•     By Sherri Oslick

    Gavel_31
    About
    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.


    Galderma Laboratories, LP et al. v. Actavis Mid-Atlantic, L.L.C.

    4:08-cv-00115; filed February 21, 2008 in the Northern District of Texas

    Infringement of U.S. Patent No. 7,316,810 ("Foaming Composition for Washing and Treating Hair and/or Scalp Based on an Active Principle," issued January 8, 2000) following a paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Galderma’s Clobex® Shampoo (clobetasol propionate shampoo, used to treat psoriasis).  View the complaint here.


    Sepracor Inc. et al. v. Geopharma, Inc. et al.

    3:08-cv-00945; filed February 20, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex® (desloratidine, used to treat allergies).  View the complaint here.


    Novartis Vaccines and Diagnostics, Inc. v. Wyeth et al.

    2:08-cv-00067; filed February 15, 2008 in the Eastern District of Texas

    Infringement of U.S. Patent Nos. 6,060,447 ("Protein Complexes Having Factor VIII:C Activity and Production Thereof," issued May 9, 2000) and 6,228,620 (same title, issued May 8, 2001) based on Wyeth’s manufacture and sale of its ReFacto® (recombinant antihemophilic Factor VIII, used to treat hemophilia).  View the complaint here.


    Novartis Vaccines and Diagnostics, Inc. et al. v. Bayer Healthcare, LLC et al.

    2:08-cv-00068; filed February 15, 2008 in the Eastern District of Texas

    Infringement of U.S. Patent No. 7,138,505 ("Factor VIII:C Nucleic Acid Molecules," issued November 21, 2006) based on defendants’ manufacture and sale of their Kogenate® (Bayer) and Helixate® (CSL Behring) (recombinant antihemophilic Factor VIII, used to treat hemophilia).  View the complaint here.

  •     By Baltazar Gomez

    Logo
    Last Thursday, OREXIGEN Therapeutics, Inc. announced that the U.S. Patent and Trademark Office mailed a Notice of Allowance for a patent application directed to the treatment of obesity using zonisamide, either alone or in combination with other drugs.  According to OREXIGEN, the allowed application will complement U.S. Patent No. 7,109,198.  Both the recently allowed application (believed to be U.S. Application No. 10/830,071) and the ‘198 patent, the latter of which OREXIGEN has exclusively licensed from Duke University, will expire in 2023.

    OREXIGEN President and CEO, Dr. Gary Tollefson, stated that "[t]his notice from the USPTO is an important milestone toward issuance of the patent and would give us an additional layer of protection for our use of zonisamide in treating obesity."  Dr. Tollefson believes that the allowed application will discourage competitors from copying OREXIGEN’s approach for treating obesity with zonisamide-based compounds.

    Zonisamide is one of the active constituents of EMPATIC, a novel formulation of zonisamide and bupropion.  Bupropion is a dopamine and norepinephrine re-uptake inhibitor while zonisamide is an approved anticonvulsant medication.  The rationale behind EMPATIC is that the combination of zonisamide and bupropion affects two groups of hypothalamic neurons, the POMC and NPY/AgRP neurons, to reduce the feeling of hunger.  The POMC neurons release the hormone alpha-MSH while the NPY/AgRP neurons release AgRP.  Both alpha-MSH and AgRP competitively bind to the melanocortin MC4 receptors; alpha-MSH binding increases energy expenditure and reduces hunger, while AgRP binding reduces energy expenditure and increases hunger.  In addition, monoamines, such as dopamine, norepinephrine, and serotonin, stimulate the neurons increasing alpha-MSH secretion and reducing AgRP secretion.  The novel combination of zonisamide and bupropion exploits the opposing effects of alpha-MSH and AgRP on MC4.  Zonisamide increases monoamine secretion which increases alpha-MSH secretion and reduces AgRP secretion, while bupropion increases alpha-MSH secretion by stimulating POMC.  The net effect is that alpha-MSH is overproduced and AgRP is reduced, leading to increased energy expenditure and reduced hunger.

    Results of clinical studies support OREXIGEN’s rationale for weight loss.  Studies with EMPATIC have shown that meaningful weight loss is sustainable over long periods.  Patients with body mass indices between 30 and 40 lost in excess of 9% of their baseline body weight by week 24.  In addition, weight loss continued for another 24 weeks with patients averaging a weight loss of 12% from baseline.  The weight loss was dose dependent with the highest dose achieving the greatest weight loss.

