•     By Kevin E. Noonan

    Gavel Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, Myriad Genetics et al.
    09-cv-04515-RWS; filed May 12, 2009 in the District Court for the Southern District of New York

    Earlier today, a group of patients, physicians, academic researchers and medical societies filed suit in the Southern District of New York against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer.  The causes of action asserted in the complaint are that patent claims directed to isolated nucleic acids are not patentable subject matter as being products of nature contrary to 35 U.S.C. § 101 and Article 1, Section 8, Clause 8 of the Constitution, and violations of free speech under the 1st Amendment and due process violations of the 14th Amendment.  The lawsuit was filed by American Civil Liberties Union (ACLU) lawyers and that perennial antipatent litigant, Daniel Ravitcher from the Public Patent Foundation (PubPat).  (In homage to Donald Chisum, it would be more accurate to call it the Public No-Patent Foundation.)  Details of the complaint, the parties, the patents, the politics, and the prospects for the suit will be presented in future Patent Docs posts — in particular, we will be addressing "issues" with the complaint in a future post.  We wish to thank a Patent Docs reader for bringing this case to our attention.  The complaint can be viewed here.

  •     By Donald Zuhn

    House of Representatives Seal On April 30th, the House Committee on the Judiciary heard testimony from seven witnesses (and accepted written testimony from other interested parties) regarding the House patent reform bill (H.R. 1260) (see "House Judiciary Committee Holds Hearing on Patent Reform").  Part I of our coverage of the hearing examined written testimony submitted by hearing witnesses Dean Kamen of DEKA Research and Development Inc., the inventor of the Segway, and Jack Lasersohn, a Partner with the Vertical Group and representative of the National Venture Capital Association (NVCA), as well as testimony submitted by the Biotechnology Industry Organization (BIO).  In the second part of our coverage, we examine the written testimony submitted by Bernard Cassidy, Senior Vice President and General Counsel for Tessera Inc., and John Thomas, Professor at Georgetown University Law School.

    Tessera Mr. Cassidy's written testimony, which runs just over nineteen single-spaced pages in length, provides a detailed and well-supported attack on several provisions of H.R. 1260.  Mr. Cassidy also suggests that in view of recent Supreme Court and Federal Circuit decisions, Congress would be better suited to redirect its patent reform focus from a post-grant perspective (i.e., patent litigation) to a pre-grant perspective (i.e., application examination).  Given Tessera's position in semiconductor packaging, Mr. Cassidy's position on patent reform may come as a surprise to some (and are perhaps as surprising as the position that was taken by Tessera Vice President Taraneh Maghamé at the Senate Judiciary Committee's patent reform hearing in March; see "Senate Judiciary Committee Holds Hearing on Patent Reform").  However, the Tessera General Counsel noted that the company's success would not have been possible without "a strong patent system to protect our inventions and reward our innovators," and he contended that "[m]aintaining a strong patent system is essential to [Tessera's] continuing success."

    Stating that "[i]t is troubling to many small technology companies that, at a time of such grave economic uncertainty, Congress would seek to fundamentally alter the economic structure of our nation's patent system," Mr. Cassidy argued that "the proposed changes to the law of damages, in particular, would cause a massive and irreversible transfer of wealth from the United States to foreign manufacturers."  With respect to the damages and post-grant review provisions, Mr. Cassidy noted that "other industries share Tessera's concerns," listing venture capital, agriculture, biotech, universities, domestic manufacturers, nanotechnology, and green tech amongst opponents of these provisions of H.R. 1260.

    On the subject of damages, Mr. Cassidy stated that "[g]iven the public statements of most stakeholders to date — at least with respect to the Senate gatekeeper proposal — the Senate's work has advanced the discussion [of damages] significantly," and he encouraged the House to "take advantage of the success achieved to date in the Senate on the damages provision of the bill."  Mr. Cassidy offered this encouragement despite his skepticism that a patent damages problem exists — a skepticism rooted, at least in part, in a PriceWaterhouseCoopers 2008 study showing that patent damages awards have remained largely consistent for more than a decade, and a survey by University of Houston Law School Professor Paul Janicke showing no pattern of runaway jury verdicts in patent cases in the past four years (the Janicke study indicates that for cases that go through trial, the median damages award is less than $2 million).  For Mr. Cassidy, " Prof. Janicke's data illustrate that despite arguments made by proponents of damages reform, there is no pattern of runaway jury verdicts and that patent damages awards are modest."

