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  • Astellas Pharma, King Pharmaceuticals, and Teva Settle Adenoscan® Patent Suit

        By Baltazar Gomez —

    Astellas
    Last month, Astellas Pharma Inc., King Pharmaceuticals, Inc., and Teva Pharmaceutical Industries Ltd. announced that U.S. subsidiaries of Astellas, along with Item Development AB and King have signed settlement agreements with respect to U.S. Patent Nos. 5,731,296 and 5,070,877.  The lawsuits involving the ‘296 and ‘877 patents were filed against Teva’s subsidiaries after the subsidiaries submitted abbreviated new drug applications for a generic version of Adenoscan® (adenosine injection), a pharmacologic stress agent.  Under the terms of the settlement agreement, Teva will be able to launch their generic version of Adenoscan® pursuant to a license in September 2012, or earlier under certain conditions.

    Mainlogo
    Adenoscan® is licensed and sold by Astellas in the U.S. as a pharmacologic stress agent and as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.  Adenoscan shows consistent maximal vasodilation of coronary arteries relative to intracoronary papaverine.  The short half-life of Adenoscan® allows for short-acting pharmacologic effects, making Adenoscan® useful for diagnostic and risk evaluation in coronary artery disease.

    Teva_1
    Astellas Pharma U.S. Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc.  Astellas is a pharmaceutical company that focuses on the areas of immunology, urology, anti-infectives, cardiovascular, and dermatology.  King Pharmaceuticals, Inc., headquartered in Bristiol, Tennessee, develops novel branded prescription pharmaceuticals and acquires branded products.  Teva Pharmaceutical Industries Ltd., headquartered in Israel, develops, manufactures, and markets generic and human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

    For additional information regarding the settlement, please see:

  • Court Report

        By Sherri Oslick —

    Gavel_4
    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. Banner Pharmacaps Inc.
    1:07-cv-00754; filed November 21, 2007 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 4,988,731 ("Sodium Hydrogen Divalproate Oligomer," issued January 29, 1991) and 5,212,326 (same title, issued May 18, 1993) following a paragraph IV certification as part of Banner’s filing of an ANDA to manufacture a generic version of Abbott’s Depakote® (divalproex sodium, used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches).  View the complaint here.


    Novartis Vaccines and Diagnostics, Inc. v. Hoffmann-La Roche Inc.
    2:07-cv-00507; filed November 19, 2007 in the Eastern District of Texas

    Infringement of U.S. Patent No. 7,285,271 ("Antigenic Composition Comprising an HIV gag or env Polypeptide," issued October 23,2007) based on Roche’s manufacture and sale of its FUZEON® (enfuvirtide, used to treat HIV infection).  View the complaint here.


    Elan Corporation PLC et al. v. Barr Laboratories Inc.
    1:07-cv-00736; filed November 16, 2007 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Novartis’ Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Celgene Corporation et al. v. Barr Laboratories, Inc. et al.
    2:07-cv-05552; filed November 16, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), and 6,635,284 (same title, issued October 21, 2003), all licensed exclusively to Novartis in certain fields of use, following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Novartis’ Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
    1:07-cv-00731; filed November 15, 2007 in the District Court of Delaware

    Declaratory judgment that Impax’s Paragraph IV notices are null, void, and without legal effect, that the Court therefore has no subject matter jurisdiction over the claims surrounding the patents at issue, that Impax’s notices did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act, and that Impax must serve new Paragraph IV notices upon Endo if and when the FDA accepts Impax’s ANDA.  Also, infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a paragraph IV certification as part of Impax’s filing of an ANDA to manufacture a generic version of Endo’s Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.


    Teva Pharmaceutical Industries Ltd. et al. v. Apotex, Inc. et al.
    3:07-cv-05514; filed November 15, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,699,997 ("Carvedilol," issued March 2, 2004), 6,710,184 ("Crystalline Solids of Carvedilol and Processes for Their Preparation," issued March 23, 2004), 7,056,942 ("Carvedilol," issued June 6, 2006), and 7,126,008 (same title, issued October 24, 2006) based on Apotex’s sale and/or manufacture of a generic version of GSK’s Coreg® (carvedilol, used to treat congestive heart failure).  View the complaint here.


