Supreme Court to Consider Constitutionality of AIA Inter Partes Review Proceedings

By Rachael Peters Pugel and Andrew F. Halaby The Supreme Court has granted a writ of certiorari challenging the constitutionality of inter partes review proceedings conducted by the United States Patent and Trademark Office under the America Invents Act.  The Court’s ruling in this matter, especially if it holds inter partes reviews to be unconstitutional, could massively destabilize the patent law system by casting into doubt an administrative regime that has diverted thousands of patent disputes from the federal court system, as well as the many hundreds of decisions invalidating patent claims so far yielded by that regime. Post-issuance proceedings   Read More »

Posted in Inter Partes Review, IP and Technology Litigation, Patent Litigation, Post Grant Proceedings | Tagged , , , , ,

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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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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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Supreme Court Holds Laches May Not Bar Patent Infringement Damages Within 6-Year Statutory Limitations Period

The United States Supreme Court announced today that laches, an affirmative defense based on an injured party’s delay in bringing suit, may not bar patent infringement damages within the six-year period under § 286 of the Patent Act. The Court’s decision in SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC reversed the Federal Circuit’s 2015 en banc decision, which held that laches may limit patent infringement damages even during the six-year limitations period. Reversing the Federal Circuit, the Court held that § 286 establishes a statute of limitations for patent infringement claims such that “a patentee may recover damages   Read More »

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