    Mr. Cassidy argues that "[d]ismantling the long-established framework for calculating reasonable royalties at trial will encourage infringers, and perhaps even existing licensees, to reject negotiated, market-based royalties," and "weaken the value of patents generally and unfairly advantage large companies looking to acquire a smaller innovator's property."  He contends that:

    [T]he tried and true principles that underlie Georgia Pacific and patent damages law generally are so firmly grounded in our legal system that it would be difficult to justify any significant departure without acknowledging an effort to transform patent rights into something far different, and far less valuable, than the nation's founders intended.

    And he points to that which should be plainly obvious when stating that "[p]atent damages rules are based on the same principles that underlie compensatory damages generally; thus, the risks of inflated settlements are no greater in patent negotiations than in the context of any other commercial dispute."

    As for post-grant review, Mr. Cassidy argues that:

    The proposed hybrid [post-grant opposition]/inter partes system would (i) unleash a wave of administrative litigation with many of the costs and complexities of judicial litigation, (ii) invite serial and harassing validity challenges throughout the life of a patent, and (iii) effectively eliminate the statutory presumption of validity essential to a patent’s enforceability.

    Instead of elaborating on these criticisms, however, Mr. Cassidy focuses the remainder of his testimony on a discussion of recent court decisions that "have unquestionably changed major areas of the law and shifted the balance of power between patent holders and users, tightening standards of patentability and narrowing patent rights and remedies."  He "urges Congress and the Administration to allow these decisions to be implemented in the marketplace and consider carefully the impact of these decisions before enacting any legislation that will further decrease the value or enforceability of patents."  Among the cases that he discusses are:  eBay Inc. v. MercExchange, L.L.C., Medimmune, Inc. v. Genentech, Inc., KSR Int'l Co. v. Teleflex Inc., Microsoft Corp. v. AT&T Corp., Quanta Computer, Inc. v. LG Electronics, Inc., In re Seagate Technology, LLC, In re Bilski, and In re TS Tech USA Corp.

    With respect to KSR, Mr. Cassidy states that:

    In KSR International Co. v. Teleflex Inc. the Supreme Court altered the objective patentability test of obviousness which had been used by the USPTO and federal courts for two decades.  The test was, and is still believed by many to be, necessary to avoid the inappropriate application of 20/20 hindsight to obviate non-obvious, and otherwise patentable inventions.

    On the Quanta decision, he argues that:

    Quanta is now being cited in some quarters as justification for amended damages rules that would value reasonable royalties according to a patent's "essential" or "inventive" features, comparable to the "prior art subtraction" test proposed in previous legislation.  This argument has no merit and reflects a fundamental misunderstanding and misapplication of the Quanta decision.  Neither Quanta nor the Court's discussion of a patent's essential features has any bearing on reasonable royalty valuation rules.  Instead, Quanta addresses a completely different inquiry, namely the point at which downstream patent users should be free to engage in commercial transactions involving patented products without any liability to the patentee.

    While the eight cases listed above "address[] virtually all of the substantive issues that originally prompted calls for patent legislation, including injunctions, willfulness, venue, and standards relevant to the patent-eligibility of claims and validity of issued patents," Mr. Cassidy notes that "the courts are obviously not institutionally positioned to address the USPTO's resource constraints and operational deficiencies, which have diminished the overall quality, predictability and efficiency of pre-grant patent examination processes," and concludes that "[t]hese problems merit urgent attention and should be the focus of current patent reform efforts."