    Allergan, Inc. v. Cayman Chemical Company et al.
    8:07-cv-01316; filed November 7, 2007 in the Central District of California

    Infringement of U.S. Patent No. 6,262,105 ("Method of Enhancing Hair Growth," issued July 17, 2001) based on defendants manufacture and sale of eyelash growth products with prostaglandin F ("PGF") as the active ingredient (Allergan’s Lumigan® ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension, contains a PFG as the active ingredient).  View the complaint here.

  • Conference & CLE Calendar

    Calendar_4
    December 3, 2007 – 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice – PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

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

    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

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

  • Happy Thanksgiving from Patent Docs

    Thanksgiving
    The authors and contributors of Patent Docs wish their readers a Happy Thanksgiving.  Publication of Patent Docs will resume on November 25th.

  • Mitt Romney on Patents

    A Reason for Thanksgiving

        By Kevin E. Noonan —

    Patent law is no longer the backwater it resembled prior to the creation of the Federal Circuit, but it rarely receives the limelight of national attention.  Until recently, that is, when it seems every editorial and pundit is weighing in on how "broken" the patent system is and how great is the need for patent "reform."  Even Judge Cacheris’ decision to stay implementation of the Patent and Trademark Office’s ill-conceived "new rules" received scant attention from national media outlets.

    Romney_mitt
    So it comes as a pleasant surprise that a leading contender for President, Governor Mitt Romney of Massachusetts (at right), released today a fundraising letter focusing on the Judge’s stay and the importance of patents to American innovation.  Significant portions of the letter include:

    As you know, I have continuously advocated a strong U.S. economy.  I firmly believe that part of the underpinnings of our strong economy is the protection offered by a strong U.S. patent system.

    In that regard, thank you for sending the legal briefs and the October 31, 2007 decision of James C. Cacheris, United States District Court Judge in the Eastern District of Virginia, in the case of SmithKline Beecham Corporation v. Jon W. Dudas.  Through your discussion with my policy staff, I am aware that Judge Cacheris granted a preliminary injunction in the SmithKline decision against the United States Patent and Trademark Office (PTO), to stay the implementation of the highly controversial August 21, 2007 final rules until the resolution of the lawsuit.  I understand that you and many others strongly oppose the final rules as weakening the patent system.

    Numerous amicus briefs were filed in this lawsuit, all opposing the implementation of the new rules by the PTO.

    With his preliminary injunction against the PTO, Judge Cacheris emphasized the importance of a dependable patent system to protect the significant investment capital of innovators.  I applaud his decision.  If I am privileged to serve as President of the United States, a tenet of my administration will be to strengthen the U.S. patent system and immunize it from the type of anti-innovation governmental meddling duly enjoined by Judge Cacheris.

    Even more importantly, Governor Romney pledged actions long called-for by members of the patent community:

    In particular, I have the following initial goals:

    (1) Ensure that the Undersecretary of Commerce and Director of the PTO will be a distinguished U.S. patent lawyer with many years of experience.

    (2) Propose to Congress and/or support only such patent reform legislation as will strengthen the U.S. patent system.

    (3) Carefully consider appointing to the United States Court of Appeals for the Federal Circuit, as vacancies arise, excellent lawyers who have experience practicing U.S. patent law, particularly since all decisions in patent cases by the United States district courts are appealable to the Federal Circuit.

    Governor Romney has clearly been speaking with someone who understands the issues facing patent applicants in the face of the recent "anti-patent" activities of interest and industry groups, Congress, and the administration of the Patent Office.  Regardless of Governor Romney’s chances at his party’s nomination or, ultimately, the Presidency, this letter lifts patent law (at least for a day) into the national policy debate usually limited to issues like Iraq and immigration.

    Obama_barack
    Which, of course raises the issue of what the other candidates think about IP.  Senator Barack Obama (at left) has gotten most of his publicity on the issue from his support for a Senate bill banning patents on tax-avoidance strategies (S 2369).  However, his official campaign website has the following policy statements about protecting technology and patent reform:

    Protect American Intellectual Property Abroad:  The Motion Picture Association of America estimates that in 2005, more than nine of every 10 DVDs sold in China were illegal copies.  The U.S. Trade Representative said 80 percent of all counterfeit products seized at U.S. borders still come from China.  Barack Obama will work to ensure intellectual property is protected in foreign markets, and promote greater cooperation on international standards that allow our technologies to compete everywhere.

