• BIO and Personalized Medicine

    By Andrew Williams —

    BIO International Convention The 2011 BIO International Convention in Washington, D.C. begins next week.  If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the convention.  Today, in this final installment, we review just a few of the many opportunities for those interested in learning more about how the promise of personalized medicine is affecting the BIO industry.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#4723 – Hall C).

    It would be difficult to find a topic that has had more of an impact on the field of biotechnology in recent years than that of personalized medicine.  In fact, there are two tracts at this year's BIO International Convention devoted to the topics of biomarkers and diagnostics:  the Biomarker track, and the Diagnostics and Personalized Medicine track.  The issues surrounding personalized medicine are not only being played out in the laboratory or the hospitals, but the U.S. court system is also weighing in.  Patent Docs readers should be quite familiar with the ACLU's case against Myriad Genetics (see "AMP v. USPTO: Oral Argument at the Federal Circuit"), amongst others, in which the ACLU is alleging that genes are "products of nature," and therefore are not patent eligible.  However, this case is centered on issues involving the genetic screening for breast and ovarian cancer risk.  Moreover, on Monday this past week, the Supreme Court granted certiorari in the Mayo Collaborative Services v. Prometheus Laboratories Inc. case.  The patents at issue in the Prometheus case claim tests for optimizing drug dosage in the treatment of autoimmune diseases such as Crohn's disease by determining the level of a metabolite in the patient.  Mayo alleges that Prometheus' patents hinder a doctor's ability to consider a biological phenomenon in treating a patient.  Prometheus counters by pointing out that its patents claim concrete and improved methods for treating patients.  The Federal Circuit sided with Prometheus, finding that all of the claims were patent eligible.  Because the Prometheus case is considered by many to be about the patent eligibility of diagnostic claims, any decision by the Supreme Court will have serious implications on the field of personalized medicine.

    Last Friday, we highlighted various sessions that would address how the U.S. court system is impacting the BIO community.  Two of those panels could easily be highlighted in today's review, because they involve issues that will impact diagnostics and biomarkers:  "IP issues Affecting Biomarker-Based Diagnostics" on Monday, June 27 from 3:45 to 5:00 pm, and "The Myriad Case and the Patentability of Isolated DNA Molecules" on Tuesday, June 28 from 8:30 to 9:45 AM.  Nevertheless, because these sessions were already described in detail, the present review will highlight four different sessions.

    "IP Challenges for Personalized Medicine: Navigating Bilski, Myriad, and Prometheus," on Wednesday, June 29 from 2:00 to 3:30 PM, is sure to be of interest to Patent Docs readers.  The session will address personalized medicines' reliance on "so-called" gene patents, and the public's perception of such patents.  The panel promises to highlight the instrumental role that gene patents have played in the biotech industry, and to explore how companies can deliver on the promise of personalized medicine.  The recent and upcoming cases of Bilski v. Kappos, Myriad, and Prometheus, among others, and their impact on biotechnology will be explored.  The panel includes the Associate General Counsel of BIO, Hans Sauer, as well as Kristin Neuman of Proskauer Rose LLP and Mark Seka, Global Head of IP for Novartis Molecular Diagnostics.  The session will be moderated by Jennifer Gordon of Baker Botts L.L.P.

    Another session in the Diagnostics and Personalized Medicine track that should be of interest to Patent Docs readers is "Personalized Medicine and Already Approved Drugs: The Plavix Case Study and What You Don't Know Can Hurt You" on Tuesday, June 28 from 3:45 to 5:00 PM.  The session will focus on the recent FDA decision to add genetic polymorphism information to the label for Plavix (clopidogrel), one of the biggest blockbuster drugs in the world.  This decision could dramatically affect sales of the drug.  The panel will consider this case study of how parties other than original drug developers can affect sales of leading drugs.  The session will also describe strategies to help prevent drug developers from being blindsided with new information.  The panel consists of Gabriela Lavezzari, Senior Manager Extramural R&D of Medco Research Institute; Joe Meyer, COO of Biomedicine Diagnostics for Eli Lilly & Co.; and Cecilia Schott, Business Development, Personalized Healthcare for AstraZeneca, Research & Development, Inc.  The session will be moderated by Amit Agarwal of Scientia Advisors.

    Another session of interest is unfortunately at the same time as the above panel (3:45 to 5:00 on Tuesday, June 28):  "The Evolving Business Model for Biomarkers: Status and Future Perspectives."  This session will highlight some of the newest developments in the area of biomarkers and personalized medicine, recognizing that a number of drugs on the market depend on companion diagnostics.  The panel promises to outline the business models and economics of the future of personalized medicine.  In addition, the new relationships between biotechnology, pharma, and diagnostic companies will be explored.  The panel includes Bryan Dechairo, Senior Director, Development Head of Personalized Medicine at Medco Health Solutions, Inc.; Mark Erwin, Sr. Director, Reimbursement & Government Affairs of Prometheus Laboratories, Inc.; Jogaoro Gobburu, Director, Division of Pharmacometrics at the FDA; Stephen Little, VP for Personalized Healthcare for QIAGEN; and Bernhard Sixt, CEO of Agendia.  The session will be moderatored by Christoph Huels of Merck Serono.

    The final session that we will preview, but certainly not the final session dedicated to the topic of personalized medicine, is "Rediscovering the Promise of Biomarkers" on June 28 from 8:30 to 9:45 AM.  The session will explore the regulatory challenges of bringing new biomarker products to market, despite the scientific and clinical rationale supporting their development.  The panel will look at models, such as the Biomarkers Consortium, which can include federal regulatory participation, along with scientists and industry.  International issues will also be explored.  The panel includes Phil L'Huillier, Director of Business Management, Cancer Research Technology Ltd.; Shawnmarie Mayrand-Chung, Program Director for The Biomarkers Consortium, NIH; Janet Wilson-McManus, COO of PROOF Centre; and Issam Zineh, Associate Director for Genomics with the U.S. Food and Drug Administration.

