Patent Law

Biotech Director at EPO Discusses European Patent Practice - Part II

Posted on June 24, 2009
By Bradley Crawford -- In the first post in this series, background information from Mr. Enrique Molina Galan's presentation at BIO 2009 was reported. The focus of this post is on the second part of his talk, where Mr. Molina Galan described the European Patent Office's role in fostering innovation...

Committee Publishes National Model Patent Jury Instructions

Posted on June 24, 2009
By Sherri Oslick -- Assembled by Chief Judge Paul R. Michel (at right) of the United States Court of Appeals for the Federal Circuit, a committee comprising litigators and judges from across the nation has prepared and published model jury instructions for patent infringement cases based on the experience of those both on the bench and in the bar...

The Genetics of Complex Behaviors: It Really Isn't That Simple

Posted on June 23, 2009
By Kevin E. Noonan -- Early last week, the Journal of the American Medical Association published a study ("Interaction Between the Serotonin Transporter Gene (5-HTTLPR), Stressful Life Events, and Risk of Depression") by Neil Risch at the University of California, San Francisco and colleagues at the National Institutes of Mental Health, Johns Hopkins University, Yale University School of Medicine, the Rockefeller University, the University of Pittsburgh School of Medicine, and Virginia Commonwealth University that showed no statistically-significant link between depression and the short HTT allele...

Court Report

Posted on June 23, 2009
By Sherri Oslick -- 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. Sepracor Inc. et al. v. Synthon Pharmaceuticals, Inc. et al. 5:09-cv-00264; filed June 17, 2009 in the Eastern District of North Carolina Infringement of U...

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Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation

Posted on June 22, 2009
By Kevin E. Noonan -- As reported last week by FierceBiotech, EvaluatePharma, a market forecasting firm specializing in the life sciences sector, released its prediction on the future of the pharmaceutical industry. According to EvaluatePharma, six of the top ten selling drugs by 2014 will be biologics...

Utility under Canadian Patent Law and the Doctrine of Sound Prediction

Posted on June 22, 2009
By Claire Palmer -- In Canada, for subject matter to be patentable, it must be novel, inventive, and have utility. A patent will fail for lack of utility if it can be shown that "the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do" (Consolboard Inc...

Conference & CLE Calendar

Posted on June 22, 2009
June 21-23, 2009 - IP Business Congress (Intellectual Asset Management magazine) - Chicago, IL June 22-27, 2009 - Innovation Week 2009 (U.S. Patent and Trademark Office) - Arlington, VA June 29-30 - Product and Pipeline Enhancement for Generics (Marcus Evans) - Washington, DC July 6, 2009 - Prior Art & Obviousness 2009: The PTO & CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) - New York, NY July 8, 2009 - Markman Hearings and Claim Construction in Patent Litigation (Practising Law Institute) - New York, NY July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute)...

Corporate Intellectual Property Conference

Posted on June 20, 2009
The Law Bulletin Publishing Company will be holding its 4th Annual Corporate Intellectual Property Conference on July 15, 2009 in Chicago, IL. The conference will address the following topics: ? Protecting and leveraging IP assets in a down economy; ? Update on major case law affecting IP; ? Licensing IP assets: Strategies for success; ? Damages: Valuation and presentation; and ? Copyright and trademark issues...

Generic Pharmaceuticals Conference

Posted on June 20, 2009
Marcus Evans has announced its 2nd Annual Product and Pipeline Enhancement for Generics conference on "Formulating a Concrete Plan for Sustainability in the Rapidly Changing Global Generic Pharmaceutical Market." The conference, to be held on June 29-30, 2009 in Washington, DC, will offer presentations on the following topics: ? Ensuring the sustainability of the generics industry; ? Devising a risk-balanced patent strategy to mitigate potential lawsuits; ? Recent developments in the law impacting Hatch-Waxman litigation; ? Integrating your patent and regulatory strategies; ? Comprehending the factors involved in a profitable IP strategy; ? Best practices for navigating the global biogenerics...

