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  • Apotex Corp. v. Merck & Co., Inc. (Fed. Cir. 2007)

        By Donald Zuhn —

    Merck
    Last month, the Federal Circuit affirmed a District Court’s finding on summary judgment that Merck & Co., Inc. had not obtained favorable rulings in two prior proceedings by fraud.  The prior proceedings included an infringement suit involving U.S. Patent Nos. 5,573,780 (the ‘780 patent) and 5,690,962 (the ‘962 patent) owned by Apotex Corp., and Apotex’ appeal of that decision to the Federal Circuit.

    Apotex_1
    In 1996, Apotex had filed suit against Merck (Apotex I), contending that Merck’s process of formulating and producing enalapril tablets (under the brand name Vasotec®) infringed the ‘780 and ‘962 patents.  The District Court, however, determined that Merck had invented the claimed process before Apotex had made the invention, and therefore, found Apotex’ patents invalid under 35 U.S.C. § 102(g).  In 2001, the Federal Circuit affirmed the District Court’s finding (Apotex II).

    Msd07140
    In Apotex I and Apotex II, Apotex argued that Merck had suppressed or concealed its practice of the claimed invention, and therefore, that even if Merck had practiced the claimed process before Apotex, Merck’s practice of the claimed process infringed Apotex’ patents.  In Apotex I, the District Court rejected Apotex’ argument, finding that Merck had not suppressed or concealed the invention because it had widely distributed a list of ingredients for its enalapril tablets and because a Merck executive had narrated a videotape describing the Merck process during a Canadian trial in 1991.  In Apotex II, the Federal Circuit affirmed, determining that the narration of the Merck process in the Canadian trial constituted a public disclosure of the process.

    Following the unfavorable decisions in Apotex I and Apotex II, Apotex returned to the District Court (Apotex III), asserting that Merck had obtained favorable rulings in the two prior proceedings by fraud.  In particular, Apotex contended that Merck had misrepresented facts and made false statements in its summary judgment and appellate briefs (the alleged misrepresentations and false statements were primarily related to Merck’s ingredient list and narration of its process in the Canadian trial).  According to Apotex, Merck had admitted that it had made false statements when one of its key witnesses gave contradictory testimony in 2004 in a different case involving a related compound, quinapril.

    In Apotex III, the District Court again ruled against Apotex, finding that the 2004 testimony involved manufacturing details not disclosed or claimed in Apotex’ patents, and further, that many of the allegedly false statements constituted only attorney argument, rather than evidence or testimony.  The Federal Circuit again affirmed, finding that the District Court had correctly ruled that the evidence and argument adduced and presented at trial did not establish fraud.

    Apotex Corp. v. Merck & Co., Inc. (Fed. Cir. 2007)
    Panel: Circuit Judges Newman, Rader, and Prost
    Opinion by Circuit Judge Newman

    Additional information regarding this case can be found at Patently-O.

  • The OMB Isn’t Listening, Either

        By Kevin E. Noonan —

    Office_of_management_budget_omb_sea
    The Office of Management and Budget (OMB), the part of the Executive Branch charged with, among other things, assessing the economic impact of rules and regulations promulgated by various agencies of the Federal government, today issued its decision regarding the U.S. Patent and Trademark Office’s "Changes to Information Disclosure Statement Requirements and Other Related Matters" (new Information Disclosure Statement (IDS) rules).  The new IDS rules were published for comment on July 10, 2006, and submitted to the OMB on July 27, 2007.

    Uspto_seal
    The OMB determined that there would be no significant economic impact from the new IDS rules, which is the position espoused by the Patent Office.  (The OMB made the same decision, based on the same types of representations, with regard to the new continuation and claims rules now enjoined by Judge Cacheris in the GSK v. Dudas case, which is currently pending.)  This would be unremarkable, except for the fact that OMB received a great deal of information (and a great deal more information than it had regarding the new continuation and claims rules) that is directly contrary to its decision.  On October 17th, David Boundy of Cantor Fitzgerald, joined by representatives from across the technology, business, and not-for-profit spectrum (see list below), sent a detailed letter to Susan E. Dudley, the Administrator of OMB’s Office of Information and Regulatory Affairs, pointing out the deficiencies in the Patent Office’s analysis of the economic effects of the proposed IDS rules (see "Cantor Fitzgerald VP Criticizes IDS Rule in Letter to OMB").  After reminding Ms. Dudley of the Patent Office’s "shenanigans" concerning the purported lack of economic impact of the proposed continuation and claims rules, Mr. Boundy set forth an analysis showing that the new IDS rules would "impose billions of dollars of burden on patent applicants and owners."  Despite the assertions by the Patent Office that the new IDS rules would generate a "savings" for the Office, the amount was not specified on the Patent Office’s submission to the OMB nor was it reflected in the FY 2008 budget, according to Mr. Boundy.  He also alleged that the rules were contrary to binding case law, since they impose restrictions on the submission of prior art to the Office, contrary to an applicant’s duty of candor.  According to Mr. Boundy’s letter, the Patent Office will force applicants to violate the duty of candor merely to "ease the USPTO’s workload," despite the imposition of application, search, and examination fees meant to defray the cost of Office activities.

