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Patent Law

Patent Docs Patent Docs

Focuses on recent developments in biotechnology and pharmaceutical patent law, offering updates regarding changes in Patent Office rules and procedures that affect biotech/pharma patent prosecution, providing summaries of recent court decisions that impact biotech/pharma patent litigation and prosecution, and monitoring newly filed biotech/pharma patent litigation. In addition, Patent Docs highlights recently issued biotech/pharma patents, and reports on biotech/pharma news.
By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

Post Frequency: 20.5/day

Last Entry: April 01, 2011 at 01:59:00

Recent Entries: 1661

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EPO Prepares to Roll out New Prior Art Search Disclosure Rules

Posted on November 02, 2010
By James DeGiulio -- On January 1, 2011, all direct European patent applications and European national phase applications will be subject to new EPC Rules 141 and Rule 70b, which modify the requirements for supplying search results on priority applications...


DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief

Posted on November 01, 2010
By Kevin E. Noonan -- The United States government (or at least that part of it constituting the Department of Justice) has filed an amicus curiae brief in the AMP v. USPTO case (Myriad) in which it advocates a change in policy regarding the patent-eligibility of isolated genomic DNA...


Court Report

Posted on November 01, 2010
By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Zydus Pharmaceuticals USA, Inc. v. Eli Lilly and Company 3:10-cv-05584; filed October 27, 2010 in the District Court of New Jersey Declaratory judgment that Zydus may proceed with the manufacture and sale, in conjunction with Zydus' approved ANDA, of a generic version of Eli Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder), based on a finding of invalidty of U...


Conference & CLE Calendar

Posted on November 01, 2010
November 3, 2010 - "Whole-Genome Sequencing v. Gene Patents: The Coming Showdown" (Intellectual Property Owners Association) - 2:00 PM (ET) November 8, 2010 - Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) - New York, NY (Groupcasts to be held in Atlanta, Philadelphia, Pittsburgh, and Mechanicsburg, PA) November 8-9, 2010 - Patent Litigation 2010 (Practising Law Institute) - Atlanta, GA November 15-16, 2010 - European Pharmaceutical Regulatory Law Boot Camp*** (American Conference Institute) - New York, NY November 15-16, 2010 - Patent Litigation 2010 (Practising Law Institute) - New York, NY (Groupcasts to be held in...


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PTO Day

Posted on October 30, 2010
The Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark Office will be co-sponsoring the 21st Annual Conference on USPTO Law and Practice (PTO Day) on December 6, 2009 in Washington, D.C. The PTO Day program includes patent general sessions on the following topics: ? PTO Year in Review, Update on PTO Operations and IT Updates ? Patentable Subject Matter: It's Not Just About Computers And breakout sessions on the following topics: ? Chemical/Biotech Patent Examining Practice ? Including Q&A ? Work Sharing and Prioritizing Examination Initiatives ? Interlocutory Ex parte Appeals Practice ? Professional Responsibility for IP Practitioners...


CLE on Whole-Genome Sequencing v. Gene Patents

Posted on October 30, 2010
The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Whole-Genome Sequencing v. Gene Patents: The Coming Showdown" on Wednesday, November 3, 2010 beginning at 2:00 PM (ET). The IPO webinar will address the question: when sequencing all or a portion of an individual's genome, are individual gene patents infringed upon by either the company providing the sequence, a company selling software to analyze the sequence, or the individual purchasing or requesting it? The webinar will also look at who the direct infringer would be, and whether someone would be liable for indirect infringement...


IQPC Offers Podcast on Polymorph Patents

Posted on October 30, 2010
International Quality & Productivity Center (IQPC) has made a podcast on polymorph patents available on its website. The podcast, which answers the question of how can polymorph patents increase cost efficiency, is an interview with Mandar Kodgule, Head of Intellectual Property and Strategic Planning at Wockhardt...


Myriad Files Appeal Brief in AMP v. USPTO

Posted on October 29, 2010
By Kevin E. Noonan -- Myriad Genetics filed its appellant's brief in Association of Molecular Pathology v. U.S. Patent and Trademark Office last Friday, joined by the Directors of the University of Utah Research Foundation (Lorris Betz, Roger Boyer, Jack Brittain, Arnold B...


Pfizer and Biocon Sign Global Commercialization Agreement on Biosimilars

Posted on October 28, 2010
By Donald Zuhn -- Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, the biotech industry has waited to see which company might be the first to take advantage of the new approval pathway...