    Thomas, John In contrast with Mr. Cassidy's written testimony, Prof. John Thomas' (at right) testimony focuses on the issue of damages, and takes a decidedly different stance on that issue.  Stating that "the perception is widely shared that the rules pertaining to damages are less certain than many other patent doctrines," Prof. Thomas argues for "greater precision in patent law's damages principles."  He contends that "[p]revailing legal standards with respect to reasonable royalty determinations have been roundly criticized for their indeterminancy and logical shortcomings," adding that:

    Experience suggests that the Georgia-Pacific factors are difficult to apply consistently.  Although Georgia-Pacific provides a long list of ingredients, it offers no recipe–that is to say, no principles for deciding whether one of the seemingly randomly ordered elements should be weighed more heavily than another in a given determination.  The laundry list of Georgia Pacific factors, many of which include several sub-components, cannot plausibly be considered to provide a "standard" for setting reasonable royalty rates at all.

    And although Prof. Thomas suggests (without citation) that "[t]here seems to be widespread acceptance of th[e] basic position that damages should be based upon the incremental value of the invention" — as called for in the House bill's damages provision, which proposes that reasonable royalties relate "only to the portion of the economic value of the infringing product or process properly attributable to the claimed invention’s specific contribution over the prior art" — Prof. Thomas does not explain why the House provision would provide more precision or any greater certainty than the Georgia-Pacific factors, for which a body of case law already exists.

    Prof. Thomas similarly fails to provide support for his statement that "damages rulings are widely viewed as unpredictable and difficult to review, but also as tending towards overcompensation to the patent proprietor."  Absent any discussion of median damages awards (as provided in Mr. Cassidy's testimony), it is also difficult to gauge the types of awards that Prof. Thomas would consider as constituting "overcompensation."

    Although the hearing was not made available for online viewing last month, a link to the hearing webcast is now available at the Committee's website.  Written testimony for each witness can also be found at the Committee's website.  Patent Docs will examine written testimony provided by the remaining witnesses, as well as reaction in the patent community to the hearing, in subsequent posts.

  •     By Mark Chael

    Immunomedics On May 5th, Immunomedics, Inc. announced that its majority-owned subsidiary, IBC Pharmaceuticals, Inc., was granted U.S. Patent No. 7,527,787, entitled "Multivalent Immunoglobulin-based Bioreactive Assemblies."  Claim 1 from the patent reads:

    1.  A hexameric stably tethered structure comprising an IgG antibody attached to two AD2 moieties of SEQ ID NO: 4 and four antigen-binding antibody fragments of the same or different IgG with each fragment attached to a DDD2 moiety of SEQ ID NO: 2; the AD2 moieties bound to the DDD2 moieties.

    The four antigen-binding antibody fragments can be Fab fragments.  In particular, these Fab fragments can be the Fab fragments of humanized antibody hMN-14 that binds to CEA, humanized antibody hA20 that binds to CD20, humanized antibody hLL2 that binds to CD22, humanized antibody hL243 that binds to HLA class II, humanized antibody hCC49 that binds to TAG-72, humanized antibody hLL1 that binds to CD74, humanized antibody hPAM4 that binds to MUC 1, humanized antibody hRS7 that binds to EGP-1, humanized antibody hR1 that binds to IGF1R, anti-CD 14, anti-CD 111, adalimumab, infliximab, omalizumab, palivizumab, and humanized antibody hMN-15 that binds to CEA.

    The abbreviation "AD" in claim 1 refers to the Anchoring Domain of A-kinase anchoring proteins (AKAPs), while "DDD" refers to the Dimerization and Docking Domain of cyclic-AMP-dependent protein kinase (PKA).  These two domains cooperate in this Dock-and-Lock (DNL) technology.

    According to a recent paper authored by the inventors of the '787 patent (and others), the Dock-and-Lock technology is:

    [A] new approach to develop targeting molecules for improved cancer imaging and therapy.  It involves the use of a pair of distinct protein domains involved in the natural association between cyclic adenosine monophosphate (cAMP)-dependent protein kinase A (PKA) and A-kinase anchoring proteins (AKAPs).  The dimerization and docking domain found in the regulatory subunit of PKA and the anchoring domain (AD) of an interactive AKAP are each attached to a biologic entity, and the resulting derivatives, when combined, readily form a stably tethered complex of a defined composition that fully retains the functions of the individual constituents.

    Another recent patent assigned to IBC Pharmaceuticals, U.S. Patent No. 7,521,056, relates to the same technology as the '787 patent.  These two patents may be the first drawn to the PKA/AKAP Dock-and-Lock technology.