    Cantor_fitzgerald
    The substance of Mr. Boundy’s letter focused on the mechanics of compliance with the duty of candor, and how the proposed IDS rules interfere with an applicant being able to comply.  He describes the "Hobson’s choice" faced by applicants who will be permitted only to submit the "most material information" or to submit an Examination Support Document, the folly of which has been discussed in previous posts (see "USPTO Releases ESD Guidelines" and "37 C.F.R. § 1.265: Examination Support Document").  He also argues, as GSK argued in the preliminary injunction hearing before Judge Cacheris on the continuation and claims rules, that the proposed IDS rules will harm innovation and the patent system by discouraging one of its most important features:  public disclosure of inventions.  If defensible patent protection is uncertain, he argues, inventors and companies will utilize trade secret protection more often, to the public’s (ultimate) detriment.

    The letter also contains both practical and theoretical reasons why the proposed IDS rules are not viable, and evidence that their impact will fall on just those sectors (the most innovative and "important" industries) that can be expected to be (otherwise) at the forefront of innovation.  He even includes alternative proposals, including deferred examination and expanded peer-to-peer art search and review efforts.  The letter is also supported by an economic analysis by Phillip Steiner showing a $2 billion dollar economic impact, excerpts of testimony on the issue before Congress by Ronald Stern, the president of the patent examiner’s union, and a statistical analysis from Jennifer Johnson of Zymogenetics, illustrating how the proposed IDS rules will have a disparate impact on biotechnology and the pharmaceutical arts.  In addition to Mr. Boundy’s letter, letters were submitted by Dr. Richard Belzer (see "OMB Receives Second Letter Criticizing Proposed IDS Rule") and others.

    All of which, of course, fell on the deaf ears of the OMB.  It is clear that the various agencies meant to protect Americans from just this sort of ill-advised and economically dangerous rulemaking are all "singing from the same hymnbook," and that the only remedy (short of a court challenge as with the continuation and claims rules) is to wait out the waning days of the current administration.  The Patent Office has not announced when it will be promulgating these rules by publication of the final rules in the Federal Register, or whether Deputy Director Peterlin will be "pre-announcing" them to reporters at The Wall Street Journal, as she did with the new continuation and claims rules.  However, prudence suggests that the leaders of the industries that will be most affected by these rules changes get to work now, not later, to make plans to challenge the rules, either in the courts or otherwise.  U.S. innovation was fortunate in having Judge Chacheris’ clear-minded reasoning in setting aside (for now) the misguided continuation and claims rules.  We may not be that lucky a second time.

    Those joining in Mr. Boundy’s letter:

    • Bryan P. Lord, General Counsel, AmberWave Systems Corp
    • Dr. James E. Butler, Senior Director, Patents, Amylin Pharmaceuticals
    • Michael C. Schiffer, Vice President, General Patent Counsel, Beckman Coulter Inc.
    • David W. Highet, Vice President and Chief Intellectual Property Counsel, BD
    • Margaret M. Dunbar, Director, Intellectual Property, Burnham Institute for Medical Research
    • David L. Gollaher, President & CEO, California Healthcare Institute
    • Dean Alderucci, Chief Operating Officer and Assistant General Counsel, Innovation Division, Cantor Fitzgerald L.P.
    • Duane Roth, CEO, CONNECT
    • Jeffrey A. Birchak, Vice President, Intellectual Property, Fallbrook Technologies Inc.
    • David P. Vandagriff, Vice President – Intellectual Property, Helius, Inc.
    • Shirley Hubers, Vice President, Heritage Woods, Inc.
    • Marcus J. Millet, on behalf of Lerner, David, Littenberg, Krumholz & Mentlik, LLP
    • Michael Erlanger, Chairman and CEO, Marketcore, Inc.
    • Mark Nowotarski, Editor, Insurance IP Bulletin
    • Joe Kiani, Chairman and CEO, Masimo Corp.
    • Mark Leahey, Executive Director, Medical Devices Manufacturers’ Assn.
    • Neal Gutterson, Ph.D., President and Chief Executive Officer, Mendel Biotechnology, Inc.
    • Paul K. Laikind, Director, President, and CEO, Metabasis Therapeutics, Inc.
    • Reza Green, Chief Patent Counsel, Novo Nordisk Inc.
    • Douglas G. Lowenstein, Chairman & CEO, Polestar Capital Partners LLC
    • Liza K. Toth, Associate Chief Intellectual Property Counsel, Senior Director, SanDisk Corporation
    • Thomas Fitting, Chief Patent Counsel, The Scripps Research Institute
    • Kerry A. Flynn, Vice President, Intellectual Property, Shire
    • Derek P. Freyberg, Vice President, Intellectual Property, Telik, Inc.
    • David A. Manspeizer, Vice President – Intellectual Property and Associate General Counsel, Wyeth
    • Jennifer K. Johnson, Senior Associate General Counsel, Patents, ZymoGenetics, Inc.

    For more information on this topic, please see:

  • Margaret Peterlin Gets to Keep Her Job

        By Kevin E. Noonan —

    Seal11
    Judge James Robertson of the U.S. District Court for the District of Columbia has dismissed a private lawsuit challenging the appointment of Margaret Peterlin as Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the U.S. Patent and Trademark Office.

    The suit was brought by Greg Aharonian, noted intellectual property crusader; David Lentini and David Pressman, both patent attorneys and authors; and Steven Morsa, an inventor, based on the provisions of 35 U.S.C. § 3(b)(1) that the person holding Ms. Peterlin’s office must be a "citizen of the United States who has a professional background and experience in patent or trademark law."  Ms. Peterlin, a former Capitol Hill staffer, has no known experience relevant to her position.  According to the Complaint, she is not registered to practice before the U.S. Patent and Trademark Office, never "interacted" with a patent or trademark examiner, never prepared a legal opinion regarding validity or non-infringement of a patent or trademark, never drafted or prosecuted a patent or trademark application, never litigated a patent or trademark lawsuit, never published as legal or scholarly article on patent or trademark law, has never been a member of a legal (e.g., AIPLA) or industry (e.g., INTA or AUTM) group concerned with patents or trademarks, and does not have a science or engineering background.  Even as a staffer, Ms. Peterlin allegedly was not involved in intellectual property matters when working for Representative Hastert (R-IL) in Congress.

    Peterlin_maragret
    None of this mattered to the Court, which did not reach the merits.  The Court dismissed the complaint on the grounds that Congress expressly did not provide a private cause of action with regard to two of plaintiffs’ grounds for the complaint.  First, that Ms. Peterlin’s (at left) alleged lack of statutory competence for her position was relevant to an asserted "serious deterioration in the quality of issued patents and trademarks, the timeliness of examination of patent and trademark applications, and the overall morale of patent and trademark examiners, as a result of senior management who lack professional experience in patent and trademark law" (emphasis added).  Second, that the U.S. Patent and Trademark Office "has a history of labor relations problems with the corps of examiners that is exacerbated by the lack of professional patent and trademark experience in among the most senior USPTO managers."  Defendants had made this argument in their motion to dismiss, which was undisputed (or, at least, unopposed) by plaintiffs, and thus the Court easily dismissed the complaint on these grounds, citing FDIC v. Bender, 127 F.3d 58, 67-68 (D.C. Cir. 1997) that "when a plaintiff files an opposition to a motion to dismiss addressing only certain arguments raised by the defendant, a court may treat those arguments that the plaintiff failed to address as conceded."

