also on any isolated biological (or "natural") product.

    Katyal, Neal The letter, from ASG Neal Katyal (at left), informs the Court that he intends to argue the "government's" position himself, and that the parties will not oppose his motion to participate.  He asks the Court to accommodate his schedule, by calendaring the argument on April 4th, to permit him to participate in oral argument before the Supreme Court (on global warming) and before the 4th Circuit (on the Affordable Care Act).  Despite this busy schedule, the ASG asks the Court to grant his motion to personally participate in the Myriad argument, indicating how important the administration evidently believes this issue to be.

    Department of Justice (DOJ) Seal This scenario of one part of the Executive branch arguing against another smacks of a "gang-that-couldn't-shoot-straight" administration, and if the consequences were not so significant it might pass for political theater to the enjoyment of President Obama's political opponents but without great effect on the national polity.  But the "government's" position, that natural products cannot be patent-eligible, has real-world and deleterious consequences far beyond the limited scope of patent eligibility for isolated human genes (the overwhelming majority of which will be outside the reach of patent protection in a little less than ten years).  The very property the government's brief argues makes isolated genomic DNA patent-ineligible — that it is a "product of nature" — applies with even greater force for all other valuable and useful "products of nature" including almost all biologic drugs.  There is typically substantially less modification involved in isolating these compounds, which are in fact merely isolated (separated from other impurities) rather than chemically changed (by breaking covalent bonds that hold the DNA molecule together).  Simply put, the government's position would prevent patent protection (and thus retard commercialization) of any useful compound found in plants, microorganisms, animals, etc.  This rationale also applies to products of genetic engineering, because while methods, cells for producing biologic drugs, and other components of the chain of production may be patentable, the drug itself will be less patentable the more closely it mimics the "natural product."  Since differences between synthetically produced biologic drugs and the compounds as they exist in nature carry the risks of differences in stability, in vivo half-life, biological activity, and immunogenicity, the "government's" position that ASG Kaytal is so anxious to argue disincentives biologic drug production, by putting drugs that are closest in stability, in vivo half-life, biological activity, and immunogenicity to the "natural product" in the most jeopardy of failing to be eligible for patent protection.  Estimates (even the "government's" estimates from the Federal Trade Commission) of the investment costs for bringing a biological drug to market are in the $1 billion range.  It is unlikely that such an investment will be made in the uncertain environment that would result from the Court adopting the "government's" views on patent eligibility for such "natural products."

    Commerce Department Seal Looking on the bright side, the possibility exists that, under the kind of piercing questioning that ASG Kaytal is likely to face from whatever Federal Circuit panel hears this argument, he will begin to have a glimmer of an understanding on how completely the "government" has botched the opportunity to benefit from the experience of senior PTO officials and experienced legal staff, and that merely being the latest installment of the "best and brightest" isn't always enough.  In instances such as these, involving questions having such real-world consequences, operating from "first principles" and attempting to impose a political solution that satisfies as many of your supporters' constituencies as possible is almost certain to involve unexpected and unintended consequences.  Regardless of whether ASG Kaytal experiences his own personal epiphany on these matters, it is also possible that the Supreme Court will come to appreciate the deficiencies in the "government's" arguments, and that this will make it less likely to grant certiorari on the question of patent eligibility for isolated genes should the Federal Circuit reverse the District Court on the merits.  That would be an outcome deserving of the political theater the ASG's day before the Federal Circuit is certain to become.

    Patent Docs thanks Hal Wegner for alerting us to and providing a copy of ASG Kaytal's letter.

    For information regarding this and other related topics, please see:

    • "AMP v. USPTO — Briefing Update III," February 8, 2011
    • "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
    • "AMP v. USPTO: Appellees' Brief," January 12, 2011
    • "AMP v. USPTO — Briefing Update II," December 16, 2010
    • "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
    • "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
    • "AMP v. USPTO — Briefing Update," December 14, 2010
    • "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
    • "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
    • "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
    • "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
    • "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
    • "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
    • "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
    • "AMP v. USPTO — Briefing Update," November 1, 2010
    • "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
    • "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
    • "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
    • "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
    • "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
    • "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
    • "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
    • "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
    • "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
    • "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
    • "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
    • "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
    • "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
    • "Round One Goes to the ACLU," March 29, 2010
    • "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010