    OREXIGEN is also pursuing another drug combination, CONTRAVE, which in patient studies has shown weight loss without a plateau after 36 weeks of treatment.  CONTRAVE is a combination of bupropion and naltrexone designed to block the natural inhibition of alpha-MSH secretion by ß-endorphin.

    Obesity has become a major health problem in the Unites States and around the World.  The World Health Organization estimates that there are more than 1 billion overweight adults worldwide, and that at least 300 million of these individuals are clinically obese.  In the United States, data from two National Health and Nutrition Examination Surveys show that among adults aged 20-74 years, the prevalence of obesity increased from 15.0% (in the 1976-1980 survey) to 32.9% (in the 2003-2004 survey).  But obesity also increases the risk of many serious diseases, such as hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and even cancer.  So therapies such as EMPATIC and CONTRAVE represent important advances in the fight against obesity.

    Among the allowed claims of the ‘071 application are independent claims 18, 35, 44, and 53:

    18.  A method of reducing the weight of an overweight subject, said method comprising:  identifying an overweight subject and administering to said overweight subject a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof, in an amount effective to reduce the weight of said subject.

    35.  A method of reducing weight in an overweight subject, said method comprising:  identifying an overweight subject and administering to said overweight subject a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof, in an amount effective to induce weight loss in said subject, wherein the weight loss
    is ≥ 5%, or wherein said weight loss continues during the period of administration of said composition comprising zonisamide or a pharmaceutically acceptable salt thereof.

    44.  A method of treating obesity by reducing the weight of an obese subject, said method comprising:  identifying an obese subject and administering to said obese subject an effective amount of a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof.

    53.  A method of treating obesity by reducing the weight of an obese subject, said method comprising:  identifying an obese subject and orally administering to said obese subject a capsule comprising a pharmaceutical composition comprising zonisamide or a pharmaceutically acceptable salt thereof, wherein said subject receives a daily dose of 100 to 600 mg of zonisamide.

  • Calendar_30
    February 25-26, 2008 – Pharma/Biotech Patent Claim Drafting and Prosecution (American Conference Institute) – New York, NY***

    February 25-26, 2008 – Strategic Intellectual Property Planning (American Conference Institute) – Scottsdale, AZ

    March 12, 2008 – Biotechnology, Chemical & Pharmaceutical Art Group Customer Partnership Meeting (U.S. Patent and Trademark Office)

    March 30-April 1, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    March 31-April 1, 2008 – Document Management, E-Discovery, and Litigation Readiness (American Conference Institute) – New York, NY

    April 3-5, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    April 7, 2008 – Successful Mulitlateral Patents (Law Seminars International) – Arlington, VA

    April 10-12, 2008 – 23rd Annual Intellectual Property Law Conference (American Bar Association) – Arlington, Virginia

    April 25, 2008 – Patent Claim Construction (Law Seminars International) – Atlanta, GA

    April 30-May 1, 2008 – Pharma/Biotech Collaborative Agreements (American Conference Institute) – San Francisco, CA

    June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

    ***Patent Docs is a media sponsor of this conference or CLE.

  •     By Kevin E. Noonan

    A prominent Israeli commentator has added his voice to the growing chorus of objections to the patent "reform" bill under consideration by the Senate (S. 1145).  In an opinion piece published by the Jerusalem Post on Wednesday, Bernard Frieder, a technology specialist with experience consulting on intellectual property issues for U.S., Israeli, and U.K. companies who served as a cabinet officer in the British government, raised four separate reasons why the bill would hurt innovation and weaken patent protection (see "A patent ‘reform’ bill in the US has me worried").

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    First, Mr. Frieder asserts that the provisions of the bill requiring prior art searching and characterization of the prior art would "greatly increase the costs of securing a basic US patent and expand filing requirements and processing time, thereby reducing a patent’s term of protection."

    Second, the provisions for post-grant review would harm patentees in two ways.  The patent would lose value as a secure asset because the bill would permit a patent to be challenged throughout its term, a situation resulting in "no closure" for the patentee.  In addition, the statute would expand the grounds for challenging a patent (presumably compared with the limited scope of re-examination proceedings currently available), including "non-intentional" errors having no material affect on the decision to grant the patent.