    The third basis for the complaint, that appointment of Ms. Peterlin violated the Administrative Procedures Act (APA) by being "arbitrary, capricious or contrary to law," garnered more consideration by the Court but ultimately led to the same result.  The Court said that while the APA provided a cause of action, the patent statute, specifically § 3(b)(1), precluded judicial review because the statute "lacks standards that a court could meaningfully use in evaluating this type of high-level personnel decision."  The Court said that the vagueness and "highly subjective" standard enunciated by the statute made the decision of whom to appoint to the Deputy Director position properly "committed to agency discretion by law," citing 5 U.S.C. § 701(a)(2) and Webster v. Doe, 486 U.S. 592 (1988).  The Court set forth a number of considerations that could be raised (and some of which were raised in the complaint), and could find no statutory guidance from Congress on which of these criteria should be applied.  The Court also cautioned that, should the APA provide judicial review of this type of appointment, the determination of who was qualified for an executive position would not only be outside the province of the executive branch, but would fall to the judiciary absent an explicit expression of Congressional intent.  The Court deigned not to find this responsibility in the judiciary absent more direct instructions in the statute.

    Ms. Peterlin thus has another thirteen months or so to make whatever mark she will on the procedures and practices of the U.S. Patent and Trademark Office.  Although not subject to judicial expulsion, it is not too much to hope that she will acknowledge whatever deficiencies are in her background and experience that limit or prevent her from exercising the duties of her office effectively, and reach out to her various constituencies – patent and trademark examiners, inventors and applicants, the patent and trademark bar, and the public – that could help her be most effective.  Besides holding out the prospect of actually addressing the real problems besetting the Office, any such behavior from Ms. Peterlin would be a refreshing change from the hostility and adversarial stance taken in recent times by Patent Office management.

  • Court Report

        By Sherri Oslick —

    Gavel_2
    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.


    Abbott Laboratories v. Zydus Pharmaceuticals (USA), Inc.
    3:07-cv-05821; filed December 6, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,511,678 ("Controlled Release Formulation of Divalproex Sodium," issued January 28, 2003), 6,528,090 (same title, issued March 4, 2003), 6,713,086 (same title, issued March 30, 2004), and 6,720,004 (same title, issued April 13, 2004) following a paragraph IV certification as part of Zydus’ filing of an ANDA to manufacture a generic version of Abbott’s Depakote® ER (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches).  View the complaint here.


    Human Genome Sciences Inc. v. Immunex Corp. et al.
    1:07-cv-00780; filed November 30, 2007 in the District Court of Delaware

    Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Immunex (now Amgen) in the interference between U.S. Patent Application 09/378,045 ("Receptor That Binds TRAIL"), assigned to Immunex and U.S. Patent No. 6,872,568 ("Death Domain Containing Receptor 5," issued March 29, 2005), assigned to Human Genome Sciences.  View the complaint here.


    Sepracor Inc. et al. v. Anchen Pharmaceuticals, Inc.
    3:07-cv-05737; filed November 30, 2007 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 Anchen’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex® (desloratidine, used to treat allergies).  View the complaint here.


    Schering Corporation v. Anchen Pharmaceuticals, Inc.
    2:07-cv-07840; filed November 30, 2007 in the Central District of California

    Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Anchen’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).  View the complaint here.


    Senju Pharmaceutical Co. Ltd. et al. v. Apotex Inc. et al.
    1:07-cv-00779; filed November 29, 2007 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued on December 25, 2001), following a paragraph IV certification as part of Apotex’s filing of an ANDA to manufacture a generic version of plaintiff’s Zymar® (gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis).  View the complaint here.


    Sun Pharmaceutical Industries, Limited v. Eli Lilly and Company
    2:07-cv-15087; filed November 29, 2007 in the Eastern District of Michigan

    Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 5,464,826 ("Method of Treating Tumors in Mammals with 2′,2′-difluoronucleosides," issued November 7, 1995) in conjunction with Sun’s filing of an ANDA to manufacture a generic version of Eli Lilly’s Gemzar® (gemcitabine hydrochloride for injection, used to treat non-small cell lung cancer, pancreatic cancer, breast cancer, and ovarian cancer).  View the complaint here.  As reported here, Eli Lilly had filed suit against Sun in the Southern District of Indiana; the case was voluntarily dismissed without prejudice by Eli Lilly.