Appellees File Reply Brief in Therasense v. Becton Dickinson

Posted on October 27, 2010
Appellees Becton, Dickinson & Co. and Nova Biomedical Corp. filed their responsive brief in Therasense, Inc. v. Becton, Dickinson & Co. on October 8th. While addressing the Federal Circuit's questions generally directed to its application of the inequitable conduct doctrine, appellees' brief is particularly focused with its main objective -- having the en banc Court affirm the District Court's finding that Abbott committed inequitable conduct in procuring the patent-in-suit (U...


USPTO and EPO to Develop Joint Patent Classification System

Posted on October 26, 2010
By Donald Zuhn -- In a joint press release issued on Monday, the U.S. Patent and Trademark Office and European Patent Office announced that the two offices would be working together to develop a joint patent classification system. One of the goals of the joint effort will be to align the EPO classification and U...


Court Report

Posted on October 26, 2010
By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sandoz Inc. v. Boehringer Ingelheim 1:10-cv-01767; filed October 19, 2010 in the District Court of the District of Columbia Declaratory judgment of invalidity and non-infringement of U...


Court Report

Posted on October 25, 2010
By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Galderma Laboratories LP et al. v. Actavis Mid Atlantic LLC 1:10-cv-00887; filed October 15, 2010 in the District Court of Delaware ? Plaintiffs: Galderma Laboratories LP; Galderma SA; Galderma Research and Development SNC ? Defendant: Actavis Mid Atlantic LLC Infringement of U...


Conference & CLE Calendar

Posted on October 25, 2010
October 25, 2010 - Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) - San Francisco, CA November 8, 2010 - Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) - New York, NY (Groupcasts to be held in Atlanta, Philadelphia, Pittsburgh, and Mechanicsburg, PA) November 8-9, 2010 - Patent Litigation 2010 (Practising Law Institute) - Atlanta, GA November 15-16, 2010 - European Pharmaceutical Regulatory Law Boot Camp*** (American Conference Institute) - New York, NY November 15-16, 2010 - Patent Litigation 2010 (Practising Law Institute) - New York, NY (Groupcasts to be held in...


ACI Paragraph IV Disputes Conference

Posted on October 23, 2010
American Conference Institute (ACI) will be holding a West Coast edition of its Paragraph IV Disputes conference on December 8-9, 2010 in San Francisco, CA. The conference will allow attendees to: ? Identify patents for small molecules and small proteins that may be ripe for a Paragraph IV challenge; ? Recognize an ANDA applicant's initial obligations and reevaluate Orange Book tactics; ? Incorporate post-KSR obviousness considerations into Paragraph IV litigation strategies; ? Comprehend the procedural and substantive requirements for the contents and delivery of the Notice Letter; ? Develop a plan to use the 45 day post-Notice Letter receipt period...


Biotech/Pharma Docket

Posted on October 22, 2010
By James DeGiulio -- Novo Fails to Dismiss Suit over Validity of Prandin Patent The five year dispute over the validity of the patent covering the diabetes drug Prandin continues, as Novo Nordisk's attempt to dismiss the case with Sun Pharmaceutical Industries and Caraco Pharmaceutical Laboratories was recently denied...


Bayer Submits Brief in Therasense v. Becton Dickinson

Posted on October 21, 2010
By Kevin E. Noonan -- Co-defendant Bayer Healthcare LLC has submitted its brief in the Federal Circuit's en banc reconsideration in Therasense Inc. v. Becton Dickinson & Co. The brief's basic argument is that the Court's application of the inequitable conduct doctrine needs to be revised in keeping with traditional standards and that the Court should apply an "unclean hands" approach...


GSK Forms Alliance for Development of Gene Therapy Techniques for Rare Diseases

Posted on October 21, 2010
By James DeGiulio -- Earlier this year, we reported on the therapeutic potential of gene therapy experiencing a revival of sorts after falling out of favor for over 10 years (see "Gene Therapy Experiencing a Revival"). That revival continues, as evidenced by a press release issued by GlaxoSmithKline on Monday, in which the pharmaceutical company reports that it has licensed a gene therapy treatment for a rare disease that afflicts just 350 children worldwide...


USPTO Peer to Patent Program Expanded to Include Biotech Patent Applications

Posted on October 20, 2010
By Sherri Oslick -- The U.S Patent and Trademark Office announced on Tuesday that it plans to expand the Peer to Patent pilot program to include applications in biotechnology, biopharmaceuticals, and bioinformatics, among other areas. The Peer to Patent program previously was limited to software and business method applications...


KU to Hold Biolaw Conference

Posted on October 20, 2010
The University of Kansas School of Law will be holding its fourth annual biolaw conference from 8:30 am to 4:30 pm this Friday, October 22. This year's conference, entitled "Biolaw 4.0: Law at the Frontiers of Biology," will feature a keynote address by British geneticist Kevin Davies, the author of "The $1,000 Genome -- The Revolution in DNA Sequencing and the New Era of Personalized Medicine...