    Third, the changes in the damages provisions would permit "deep-pocket challengers" to exploit "smaller, financially vulnerable companies, giving unfair advantage to the entrenched global companies over the upstart innovators" responsible for much technological progress.

    Fourth, Mr. Frieder believes that eliminating the capacity for an applicant to keep an application confidential, by attesting that no foreign-filed application would be filed that would publish, would have devastating consequences.  Indeed, Mr. Frieder alleges that "Israeli inventors working in Japan, for instance, regularly have their ideas stolen by intellectual property pirates based in Korea, Russia, and China, who only need to access the Japanese Patent Office’s Web site to get all the information they need to reverse-engineer and plagiarize someone else’s creation before a patent has been issued."  Mr. Frieder notes that Israeli follows the practice of the U.S. prior to passage of the American Inventors Protection Act of 1999, of keeping pending applications confidential until a patent is granted.

    These changes are particularly important for Israeli scientists, engineers, society, and economy, Mr. Frieder writes, because Israelis disproportionately use the U.S. patent system to protect their intellectual property.  Mr. Frieder states that Israelis, per capita, have the largest number of biotechnology start-up companies and more American patents than any other country, having increased from 632 in 1990 to 3,617 in 2007.  This intellectual property is used by Israeli companies in medical devices, instant messaging, flash disk drives, "voice-over-internet protocols," and other areas of technology, Mr. Frieder asserts.  He also states that "Israel is second only to California’s Silicon Valley as a driver of global innovation," and U.S. patents protect this innovation.

    Many of the concerns voiced by Mr. Frieder have been raised by others.  In a linked piece, Senator Patrick Leahy (D-VT) had the opportunity to defend the bill.  He did so by generically reciting the now familiar refrain of the need to prevent "bad" patents, disproportionate assessment of damages, and the advantages of harmonizing the U.S. system with the "first to file" system found in most other countries.  He does not address any of Mr. Frieder’s concerns directly.

    Mr. Frieder ends his piece by saying:

    US patent reform is a global issue, and Israelis – individuals, associations, and government alike – ignore the bill’s implications at our peril.  We should be doing all we can to make US lawmakers aware of our concerns.

    Mr. Frieder and his Israeli countrymen are limited to op-ed pieces, not having their own Senator to write to voice their concerns.  None of us have this excuse.

    For additional information on this and other related topics, please see:

    • "Judge Michel Doesn’t Think Much of Senate Bill S. 1145, Either," February 20, 2008
    • "The (Un)Intended Consequences of the Law," February 18, 2008
    • "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation – Part I," February 14, 2008
    • "BIO Report Indicts "Patent Reform" Proponents," February 13, 2008
    • "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008
    • "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008
    • "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008
    • "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008
    • "The Letters Keep Coming Over the Senate Transom," January 30, 2008
    • "U.S. Senate Mailbox Filling with Letters against Passage of Patent ‘Reform’ Bill: An Update," January 23, 2008
    • "U.S. Senate Mailbox Filling with Letters against Passage of Patent ‘Reform’ Bill," January 18, 2008
    • "Patent Reform Discussed on Senate Floor," December 21, 2007
    • "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry’s Radar," December 20, 2007
    • "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007
    • "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007
    • "Senate May Act on Patent ‘Reform’ Bill in the New Year," December 2, 2007
    • "The Wall Street Journal Gets It Half Right," November 5, 2007
    • "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
    • "Patent ‘Reform’ Bill Passes House of Representatives," September 9, 2007
    • "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007
    • "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
    • "Patent Reform Bill to Be Delayed?" June 12, 2007
    • "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007
    • "Could Creating a U.S. ‘Utility Model’ Patent Fulfill the ‘Need’ for Patent Law Reform?" May 21, 2007

  •     By Donald Zuhn

    Office_of_management_budget_omb_sea
    Last October, we reported on two letters that were sent to the Office of Management and Budget (OMB), each of which criticized the IDS rules package proposed by the U.S. Patent and Trademark Office in July 2006 (see "Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808).  One letter was sent by David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald L.P., on behalf of twenty-five companies and organizations (see "Cantor Fitzgerald VP Criticizes IDS Rule in Letter to OMB").  The other letter was prepared by Dr. Richard Belzer, a former civil service staff economist in the Office of Information and Regulatory Affairs within the OMB, on behalf of clients he declined to identify (see "OMB Receives Second Letter Criticizing Proposed IDS Rule").

