| 1/20/2012 |
A Comparison of US and EU Biosimilars Regimes |
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| Economic barriers, along with regulatory complexity and uncertainty, are shaping the biosimilars industry into something entirely different from the generic small molecule pharmaceutical industry. The sharp demarcation between branded and generic small molecule pharmaceutical companies may not exist in the biologics context. more |
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| 10/6/2011 |
Classen v. Biogen Idec et al. – The Latest Installment in the Patent-Eligibility Arena |
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| On August 31, 2011, the Federal Circuit issued its long-awaited decision in Classen Immunotherapies, Inc. v. Biogen Idec et al. more |
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| 8/29/2011 |
Patenting Personalized Medicine Inventions after Myriad |
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| The Federal Circuit's recent decision in Assoc. for Mol. Pathology v. USPTO (2010-1406) (informally referred to as the Myriad decision), provides some clarity to entrepreneurs and scientists working in the personalized medicine industry. more |
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| 8/5/2011 |
First to File in the Unpredictable Arts: Change in Law Requires Balancing of Competing Interests |
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| Currently pending before Congress is the "America Invents Act." Although patent reform has been proposed several times in the past decade, this year its imminent passage is widely expected. more |
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| 6/15/2011 |
The Patentability Black Hole |
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| An inventor faces a number of significant hurdles and pitfalls in patenting his invention. Having a patent specification providing proper and sufficiently thorough disclosure of the invention being claimed by the patentee can, by itself, be a large hurdle, especially in the biosciences where experimental data is essential. more |
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| 7/19/2010 |
Patent Strategy for Personalized Medicine in Light of Bilski |
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| Advanced medical diagnostics, such as those that use information derived from multiple genetic variations or biomarker expression levels, certainly fall within the scope of patentable subject matter, according to the guidance provided by the Bilski decision. Significant investment is required to develop and market complex personalized medicine diagnostics that prognose risk or outcome based on a number of genetic or biological markers. Such methods do not preempt any basic law of nature because alternative predictive models can be developed using different sets of markers. Consequently, they should not be subject to § 101 rejections under current law. more |
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| 6/28/2010 |
Patent Alert: Supreme Court Unanimously Rejects Bilski Patent Application but Narrowly Upholds Business Method Patents |
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| The Bilski case presented the Supreme Court with an opportunity to eliminate business methods from the scope of patentable subject matter more |
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| 4/7/2010 |
Tax Alert: Qualifying Therapeutic Discovery Project Credits and Grants |
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| The enactment on March 23, 2010 of the Patient Protection and Affordable Care Act of 2010 established a 50% nonrefundable tax credit for qualified investments in qualifying therapeutic discovery projects of eligible taxpayers. more |
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| 1/13/2010 |
Bracing for Change in Patentability for Methods: Strategies for Companies and Venture Capitalists to Manage the Bilski Risk |
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| Four Fenwick attorneys recently attended an oral argument at the U.S. Supreme Court at which justices surprised the patent community by signaling that they likely will cut back on the types of methods that are eligible for patent protection. more |
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| 12/3/2009 |
Patent Pools in Life Sciences |
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| A patent pool is defined as an arrangement among multiple patent holders to aggregate their patents where all pooled patents are made available to each member of the pool, and standard licensing terms are offered to licensees who are not members of the pool. more |
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| 9/2/2009 |
Ariad Written Description Ruling Could Significantly Impact Biotech Patents |
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| The fate of many chemical and biotechnology patents will soon depend on the Federal Circuit's interpretation of the first paragraph of section 112 of the Patent Act. more |
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| 7/24/2009 |
An Unclear Diagnosis |
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| What constitutes patentable subject matter? The tension between the broad language of 35 U.S.C. Section 101 and the limitations of its scope by the courts is playing out in the context of patent eligibility of process claimsy... more |
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| 3/16/2009 |
2008 Silicon Valley Life Science VC Survey |
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| The results of our fifth annual San Francisco Bay Area Life Science Venture Capital Valuation Survey... more |
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| 3/16/2009 |
Making Sense of the Revived "Machine-or-Transformation" Test in In re Bilski |
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| On October 30, 2008, in In re Bilski, No. 07-1130 (Fed. Cir. Oct. 30, 2008) the Federal Circuit handed down the latest judicial effort to provide guidance about the types of subject matter that are eligible for patent protection...