    Protect Intellectual Property at Home:  Intellectual property is to the digital age what physical goods were to the industrial age.  Barack Obama believes we need to update and reform our copyright and patent systems to promote civic discourse, innovation and investment while ensuring that intellectual property owners are fairly treated.

    Reform the Patent System:  A system that produces timely, high-quality patents is essential for global competitiveness in the 21st century.  By improving predictability and clarity in our patent system, we will help foster an environment that encourages innovation.  Giving the Patent and Trademark Office (PTO) the resources to improve patent quality and opening up the patent process to citizen review will reduce the uncertainty and wasteful litigation that is currently a significant drag on innovation.  With better informational resources, the Patent and Trademark Office could offer patent applicants who know they have significant inventions the option of a rigorous and public peer review that would produce a "gold-plated" patent much less vulnerable to court challenge.  Where dubious patents are being asserted, the PTO could conduct low-cost, timely administrative proceedings to determine patent validity.  As president, Barack Obama will ensure that our patent laws protect legitimate rights while not stifling innovation and collaboration.

    Edwards_johnSenator John Edwards (at right) has the following as part of his plan to reduce health care costs:

    Improving the Patent System and the FDA:  The patent system sometimes encourages greater investment in profitable but minor innovation ("me-too drugs") than in the costly and speculative research that generates true breakthroughs.  In 2005, only 20 percent of FDA approved drugs were new molecular entities.  In addition, the patent system gives companies long-term monopolies that can make life-saving drugs prohibitively costly for patients.  Edwards will convene an expert panel to explore whether there are certain key disorders where prizes for breakthroughs – as an alternative to patent monopolies – would offer new incentives to researchers, guaranteed gains to companies, and lower costs to patients.  Prizes would supplement, but not replace, the current patent system.  Additionally, Edwards will eliminate loopholes and trade obstacles that block generic drugs and let the FDA approve biogenerics, saving up to $43 billion over 10 years. [Woolley, 2006; Stiglitz, 2005; CAGW, 2007]

    Senator John McCain, Mayor Rudy Giuliani, Senator Hillary Clinton, Governor Bill Richardson, Senator Joseph Biden, Governor Michael Huckabee, Senator Christopher Dodd, Senator Michael Gravel, Senator Fred Thompson, Congressman Duncan Hunter, Congressman Tom Tancredo, Congressman Ron Paul, and Congressman Dennis Kucinich do not specifically address intellectual property issues on their campaign websites.

  • Patent Profile: Avicena Group Announces Issuance of Patent for ALS Therapeutic

        By Donald Zuhn —

    Theavicenagroupinc
    Last week, Avicena Group, Inc. announced that it had been granted U.S. Patent No. 7,285,573.  The ‘573 patent, which relates to use of creatine (lower left) and creatine phosphate (lower right) for treating amyotropic lateral sclerosis (ALS) or "Lou Gehrig’s Disease," is the fifth U.S. patent to be awarded to the Palo Alto, California-based biotech company.

    Creatine
    According to the statement released by Avicena, the ‘573 patent "provides further protection for the Company’s growing portfolio of drug candidates for the treatment of ALS, which are designed to slow disease progression and improve the quality of life for patients."  Among Avicena’s ALS drug candidates are AL-02 and AL-08, which have been the subjects of Phase II/III trials conducted by the Northeast ALS Consortium (NEALS), Carolinas Medical Center, and Utrecht University.  The results of these trials indicate that Avicena’s ALS drug candidates show a 1.47-fold increase in median survival compared to results in patients taking a placebo.  Avcena Chairman and CEO Dr. Belinda Tsao Nivaggioli stated that the company was "very excited about the prospects of AL-02 for the treatment of ALS" and was currently preparing for confirmatory Phase III trials in early 2008.