  • Conference & CLE Calendar

    Calendar_2
    December 13, 2007 – Pharmaceutical and Biotech Patent Law: Recent Developments (Practising Law Institute)

    January 4-8, 2008 – 25th Annual National CLE Conference (law Education Institute, Inc.) – Vail, CO

    January 9, 2008 – Patent Claim Construction (Law Seminars International) – San Francisco, CA

    January 25-26, 2008 – Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets (Law Seminars International) – San Francisco, CA

    January 30-February 1, 2008 – Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY***

    February 15, 2008 – Patent Claim Construction (Law Seminars International) – Chicago, IL

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

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

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

  • PRG Offers Advanced IP Courses

    The site for the Patent Resources Group (PRG) Advanced Courses this Spring is in Bonita Springs, FL.  The usual courses will be offered, including:  Chemical Patent Practice; Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, Litigation & Licensing; and a new course entitled FDA Orange Book and Listable Small Molecule Patent Practice.  A number of other courses relating to licensing, patent drafting, and litigation are also available.  A complete course listing can be found on the PRG website.  CLE credit is available for these comprehensive courses.  Some of the courses are offered March 30 to April 1, 2008, while others are offered April 3-5, 2008.  A one-day course entitled Inequitable Conduct Under Current Federal Circuit Law is offered April 2, 2008.

    Patent_resources_group_prg

  • BIO Issues Statement Regarding USPTO Performance Report

        By Donald Zuhn —

    Biotechnology_industry_organization
    On Monday, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released a statement regarding the 2007 Performance and Accountability Report issued by the U.S. Patent and Trademark Office on November 15th (see "USPTO Announces "Record Breaking" 2007 Performance").  At the time of the report’s release, the Patent Office stated that the report’s numbers "reveal historic improvement in the quality of patent and trademark reviews and subsequently the quality of issued patents and registered trademarks."

    Greenwood_jim
    According to Mr. Greenwood (at left), the report shows a high number of new patent applications and issuances in 2007 and "marked improvement in the quality of patents issued, demonstrating a more rigorous process of patent examination."  In view of the report’s findings, Mr. Greenwood urges the Senate, which is considering its own patent reform bill (see "Senate May Act on Patent "Reform" Bill in the New Year"), to "tread carefully and deliberately when considering patent reform."  Mr. Greenwood contends that the Patent Office report "undermine[s] the calls for draconian ‘reforms’ to the patent system," and argues that the report clearly indicates that "the fundamentals of our current system are sound, and improving over time."  Mr. Greenwood also contends that patent reform proposals that "encourage infringement and weaken the certainty and predictability of patents must be rejected," since "[s]uch proposals would discourage investment in innovative industries such as biotech, in which it often takes more than a decade and hundreds of millions of dollars to bring a product to market."

    For additional information on this topic, please see:

  • Genentech Beset with Avastin® Woes

        By Kevin E. Noonan —

    Genentech
    For the past several months, Genentech has been assailed by ophthalmologists and patients over its decision to ban compounding pharmacies from reformulating its anticancer drug Avastin® (bevacizumab, a monoclonal antibody) to be used for treating neovascular or "wet" age-related macular degeneration (AMD), a condition that if untreated leads inexorably to blindness (see "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration").  This use of Avastin® is an off-label use; Genentech makes a related drug, Lucentis® (ranibizumab injection), that has been approved for AMD treatment.  The choice of the off-label use is related to the cost differential between the drugs:  Avastin® treatment costs from $20-60 per dose, while Lucentis® treatments cost $2,000/dose.  Since neither drug is a cure for AMD, patients require maintenance doses substantially for the remainder of their lives.  The cost differential is due to both differences in cost (Avastin® is priced at only $600/vial) and because it is injected into the eye at such small doses (0.1cc) that each vial can deliver 30 doses ($20/dose).

    Although initially defending their decision (see "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration"), more recently the company has responded in a more conciliatory way to the outrage, protests, and threats of political and legal action from its customers and their physicians (see "Age-related Macular Degeneration Patients Get a (Limited) Reprieve").  For example, the company recently postponed the deadline for its compounding pharmacy ban from November 30th to the end of the year.  It has also taken steps to explain its position to organized ophthalmology groups like the American Society of Retinal Specialists (ASRS) and American Association of Ophthalmologists (AAO), particularly with regard to the relationship between its ban and FDA concerns over sterility and packaging of the reformulated Avastin®, and concerns that Avastin® had not been "designed, manufactured or approved" for the off-label use.

