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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 and pharmaceutical patent owners a more fruitful patent term while providing follow-on manufacturers to more quickly market their products once medical patents expire. Unlike other products, advanced medical devices and drugs must be FDA approved. These products can’t be marketed until proven sufficiently safe and effective through tests and clinical trials. FDA approval is expensive and time consuming. But it’s more than a matter of time and money. Medical innovators—especially drug developers—face the significant risk that a potential product will not live up to its promise.
Continue Reading Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation

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 lost its post-trial challenge for judgment as a matter of law (JMOL) and appealed to the United States Court of Appeals for the Federal Circuit. On rehearing, a Federal Circuit panel took the opportunity to give courts a larger role—and juries a smaller role—in deciding whether patent infringers acted willfully. The jury’s role in deciding willfulness is now limited to determining whether the infringer subjectively knew or should have known that it was infringing a valid patent. It is now the court’s duty to assess whether there was any objectively reasonable argument that the patent was invalid or not infringed. The Federal Circuit’s decision in Bard v. W.L. Gore will likely make multiplied patent damages awards harder to obtain.
Continue Reading Courts to play greater role moderating enhanced damages for willful patent infringement

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 in Mayo Medical Laboratories v. Prometheus Laboratories 566 U.S. ____ (US 2012). The Prometheus decision has been extensively discussed in the media but its possible impact on the Federal Circuit decision in Myriad has received much less attention.
Continue Reading Applying Prometheus To Myriad: Possible Outcomes

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 to Fed. R. Civ. P. 12(b)(6). Defendants/appellees (collectively, “Appellees”) each filed an Abbreviated New Drug Application (“ANDA”) with Section viii statements, seeking approval for methods of use not claimed in a patent listed in the Orange Book.
Continue Reading Section viii Statements — Still A Viable Route to Generic Approval Where the Application Is Not Claimed in an Orange Book Patent

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

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 breached. More often, limitations of liability provisions are used to shift risk to the sponsor of the clinical trial. But, if your contracts are well negotiated and drafted, the risks can be carefully and fairly allocated between the parties in a balanced and reasonable manner. Because of the complexity of the legal relationships and liabilities found in clinical trials, this article is limited to a brief description of limitation of liability clauses, and their general strengths and weaknesses.Continue Reading Limiting Liability in Clinical Trials: Non-Lawyers, Lawyers Beware