  • By Donald Zuhn —

    Temazepam Today, in Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., the Federal Circuit affirmed a decision on summary judgment by the District Court for the District of New Jersey that the claims of U.S. Patent No. 5,211,954 were invalid for obviousness.  Tyco Healthcare Group LP and Mallinckrodt, Inc. ("Tyco") own the '954 patent, which has two independent claims directed to temazepan formulations.  Claim 1 reads:

    A hard gelatin capsule containing a temazepam formulation consisting essentially of 6 to 8 milligrams of crystalline temazepam having a surface area of from 0.65 to 1.1 m2/g and 95% of the temazepam having a particle size of less than 65 microns in admixture with a pharmaceutically acceptable carrier therefor.

    Claim 2 differs from claim 1 only in that it recites a composition containing 7.5 mg of temazepam.  Temazepam is a hypnotic (or sleep-inducing) drug that has been marketed internationally for the treatment of insomnia since the 1970's, and has been marketed in the U.S. since 1981 (under the name Restoril®).  In 1991, Tyco's predecessor-in-interest began marketing Restoril® in 7.5 mg dosages.

    RESTORIL Seeking approval to market a generic version of 7.5 mg temazepam, Mutual Pharmaceutical Co., Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response to Mutual's ANDA filing, Tyco brought suit against Mutual Pharmaceutical Co., Inc. and United Research Laboratories, Inc. ("Mutual") for infringement of claims 1 and 2 of the '954 patent.  After Mutual received tentative approval for its ANDA, Tyco moved for a preliminary injunction.  The District Court denied Tyco's motion on the basis that Mutual's ANDA disclosed a temazepam formulation in which the crystalline temazepam had a surface area of at least 2.2 m2/g, and therefore, the disclosed formulation could not literally infringe the '954 patent.  Mutual then moved for summary judgment of noninfringement and invalidity, and the District Court granted Mutual's invalidity motion, determining that the '954 claims were obvious.  In support of this determination, the District Court noted that Restoril® capsules had been sold in the U.S. in 15 mg and 30 mg dosages more than a year before the priority date of the '954 patent, the 1983 edition of the British National Formulary ("BNF reference") directed physicians to use temazepam at a dosage of between 5 and 15 mg for the treatment of insomnia in the elderly, and the parties agreed that physicians always seek to prescribe the lowest effective dose of any medication, particularly hypnotics such as temazepam.

    Federal Circuit Seal In affirming the District Court's determination of obviousness, the Federal Circuit noted that "[t]he only physical feature distinguishing the ’954 claims from the Restoril® 15 mg capsules is the amount of temazepam contained in the capsule."  The Court also noted that in a Supplemental New Drug Application filed for the 7.5 mg dosage, Tyco's predecessor-in-interest stated that for "[t]he formulation and manufacture of Restoril® Capsules, 7.5 mg are similar to that used for the 15 and 30 milligram capsules [and t]he formulation differs only in the reduction of the dose."  "Given that uncontested description," the Court concluded that "the only limitation of the two '954 claims that was not fully disclosed by the prior art Restoril® capsules is the lower dosage of temazepam."  As the Federal Circuit observed, that lower dosage can be found in the BNF reference, which discloses that temazepam can be used to treat insomnia and suggests the use of a dose of "10-30 mg (elderly patients 5-15 mg), increasing in severe insomnia to 60 mg."  Citing Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004), the Court noted that "[o]rdinarily, 'where there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.'"

    On appeal, Tyco attempted to overcome this presumption of obviousness by showing unexpected results, that the 7.5 mg dosage enjoyed commercial success, and that the prior art teaches away from the claimed dosage range of 6 to 8 mg.  Tyco also contested the District Court's interpretation of the BNF reference, relying on its expert's statement that the reference "nowhere states that a temazepam dose of 5 mg, 6 to 8 mg, or 7.5 mg, is effective in treating insomnia," nor "state[s] that 7.5 mg was effective" (emphasis added).  Citing In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990), for the proposition that "[t]he discovery of a new property or use of a previously known composition, even when that property and use are unobvious from the prior art, can not impart patentability to the known composition," the Court countered that "[t]he recommendation in the BNF of a range of temazepam dosages that include the dosages claimed in the '954 patent renders obvious the claims to those dosages even in the absence of documentation in the BNF of the effectiveness of such dosages" (emphasis added).

    In support of its teaching away argument, Tyco cited three references:  (1) Nicholson 1976, which discloses that subjects given a 10 mg dose of temazepam produced a "marked reduction" in the time it took to fall asleep (i.e., sleep onset latency), but "little or no increase in total sleep time" (the '954 patent, in contrast, shows both reduced sleep onset latency and increased total sleep time); (2) Nicholson 1979, which discloses that subjects given 10, 20, or 30 mg doses of temazepam showed no statistically significant change in total sleep time or sleep onset latency; and (3) Matejcek, which states that "temazepam 5-mg values were excluded from the test procedure, since this dose is known to be of no clinical importance as a hypnotic."  In response, the Federal Circuit observed that "none [of the references] states that a sleeping pill must achieve improvement on both parameters [i.e., total sleep time and sleep onset latency] in order to be considered effective."  In addition, the Court noted that contrary to the cited statement in Matejcek, that reference "did include 5 mg temazepam capsules in its test procedure and displayed results for those capsules in two tables in the article."

    With regard to Tyco's argument that secondary considerations support a finding of nonobviousness, the Federal Circuit discounted Tyco's citation of the '954 specification, which describes the experimental results as being "unexpected," stating that "[u]nsupported statements in the specification . . . cannot support a finding of unexpected results."  As for Tyco's argument of commercial success (annual sales of the 7.5 mg capsules averaged more than $30 million over a decade), the Court stated that "[t]he district court acknowledged the product’s commercial success but properly found that the evidence as a whole did not overcome Mutual's strong prima facie case of obviousness."  The Federal Circuit therefore upheld the District Court's determination on summary judgment that the two claims of the ’954 patent were invalid for obviousness.