Geron Initiates Human ES Cell Clinical Trial

Posted on October 19, 2010
By Donald Zuhn -- Last week, Geron Corp. announced that it had enrolled the first patient in the company's clinical trial of GRNOPC, a human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cell line. The trial's first patient, who has asked to remain anonymous, was enrolled at Shepherd Center in Atlanta, GA, one of seven U...


NVCA Reports 31% Drop in Venture Funding for Third Quarter

Posted on October 18, 2010
By Donald Zuhn -- On Friday, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the third quarter of 2010. The NVCA quarterly study, which the group conducts with PriceWaterhouseCoopers using data from Thomson Reuters, indicates that venture capitalists invested $4...


Conference & CLE Calendar

Posted on October 18, 2010
October 18-20, 2010 - Intellectual Property Counsels Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) - Boston, MA October 18-19, 2010 - 5th Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - Washington, DC October 18-19, 2010 - Congress on Paragraph IV Disputes*** (Center for Business Intelligence) - Alexandria, VA October 21-23, 2010 - AIPLA 2010 Annual Meeting (American Intellectual Property Law Association) - Washington, DC October 25, 2010 - Advanced Patent Licensing 2010: Current Developments and Best Practices (Practising Law Institute) - San Francisco, CA November 8, 2010 - Advanced Patent Licensing 2010: Current Developments and...


Developing IP Strategies for Crystalline Forms Conference

Posted on October 16, 2010
International Quality & Productivity Center (IQPC) will be holding its 6th Annual Developing IP Strategies for Crystalline Forms conference from December 7-8, 2010 in London, England. The conference will allow attendees to: ? Protect business critical patents at an international level with updates regarding recent developments from around the world; ? Protect new patent revenue through implementation of correct concepts for true innovative forms; ? Prevent incoming attacks by understanding requirements to support claims; ? Capitalize on patents in emerging markets to increase product profitability through appropriate drafting for each country; and ? Maximize patent protection and benchmark protection strategies...


New False Marking Bill Introduced in the House

Posted on October 15, 2010
By Donald Zuhn -- On September 29, Rep. Robert Latta (R-OH) (at right) introduced a bill in the House (H.R. 6352) that would amend Title 35 to modify the penalty for false marking, as well as make other changes to the false marking statute. The bill, entitled the Patent Lawsuit Reform Act of 2010, was referred to the House Committee on the Judiciary after being introduced...


Biotech/Pharma Docket

Posted on October 15, 2010
By James DeGiulio -- Impax Settles Amrix Patent Suit with Cephalon Impax and Cephalon have reached an agreement to settle the suit over Impax's generic version of Cephalon's muscle relaxant drug Amrix. Impax filed an Abbreviated New Drug Application (ANDA) for its generic version of Amrix in September 2008, and Cephalon brought suit against Impax on January 7, 2009 for infringement of U...


"At-Home" Testing for BRCA Gene Mutations

Posted on October 14, 2010
By Kevin E. Noonan -- With great fanfare (if not braggadocio), researchers at the University of Maryland, College Park have published a paper in Genome Biology that purports to provide the means for individuals to assess their risk for breast or ovarian cancer despite patenting of isolated human BRCA1 and BRCA 2 genes by the University of Utah (licensed to Myriad Genetics)...


USPTO Adopts New Measure of Patent Examination Quality

Posted on October 14, 2010
By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office announced that it was adopting new, more comprehensive procedures for measuring the quality of patent examination. The new procedures were developed by a joint USPTO-Patent Public Advisory Committee (PPAC) Task Force following consultation with the patent community and public...


USPTO Extends Enhanced First Action Interview Pilot Program

Posted on October 14, 2010
By Donald Zuhn -- Last week, the U.S. Patent and Trademark Office announced that it was extending the Enhanced First Action Interview (FAI) pilot program for another six months. As a result of the extension, the Office will now consider requests to participate in the pilot program that are filed on or before April 1, 2011...


Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd. (Fed. Cir. 2010)

Posted on October 13, 2010
By Kevin E. Noonan -- The Federal Circuit expanded the scope of Article III jurisdiction under the Declaratory Judgment Act (28 U.S.C. § 2201) in the Hatch-Waxman context in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd. Specifically, the Court held that listing patents on the Orange Book could provide a sufficient injury-in-fact for an Abbreviated New Drug Application (ANDA) filer to assert an actual controversy, when its entry into the marketplace is blocked by a prior first ANDA filer...


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