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  • 2011 BIO International Convention Preview – Part II

    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.

  • Patent Reform Update

    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."

  • Biotech/Pharma Docket

        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.

  • Is the End of Fee Diversion Dead in the Leahy-Smith America Invents Act?

    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.

  • Court Report

    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 African Minister of Science and Technology and Other IP Leaders to Speak at Conference on “Accelerating IP and Innovation in South Africa”

    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.

  • Conference & CLE Calendar

    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

  • Webinar on Stanford v. Roche

    Technology Transfer Tactics
    Technology Transfer Tactics will be offering a webinar entitled "Stanford v. Roche: The Impact on Management of University IP" on July 8, 2011 from 1:00 – 2:00 PM (Eastern).  Patent Docs author Dr. Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP will discuss what the Stanford v. Roche decision means for the future of university IP management as well as provide:

    • A clear understanding of the Supreme Court's decision
    • How to assure clearcut assignment of IP
        – How to deal with existing and future  collaborative research agreements
        – Strategies for reviewing and strengthening existing faculty agreements
        – Incorporating assignment into grant acceptance, invention disclosure, employment contracts
    • Tips for managing the fallout among faculty
    • Thorough review of Justice Breyer's dissent
    • Likelihood and focus of future challenges
    • Implications for:
        – First inventor to file
        – Bayh-Dole

    The registration fee for the webinar is $197 ($247 for registration plus CLE processing).  Those interested in registering for the webinar, can do so here.

  • Webinar on Therasense Decision

    Strafford #1 Strafford will be offering a webinar entitled "The New Inequitable Conduct Standard in Patent Litigation: Asserting and Defending Inequitable Conduct Challenges After the Landmark Therasense Decision" on July 26, 2011 from 1:00 – 2:30 PM (EDT).  James J. Foster of Wolf Greenfield & Sacks and David P. Enzminger of Winston & Strawn will provide guidance to counsel for patent holders and challengers on the Federal Circuit's landmark en banc decision in Therasense v. Becton Dickinson, the new standard for inequitable conduct and its impact, and best practices for operating under the new standard.  The webinar will review the following questions:

    • How does Therasense change the legal standard for materiality?
    • What exception to the new standard did the court create?
    • What will be the practical effect on patent litigation?
    • What impact will the new standard have on patent prosecution?

    An interactive Q&A session will follow the presentation.

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by July 1, 2011 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • CLE on Therasense Decision

    LSI - Law Seminars International - red Law Seminars International (LSI) will be offering a one-hour telebriefing entitled "Inequitable Conduct after Therasense: Practical And Strategic Implications of the Recent Federal Circuit Ruling" on June 24, 2011 beginning at 1:00-2:30 PM (ET).  Christian E. Mammen of Mammen Law in Berkley will moderate a panel including David C. Bohrer of Confluence Law Partners and Stephen G. Kunin of Oblon, Spivak, McClelland, Maier & Neustadt, LLP.  The panel will discuss the strengths and weaknesses of the three opinions in the Therasense case, offer their insights about the future of the defense, share their thoughts on the prospect of certiorari being granted in Therasense, and also discuss the related implications of the Supreme Court's ruling in Microsoft v. i4i concerning the burden of proof for invalidity.  Among the topics to be covered are:

    • The state of inequitable conduct after Therasense
    • Key issues raised in the three opinions in the Therasense case
    • Insights about the future of the inequitable conduct defense
    • Practical takeaways for patent litigators

    The registration fee is $125 per caller and $50 each additional person on the same line who desires continuing education credit.  Those interested in registering for the telebrief, can do so here.