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| 3/16/2009 |
On Shaky Ground: The (Near) Future of Patents After Bilski |
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| On October 30, 2008, in In re Bilski, No. 07-1130 (Fed. Cir. Oct. 30, 2008) the Federal Circuit handed down the latest judicial effort to provide guidance about the types of subject matter that are eligible for patent protection...
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| 3/19/2008 |
2007 Silicon Valley Life Science VC Survey |
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| The results of our fourth annual San Francisco Bay Area Life Science Venture Capital Valuation Survey show a continuation of the positive trend in the life science venture environment.
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| 8/31/2007 |
Perspective: Patents, post-MedImmune |
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| Earlier this year, the Supreme Court shook the foundations of patent licensing and technology transfer, altering the balance of power between patent holders and their licensees and creating profound implications for the life-sciences industry.
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| 7/30/2007 |
Litigation Alert: Integra LifeSciences I, Ltd. v. Merck KGaA—Applying the Supreme Court's Broad Interpretation of the FDA Exemption for Patent Infringement |
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| On July 27, the Federal Circuit in Integra LifeSciences v. Merck ruled on the Supreme Court's broad interpretation of the patent infringement exemption set forth in 35 U.S.C. § 271(e)(1), for "uses reasonably related to the development and submission of information" to the Food and Drug Administration (FDA)
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| 1/10/2007 |
Litigation Alert - Supreme Court Knocks Down Federal Circuit Rule and Allows Licensees to Challenge a Licensed Patent |
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| Yesterday, the Supreme Court ruled in MedImmune v. Genentech that a patent licensee does not need to breach its license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed.
more |
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| 3/28/2006 |
2005 Trends in Life Sciences Partnering and Collaborations |
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| Ten years ago, when a biotech company needed to raise capital, the avenue most frequently sought was the capital markets. Today, rising drug development costs can approach $1 billion, making a biotech's need for capital more intense than ever.
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| 3/7/2006 |
Life Sciences Companies Face Special Disclosure Challenges |
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| Life sciences companies face difficult disclosure issues because they operate in a particularly complex and financially sensitive regulatory environment.
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| 1/3/2006 |
University Licensing: An Introduction to Licensing Technology from Universities |
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| What do Yamaha synthesizers, gene splicing and DSL have in common? They are all based on technology licensed from universities. As these examples show, universities often develop and license new cutting edge technologies.
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| 11/11/2005 |
Follow-on Biological Products—Legal Issues |
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| Many biologics, including blockbusters like Epogen/Procrit, are nearing patent expiration, and generics manufacturers, including Sicor (acquired by Teva), Barr Laboratories, and Ivax Corporation, are hoping to market generic biologics.
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| 11/3/2005 |
Authorized Generics: Antitrust Issues and the Hatch-Waxman Act |
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| An authorized generic (AG) is a pharmaceutical product that was originally marketed and sold by a brand company, but is relabeled and marketed under a generic product name.
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| 9/30/2005 |
Corporate and Securities Law Update - Sweeping New Rules Apply to Securities Offerings by Technology and Life Science Companies |
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| A major modernization of federal regulations that apply to registered securities offerings takes effect December 1, 2005.
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| 11/18/2004 |
Intellectual Property Strategy and Best Practices in China and India Life Sciences Business Transactions |
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| This paper is based on a presentation made at the Asia America Multitechnology Association ("AAMA") Conference on October 8, 2004.
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| 12/5/2003 |
Will China Become a Global Power in Biotech? |
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| There are a number of dimensions in becoming a global power.
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| 1/1/2003 |
Patent Licensing for High Technology and Life Sciences Companies |
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| Virtually all high technology companies rely on licenses to achieve their business goals.
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