    Tyco Healthcare Group LP v. Mutual Pharmaceutical Co. (Fed. Cir. 2011)
    Panel: Circuit Judges Newman, Bryson, and Gajarsa
    Opinion by Circuit Judge Bryson

  • By Donald Zuhn —

    BIO Reaffirms Support for H.R. 1249

    Biotechnology Industry Organization (BIO) In a statement released earlier today, the Biotechnology Industry Organization (BIO) reaffirmed its support for H.R. 1249 and urged the House to pass the bill this week.  BIO President and CEO Jim Greenwood noted that the organization was "pleased that Judiciary Committee Chairman Lamar Smith (R-TX) and Appropriations Committee Chairman Harold Rogers (R-KY) have reached agreement on U.S. Patent and Trademark Office (PTO) funding and that the appropriators are committed to ensuring that the PTO will retain the entirety of the fees it collects from inventors."


    Patent Reform Coalition Also Reaffirms Support for H.R. 1249

    Coalition for 21st Century Patent Reform Like BIO, the Coalition for 21st Century Patent Reform issued a statement today reaffirming its support for moving H.R. 1249 to the House floor this week for a vote.  Although the group noted that it "preferred Section 22 of H. R. 1249, as reported by the Judiciary Committee, addressing the diversion of fees paid by users of USPTO services," the Coalition "decided to support the USPTO funding agreement that, if fully implemented, is intended to provide the Office with full access to the fees paid by inventors."  The group indicated that it "will be vigilant as the full implementation of the commitments made under the agreement is completed."


    Innovation Alliance Reiterates Opposition to House Bill

    Innovation Alliance In a follow-up to a statement the group released on Monday, the Innovation Alliance reiterated that in view of changes to the bill's USPTO funding provisions, the group "has no choice but to vigorously oppose the version of the America Invents Act scheduled to be considered by the full House of Representatives [on Wednesday]."  In today's statement, the Innovation Alliance noted that it had "consistently said that it would oppose any patent bill that does not end permanently the diversion of user fees from the U.S. Patent and Trademark Office," and that "[u]nfortunately, we have come to that point" with the current version of the bill.

    In defending its position, the group explained that:

    The compromise language released yesterday does not end fee diversion permanently and enable USPTO to plan predictably and on a sustainable basis.  In fact, it requires the USPTO to continue to rely upon the appropriators to have access to and use of all the application and other user fees it earns.  Any future appropriations bill could easily divert USPTO funds to other uses.  As a result, it will be difficult if not impossible for USPTO to make multi-year plans, to hire and retain personnel, and to improve operations and information technology, all of which are critical to decrease the substantial backlog of pending patent applications.

    "While appropriators have promised not to divert the fees USPTO collects," the group suggested that "current and future budget pressures will only increase, and future appropriators may not feel as constrained from diverting USPTO fees to other uses."  The Innovation Alliance contended that "[w]ithout a permanent end to fee diversion and USPTO's guaranteed access to collected fees — such as was contained in the Senate-passed bill and Section 22 of the bill as approved by the House Judiciary Committee — the America Invents Act is an unfunded mandate on an important agency that is already overburdened and under-resourced."


    AIPR Urges Adoption of Conyers/Sensenbrenner/Manzullo Amendment

    American Innovators for Patent Reform The American Innovators for Patent Reform (AIPR) announced its support earlier today for an amendment to H.R. 1249 that was introduced by Representatives John Conyers, Jr. (D-MI), James Sensenbrenner, Jr. (R-WI), and Don Manzullo (R-IL) on June 13, 2011, and which would strike the entire bill except for sections 2 (Definitions), 22 (Patent and Trademark Office funding), and 31 (Budgetary effects).  According to the group's statement, "[t]he amendment would end fee division and establish full funding for the U.S. Patent and Trademark Office (USPTO), enabling the agency to keep all fees it collects."  The statement "urges all members of the House to vote in favor of the amendment when H.R. 1249 comes to the floor for a vote, probably this week."  AIPR President Alexander Poltorak asserted that "[d]iverting fees that the Patent Office collects from inventors and patent applicants is nothing short of a tax on innovation," adding that "[p]ermanently ending fee diversion should be a core feature of any patent reform."  The AIPR concluded today's statement by urging supporters of the amendment to contact their Representatives immediately.


    Six Organizations Add Support to Conyers/Sensenbrenner/Manzullo Amendment

    In a joint letter sent to all House members, six organizations representing small businesses, start-up entrepreneurs, independent inventors, and technical professionals urged lawmakers to adopt the Conyers/Sensenbrenner/Manzullo amendment, that the coalition contended "will stop the diversion of patent user fee revenue to other governmental uses."  The six organizations signing onto the letter were IEEE-USA, National Congress of Inventor Organizations, IP Advocate, National Small Business Association, National Association of Patent Practitioners, and the Professional Inventors Alliance USA.  The letter states that by removing most sections of H.R. 1249, the amendment "would eliminate many harmful provisions in the bill that, if enacted, would cause innovation disruption and create legal uncertainty for many years to come."  One of the "harmful provisions" highlighted in the letter is Section 10, which the coalition contends "would otherwise grant the PTO broad authority to set fees based on no guidance or policy constraints except the PTO’s opaque and unknown interpretations of 'aggregate costs'."  The letter also asserts that H.R. 1249 contains "a major legal flaw which indicates lack of adequate forethought in drafting and amending this bill."  In particular, the letter explains that:

    Owing to substantial spread in examination timing across examiner workgroups at PTO, a later-filed application can be issued well before an earlier-filed prior-art application reaches an examiner’s desk for examination.  With no effective legal recourse available to the first-filer of the pending application for removing the later-filed issued patent, the second-filer would end up with a valid patent, solely due to PTO administrative delay variations.  This result is in direct contradiction to H.R. 1249’s stated purpose of awarding patents to the first-inventor-to-file.


