Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

By Jacob C. Jones and David G. Barker On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA approval. This means that, in some circumstances, manufacturers can begin marketing biosimilars immediately after FDA approval. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) required Sandoz to give Amgen notice 180 days before selling its biologic Zarxio, an FDA approved biosimilar drug that relied on the prior approval of Amgen’s Neupogen.  Sandoz   Read More »

Posted in Biosimilars, IP and Technology Litigation, Patent Litigation | Tagged , , , , , , , , , , ,

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Supreme Court Decision Limits Post-Sale Restrictions by Patent Owners

The United States Supreme Court today held in Impression Products, Inc. v. Lexmark International, Inc. that the doctrine of patent exhaustion limits post-sale restrictions by patent owners and that patent rights are exhausted once a product is sold domestically or internationally. Partially continuing the recent theme of unanimous intellectual property decisions (see here and here), the Supreme Court held 8-0 that domestic sales — even restricted sales — exhaust patent rights, and 7-1 that international sales also exhaust patent rights. Under its “Return Program,” Lexmark allowed customers to purchase a reduced-price toner cartridge if the customer agreed to use the   Read More »

Posted in IP and Technology Litigation, Patent Litigation | Tagged , ,

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Unanimous Supreme Court Decision Limits Venue in Patent Infringement Suits

By Peter R. Montecuollo and David G. Barker In yet another unanimous intellectual property decision (see here), the United States Supreme Court today held in TC Heartland LLC v. Kraft Foods Group Brands LLC that “reside,” as used in the patent venue statute, 28 U.S.C. § 1400(b), “refers only to the State of incorporation,” and not to each state where a domestic, corporate defendant is subject to personal jurisdiction.  This limitation alters the venue landscape for patent infringement suits that has been in place since the Federal Circuit’s 1990 decision in VE Holding Corp. v. Johnson Gas Appliance Co. Kraft   Read More »

Posted in IP and Technology Litigation, Patent Litigation | Tagged , ,

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Federal Circuit Provides Clarity to “On-Sale Bar” for Patents Under AIA

Under the America Invents Act (AIA), 35 U.S.C. § 102(a) bars the patentability of an “invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” The AIA added “otherwise available to the public” to the patent statutes, which has caused much debate over whether such language changes the definitions of “on sale” or “public use” from their definitions under pre-AIA law. On May 1, 2017, in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, the Federal Circuit shed light on the definition   Read More »

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Glimmers of Justice Gorsuch’s Prospective IP Jurisprudence

On April 10, 2017, Neil Gorsuch was sworn in as the 113th justice of the Supreme Court, filling the vacancy left by Justice Antonin Scalia.  While on the Tenth Circuit, Justice Gorsuch wrote opinions on complex trade secret, copyright, and trademark issues in a detail-oriented manner that indicates balanced treatment of intellectual property owners and challengers. His intellectual property opinions delve into complicated issues and thoroughly explain his reasoning.  But his criticism of Chevron deference, exemplified in his concurring opinion in Gutierrez-Brizuela v. Lynch (2016), raises questions about how he will approach agency interpretation of intellectual property laws. Click here   Read More »

Posted in Copyright Litigation, IP and Technology Litigation, Patent Litigation, Trade Secrets Litigation, Trademark Litigation | Tagged

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