    Other similar, so-called Dock-and-Lock systems are known.  For example, scientists at SibTech, Inc. published a report in 2006 about such a system "based on mutated fragments of human RNase I that spontaneously bind to each other and form a conjugate with a disulfide bond between complimentary cysteine residues."  Each of the mutated RNase I fragments may be independently linked to functionally heterogeneous compounds.

  •     By Kevin E. Noonan

    Biotechnology Industry Organization (BIO) Last Friday, the Biotechnology Industry Organization (BIO) presented its members-only 2009 Spring IP Policy Briefing to member companies, particularly directed to member law firms.  The presentation was moderated by Lila Feisee, BIO's Managing Director, Intellectual Property.  The briefing included discussions on Membership Benefits, U.S. court cases, biosimilars and patent reform legislation, and the Department of Health and Human Service's draft report from the Committee on Genetics, Health and Society.

    The Membership Benefits overview, presented by Jason Rupp, BIO's Membership Director, reminded participants of BIO's demographics:  the organization has a staff of 160 and a membership of about 1,200 biotechnology and related companies.  Two-thirds of these are R&D-focused organizations, with another 16% consisting of academic or other non-profit groups.  The remainder are made up of service providers and state or international affiliates.  Mr. Rupp mentioned several opportunities for participation on a number of committees, as well as other member benefits directed to practical business solutions (found at www.biobusinessolutions.com).

    One of these committees, the amicus committee, files between 4 and 6 briefs a year; recent cases where BIO filed an amicus brief included eBay Inc. v. MercExchange, L.L.C.; KSR Int'l Co. v. Teleflex Inc.; Ferring B.V. v. Barr Labs., Inc.; In re Seagate Technology, LLC; Quanta Computer, Inc. v. LG Electronics, Inc.; Tafas v. Dudas; In re Bilski; In re Kubin; Amgen v. Hoffman-LaRoche; Aventis Pharma S.A. v. Amphastar Pharmaceuticals; and Prometheus v. Mayo (see BIO's Amicus Briefs page for links to the organization's filed briefs).  The amicus committee considers cases that impact BIO members generally and does not typically take a position relating to specific commercial disputes or in cases between BIO members.  Recent cases where BIO did not file an amicus brief include Laboratory Corp. v. Metabolite Labs., Inc.; Medimmune, Inc. v. Genentech, Inc.; Microsoft Corp. v. AT&T Corp.; Pharmastem Therapeutics, Inc. v. Viacell, Inc.; and In re Bilski's petition for certiorari.  The committee is currently interested in petitions for rehearing en banc in the Kubin and Tafas cases, and in the patent term adjustment dispute in Wyeth v. Doll.

    Sandra J.P. Dennis, BIO's Deputy General Counsel for Healthcare, then discussed the current state of biosimilars legislation.  She reminded listeners that the last (110th) Congress saw five bills introduced, by Mr. Waxman (D-CA), Mr. Inslee (D-WA), and Ms. Eschoo(D-CA)/Mr. Barton (R-TX) in the House, and Senator Gregg (R-NH) and Senators Kennedy (D-MA), Clinton (D-NY), Hatch (R-UT), and Enzi (R-WY) in the Senate; the latter bill represented a compromise on the all-important data exclusivity period at 12 years.  In this Congress, Mr. Waxman has introduced a bipartisan bill (H.R. 1427), joined by Mssrs. Deal (R-GA), and Pallone (D-NJ) and Ms. Emerson (R-MO) that provides only 5 years of data exclusivity and only if the "major substance" had not been previously approved (3 years otherwise) (see "Waxman Introduces Follow-on Biologics Bill").  There is a competing bill, H.R. 1548, introduced by Ms. Eschoo, Mr. Inslee, and Mr. Barton (that has more than 65 co-sponsors) that specifies 12 years of data exclusivity with provisions for an additional 2 years for a "medically-significant new indication" and 6 months for pediatric studies (see "Second Follow-on Biologics Bill Is Introduced in House").  In the Senate, a companion to the Waxman bills has been introduced (see "Third Follow-on Biologics Bill Introduced in 111th Congress"), and Senator Kennedy is expected to introduce a bill with a 12-year data exclusivity period.