    Four Representatives Seek "No" Vote on H.R. 1249

    Conyers, John Last week, Representatives John Conyers, Jr. (D-MI), Donald Manzullo (R-IL), F. James Sensenbrenner, Jr. (R-WI), and Marcy Kaptur (D-OH) circulated a letter to their colleagues, asking other House members to join them "in opposing H.R. 1249, patent legislation that would favor large multinational corporations over U.S. inventors" (see "Patent Reform News Briefs," June 13, 2011).  Today, Representatives Conyers (at right), Sensenbrenner, and Manzullo, joined this time by Rep. Dana Rohrabacher (R-CA), distributed a similar letter once again asking their colleagues to vote "no" on H.R. 1249.  While noting that the three legislators "may have different concerns with the legislation," the letter's authors state that "as Members of Congress including two former Chairs of the House Judiciary Committee, a former Chair of the Small Business Committee, and a former Chair of two Science, Space and Technology Subcommittees, we agree that this special interest bill will cost jobs, harm small start-up inventors, and stifle innovation and investment here in the United States."  In addition, the letter indicates that:

    [A]ccording to the Congressional Budget Office, the Manager's Amendment would violate the new cut-go rules [recently adopted by the Republican Majority].  This is because the base bill is estimated to have a discretionary cost of $446 million over the next five years ($1.1 billion over the next ten years) and, the Manager's Amendment, by undoing the anti-fee diversion language, eliminates a procedure that would have decreased the budget deficit by $ 717 million over five years.  The net result is that the Manager's Amendment will leave us with a bill that increases discretionary costs by almost one-half billion dollars over five years.

    As in last week's letter, the group itemizes "additional concerns" with the bill, including: (1) Section 22 of the latest Manager's Amendment, which "codifies the status quo: funding for the USPTO will be at the discretion of the appropriators"; (2) Section 18, which "provides large banks a special, new bailout at the expense of inventors and the American taxpayer, and even worse, would do so on a retroactive basis"; (3) the change from a first-to-invent to first-to-file system, which some groups believe is "a dangerous and unconstitutional effort to overturn over 220 years of patent practice"; (4) Section 27 of the latest Manager's Amendment, which "requires a study on methods to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist," and therefore, "has the potential to complicate pending litigation on the legality of patents on human genes"; and (5) Section 16, which "undermines the false marking statute by retroactively changing the law applicable to pending enforcement actions."

    The letter concludes by providing a link to a list of letters and statements from groups opposing H.R. 1249 that have been posted on a webpage on the Democrats' House Committee on the Judiciary website.

  • BIO and Biosimilars

    By Andrew Williams —

    BIO International Convention The 2011 BIO International Convention in Washington, D.C. begins next week.  If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the convention.  Last week, we highlighted four sessions on how the Supreme Court is impacting the BIO community.  Today, we present opportunities for those interested in learning more about how the biotech industry is adjusting to the new biosimilar framework.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#4723 – Hall C).

    For BIO attendees interested in learning more about the relatively new pathway for FDA approval of biosimilars, also known as follow-on biologics, there are several sessions devoted to the intricacies of the new law, or how the new legislation is impacting the BIO community.  The biosimilar framework was introduced last year in the Omnibus Health Care bill.  It is no surprise that biosimilars were a hot topic at the 2010 BIO International Convention, and it continues to garner much interest one year later at this year's convention.

    From the perspective of navigating the new biosimilar litigation pathway, the session " A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars," will take place from 3:45 to 5:00 PM on Monday, June 27.  This panel will look at the new patent litigation procedure established for FDA approval of follow-on biologics.  There are significant differences between the biosimilar pathway and the traditional small molecule Hatch-Waxman model.  For example, biologics receive 12 years of data exclusivity instead of five, but the new law discards the Orange Book concept, and instead requires a cumbersome mutual disclosure procedure to foster cooperation and early resolution.  The panel will explore different tactical and strategic choices along this new patent litigation timeline.  In addition, the session promises to consider questions and concerns that companies face in planning to navigate this new pathway.  The panel is well qualified to speak on this subject, because it includes representatives from companies expected to be at the forefront of this new paradigm:  Mark Bowditch, Esq., Senior Patent Attorney at Sandoz, Inc., Edward Murray, Managing Counsel, IP Litigation, Merck & Co., Inc., and Bart Newland, Vice President Chief Intellectual Property Counsel, Biogen Idec Inc.  This session will be moderated by Eric Marandett of Choate Hall & Stewart, LLP.

    In another session, the new framework for FDA licensing of biosimilars will be explored from the perspective of the FDA approach to biosimilar review.  " Navigating the New Law on Licensing Biosimilars," will be presented by the Achieving Regulatory Approval and Compliance Track from 3:45 to 5:00 PM on Tuesday, June 28.  This panel will look at the meaning of terms such as " highly similar," "interchangeability," and " biobetters," the latter of which are products that present advances over existing products.  The scientific challenges that affect regulators and the companies seeking biosimilar approval will be reviewed.  And, because biosimilars have been approved in the European Union for more than a decade, the panel will discuss the EU experience, and predict what it may mean for companies seeking approval in the U.S.  The panel comprises Rachel Behrman, Director, Office of Medical Policy, FDA; Alison Dennis of Field Fisher Waterhouse, London; Eric Floyd, VP for Global Regulatory Affairs, Hospira; and Kimberly Greco, Director, Regulatory Affairs, Amgen.  The session will be moderated by David Adams of Venable, LLP.

    To address how follow-on biologics are influencing collaborations between global pharma and biotechs, the session "Lessons From In-Licensing Partnership: Biotech Company Partners with Global Pharma to Deliver Cutting-Edge Follow-On Biologics" will take place from 10:00 to 11:30 PM on Wednesday, June 29.  The panel will provide exclusive insight on how global pharma and biotech companies can collaborate to develop, gain authorization, and globally commercialize cutting-edge follow-on biologics.  The critical success factors needed to navigate new technology platforms, tech transfers, and global positioning will be discussed.  The panel will also describe how to build strong alliances to advance the development of novel therapies.  The panel comprises Arun Chandavarkar, Chief Operating Officer of Biocon Ltd.; Stephen Hoge, Principal at McKinsey & Co.; and Diem Nguyen, General Manager, Biosimilars, Pfizer – EM/EPBU Unit.  The session will be moderated by Peter Pitts, President of the Center for Medicine in the Public Interest.