    Belzer_2
    Earlier this week, Dr. Belzer (at left), who holds degrees in public policy (Ph.D., Harvard University, 1989; M.P.P., John F. Kennedy School of Government, 1982) and agricultural economics (M.S., University of California, Davis, 1980; B.S. University of California, Davis, 1979), informed us that a subsequent submission regarding the paperwork burdens of the final continuation and claims rules and the final IDS rules was sent to the OMB in mid-January (Dr. Belzer’s initial burden estimate was submitted to the OMB on September 26, 2007).  The final continuation and claims rules, which were published last August, are the subject of pending litigation in the Eastern District of Virginia between Dr. Triantafyllos Tafas/GlaxoSmithKline and the Director of the USPTO, Jon Dudas (see "PLI’s John White Discusses Tafas/GSK v. Dudas").  The final IDS rules were approved by the OMB in December, but have yet to be published (see "The OMB Isn’t Listening, Either").

    According to Dr. Belzer, the USPTO was required, under the Paperwork Reduction Act of 1980, to prepare and publish "objectively supported" estimates of the paperwork burden that would result from the implementation of these rules packages.  Dr. Belzer contends that the USPTO failed to provide estimates that were objectively supported, as required by the Act.  In his own 120-page submission, Dr. Belzer estimates that the paperwork burdens resulting from these new rules packages will run between $13 and $34 billion per year (that’s billion, not million), which Dr. Belzer notes is seven to twenty times the cost of the current paperwork inventory for the entire Department of Commerce.  The $13 to $34 billion burden estimate presented in Dr. Belzer’s submission is represented graphically below (in a figure that appears on page 3 of the submission):

    Burden_estimates_2

    In the letter accompanying Dr. Belzer’s revised alternative burden estimates, he states:

    We estimate that PTO’s recent and anticipated regulatory actions will result in between 45 million and 73 million new burden-hours.  These burdens translate into 26,000 to 40,000 full-time equivalent work-years (2,000 hours per year).  There are approximately 15,000 attorneys and agents licensed to practice before PTO.  If every one of them were occupied full-time fulfilling these new paperwork burdens, it would require between 87% and 133% of their available time.  The actual prosecution of patents to protect economically vital innovations and inventions could grind to a halt.

    In contrast with his own estimates, Dr. Belzer labels the burden estimates in the Patent Office’s barely 31-page long Supporting Statement as being "unsupported by any publicly disclosed data, models, or any other factual basis, even though the Office claims to adhere to applicable information quality guidelines."

    Glaxosmithkline_gsk
    Dr. Belzer also notes that while the USPTO is required by law to respond to his submission, it has not yet done so.  He speculates that the Patent Office’s failure to respond may be a stall tactic, with the Office waiting (like the rest of us) for a decision in Tafas/GSK v. Dudas.  Dr. Belzer expects that the OMB will apply more pressure on the Office to reply after the GSK case is resolved.  With regard to the accuracy of his own estimates, Dr. Belzer declares that "[i]f my estimates are wrong, [the USPTO] should say so.  Their unwillingness to respond suggests that they do not believe I am wrong."

    Despite Dr. Belzer’s rather large estimate for the paperwork burdens associated with the PTO’s new rules packages, he concedes that even his latest estimate does not take into account the Patent Office’s "quietly proposed" change in Markush practice (see  "Patent Office Proposes New Rules for Alternative Claiming").  He warns, however, that "[t]he best time to get those estimates prepared and submitted to OMB is now, not after PTO has finalized the rule," and therefore, is actively seeking the help of individuals having expertise in Markush practice, as well as financial support for such an effort.  Anyone willing to help with either aspect is encouraged to contact Dr. Belzer at rbbelzer@post.harvard.edu or regcheck@mac.com.

    UPDATE:  Gene Quinn of the PLI Patent Blog reported today (February 22) about discussions he has had with Dr. Belzer regarding his revised alternative burden estimates.

  •     By Kwame Mensah

    Geron
    Geron Corporation recently announced that it had been granted U.S. Patent No. 7,326,572, entitled "Endoderm cells from human embryonic stem cells."  The ‘572 patent covers a method for producing endoderm cells from human embryonic stem cells (hESCs).  The production of endoderm cells is a critical step in generating pancreatic islet cells from hESCs.  Geron is developing ways to use this method in the treatment of diabetes.