    Hans Sauer, BIO's Associate General Counsel for Intellectual Property, addressed patent reform legislation.  Mr. Sauer characterized the Senate bill, S. 515, as a bill BIO could support, in contrast to the bills introduced (S. 1453) and passed (H.R. 1983) in the last Congress.  Turning to specific provisions, Mr. Sauer said that BIO does not support the "trigger" provisions in the House bill on changing U.S. patent law to "first inventor to file" from "first inventor to invent."  These provisions, not contained in the Senate bill, would forestall the legislated change until the President certified that the European Patent Office and the Japan Patent Office had instituted a "grace period," like ours, for an inventor's own prior disclosure.  He said that BIO supports the Senate compromise on damages and post-grant review, and opposes provisions in the House bill that include public use or on-sale activity as prior art.  BIO also opposes provisions in the House bill that specify a reasonable royalty determination would be based on "specific contribution[s] over prior art."  BIO is also concerned, he said, about the absence of inequitable conduct reform in the pending bills, and noted that while some stakeholders have attempted to use reforming of inequitable conduct as a bargaining chip for damages apportionment, this was not acceptable to BIO — inequitable conduct reform is not "tradable" for "harmful damages language."  While BIO seeks repeal/elimination of the best mode requirement, the Senate compromise that retains the provision but strips it of any meaningful penalty for failing to disclose the best mode is acceptable to BIO.  He also mentioned provisions on willfulness, interlocutory appeals, venue, mandatory publication, and ending fee diversion.

    The last presentation, by Ms. Feisee, concerned the draft report from th
    e HHS Secretary's Advisory Committee on Genetics, Health and Society.  This draft report, dealing with recommendations on gene patenting and licensing practices, actually contains good news — the purported anticompetitive effects of the mythical "tragedy of the anti-commons" do not exist, and the report concludes (somewhat begrudgingly) that patents are not "a cause of concern in relation to price and access."  Rather than provide recommendations consistent with these empirical findings, however, the report presents "a range of potential policy options" for consideration, including policies that "promote 'broad licensing'" of genetic inventions, pursuing an Executive Order "clarifying authority under the Bayh-Dole Act" that would "impose a requirement for non-exclusive licensing" of materials produced using Federal funds, and "clarifying" Patent Office policies relating to genetic materials.  Despite its express findings, somewhat incredibly the report also proposes statutory changes (to be promoted, no doubt, as "reform")  to restrict patents on nucleic acid-based inventions.  Comments on the report are due by May 15th; BIO will be providing comments.

    BIO intends to have another policy briefing later this summer.

  •     By Sherri Oslick

    Gavel_2About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Yeda Research and Development Co., Ltd., v. Doll

    1:09-cv-00820; filed May 4, 2009 in the District Court of the District of Columbia

    Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,445,802 ("Site-Specific In Situ Generation of Allicin Using a Targeted Alliinase Delivery System for the Treatment of Cancers, Tumors, Infectious Diseases and Other Allicin-Sensitive Diseases," issued November 4, 2008).  View the complaint here.

    Monsanto Co. et al. v. E.I. Dupont De Nemours and Co. et al.
    4:09-cv-00686; filed May 4, 2009 in the Eastern District of Missouri

    Infringement of U.S. Patent No. RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' development of a stacked soybean product incorporating Monsanto's Roundup Ready® technology.  View the complaint here.

    Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc.
    4:09-cv-40089; filed May 1, 2009 in the District Court of Massachusetts

    Infringement of U.S. Patent No. 7,223,394 ("Human Antibodies that Bind Human TNF alpha," issued May 29, 2007) based on Centocor's imminent launch of it's Simponi product (golimumab, used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis).  View the complaint here.

    Warner Chilcott Laboratories Ireland Ltd. et al. v. Mylan Pharmaceuticals Inc. et al.
    2:09-cv-02073; filed May 1, 2009 in the District Court of New Jersey

    Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used for adjunctive treatment of severe acne).  View the complaint here.