    Finally, we highlight "Biologics & Biosimilars: What is the Science Telling Us," which will take place from 8:30 to 9:45 on Thursday, June 30, and will explore how science can and should inform the policymaking in the field of biosimilars.  The panel notes that policy issues continue to evolve along with the science surrounding biosimilars.  As examples, the panel will highlight the U.S. pathway for approval of biosimilars and the issues Europe has faced with the intricacies of Monoclonal Antibodies.  The panel promises to discuss emerging scientific issues that are informing policy matters on biosimilars.  In addition, the session will provide an update on the key policy and regulatory developments since 2010.  The panel comprises Michael Kamarck, President, MerckBioventures, Merck & Co Inc.; Bryan Lian, Executive Director of the Institute of Health Law Studies; and Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations.  This session will be moderated by Chris Morrison, Editor-in-Chief, Elsevier Business Intelligence.

  • By Donald Zuhn —

    H.R. 1249 Floor Debate to Take Place Later This Week?

    Washington - Capitol #5 In today's IPO Daily News, the Intellectual Property Owners Association (IPO) reported that floor debate of the House version of the "America Invents Act" (H.R. 1249) is now scheduled to take place "on Wednesday or later in the week."  The House Rules Committee, which was scheduled to meet last week to discuss the parameters for floor debate of the bill, has announced that it will meet tomorrow at 5:00 pm to determine how the floor debate will proceed.  The delay was due to a disagreement between some House members over the USPTO funding provisions of H.R. 1249.  This disagreement appears to have been resolved late last week (see "Is the End of Fee Diversion Dead in the Leahy-Smith America Invents Act?").


    Midwest Representatives Write in Support of H.R. 1249

    Donnelly, Joe Last week, Representatives Joe Donnelly (D-IN) (at right) and Dan Boren (D-OK) (below) distributed a letter in which they urge their colleagues in the House to support passage of H.R. 1249.  The pair note that "[f]or decades, America's economic prowess has been secured through a reliable and efficient patent system," but argue that "[i]ncreasingly,  . . . existing patent laws have not [been] able to keep up with the pace of 21st Century technological developments or our foreign competitors."

    Boren, Dan Citing the USPTO's 700,000 application backlog, the letter explains that the Office "lack[s] the resources and funding to process patent applications in a timely and efficient manner," and declares that after six years of effort, Congress has finally reached a "bipartisan agreement on a patent reform bill that updates our patent laws in a balanced and fair manner and gives the USPTO the tools and funding it needs to support all inventors."  The letter also characterizes the U.S. "first to invent" patent system as being "cumbersome and inefficient, making it more difficult for innovators to gain patents while at the same time providing little benefit to those challenging a patent."  According to the pair, the backlog and first to invent system "hinder[] our ability to remain competitive with the rest of the world and create jobs here at home."


    Innovation Alliance Vigorously Opposes H.R. 1249 in View of Altered USPTO Funding Provisions

    Innovation Alliance Today, the Innovation Alliance released a short statement in which the group (which represents innovators, patent owners, and stakeholders from a diverse range of industries) noted that it was "greatly disappointed by reports that some in the House of Representatives have chosen to remove language from Section 22 that would have permanently ended fee diversion."  According to the group, the new language in the bill "amounts to a promise to end fee diversion in the future, a promise that has repeatedly been broken in the past."  The Innovation Alliance added that it was "very concerned that USPTO will continue to earn significantly more fees than the funds it is allocated, and Congress will continue to impose the tax on innovation that fee diversion represents."  As a result, the group said it "ha[d] no choice but to vigorously oppose the America Invents Act," and it promised to "work with our allies both on and off the Hill to ensure that any patent bill that becomes law ends fee diversion permanently."


    ABA Urges Chairman Smith to Reject Changes to USPTO Funding Provisions

    ABA In a letter sent to House Judiciary Chairman Lamar Smith (R-TX) today, the American Bar Association (ABA) stated that the group "considers the funding mechanism provided by section 22 with its revolving fund to be an indispensible component of any patent reform measure, one that is essential for the Office to conduct effective and efficient financial planning and business operations."  With respect to the compromise worked out between proponents of H.R. 1249 and the House Appropriations Committee, the ABA declared that "the language proposed to replace section 22 would destroy this essential component of H.R. 1249."  The ABA urged Chairman Smith "to reject this proposed substitute for section 22," and recommended that "these differences be resolved through the regular order, under the process for amendment that the Rules Committee has announced," which the ABA argued was "the appropriate and fair way to resolve these differences.'


    NAR Predicates Support for H.R. 1249 on Retention of USPTO Funding Provisions

    NAR In a letter distributed to House members today, the National Association of REALTORS (NAR) noted that while it supported H.R. 1249, this support was "predicated upon the retention of important anti-fee diversion provisions contained in section 22 of the bill."  The industry group, which represents a variety of real estate industry professionals, "believes it is critically important that the U.S. Patent Trademark Office have access to all user fees paid to the agency by patent and trademark applicants."  Without the funding provisions of section 22, the NAR expects that "delays in processing patent applications will continue to undermine American innovation and stymie the nation’s economy."

  •     By James DeGiulio —

    Allergan and Hi-Tech Settle Combigan Patent Dispute

    Allergan Allergan has resolved its dispute with Hi-Tech Pharmacal over the latter's bid to market a generic version of Allergan's glaucoma treatment Combigan.  In June 2009, Allergan sued Hi-Tech in the U.S. District Court for the Eastern District of Texas, claiming that Hi-Tech's ANDA filing infringed U.S. Patent Nos. 7,030,149; 7,320,976; 7,323,463; and 7,642,258 (see "Court Report," June 14, 2009).  Allergan sought injunctive relief as well as an order prohibiting approval of Hi-Tech's ANDA until the allegedly infringed patents expire.  Allergan has also brought similar infringement suits against generic-drug makers Sandoz, Apotex, and Watson, which are still pending.