    Geron’s senior vice president of business development and chief patent counsel, Dr. David J. Earp, believes that the ‘572 patent broadens the coverage for Geron’s islet cell production protocol beyond the scope of U.S. Patent No. 7,033,831, which was issued to Geron in 2006.  Earp states that "[a]dded to our already robust portfolio of IP covering the scalable production of pluripotent stem cells, these patents reinforce our proprietary position for diabetes cell therapy."

    Geron’s president and chief executive officer, Dr. Thomas B. Okarma, commented on the utility of the method covered by the patent stating that it "has been validated in a number of studies published in leading journals by scientists from both Geron and other organizations."  Okarma also states that transplanted pancreatic islet cells of the method prolong the survival of severely diabetic animals as well as produce detectable human insulin in their bloodstream.  Geron is continuing to develop plans "aimed at producing a cell therapy capable of restoring normal glucose regulation in patients suffering from diabetes."

    Warf_2
    Geron’s portfolio of owned and in-licensed patents includes over 30 patents issued in the U.S., more than 65 issued in other countries, and over 130 applications pending worldwide that relate to pluripotent stem cells.  Geron also holds the exclusive right to develop and commercialize hESC-derived pancreatic islet cells, cardiomyocytes, and neural cells for therapeutic applications under the fundamental hESC patents assigned to the Wisconsin Alumni Research Foundation (WARF).

    The ‘572 patent is a divisional of U.S. Patent Application No. 10/313,739, filed Dec. 6, 2002, now U.S. Patent No. 7,033,831, which claims priority to U.S. Provisional Application No. 60/338,885, filed Dec. 7, 2001.  Representative claims 1 and 3 of the ‘572 patent recite:

    1.  A method for generating endoderm cells from human embryonic stem (hES) cells or human embryonic germ (hEG) cells, comprising culturing the hES cells or hEG cells in a medium comprising a sufficient amount of Activin A to cause differentiation of said cells into endoderm, thereby generating endoderm cells, wherein the endoderm cells express the markers Sox 17, HNF313 and HNF4a.

    3.  The method of claim 1, wherein the cells are human embryonic stem cells.

    For additional information regarding this or other related topics, please see:

    • "stART Licensing Announces Issuance of Patents for Cloning Ungulates," January 3, 2008
    • "It’s Time to Stop the Hypocrisy over Stem Cell Patents – Part III," July 4, 2007
    • "It’s Time to Stop the Hypocrisy over Stem Cell Patents – Part II," April 26, 2007

  •     By Christopher P. Singer

    Uspto_seal_no_background
    In a Federal Register notice published on February 20, 2008, the U.S. Patent and Trademark Office announced proposed changes to the rules regarding submission of biological deposits in patent applications.  In particular, the revised rules would require that any deposit of biological material be made before the application publishes, and that all restrictions on access to the deposited material imposed by the depositor be removed upon publication.  The motivation behind this change, as articulated in the Notice, is to provide equal access to all information referred to in the published patent application, whether that information is contained in another patent document or in a biological deposit.  The changes address the interplay of biological deposits, written description and enablement (35 U.S.C. § 112), and publication of U.S. patent applications under the AIPA.

    A brief overview of biological deposits

    Internationally, biological deposits are governed by the Budapest Treaty.  In the U.S., a deposit of biological material can provide adequate written description for a biological invention (see, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)).  For purposes of enablement, the Federal Circuit has held that even "the availability of a sample to the public after the patent has issued will meet the enablement requirement."  In re Lundak, 773 F.2d 1216, 1223 (Fed. Cir. 1985).  Since the AIPA went into effect, certain commentators have argued that because the publication of a U.S. application can create provisional rights for the applicant, the published application must be in compliance with the enablement and written description requirements of § 112.  This means that, if needed for § 112 purposes, a deposit of biological material would need to be made prior to publication (i.e., that the AIPA supersedes the rule stated in Lundak).  A more detailed and complete description of the rationale behind these proposed rule changes is provided in the Notice.

    Certain notable rule changes include:

    Section 1.804 would provide that if a biological material is necessary to preserve the availability of provisional rights under 35 U.S.C. § 154(d), the deposit of the biological material must be made prior to filing an application or during the pendency of an application, provided that the deposit is made before technical preparations for publication of the application as a patent application publication have begun (see § 1.215(a)).

