In a move that could drastically change the patent law landscape, the United States Supreme Court recently granted certiorari in Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, to answer the question whether the inter partes review (IPR) process violates the U.S. Constitution by “extinguishing private property rights through a non-Article III forum without a jury.”

In 2001, Oil States Energy Services LLC (“Oil States”) was granted U.S. Patent No. 6,179,053 for a lockdown mechanism to ensure a mandrel is locked in an operative position during fracking.  Oil States sued Greene’s Energy Group LLC (“Greene’s Energy”) in the Eastern District of Texas in 2012 for infringing this patent, and in turn, Greene’s Energy petitioned the United States Patent and Trademark Office (USPTO) to institute an IPR on the patent.  This petition was granted. After the proceedings, the Patent Trial and Appeal Board (PTAB), the administrative body of the USPTO that handles IPRs, concluded the challenged patent claims were invalid.  Oil States appealed to the Federal Circuit, which affirmed the decision, and Oil States then petitioned the Supreme Court for certiorari.

Continue Reading Supreme Court to Decide the Constitutionality of Inter Partes Review

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

DC_SupremeCourtIn keeping with recent erosion of patent rights, patent owners’ power to control the post-sale use and sale of their patented products was severely limited this week by the U.S. Supreme Court in the highly anticipated case regarding the patent exhaustion doctrine, Lexmark Int’l, Inc. v. Impression Prods., Inc., No. 15-1189.

As we reported earlier here and here, the Federal Circuit previously provided patent owners with some power to control their patented products—even after an authorized sale.  Specifically, the Federal Circuit held, in an en banc decision, that a patent owner’s patent rights are not exhausted if a patented product is sold with a clearly communicated restriction and that an authorized foreign sale of a product does not exhaust the patent owner’s U.S. patent rights to exclude associated with that product.

Continue Reading Supreme Court Overrules and Rewrites 25 Years of Federal Circuit Law on Patent Exhaustion

LifeSciences_TestOn May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.

Continue Reading Amgen Sues Coherus Under BPCIA After Completing Patent Dance

Supreme-Court-seal II. jpgYesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.  The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product.  The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.

To read our full alert on the oral argument, please click here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

Supreme-Court-seal II. jpgIn a widely anticipated move with implications for patent litigation across the country, the Supreme Court ruled today that the equitable defense of laches is not available to limit damages in patent infringement cases subject to the six-year damages limitation of 35 U.S.C. § 286.

In S.C.A. Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC, the Supreme Court extended to the patent context its reasoning in Petrella v. Metro-Goldwyn-Mayer, Inc. (2014) that laches cannot defeat a claim for copyright infringement damages brought within the rolling three-year limitations period prescribed by the Copyright Act.

Continue Reading Supreme Court Shuts the Door on Patent Laches

keyboard_566705419In recent years, software patents have come under fire from legislation (the American Invents Act) that has generally made patents easier to invalidate, and from court decisions (the Supreme Court’s decision in Alice v. CLS Bank and its progeny) that have made computer-implemented inventions more vulnerable to subject matter eligibility challenges. Some observers have concluded that software patents are no longer worth pursuing. We disagree. Although there are real challenges, and patents on some software or other computer-implemented inventions may now be quite difficult (or even impossible) to obtain or enforce, a well-written and well-prosecuted patent application can circumvent many of these obstacles.

To read our full advisory on software patent eligibility, please click here.

shutterstock_484403530The New Year brings excitement and anticipation of changes for the best.  Some of the pending patent cases provide us with ample opportunity to expect something new and, if not always very desirable to everybody, at least different.  In this post, we highlight several cases that present interesting issues and that we anticipate may provide for new and important developments in the patent law this year.

Continue Reading IP Cases to Watch in 2017

map_2951165992On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.

Continue Reading Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

The plot just thickened in the long-running debate over where patent cases should be litigated.

Yesterday the U.S. Supreme Court agreed to review the Federal Circuit’s decision in TC Heartland LLC v. Kraft Foods, in which the Federal Circuit held that patent suits may be filed in any judicial district in which the defendant sells an allegedly infringing product.  The Federal Circuit has consistently applied this interpretation of the patent venue statute since its 1990 decision in VE Holding.

Continue Reading Supreme Court to Hear Patent Venue Case