    Alcon Research Ltd. v. Barr Laboratories Inc.
    1:09-cv-00318; filed April 30, 2009 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 5,510,383 ("Use of Cloprostenol, Fluprostenol and Their Salts and Esters to Treat Glaucoma and Ocular Hypertension," issued April 23, 1996), 5,631,287 ("Storage-Stable Prostaglandin Compositions," issued May 20, 1997), 5,849,792 (same title, issued December 15, 1998), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999) and 6,011,062 ("Storage-Stable Prostaglandin Compositions," issued January 4, 2000) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Alcon's Travatan® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

    Pfizer Inc. et al. v. Lupin Ltd. et al.
    1:09-cv-01113; filed April 30, 2009 in the District Court of Maryland

    Pfizer Inc. et al. v. Sandoz Inc.
    3:09-cv-02052; filed April 30, 2009 in the District Court of New Jersey

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999), 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001), and 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Lupin complaint here.

    Pfizer Inc. et al. v. Wockhardt Ltd. et al.
    3:09-cv-02069; filed April 30, 2009 in the District Court of New Jersey

    Pfizer Inc. et al. v. Sun Pharma Global Inc. et al.
    3:09-cv-02070; filed April 30, 2009 in the District Court of New Jersey

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Wockhardt complaint here.

    Novartis AG v. Doll
    1:09-cv-00804; filed April 20, 2009 in the District Court of the District of Columbia

    Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,446,175 ("Antibodies to human IL-1β," issued November 4, 2008).  View the complaint here.

  • CalendarMay 18-21, 2009 – BIO International Convention (Biotechnology Industry Organization) – Atlanta, GA

    May 20, 2009 – Tafas v. Doll — Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims*** (American Conference Institute) – 1:00-2:30 PM (EST)

    June 16-17, 2009 – Biotech Patenting (C5) – Munich, Germany

    June 19, 2009 – Patent Enforcement & Early Stage Litigation (Law Seminars International) – San Francisco, CA

    June 22-27, 2009 – Innovation Week 2009 (U.S. Patent and Trademark Office) – Arlington, VA

    June 21-23, 2009 – IP Business Congress (Intellectual Asset Management magazine) – Chicago, IL

    July 14-15, 2009 – Pharma/Biotech Collaborative Agreements (American Conference Institute) – San Francisco, CA

    July 15, 2009 – Cost-Effective Patent Strategies (Law Seminars International) – Seattle, WA

    July 21-22, 2009 – FDA Boot Camp*** (American Conference Institute) – Chicago, IL

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

  • Chicago #5 American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL.  The conference will allow attendees to:

    • Master the basics of the approval processes for drugs, biologics, and devices, including in-depth discussion of the application, pre-approval, and post-approval requirements;
    • Comprehend the structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDHR;
    • Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
    • Learn how devices are classified, monitored, and regulated;
    • Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
    • Recognize the pivotal role of labeling in the drug and biologics approval process;
    • See the importance of cGMPs to the post-approval regulatory process;
    • Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls; and
    • Understand the implications of recent legislative and caselaw developments in the area of drug and biologic import/export guidelines.

    779L09-CHI In particular, ACI's faculty will offer presentations on the following topics:

    • The basics:  Understanding and working with the FDA and the New Administration — Jurisdiction, functions, organizations & operations;
    • The nature of the approval process;
    • Essential requirements of the clinical trials processes;
    • Patent & IP spotlight:  Hatch-Waxman, the patenting process, and more — to be presented by MBHB colleague and Orange Book Blog author Aaron Barkoff;
    • Drugs, biological products:  Labeling;
    • Current good manufacturing practices (cGMPs) and quality system regulation (QSR);
    • Import/export guidelines & emerging international regulatory concerns;
    • Non-patent exclusivity (part of the conference's patent track);
    • Bioequivalence:  What patent lawyers need to know (patent track);
    • Follow-on (comparable or biosimilar) biologics (patent track);
    • Medical devices:  Classification and the essentials of the device premarket review process;
    • Post-market requirements and concerns for medical devices;
    • Medical device labeling and advertising; and
    • Recalls guidance for drugs, biologics, and medical devices.