    Creatine_phosphate
    The ‘573 patent issued from U.S. Application No. 10/718,846, filed November 21, 2003, and claims the benefit of U.S. Application No. 08/853,174 (which issued as U.S. Patent No. 6,706,764), which was a national stage application of International Application No. PCT/US95/14567, which claims the benefit of U.S. Application No. No. 08/336,388, filed November 8, 1994.  Representative independent claims 1, 3, 5, and 7 of the ‘573 patent recite:

    1.  A method for treating a subject afflicted with amyotrophic lateral sclerosis, comprising administering to the subject an amount of creatine, such that the subject is treated for amyotrophic lateral sclerosis.

    3.  A method for treating a subject afflicted with amyotrophic lateral sclerosis, comprising administering to the subject an amount of creatine phosphate, such that the subject is treated for amyotrophic lateral sclerosis.

    5.  A method for reducing progression of amyotrophic lateral sclerosis in a subject, comprising administering to the subject an amount of creatine, such that the progression of amyotrophic lateral sclerosis in said subject is reduced.

    7.  A method for reducing progression of amyotrophic lateral sclerosis in a subject, comprising administering to the subject an amount of creatine phosphate, such that the progression of amyotrophic lateral sclerosis in said subject is reduced.

  • IPO Announces Program Changes for PTO Day

    IPO #2 Earlier this month, we reported that the Intellectual Property Owners Association (IPO) and the U.S. Patent and Trademark Office would be co-sponsoring the 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice (PTO Day) on December 3, 2007 in Washington, D.C.  At the time, we stated that it would be interesting to see whether some of the scheduled topics will change in view of the recent decision in the consolidated cases of Tafas v. Dudas and SmithKline Beecham Corp. v. Dudas.

    Uspto_seal
    Today, the IPO announced that because of the "holdup" of the new continuation and claims rules, previously scheduled topics on the new rules were being replaced with other topics.  In the patent portion of the revised program, the presentation entitled "Understanding the New Patent Rules on Continuations and Claims" will be replaced with a presentation entitled "Implications of Patent Reform Legislation for USPTO Practice," and the patent-related breakout session concerning "Questions and Answers on the Continuations and Claims Rules" will be replaced with a breakout session regarding "Selected Patent Practice Tips, Initiatives, and Guidelines."

  • A Simple Question about Patent Quality

        By Kevin E. Noonan —

    Let’s put our cards on the table.  The zeitgeist in the patent world these days is that the U.S. Patent and Trademark Office engaged in a frenzy of granting "bad" patents over the past few years, and that the issue of patent "quality" has caused a crisis in the Patent Office that cries out for "reform" (see "The IPO’s Marc Adler on Patent ‘Quality‘").

    Since "one man’s ceiling is (frequently) another man’s floor," there is the distinct possibility that "quality," like beauty is in the eye of the beholder.  "Everybody knows" that there are bad patents out there, but so far as I know, what "everybody knows" is in the sphere of anecdotal evidence (like many herbal cures, UFO sightings, and urban myths).

    Wanted_bad_patents
    So we here at Patent Docs are posing a simple challenge for our readers.  We are inviting our readers to send us the Patent Number for any patent granted between U.S. Patent No. 7,296,299, which issued on November 13, 2007, and U.S. Patent No.
    5,296,299, which issued on March 22, 1994, that you believe is a "bad" patent.  That’s a range of two million and one patents.  It would help if the submitter told us why he or she thinks the patent is a "bad" patent, but we are most interested in obtaining as many allegations of "bad" patents as we can.

    We do not want to ask for any similar number of "bad" applications for a number of reasons.  First, some bad applications are easy to spot, and to dismiss – perpetual motion machines, laws of nature, and clearly unpatentable subject matter for example.  Also, every American has the right to apply for a patent, even on the most simple device, and nothing in the statute permits the Office to prevent a patent application, however looney, from being filed.  (And, of course, many perfectly good inventions look a little looney when they are first proposed – talking through wires, indeed!).  Finally, bad applications aren’t identified as the problem, bad patents are, and that’s where we would like to keep the focus of these efforts.