    Kohl_senator
    While these latest actions have been applauded by these organizations, the decision to ban compounding formulary from diluting Avastin®, and the original handling of the decision and how it was presented to the AMD community, prompted threats of political action.  It seems that despite its efforts to recoup lost goodwill, Genentech now faces just this kind of political action.  On October 18th, Senator Herb Kohl (D-WI) (at left), Chairman of the Senate’s Special Committee of Aging, sent a letter to Kerry Weems, Acting Administrator of the Center of Medicare and Medicaid Resources regarding the proposed ban.  Citing an October 12th Wall Street Journal article on the topic, Senator Kohl termed Genentech’s decision "troubling," particularly since he understood the action was taken to boost sales of Genentech’s Lucentis®.  The Senator cited a particular portion of the Journal article that predicted an increase of from $1 billion to $3 billion per year in Medicare costs due to the ban, and stated that any action that would impose such increased costs on American taxpayers concerned him.  Senator Kohl also cited testimony from another physician’s group, Physicians for Clinical Responsibility, regarding Genentech’s lack of cooperation with a National Eye Institute study comparing the efficacy of AMD treatment between Lucentis® and Avastin®.

    The Senator was clear about what he wanted:  he asked Administrator Weems to provide the answers to two questions:

    1.) How much has Medicare spent on Lucentis and Avastin during the period 2005-present?

    2.) What measures, if any, have CMS officials taken to explore the reduction of expenditures on expensive drugs such as Lucentis by using alternative treatments such as Avastin?

    Senator Kohl ended his letter by saying that saving taxpayer dollars was of the "utmost importance," implying further action if he and his committee did not receive satisfactory answers.

    Fda
    And if that weren’t enough bad news, on Monday the Food and Drug Administration’s Oncologic Drugs Advisory Committee released a report that showed that even though Avastin® slowed the spread of metastatic breast cancer in the breast cancer sufferers in the study, it did not increase overall survival times.  At the same time, including Avastin® with more conventional breast cancer chemotherapeutic treatments, such as paclitaxel, increased (by 20%) the incidence of serious side effects, including heart attack, stroke, bleeding, and other complications, including six deaths in 363 study subjects.  An advisory committee voted 5-4 yesterday against approval of Avastin® for combination chemotherapy in breast cancer.  Although the final decision will be made by FDA, the agency typically follows the advice of its advisory committees, which are made up of physicians and other experts.  It is thus possible that Genentech’s problems over the Avastin®/Lucentis® situation are far from over.

    For additional information on this topic, please see:

  • USPTO News: USPTO e-Commerce Update

        By Christopher P. Singer —

    PDX Program

    Uspto_seal
    In an e-Commerce alert notice sent by e-mail today, December 5, 2007, the USPTO provides a number of tips for completing a successful priority document exchange (PDX) request.  Throughout the past year, the USPTO began exchanging priority documents electronically with the EPO and JPO through secure electronic connections at no cost to applicants.  Since the time this PDX program began, a number of requests have been filed incorrectly (and thus denied) because Applicants are not authorizing release of a copy of unpublished U.S. applications.  The USPTO encourages that applicants file the Form PTO/SB/39 with the USPTO in order to authorize release of unpublished U.S. applications, and provide a checklist for successful filing:

    • Log into EFS-Web as a Registered e-Filer.
    • Certify your identity.
    • A request can be made at the time of filing a new application or as a follow-on document.  If you are filing a follow-on document, select "Existing application/patent" on the filing type selection screen following log in.
    • After selecting "Existing application/patent," enter the Application Number and Confirmation Number in the appropriate fields.
    • To authorize the USPTO to electronically transmit Official Priority Documents to the EPO or JPO and enter them into the file wrapper, attach a completed Form PTO/SB/39 on the Attach Documents screen in EFS-Web.  Form PTO/SB/39 must be signed in accordance with 37 C.F.R. § 1.14(c).  See 37 C.F.R. § 1.14(h)(2).  The form can be found here.
    • Select "Priority Documents" from the Category drop-down list.
    • Select "Authorization to Access Application by Trilateral Office" from the Document Description drop-down list.
    • Click "Upload and Validate" button.
    • Review your documents and select "Continue."
    • There are no fees associated with requesting priority documents.  If there are no other fees due, proceed and click "Submit."

    Alternatively, Form PTO/SB/39 can be faxed to the Central Fax number at 571-273-8300 or mailed to: Commissioner of Patents, P.O. Box 1450, Alexandria VA 22313-1450.  More information about the PDX program can be found here.