    Hi-techlogo On May 31, in accordance with a May 20 settlement, Judge T. John Ward signed off on an Order dismissing all claims in Allergan's suit against Hi-Tech.  The dismissal stipulated that all four Allergan patents related to Combigan were valid and infringed by the generic product described in Hi-Tech's ANDA.  According to the stipulation, Allergan's claims are dismissed with prejudice, and each party shall bear its own costs, expenses, and attorneys' fees.


    Novartis and Sun Settle Focalin Patent Suit

    Novartis Novartis Pharma has resolved a patent infringement suit with Sun Pharmaceutical Industries over Sun's proposed generic version of Novartis' attention deficit disorder drug Focalin.  In July 2010, licensee Novartis and patent owner Celgene brought suit in the U.S. District Court of New Jersey, claiming that Sun's ANDA for its proposed generic Focalin would infringe U.S. Patent Nos. 5,908,850; 6,355,656; and 6,528,530 (see "Court Report," July 11, 2010).  The plaintiffs asked to be given access to the ANDA, but Sun would not agree to provide it on reasonable terms, instead sending Novartis and Celgene a statement that acknowledged that the proposed generic version would infringe two of the three patents for Focalin.  With respect to the third patent, Sun stated that the generic would not infringe.  In March 2011, the parties notified the District Court that they had reached a settlement and requested a stay pending regulatory approval.

    Sun Pharma On June 10, after counsel for the parties notified the District Court that regulatory review of the settlement had been completed, Judge Susan D. Wigenton signed off on the agreement dismissing the case without prejudice.  The litigation over Focalin continues, however, as manufacturer Elan has brought suit against Intellipharmaceutics, Par Pharmaceuticals, and Teva over a planned generic Focalin.  All three of these cases remain pending.


    Antitrust Sanctions Upheld Against Pfizer in Neurontin Case

    Pfizer Sanctions for a witness testimony violation were upheld on appeal in a case involving accusations that Pfizer used patent litigation to delay generic competition for the epilepsy drug Neurontin.  The plaintiffs, which include CVS Pharmacy, Rite Aid Corp., Louisiana Wholesale Drug Co., and Meijer, first brought suit in March 2002 alleging that Pfizer and Warner-Lambert engaged in an overarching anti-competitive scheme to acquire and maintain monopoly power in the market for gabapentin products in violation the Sherman Act.  The plaintiffs allege that Pfizer improperly listed two patents in the Orange Book, manipulated the patent approval process so a third patent could delay generic entry, initiated multiple sham suits over the patents, and engaged in fraudulent off-label promotion.  In October 2002, the case was stayed pending resolution of the infringement action.  In February 2008, following the remand by the Federal Circuit (see "In re Gabapentin Patent Litigation (Fed. Cir. 2007)"), the stay was lifted and the antitrust case continued.  Sanctions were imposed after Pfizer produced two witnesses who were not prepared to discuss why Pfizer had denied promoting Neurontin for off-label uses in the antitrust suit, despite having pled guilty to doing so in a separate criminal case in 2004.

    On June 9, Judge Faith S. Hochberg issued an Opinion and Order rejecting Pfizer's appeal of the sanctions and affirmed the Order handed down by Magistrate Judge Shwartz.  The Order gave the plaintiffs an opportunity to redepose the witnesses, banned Skadden Arps Slate Meagher & Flom LLP from appearing at the new deposition, and struck all objections at the original deposition.  During the deposition that led to the sanctions, the witness who was brought in to testify after the District Court deemed Pfizer's first witness inadequate simply recited an outline of responses Skadden had prepared.  The judge ruled that this was equivalent to failure to appear.  The judge's Order also required Pfizer to pay all attorneys' fees and costs associated with the matter.

  • David Boundy Thinks So

    David Boundy (below) of Cantor Fitzgerald and co-author (with Phillip Furlang) of the forthcoming Patent Prosection (Oxford University Press) has been at the forefront of several important patent issues in the past decade, including notably the USPTO's ill-advised "claims and continuation" rules instituted by the Dudas Administration and blocked by Judge Cacheris' decision that the Office had exceeded its authority under 35 U.S.C. § 2(b).  He has also commented on the proposed Leahy-Smith America Invents Act, and today has the following message to the patent community.

    House Insists on Its Prerogative of Fee Diversion

    By David Boundy

    Boundy, David The one good feature of the "America Invents Act," an end to fee diversion, is now removed.  Nothing remaining in the bill justifies the disruption and transition costs.  Please ask your representative to vote no, and ask your clients to do the same.  The bill is up for final vote on Wednesday (it has already passed the Senate, this is the final major vote), so urgent action is required.

    In order to pass the bill through the Senate, Sen. Coburn added language that would permanently end fee diversion.  Sen. Coburn's amendment provided that all fees collected by the Patent Office would be available to the Office, with no possibility of tampering or mischief by Congress.

    However, on Friday, House leadership leaked an agreement among Speaker Boehner and several committee chairmen regarding fee diversion, set out below.  Note that the agreed language essentially tracks today's 35 U.S.C. § 42(b) and (c), except it gives a fancy name to the earmarked account that's been in existence for 19 years.  It does not give the Office the right to spend the money it collects.  Former staffers for the Congressional appropriations process have confirmed that there is no practical difference — Congress will still be able to take funds raised by the Patent Office, and give the PTO worthless IOU's in return.  IOU's that the PTO cannot spend.  IOU's that the PTO cannot count on for multi-year planning.  IOU's that are useless for updating the PTO's IT infrastructure.  IOU's that cannot hire new examiners or raise pay for existing examiners.