    An additional post-conference master class entitled:  "Product Liability Master Class on Drug and Medical Device Preemption:  Reconciling Wyeth, Riegel and the Medical Device Safety Act of 2009" will be offered on July 23, 2009.  The master class will analyze the nuances of recent court decisions regarding preemption and provide insights into how to use these cases effectively in future litigation.

    The agenda for the FDA Boot Camp conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    ACI - American Conference Institute The registration fee ranges from $2,795 (conference) to $2,195 (conference plus workshop).  Those registering on or before June 19, 2009 will receive a $200 discount, and those registering on or before May 15, 2009 will receive a $300 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media sponsor of ACI's FDA Boot Camp conference.

  •     By Christopher P. Singer

    USPTO Seal As we previously reported by Patent Docs, the U.S. Patent and Trademark Office began a Patent Prosecution Highway (PPH) Pilot Program with the German Patent and Trademark Office (DPMA) on April 27, 2009 which will last for two years.  The USPTO issued another press release on April 20, 2009, providing links for applicants interested in reviewing the requirements for participation in the pilot program via the USPTO or DPMA.

    German Patent Office (DPMA)

  •     By Mark Chael

    ImmunoCellular On April 29, 2009, ImmunoCellular Therapeutics, Ltd. announced that the U.S. Patent and Trademark Office issued Patent No. 7,498,129, which relates to the company's monoclonal antibody platform.  The '129 patent is entitled "Myeloma Cell and Ovarian Cancer Cell Surface Glycoproteins, Antibodies Thereto, and Uses Thereof," and according to ImmunoCellular, is directed to the use of the company's antibodies to measure the effectiveness of proposed treatments for multiple myeloma and ovarian cancer.

    Claim 1 of the '129 patent reads as follows:

    1.  A method for monitoring the effectiveness of therapy for a myeloma or ovarian cancer, comprising:
        a) measuring changes in the level of the antigen recognizable by a monoclonal antibody or antigen binding fragment thereof in a bodily fluid sample from a patient undergoing therapy, wherein said monoclonal antibody is produced by the hybridoma cell line deposited at the American Type Culture Collection having accession No. PTA-450; and
        b) correlating the change in the level with the effectiveness of said therapy, wherein a decrease in the level indicates a reduced tumor burden.

    In 2007, ImmunoCellular acquired a portion of its monoclonal antibody-related technology from Molecular Discoveries.  One such monoclonal antibody, ICT-109, targets small cell lung cancer (SCLC) and pancreatic cancer.  ICT-109 is currently in pre-clinical development, and is useful as a diagnostic reagent to prescreen patients for the specific antigens to which it binds.  According to ImmunoCellular, this antibody has shown encouraging preliminary data in pre-clinical studies and may be ready to enter clinical trials in the near future for SCLC and/or pancreatic cancer.

    According to the assignment database  at the USPTO, ImmunoCellular is the assignee of record on at least seven patents and one published patent application.

  •     By Kevin E. Noonan

    U.S. Trade Representative U.S. Trade Representative Ron Kirk issued a "Special 301 Report" on April 30.  This report, on the state of intellectual property rights worldwide, identifies twelve countries on a "priority watch list" and another 33 on a "watch list," all relating to deficiencies in intellectual property protection in these countries.  The Report "guides our efforts to protect American innovation and creativity around the world," according to a press release by the Representative's office, and in these times when "[o]ur creative and innovative products can hit the global marketplace . . . . with just a keystroke," the U.S. and its trading partners must be "vigilant" to protect and enforce intellectual property rights.

    The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These watch lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

    The Priority Watch List of the report lists China, Russia, Algeria, Argentina, Canada, Chile, India, Indonesia, Israel, Pakistan, Thailand, and Venezuela; this is an upgrade in priority for Algeria, Canada, and Indonesia, who last year were on the Watch List.  Countries on this list "do not provide an adequate level of IPR [intellectual property rights] protection or enforcement, or market access to persons relying on intellectual property protection."  This year, the Watch List names Belarus, Bolivia, Brazil, Brunei, Columbia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, Greece, Guatemala, Hungary, Italy, Jamaica, Kuwait, Lebanon, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Romania, Saudi Arabia, Spain, Taiwan, Tajikistan, Turkey, Turkmenistan, Ukraine, Uzbekistan, and Vietnam; Brunei (software piracy), and Finland (lack of pharmaceutical product patent protection) are new to the Watch List this year.  Korea and Taiwan were removed from the Watch List in this report; significantly, this is the first time that Korea has not been named on either the Priority Watch List or the Watch List.