    EFS-Web 1.2

    Efsweb
    The USPTO has provided a link describing the new enhancements made to EFS-Web with the 1.2 release last month.  Enhancements include a fillable cover sheet for provisional applications, an enhanced pay fees page which lists fees based on the particular type of filing, pop-up warnings when attaching problematic documents, and a link to the Electronic Patent Assignment System (ePAS) which allows certain data fields in ePAS to be pre-populated using information from EFS-Web.

    Document Descriptions

    The Office again is stressing the importance of choosing the correct document description when filing using EFS-Web.  One "quick hint" you can use while filing is clicking on the blue "i" information icon found near Document Descriptions, when attaching a document.  A new window will open with a list of all available document descriptions.  The official USPTO business process description for each document type is provided to help proper indexing of documents.  A complete list of document descriptions can be found here.  Additional help on how to index your documents can be found here.

  • Why Does Flu Season Happen in Winter?

        By Kevin E. Noonan —

    It is always surprising to non-scientists when they discover how little we know about the answers to some fundamental questions.  Everyone knows, of course, the paradox that "we can land a man on the moon, but we can’t prevent the common cold."  More esoterically, Dr. J.R. Powell at Yale University once published a paper with his mentor, Theodosius Dobzhansky, asking the simple question:  "How far do fruit flies fly?" about the common genetic lab animal, Drosophila.  But recently the answer to a more pertinent question was established by workers in New York:  why does flu season occur in winter?   

    Flu
    This is a question that has vexed researchers for decades, even as the phenomenon has been well established:  on either side of the equator, the flu strikes in wintertime, and in the tropics (which have no "winter") there isn’t much flu or flu season at all.  Anecdotal explanations, such as crowding indoors amongst school children, were unsatisfactory in light of similar crowding in autumn with little influenza infection.  Efforts towards establishing an answer experimentally have been thwarted by the absence of a convenient laboratory animal with which to conduct a study, since the ideal candidate, the human population, is properly off-limits.

    Palese_peter
    Which is where persistence, perspicacity, and serendipity come in.  Dr. Peter Palese (at left), a renowned microbiologist and flu researcher, has the answer, which is elegant in its simplicity, and he got it from a hint found in reports dating from the infamous 1918 "Spanish flu" pandemic that killed millions.  As reported today by Gina Kolata of The New York Times (herself a renowned popular science writer), Dr. Palese noticed that an American Medical Association report from 1919 about the flu epidemic at Camp Cody in New Mexico mentioned that all the guinea pigs (of all things) died shortly after the influenza outbreak, and that necropsy showed their deaths were the result of pneumonia.  Dr. Palese tested guinea pigs for influenza infection and found, remarkably, that they are susceptible to infection with the virus and could spread it from one animal to another (a key difference with mice, who get the flu but can’t pass it to other mice). 

    Having "found" his experimental animal, the experiments themselves were straightforward.  Dr. Palese and his colleagues tested the effects of environmental temperature and humidity on the frequency of influenza infection in these guinea pigs.  They found that viral transmission decreased as the temperature and humidity increased, and that the best conditions for transmission were when the air was cold (41°F) and dry (20% humidity) – just the conditions that occur in the temperate zones during winter.  This also confirms that, unlike cold viruses that spread from direct physical contact between individuals, the flu is spread through the air like a medieval miasma.  The virus is suspended in water droplets from coughs and sneezes and persists suspended in air longer under cold and dry conditions, according to Dr. Palese. 

    It is not clear that this new information suggests anything about how to avoid the flu (Dr. Palese recommends getting a flu shot) other than providing a reason to ensure that indoor temperature and humidity is not allowed to plummet in winter in a misguided effort to save heating costs in public institutions or to avoid "mollycoddling" youngsters.  It does suggest that there may be more harm than good in avoiding dramatic changes in temperature as children go from outdoors to indoors in winter, since it is certainly likely that human transmission is influenced by population density, and crowded schools are a great place to transmit airborne viruses.  But besides these possible practical consequences, Dr. Palese’s work can be seen as a satisfying answer to another nagging question about the world.  There is a benefit to answering these questions, the benefit of reducing even incrementally our vast ignorance about the natural world, that makes the answer, and the story behind the answer, sufficient in itself for celebration.

    For those interested in the details, Dr. Palese’s report was originally published in the October 19th issue of PLoS Pathogens.