    Sec. ___.  There is established in the Treasury a Patent and Trademark Fee Reserve Fund.  If fee collections by the Patent and Trademark Office for a fiscal year exceed the amount appropriated to the Office for that fiscal year, fees collected in excess of the appropriated amount shall be deposited in the Patent and Trademark Fee Reserve Fund.  To the extent and in the amounts provided in appropriations Acts, amounts in the Fund shall be made available until expended for obligation and expenditure by the Office for the purposes described in Section 42(c) of title 35, United States Code.

    Because of the way House procedural rules operate, there is no longer an opportunity to change this or amend it.  If the bill passes, fee diversion will continue.

    If you haven't already made up your mind on this bill, this should make it up for you.  The proponents have not been able to counter the showings by the folks who create startups that this bill takes away the legal machinery that venture capital and other investors need — startup formation will fall precipitously, along with the innovation and jobs that they create.  Proponents have been unable to give any numbers for cost savings of the bill that even approach the transition costs, let alone create savings after those transition costs are borne.  The one thing that united the proponents of the bill was an end to fee diversion, and that's now gone.

    Now it's up to you.  All that's required for the triumph of evil is for good people to do nothing.  But all that's required to stop this bill is about 3000 phone calls from constituents.  Please go to www.house.gov and find your representative's phone number, and phone today.  (The bill is up for a final vote Wednesday.)  Say these words: "Please vote no on the rule for the patent bill, H.R. 1249, and vote no on final passage."  ("Vote no on the rule" means "don't allow the bill to come to the floor for a vote.")  The person that answers the phone will not know enough to ask you detailed questions, those 19 words will do the trick.  Then call five of your clients and ask them to do the same.

    Second, and far less importantly, please email me PatentProcedure [at] gmail.com, the names of companies (name of company, city and state, name of contact person, and an email address) that would be willing to sign on to a letter stating opposition to the bill of fee diversion is not ended.

    One aspect of the current PTO situation (the backlog, concerns about "quality" and others) where there has been the greatest agreement among the several categories of stakeholders across all technology areas (who don't agree on much else) is that the practice of Congressional appropriators to raid PTO coffers to fund other government programs has been responsible for the Office's performance deficiencies.  If the patent "reform" enacted by Congress fails to address this issue (by putting limits on the practice if not including an outright ban), then patent reform will have little of the changes that formed the basis for the reform movement over the past decade.  More importantly, such a bill will not do the one thing its promoters have promised:  promote innovation to stimulate the economy.  This solution is no solution at all.

  • By Sherri Oslick —

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

    Somaxon Pharmaceuticals Inc. et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
    1:11-cv-00537; filed June 16, 2011 in the District Court of Delaware

    • Plaintiffs:  Somaxon Pharmaceuticals Inc.; Procom One Inc.
    • Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

    Infringement of U.S. Patent Nos. 6,211,229 ("Treatment of Transient and Short Term Insomnia," issued April 3, 2001) and 7,915,307 ("Methods of Improving the Pharmacokinetics of Doxepin," issued March 29, 2011) following Zydus' filing of an ANDA to manufacture a generic version of Somaxon's Silenor® (doxepin, used to treat insomnia).  View the complaint here.


    Alcon Research, Ltd. et al. v. Watson Laboratories, Inc. et al.

    1:11-cv-00786; filed June 9, 2011 in the Southern District of Indiana

    • Plaintiffs: vAlcon Research, Ltd.; Alcon Pharmaceuticals, Ltd.; Kyowa Hakko Kirin Co., Ltd.
    • Defendants:  Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.

    Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997), 6,995,186 ("Olopatadine Formulations for Topical Administration," issued on February 7, 2006), and 7,402,609 (same title, issued July 22, 2008) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Alcon's Pataday® (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis).  View the complaint here.

  • South Africa Flag Conference organizers have confirmed that the Honorable Ms. Naledi Pandor, Minister of the Department of Science and Technology of South Africa, will be the keynote speaker at the "Accelerating IP and Innovation in South Africa," to be held September 18-20, 2011 at the Cape Sun Hotel in Cape Town, South Africa.  Ms. Pandor, who reports directly to South African President Jacob Zuma, is also a Member of Parliament and the National Executive Committee of the African National Congress (ANC), as well as the Deputy Chairperson of the Joint Education Trust Board and the National Director of the Black Management Forum.

    Conference Logo The conference is an opportunity for international patent and innovation specialists to share best practices with their peers in South Africa and other African countries, in a forum designed to create networking and future business opportunities with the goal of expanding South Africa's growing domestic capability.  The conference also provides an opportunity to celebrate the substantial accomplishment by South Africa, which recently became the first developing country in the world to pass transformational legislation allowing publicly funded universities and scientific research councils to own the IP they generate and to commercialize it for the benefit of the country and the world.  The newly promulgated "Intellectual Property Rights from Publicly Financed Research and Development Act" (51 of 2008) also establishes a new office to administer the legislation, the National IP Management Office (NIPMO).  The U.S. Bayh Dole Act fundamentally changed the landscape of the biotechnology industry in this country, and now South Africa has designed its own unique path to create and grow innovator companies, becoming an inspiring model for other developing countries.

    The lead sponsor of the event is the South African Department of Science and Technology.  The Co-Organizing Chairs of the event are Sherry Knowles of Knowles Intellectual Property Strategies (and former Chief Patent Counsel for GlaxoSmithKline) and McLean Sibanda, the Chief Executive Officer of The Innovation Hub, a Pretoria-based company that was instrumental in drafting and facilitating the new IPR legislation.