    Section 1.808(a)(2) would provide that all restrictions imposed by the depositor will be irrevocably removed upon the earlier of publication of the application under § 1.211 and 35 U.S.C. § 122(b) or grant of the patent, and to indicate that the rule applies regardless of whether the deposit was made to satisfy a statutory provision.

    Section 1.808(b) would add "before the patent is granted or" before "term of the patent."

    Section 1.808(c) would provide that the Office will, on request, certify that an application referring to the deposit has been filed, that the subject matter of that application involves the deposited biological material or the use thereof, that the application has been published or patented or is otherwise open to public inspection, and that the requesting party has a right to a sample of the biological material.  This is required by Rule 11.3 of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.  WIPO provides a form, BP/12, for this purpose (see "Forms under the Budapest Treaty and Regulations").

    Section 1.809(e) would delete "before or with the payment of the issue fee (see § 1.312)" and insert "(1) within a period of sixteen months after the date of filing of the application or, if the benefit of an earlier filing date is sought under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four months of the actual filing date of the later-filed application and sixteen months from the filing date of the prior-filed application; and (2) before or with any request for early publication (Sec. 1.219)."

    The Patent Office is accepting written comments to these rule changes, by e-mail, regular mail, or facsimile.  To be ensured of consideration, any comments must be received on or before April 21, 2008.  Comments are preferably sent by e-mail addressed to AB99.Comments@uspto.gov.  Alternatively, comments can be submitted by regular mail addressed to:  Mail Stop Comments–Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to (571) 273-7754, marked to the attention of Kathleen Kahler Fonda.  Comments may also be sent by e-mail via the Federal eRulemaking Portal, which can be accessed here.

  •     By Kevin E. Noonan

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    Judge Paul Michel (at right), Chief Judge of the Court of Appeals for the Federal Circuit, recently had the opportunity to speak to a meeting of the Association of Corporate Patent Counsel, one of the preeminent patent law groups in the country and one of the most exclusive clubs:  attendance at the Association’s annual meeting is by invitation only.  During his talk, Judge Michel discussed the workings of the Federal Circuit, including the arbitration initiative (one of his pet projects), the aging of the Court (seven of the twelve judges will be eligible for senior status in the next few years), and the effects of recent Supreme Court decisions on the working of the Federal Circuit and patent law in general (evincing more equanimity than perhaps the Supreme Court could reasonably expect).

    He also spoke about the recent Congressional efforts to "reform" patent law, and while his equanimity didn’t slip, his frustration with these efforts was plainly evident.  Like many in the patent community, it is clear that Judge Michel recognizes the disconnect between the problems and issues that exist in patent law and the blunt instrument the proposed legislation represents ("it’s not a scalpel, it’s a hammer").  Specifically, Judge Michel noted the preponderance of academic input in the draft Senate Report on the bill, and the dearth of evidence in the cited articles and testimony.  Some have noticed, and reported on, the carelessness and sloppiness of what is passing for academic commentary on patent law (see "BIO Report Indicts "Patent Reform" Proponents"), and although too astute to mention it, the blatant, outcome-driven politics of both the commentators and the Congressional proponents of "reform."  Sticking to specifics, Judge Michel noted that one commentator, Amy Landers (below left), advocated the proposed changes in the damages provisions on the grounds that the changes "would inject some balance into the entire market-value rule, cutting back on the recent expansion of the rule."  Judge Michel confessed to (justifiable) surprise when a close reading of her article ("Let the Games Begin: Landers_amy_2
    Incentives to Innovation in the New Economy of Intellectual Property Law
    ") revealed no examples of any expansion of the rule.  That surprise turned to suspicion (of her scholarship if not her motives) when her passage that "a consistently over-broad application of the entire market-value rule threatens to chill innovation for those seeking to design, manufacture and sell products, or invest in such endeavors" cross-cited to another part of her article that was devoid of any examples of this "consistent practice."