    We can’t predict the number of responses we will get, but we would like to see what we get once our readers get past the "peanut butter and jelly sandwich" patent and the "leaf collection bag shaped like a pumpkin" patent and the "disembodied head" patent.  Also, if what "everybody knows" is correct, we should find more and more "bad" patents issuing between 1994 and 2004 or so, with a significant decline over the past two or three years (if the Patent Office’s calculus is correct that the number of "bad" patents is disproportionately reduced as overall patent allowance rates fall).

    We cannot, of course, be exhaustive.  But we have about 900 e-mail subscribers and get over 5,000 hits on some days, so there should be enough people reading these posts that we get a representative number of submissions.  Just to be "up-front" with our own bias, we remember a website called "Bounty Quest" that offered $10,000 for prior art sufficient to invalidate patents identified on their website, and as far as we know the proprietors didn’t go broke giving out their bounties.  We suspect we will not get 2,000 "bad" patents from our survey (which would be 0.1%), and frankly if we do this number would be 30- to 50-fold better than the current Patent Office quality metrics for preventing "bad" patents from issuing.

    Happy hunting.

  • Inventorship Determination: Good Practice Reminder

        By Jason Derry —

    When a patent practitioner receives an invention disclosure form, one or more persons will be listed as connected to the invention.  It’s easy to get into the practice of simply listing all of those on the invention disclosure form as inventors when filing the application.  However, if that list was compiled by a lead scientist or supervisor or professor or anyone other than a patent attorney, it should be considered a launching point for an inventorship determination rather than a list of inventors.

    Most inventors in the biotech and pharma fields are scientists who are used to publishing their scientific results.  When these scientists are the ones who are submitting an invention disclosure form, it is very common for them to list everyone who had anything to do with the subject matter of the invention using the same criteria as they would use to list the authorship for a publication.  As patent practitioners, therefore, we should take the list and investigate how each person contributed to the invention.

    Ideally, if you work for a corporation or university or similar research institution, you have familiarized your scientists with the basics of who is and who isn’t an inventor in the eyes of the Patent Office.  Or, you have designed your invention disclosure form with questions that increase the chances of the submitter identifying only the true inventors.  However, there are many reasons why the submitter might still list someone who doesn’t qualify as an inventor, such as the submitter forgot what you taught them about inventorship, or the submitter doesn’t want to offend or risk disappointing anyone who worked on the project.  Thus, the best practice is to ultimately make that determination yourself and not rely on a non-lawyer to do so.

    Gel_loading
    Outside counsel should also be diligent in checking inventorship before filing an application.  Asking a few simple questions of a client, such as an in-house or university contact, is a good reminder that inventorship is important and that you are complete and thorough in your preparation and handling of your clients’ applications, and also increases the chances that the application you’re filing will withstand a possible inventorship challenge in the future.

    The best time to do the inventorship determination is when the application is ready to file, because inventorship must focus on the claims.  The basic questions you need to remember are as follows:  who contributed to the conception of the idea as claimed, and who was involved in reducing the idea to practice.  Once you know who was involved, you should know exactly what they did to reduce the invention to practice.  Someone who was merely following instructions and directions during the process is not an inventor.  There must be some creative contribution.

    For a more detailed review of inventorship determination, see "Determining Inventorship for US Patent Applications," by Patrick Gattari of McDonnell Boehnen Hulbery & Berghoff LLP.

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

  • Pfizer Enters Agreement to Acquire Coley Pharmaceutical Group

        By Christopher P. Singer —

    Coley_pharma_logo
    In a November 16, 2007 press release, Pfizer Inc. announced that it will acquire Coley Pharmaceutical Group, Inc. (NASDAQ: COLY).  Coley is a biopharmaceutical company that has several research programs which include vaccine adjuvants (VaxImmune®) as well as a class of immunomodulatory drug candidates that are designed to modulate Toll-like Receptors (TLRs), and are under investigation for treatment of cancers, allergy and asthma disorders, and autoimmune diseases.  According to Jeffrey B. Kindler, Pfizer’s Chairman and CEO, the addition of Coley will complement and enhance Pfizer’s vaccine and immunotherapy programs.

    Pfizer_3
    The terms of the agreement include an $8 per share cash offer from Pfizer for all of Coley’s outstanding common stock, which is estimated to total about $164 million.  The acquisition is subject to a number of closing conditions.