Category Archives: Life Sciences

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Federal Circuit Weighs in on Patent Subject-Matter Eligibility of Dietary Supplements

The Federal Circuit weighed in on patent subject matter eligibility again last week, finding certain amino-acid containing dietary supplements, and related methods of use, to be patent eligible. In Natural Alternatives Int’l v. Creative Compounds, LLC, the Federal Circuit vacated the decision of the district court in the Southern District of California, which held that … Continue Reading

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative:… Continue Reading

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. … Continue Reading

Standards of Review: Implications for Patent Challengers

The standard of review is frequently cited but often overlooked as being outcome-determinative in patent cases. A recent trio of decisions by the Federal Circuit illustrates the differences in outcome that result from the standard of review for issued patents, challenged for validity in the Federal Courts, versus that for patent applications examined for patentability … Continue Reading

CLS Bank: The patent eligibility of computerized trading platforms for exchanging obligations

By Barry Wilson and Martin Bader On July 9, 2012, a three judge panel of the Federal Circuit in CLS Bank International v. Alice Corporation (Appeal No. 2011-1301) ("CLS Bank"), decided a case of patent eligibility under 35 U.S.C. § 101. In a split decision, the panel reversed the district court’s finding that three Alice Corporation patents claiming a computerized … Continue Reading

Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S 566 U.S. ___, 132 S. Ct. 1670 (Apr. 17, 2012) By Nagendra Setty and Bill Blonigan The Hatch-Waxman Act Congress designed the Hatch-Waxman Act (codified at 21 U.S.C. § 355(b), (j), (l) and 35 U.S.C. §§ 156, 271, and 282) to inspire medical innovation by giving medical-device … Continue Reading

Courts to play greater role moderating enhanced damages for willful patent infringement

Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc. (Fed. Cir. June 14, 2012) By Martin Bader and Bill Blonigan In this medical-device patent-infringement action, an Arizona federal jury found that W.L. Gore willfully infringed Bard’s Prosthetic Vascular Graft patent. The District Court then decided to double the jury’s $185.6 million damages award. Gore … Continue Reading

Applying Prometheus To Myriad: Possible Outcomes

By Barry Wilson On March 26, 2012, the U.S. Supreme Court issued a much anticipated GVR (grant [certiorari], vacate and remand) order in the Association for Molecular Pathology v. the United States Patent Office (a.k.a. ACLU v. Myriad), remanding the case to the Federal Circuit for reevaluation in light of the Supreme Courts’ recent decision … Continue Reading

Section viii Statements — Still A Viable Route to Generic Approval Where the Application Is Not Claimed in an Orange Book Patent

By Nagendra Setty and Mark E. McGrath In its recent decision in AstraZeneca Pharmaceuticals LP v. Apotex Corp., Nos. 2011-1182 – 2011-1190 (Fed. Cir. Feb. 9, 2012) (hereinafter the “AstraZeneca Decision”) (Rader*, Bryson & Linn), the Federal Circuit affirmed a District of Delaware decision dismissing an infringement case for failure to state a claim, pursuant … Continue Reading

Supreme Court Holds That a Law of Nature Applied Using Known and Obvious Steps Is Not Patent Eligible

By Kevin Capps On March 20, 2012, the Supreme Court issued its much-anticipated decision in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., with potentially far-reaching ramifications for pharmaceutical and biotechnology companies, particularly those developing diagnostic methods and assays.… Continue Reading

Limiting Liability in Clinical Trials: Non-Lawyers, Lawyers Beware

Clinical trials are the lifeblood of biotech. Finding the right service providers (CROs, safety, IVRS, consultants, contract manufacturers and many others), as well as the right clinical investigators and sites, results in a complex web of legal obligations and potential liabilities. Limitation of liability clauses can reduce a party’s exposure if a contractual obligation is … Continue Reading
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