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    He also cited the book, Innovation and its Discontents: How Our Broken Patent System is Endangering Innovation and Progress, and What to Do About It (although he did not mention it by name), where authors Adam Jaffe and Josh Lerner argue that damages law is "totally out of control."  Their example:  State Industries Inc. v. Mor-Flo Industries Inc. (Fed. Cir. 1991) (coincidentally, a decision penned by Judge Michel), which they allege permitted "double-dipping" by assessing damages on the basis of both a reasonable royalty and lost profits.  The problem with their analysis is that, according to Judge Michel, these two measures of damages were "for different products and different time periods" and was not double-dipping at all.  Worse — and illustrating the current penchant in patent law academia 204
    for one commentator to get it wrong and another to support his incorrect analysis by citing the first — another academic relied on by the draft Senate Report, Professor Viet Dinh (at left) (who Judge Michel describes as "a very well-known former official now at Georgetown Law School") cites the State Industries case as an example of how the entire market rule is misapplied, never bothering to explain the basis for this conclusion.

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    Judge Michel also cites Professor Mark Lemley (at right) of Stanford for another common practice:  the patent law strawman (although bogeyman might be more appropriate).  Citing Professor Lemley directly for the proposition that "[a]t a minimum, courts should consider technical expert testimony on the contribution the patented component makes to the entire product" but that "courts should go further, permitting survey evidence of customers about the reason they purchased the product and the attributes of that product they find useful," Judge Michel notes that he knows of no case where such evidence has been excluded or prohibited, and that there is no Federal Circuit precedent to that effect.  Although he won’t say it, clearly Professor Lemley would prefer influencing Congress to impose his ideas by fiat rather than having these ideas tested in the crucible of litigation.

    1577
    Another concern voiced by Judge Michel is the imbalance of the testimony heard by the Senate Judiciary Committee.  The draft Report states that "[n]o doubt several alarming cases, which have captured the attention of the public and the Congress, represent the tip of the iceberg.  These, not surprisingly, involve outsized damages awards," based on testimony from another academic, Professor John Thomas (at left), who analyzed ten cases in which he considered the damages awards to be excessive.  The Committee did not hear or consider a different report, from William Rooklidge (below right) (a practitioner), analyzing the same ten cases that came to the opposite conclusion (according to Judge Michel, that "the awards were not inappropriate or unjustifiable under the facts of the case and were not a misapplication of the entire market-value rule or any other aspect of the rule of damages").  Of course, coming from a mere practitioner, this study was not considered by the Committee.  Judge Michel noted a similar disparity of opinion obtained with regard to venue, where the Committee quoted witnesses from a few companies (such as Goldman Sachs, J.P. Morgan, and Visa) but had no input from "scores" of other industries.  Nor did Judge Michel find any reliance on the testimony of members of organizations like the American Bar Association, the American Intellectual Property Lawyers Association, or the Intellectual L32451_2
    Property Owners (despite submissions by all these groups of white papers and letters, none cited in the Senate draft report), all groups Judge Michel thinks are "broad-based groups of knowledgeable lawyers" whose input, apparently, the Committee felt it could do without.  The impression left with Judge Michel is that "only certain voices are being heard."

    All this misinformation and sloppy scholarship has consequences fully recognized by Judge Michel (and anyone else in the patent community who has been paying attention):  the creation of the (false) impression that the patent system is "broken" and in need of reform.  Judge Michel cites a recent posting on the Forbes.com website, where it is claimed that "the problem with the patent system in the courts as to how damages are handled is that damages ‘are based on the cost of an entire car when the patent covered an innovative tire’" (see Robert Weber, "Congress: Reform Those Patents" [Ed.: Mr Weber wrote: "So, why are we awarding patent damages based on the value of the entire car to the inventor of the tire?"]).  Mythology, Judge Michel rightly states, but he also recognizes (and mentioned in his remarks) that members of Congress are not in the position to separate the wheat from the chaff of these various voices in the chorus of concern over the parlous state of patent law.  It is too much to expect that these legislators, who are burdened with "the innumerable problems they face: the war in Iraq and economy . . . a stimulus package, a defense appropriation bill, a counterterrorism, electronic-surveillance bill . . . very tough stuff" will be able to understand "which of these assertions or claims are accurate, are supported, are not aberrational, not the famous anecdotal evidence but are representative of what really happens out there in industry or out there in the courts."