    Scheduled conference speakers currently include:

    • Ms. Naledi Pandor, Minister of the Department of Science and Technology of South Africa
    • Chief Judge Randall Rader of the U.S. Court of Appeals for the Federal Circuit
    • Judge Louis Harms, Deputy President, Supreme Court of Appeal of South Africa; Chair, Advisory Committee on Intellectual Property
    • Mahama Ouedraogo, Executive Secretary, African Union Science, Technology and Research Commission, Lagos, Nigeria
    • Judge Brian Southwood, Gauteng High Court, Pretoria South Africa
    • Teresa Rea, Deputy Director of the U.S. Patent and Trademark Office
    • Phil Mjwara, Director General of Department of Science and Technology of South Africa
    • Todd Dickinson, Executive Director of the AIPLA
    • The impending Chief Director, National IP Management Office of South Africa
    • James Pooley, Deputy Director General for Innovation and Technology, World Intellectual Property Organization
    • Ms. Konji Sebati, Global Challenges Division, World Intellectual Property Organization
    • Gordon I. Myers, Chief Counsel, International Finance Corporation, World Bank
    • John Whealan, Associate Dean for IP, George Washington Law School
    • Roy F. Waldron, Chief IP Counsel, Pfizer Corporation
    • Dr. Frank Grassler, VP, Intellectual Property
    • Clifford Samuel, VP of Gilead International Access Operations, Gilead Sciences, Inc.
    • Representative of the Director General, African Regional IP Office (ARIPO)
    • Homi R Khusrokhan, Senior Advisor, Private Equity, Tata Capital Ltd., India
    • Jeffrey Q. Ke, WinTwin Capital, Shanghai, China and Los Angeles, California
    • Professor Tana Pistorious, University of South Africa, Professor of Mercantile Law
    • Guobin Cui, Associate Professor, Tsinghua University, School of Law, Beijing, China
    • Professor Dr. Dres. h.c. Joseph Straus, Director Emeritus, Marshall B. Coyne Visiting Professor of International and Comparative Law, George Washington University Law School, Washington D.C., Visiting Fellow Hoover Institution, Stanford University, Max Planck Institute for Intellectual Property and Competition Law (Munich, Germany)
    • Dr. Anthony E. Lockett, Medical Director and Regulatory Consultant, Information Change Ltd.
    • McLean Sibanda, CEO of The Innovation Hub, Pretoria, ZA
    • Sherry Knowles, Knowles Intellectual Property Strategies, Atlanta, GA

    The panel on entrepreneurial approaches to IP creation will include Professor Dennis C. Liotta, the Samuel Chandler Dobbs Professor of Chemistry at Emory University, co-inventor of HIV drug Emtricitabine, which is a key component of Gilead's HIV drugs Truvada and Atripla, and co-founder of iThemba Pharmaceuticals, a drug discovery company in South Africa focused on developing drugs for neglected tropical diseases; and Dr. Frank Litvack, a prominent interventional cardiologist, former Co-Director of the Interventional Cardiology Center at Cedars Sinai Medical Center in Los Angeles, Professor of Cardiology at UCLA School of Medicine, and successful serial entrepreneur of medical device and pharmaceutical companies.

    A Welcome Reception will be held Sunday evening, September 18.  The conference dinner Tuesday, September 20 will serve as the formal introduction of South Africa's new legislation.  It will also give participants and attendees the opportunity to commend the country for this impressive step to expand a domestic innovator industry which is capable of contributing to African and global advancement.

    The Agenda currently includes the following panels over two days:

    Panel 1: The Role of the Judiciary and the Court System in shaping IP Policy

    Panel 2:  Private Ownership of Federally Funded Research: Strategy, Implementation, Goals and Challenges in Developing Countries

    Panel 3: IP Education and Capacity Development for Intellectual Property and Innovation in Developing Countries

    Panel 4: Creating a Model Patent Office for Developing Countries

    Panel 5: Entrepreneurial Approaches to Creating IP and Innovation; Adapting  approaches for Developing Countries

    Panel 6: Accelerating Commercialization and Attracting Foreign Direct Investment

    Panel 7: Regulatory Aspects of Product Development and Commercialization- Data Exclusivity and Acceleration of Drug and Device Approvals in Developing Countries

    Conference Registration Those wishing to register for the conference can do so here.  Early bird Registration ends June 30.

    Patent Docs is a media sponsor for the "Accelerating IP and Innovation in South Africa" conference.

  • Calendar

    June 19-20, 2011 – IP Business Congress (Intellectual Asset Management magazine) – San Francisco, CA

    June 21, 2011 – The Impact of Therasence v. Becton on the Doctrine of Inequitable Conduct (LexisNexis) – New York, NY

    June 21-22, 2011 – 10th Annual Forum on Pharma Patent Lifecycles (C5) – London, England

    June 22, 2011 – Patent Litigation after Microsoft v. i4i (Intellectual Property Owners Association) – 2:00 PM (ET)

    June 23, 2011 – Chemical Patent Practice Road Show: Prosecution and Litigation Strategies (American Intellectual Property Law Association) – Chicago, IL

    June 24, 2011 – Inequitable Conduct after Therasense: Practical And Strategic Implications of the Recent Federal Circuit Ruling (Law Seminars International) – 1:00-2:30 PM (ET)

    June 27-30, 2011 – BIO International Convention (Biotechnology Industry Organization) – Washington, DC

    June 29-30, 2011 – Pharmaceutical Portfolio & Product Life Cycle Management (SMi Group) – London, UK

    July 8, 2011 – Stanford v. Roche: The Impact on Management of University IP (Technology Transfer Tactics) – 1:00 – 2:00 PM (Eastern)

    July 16-19, 2011 – 2011 Annual Meeting; The Nuts & Bolts of Patent Prosecution Practice; and 2011 Patent Practice Update (National Association of Patent Practitioners) – Las Vegas, NV

    July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    July 20-21, 2011 – Advanced Forum on Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – San Francisco, CA

    July 25-27, 2011 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    July 26, 2011 – The New Inequitable Conduct Standard in Patent Litigation: Asserting and Defending Inequitable Conduct Challenges After the Landmark Therasense Decision (Strafford) – 1:00 – 2:30 PM (EDT)

    August 4-7, 2011 – 2011 Annual Meeting (American Bar Association) – Toronto, Ontario

    August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

    September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

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