    Canadian Flag As in prior years, the majority of the report focuses on software and entertainment piracy.  Indeed, this is a major reason for Canada being named on the Priority Watch List, which includes the need for copyright reform as well as "weak border enforcement."  The Report also notes that the Canadian government "has not delivered on [its] commitments" to improving IPR protection and enforcement.  The Report emphasizes the problem of manufacturing and distributing counterfeit pharmaceuticals, singling out Brazil, China, India, Indonesia, and Russia as countries where such incidents have proliferated while noting that counterfeit pharmaceuticals are sold and distributed in several countries.  The report calls "a significant contributing factor" of this problem production of counterfeit bulk active pharmaceutical ingredients (APIs); China is singled out for a "loophole" in its law that permits counterfeit APIs to avoid regulatory oversight merely by not declaring an intention to be used to produce pharmaceutical products.  Algeria was added to the Priority Watch List for a law banning "numerous" imported pharmaceuticals and medical devices that prevents access by U.S. companies.

    This year, the Report also has a section on "Intellectual Property and Health Policy," specifically relating to the 2001 Doha Declaration on the TRIPS Agreement.  The Report states that the U.S. "respects a country's right to protect public health, in particular, to promote access to medicines for all."  Accordingly, the Report states that the U.S. "respects our trading partners' rights to grant compulsory licenses" consistent with the provisions of the Doha Declaration, including provisions of the August 2003 agreement whereby countries are permitted to grant such compulsory licenses not only for producing pharmaceuticals for internal use but also for export to countries unable to produce drugs themselves.  Interestingly, the Report notes that the U.S. was the first country to formally adopt the provisions incorporating these provisions into the TRIPS agreement, and that two-thirds of WTO members must ratify them by December 31, 2009 in order for them to come into effect.

    Chinese Flag Immediately following this discussion is a section highlighting efforts by the Representative to support pharmaceutical innovation by "eliminate[ing] market barriers" and to "support . . . innovation" in the pharmaceutical industry, pointing to concerns in the Report about market access barriers in Algeria and Indonesia.  Also mentioned in the Report are "concerns" about pharmaceutical regulatory and other policies of Canada, France, Germany, Italy, Japan (specifically with regard to regulatory aspects), New Zealand, and Taiwan.  Poland's adoption in 2006 of regulations establishing maximum wholesale and retail prices for imported drugs is also mentioned, as well as urging China to add new drugs to its national formulary (which controls which drugs are available in China).

    The report notes positive developments in several countries, including Korea and Taiwan (taken off the Watch List as noted above), China (relating to rebroadcast of the Olympic Games), Russia (for acceding to the WIPO Internet Treaties, and combating software piracy), Chile, Egypt, India (for passing the Drugs and Cosmetics (Amendment) Act in 2008 relating to counterfeit pharmaceuticals), Indonesia, Lebanon, Saudi Arabia, Sweden (for the PirateBay website convictions), and Vietnam.  The Report also contains a review of the status of patent and other intellectual property rights country by country for all the countries on these two Watch li
    sts.

    Section III of the Report is entitled "Notorious Markets," which sets forth a list of markets on the Internet (in China and Russia) as well as "physical" markets (in China, Russia, Mexico, India, Poland, the Philippines, the Czech Republic, Indonesia, Thailand, and the tri-border region between Paraguay, Brasil, and Argentina) where "[g]lobal piracy and counterfeiting continue to thrive."

    The U.S. Trade Representative Report provides insights into both the concerns of U.S. IP rights holders and the administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  Western governments have been frustrated, particularly with regard to pharmaceutical products, in implementation of international trade treaties designed to increase IP rights protection.  The Report is in some ways the answer to the question, "What are we going to do about it?"

    For additional information regarding this and other related topics, please see:
    • "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
    • "
    U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008