AEI Believes Advantages of Longer Data Exclusivity Period Outweigh Disadvantages

Posted on June 19, 2009
By Donald Zuhn -- In a follow-on biologics report that has received widespread media attention, the Federal Trade Commission concluded last week that a 12-14 year data exclusivity period was not needed to promote innovation by pioneer biologics companies (see "No One Seems Happy with Follow-on Biologics According to the FTC")...

The Uncertain Future of Genetic Diagnosis of Human Behavior

Posted on June 19, 2009
By Kevin E. Noonan -- Sickle cell anemia was the first known human disease associated with a genetic polymorphism (an A?T single nucleotide polymorphism, or SNP), resulting in the substitution of a valine residue (encoded by a GTG codon) for a glutamic acid residue (encoded by a GAG codon) in the beta chain of human hemoglobin...

Patent Office Extends Comment Period Regarding Deferred Examination

Posted on June 19, 2009
By Christopher P. Singer -- In a Notice published in the Federal Register (74 Fed. Reg. 28473) on Tuesday, June 16, 2009, the U.S. Patent and Trademark Office announced an additional public comment period relating to a potential deferred patent examination pathway...

Biotech/Pharma Docket

Posted on June 18, 2009
By Suresh Pillai -- Settlement Announced in Oxycontin® Litigation KV Pharmaceutical Co. announced a settlement in its litigation with Purdue Pharma LP over the painkiller Oxycontin® (see "Court Report," June 11, 2007). The settlement resolves three lawsuits filed by Purdue in the U...

USPTO NEWS: Patent Public Advisory Committee to Meet Thursday

Posted on June 18, 2009
By Christopher P. Singer -- The U.S. Patent and Trademark Office posted a notice on its website today announcing that the next meeting of the Patent Public Advisory Committee (PPAC) will be held on June 18, 2009. The meeting will be held on the USPTO campus, Madison North Auditorium, Concourse Level, 600 Dulany Street, Alexandria, VA...

President Obama to Nominate David Kappos as USPTO Director

Posted on June 18, 2009
By Donald Zuhn -- Senate Judiciary Chairman Patrick Leahy (D-VT) released a statement today indicating that President Obama intends to nominate David Kappos (at right) to be the Undersecretary of Commerce for Intellectual Property and Director of the U...

The Unwanted Consequences of Banning Gene Patenting

Posted on June 17, 2009
By Kevin E. Noonan -- Academics are useful people -- they provoke us to think and rethink our assumptions and the consequences of our institutions and practices, and can expand them in unexpected and frequently useful ways. But they also tend to live in a world constructed within the boundaries of their own skulls, and rarely have the kind of practical experience that comes from building a business or making a product...

USPTO News: E-Commerce Alert

Posted on June 17, 2009
By Christopher P. Singer -- Earlier this month, the U.S. Patent and Trademark Office sent out by e-mail its latest e-Commerce e-Alert, this one entitled "Tips to Improve Your e-Filing Effectiveness." Included in the e-Alert were four general procedures that help to streamline electronic prosecution through the use of EFS-Web and Private PAIR...

Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate

Posted on June 16, 2009
By Kevin E. Noonan -- The zeitgeist has turned harshly on patenting in the U.S., perhaps nowhere as starkly as in gene patenting. Originally the subject of op-ed rants by famous authors (see "Science Fiction in The New York Times") and quixotic bills introduced by undistinguished members of Congress (see "The Continuing Threat to Gene Patenting"), the filing by the American Civil Liberties Union of a complaint against Myriad Genetics several weeks ago seems to have opened the floodgates of opposition to these patents...

USPTO Issues Beta Release of New Website

Posted on June 16, 2009
By Christopher P. Singer -- The U.S. Patent and Trademark Office recently unveiled a beta test release of its new website. According to the USPTO, the new site has been designed to improve the overall look and feel, as well as to enhance the user experience with improved navigation...