    Alluding to the televised sessions of the British Parliament questioning the Prime Minister, Judge Michel voiced concern that no one had asked the members of the Judiciary Committee questions like:

    • "Mr. Chairman, can you assure the House that the passage of this section four on damages will not seriously devalue the patent portfolios of every company in America?"
    • "Mr. Chairman, can you assure us that this bill won’t result in more jobs and U.S. wealth going overseas?"
    • "Mr. Chairman, can you assure us that there have been some studies about the effects that will allow us to know, with reasonable confidence, what the actual consequences of these changes will be?"

    He did voice his concern that these questions had not been considered by the committee.

    What Judge Michel didn’t say but others (like BIO CEO Bill Greenwood) have is that the Senate draft report, and S. 1145, was "hijacked" by certain special interests, and the impetus behind patent "reform" is not legal but political.  Whether specifically targeted to protect specific groups (like the bankers whom had their champion, Senator Sessions of Alabama, insert provisions immunizing them from past and future patent infringement) or by certain sectors seeking to cripple the capacity of patent holders to protect their inventions from corporate depredation, the bill ready to be sent to the floor is about everything but patent "reform."  Judge Michel reminded his listeners that he was not in a position to lobby or advise Congress on the wisdom (or its opposite) in considering this bill.  Many others have, and the rest of us should join them.

    A transcript of the address given by Chief Judge Michel can be found here.

    For additional information on this and other related topics, please see:

    • "The (Un)Intended Consequences of the Law," February 18, 2008
    • "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation – Part I," February 14, 2008
    • "BIO Report Indicts "Patent Reform" Proponents," February 13, 2008
    • "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008
    • "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008
    • "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008
    • "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008
    • "The Letters Keep Coming Over the Senate Transom," January 30, 2008
    • "U.S. Senate Mailbox Filling with Letters against Passage of Patent ‘Reform’ Bill: An Update," January 23, 2008
    • "U.S. Senate Mailbox Filling with Letters against Passage of Patent ‘Reform’ Bill," January 18, 2008
    • "Patent Reform Discussed on Senate Floor," December 21, 2007
    • "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry’s Radar," December 20, 2007
    • "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007
    • "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007
    • "Senate May Act on Patent ‘Reform’ Bill in the New Year," December 2, 2007
    • "The Wall Street Journal Gets It Half Right," November 5, 2007
    • "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
    • "Patent ‘Reform’ Bill Passes House of Representatives," September 9, 2007
    • "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007
    • "San Francisco Chronicle Opines on Patent Reform," August 6, 2007
    • "Patent Reform Bill to Be Delayed?" June 12, 2007
    • "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007
    • "Could Creating a U.S. ‘Utility Model’ Patent Fulfill the ‘Need’ for Patent Law Reform?" May 21, 2007

  •     By Jason Derry —

    Pfizer
    Pfizer Inc. has announced that it has an agreement in place to acquire Encysive Pharmaceuticals Inc. for about $195 million.  Encysive is a biotechnology company that has a product currently marketed in the European Union, and several other foreign markets, for treating pulmonary arterial hypertension.  The product, THELIN (sitaxsentan sodium), is an endothelin A receptor antagonist.  THELIN has been approved in Australia and Canada, but is still awaiting approval in the U.S.  Pfizer has indicated that it will conduct the necessary Phase III trial to move the Encysive_pharmaceuticals
    drug toward approval.  Encysive has several other drug candidates in its pipeline in various clinical stages of development.  Pfizer has indicated that Encysive will eventually be merged with a Pfizer subsidiary.

    For additional information, please see:

    • Reuters report

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Baltazar Gomez

    Astrazeneca_large
    AstraZeneca PLC announced last Thursday that it was spinning off a portion of its gastrointestinal research operations into new biotech company called Albireo.  Albireo will be financed by a syndicate including Nomura Phase4 Ventures, TVM Capital, and Scottish Widows Investment Partnership.  AstraZeneca will keep a significant minority stake in Albireo, in exchange for transferring the R&D assets to Albireo.  The announcement reflects a refocusing of research efforts by the drugmaker in response to pressure on profits from generic competition.

    Gastrointestinal disease has long been an important part of AstraZeneca’s business.  The company’s best-selling medication is the widely known heartburn and ulcer pill Nexium, which accounted for $5.2 billion in global sales last year.  However, AstraZeneca had previously stated that it planned to move away from gastrointestinal diseases unrelated to Nexium, so the creation of Albireo comes as no surprise.  Albireo will take over one experimental drug in clinical development and a number of pre-clinical gastrointestinal programs from AstraZeneca.