No One Seems Happy with Follow-on Biologics According to the FTC

Posted on June 15, 2009
By Kevin E. Noonan -- Last week, the Federal Trade Commission issued a report on follow-on biologics ("Emerging Health Care Issues: Follow-on Biologic Drug Competition"). As many patent practitioners did a few years ago when the FTC issued a report on patent reform, many in the biotech and pharma community, generics companies, and Congress are asking "What is the FTC camel's nose doing in our tent?" The report is extensive, covering the likely market impact of follow-on biologics (FOB) competition, the effects of patent protection and market incentives in the face of FOB introduction, the potential impact of a Hatch-Waxman-like...

By Sherri Oslick -- About Court

Posted on June 15, 2009
By Sherri Oslick -- 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. Medicis Pharmaceutical Corp. v. Ranbaxy Inc. et al. 1:09-cv-00435; filed June 11, 2009 in the District Court of Delaware Infringement of U...

Conference & CLE Calendar

Posted on June 15, 2009
June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany June 17, 2009 - The Future of Reverse Payment Settlements: Insider's Guide to Imminent Antitrust Policy Changes (American Conference Institute) - 1:00-2:30 PM (EST) June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA June 22-27, 2009 - Innovation Week 2009 (U...

Biotech/Pharma Lobbying Scoreboard - 1st Quarter '09

Posted on June 13, 2009
By Donald Zuhn -- While the recession has certainly had an effect on biotech/pharma patent filings, the recession appears to have had little impact on lobbying expenditures in the biotech/pharma industry. With the reporting period for first quarter lobbying now passed, many biotech/pharma companies and organizations not only kept pace with, but handily surpassed, their first quarter spending from a year ago: ? The Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry's primary trade group, spent $6...

FDA Boot Camp Conference

Posted on June 13, 2009
As we noted last month, American Conference Institute (ACI) will be holding the next installment of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. Designed to provide patent attorneys with a comprehensive overview of the basics of Fodd and Drug Administration law, this conference will help attendees gain a better understanding of the underlying regulatory processes with which drugmakers must comply...

USPTO Posts Comments on Deferred Examination

Posted on June 12, 2009
By Donald Zuhn -- Last February, the U.S. Patent and Trademark Office hosted a roundtable discussion on deferred examination. The roundtable, which lasted about four hours, brought together two dozen participants, representing a variety of industries and organizations (as well as positions on the issue), to discuss the advantages and disadvantages of implementing a deferred examination system in the U...

Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories Inc. (Fed. Cir. 2009)

Posted on June 11, 2009
By Donald Zuhn -- The Federal Circuit today affirmed-in-part and vacated-in-part an order by the District Court for the Northern District of West Virginia awarding $1,011,712 in costs to Plaintiff-Appellee Daiichi Pharmaceutical Co., and remanded to the District Court for an apportionment determination of the awarded costs...

Gene Patenting Debate Continues

Posted on June 10, 2009
By Donald Zuhn -- Last Thursday, authorities on patent law and public policy were brought together to discuss the intersection of cutting-edge genetic research and intellectual property. The discussion, prompted by the recent ACLU v. USPTO case, took place on The Kojo Nnamdi Show on WAMU, Washington, DC's leading public radio station, and those interested in listening to the full 52-minute program can do so here...

Uncertain Future for Waxman Follow-on Biologics Bill

Posted on June 10, 2009
By Kevin E. Noonan -- If behavior can inform belief, it may be getting less and less likely that H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," has any reasonable chance of passing in this Congress. The bill, introduced on March 11, 2009 by House Committee on Energy and Commerce Chairman Henry Waxman (D-CA; at right), has as one of its key provisions a data exclusivity period of only 5 years (see "Waxman Introduces Follow-on Biologics Bill"), a term most in the biotechnology community believe is too short to support innovation in the sector...

Biotech/Pharma Docket

Posted on June 09, 2009
By Suresh Pillai -- Par Files Amended Complaint in Nascobal® Suit Par Pharmaceuticals filed an amended complaint against Fleming & Co. Pharmaceuticals, alleging patent and trademark infringement and unfair competition over Par's prescription nasal spray, Nascobal®...

Court Report

Posted on June 08, 2009
By Sherri Oslick -- 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. Takeda Pharmaceutical Co. et al. v. Sandoz, Inc. 1:09-cv-05210; filed June 3, 2009 in the Southern District of New York Infringement of U...

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