Court of Appeals for the Federal Circuit

On July 20, 2017, the United States Court of Appeals for the Federal Circuit in In re OptumInsight denied OptumInsight’s petition for writ of mandamus on privilege waiver. The court held that the District Court for the Northern District of California did not clearly abuse its discretion in evaluating the proper scope of waiver.

The ‘897 patent reexamination. In June 1994, Symmetry Health Data Systems, Inc. (Symmetry) responded to a request for proposal (RFP) from Aetna Life Insurance Co. and offered to license its healthcare analytics software, Symmetry Episode Treatment Group (ETG) Program, to Aetna. More than a year later, Symmetry filed a patent application that claims and describes the ETG Program. During prosecution, Symmetry did not disclose its RFP response regarding the software license to the patent office. Symmetry’s application eventually issued as U.S. Patent No. 5,835,897.

Continue Reading Federal Circuit Says PTO Submissions can Waive Privilege to Future Communications

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.

Continue Reading Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

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

A flurry of activity from various courts this past week on “exceptional cases” under Section 285 of the Patent Act provided notable guidance for practitioners and patent owners, with a particular emphasis on the motivation and conduct of the litigants. We provide a short synopsis of these cases.

By way of context, in 2014, the Supreme Court in Octane Fitness, LLC v. ICON Health & Fitness, Inc., 134 S. Ct. 1749 (2014), instructed courts to apply a totality of the circumstances test when evaluating whether a case is “exceptional” under 35 U.S.C. § 285. If a case is found to be exceptional within the meaning of the statute, monetary sanctions and fee-shifting may be imposed. This totality of the circumstances analysis was a substantial departure from the previous Federal Circuit tests, which were uniformly viewed as more rigid. Some of the factors the Supreme Court suggested district courts could consider included “frivolousness, motivation, objective unreasonableness (both in the factual and legal components of the case) and the need in particular circumstances to advance considerations of compensation and deterrence.” Our previous discussion of exceptional cases under Section 285 can be found here.

Continue Reading Pumping Up Exceptional Cases Under the Octane Fitness Standard

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

shutterstock_69589705On May 10, 2017 and following a Patent Trial and Appeal Board (PTAB) reexamination decision upholding certain claims, the United States Court of Appeals for the Federal Circuit ruled in Cisco Systems, Inc. v. Cirrex Systems, LLC that all of the appealed claims of a fiber optic patent held by Cirrex are invalid for lack of a written description support required by 35 U.S.C. § 112.  The panel applied its own construction of a key claim term requiring that a recited functional limitation take place in a specific location which the specification failed to describe.

Continue Reading You Can Not Claim What you Don’t Possess – Federal Circuit Holds Fiber Optic Claims Invalid under Section 112

723px-US-CourtOfAppeals-FederalCircuit-Seal_svgIn its opinion in Aylus Networks, Inc. v. Apple Inc., the Federal Circuit expanded the scope of prosecution disclaimer to statements made by a patent owner during Inter Partes Review (IPR) proceedings.  The Court explained that extending the doctrine to cover patent owner statements, made either before or after institution of an IPR, ensures that claims are not argued in one way to maintain patentability and a different way to support infringement allegations.  The Court also noted that its conclusion promotes the public notice function of intrinsic evidence and protects the public’s reliance on statements made during IPR proceedings.

Continue Reading Federal Circuit Expands Scope of Prosecution Disclaimer to IPR Proceedings

Last week the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals clarified the scope of the on-sale bar rule under the America Invents Act (AIA).  The on-sale bar in general means that a sale or an offer to sale of an invention more than one year prior to the effective filing date of a patent qualifies as prior art.  The Federal Circuit held that 35 U.S.C. § 102 as revised in the AIA does not change the long-settled rule that a sale can invalidate an invention even if the sale does not disclose the details of the invention.

Continue Reading Federal Circuit Clarifies the On-Sale Bar under AIA

The Federal Circuit has now reversed the Patent Trial and Appeal Board’s decision in Synopsys, Inc. v. ATopTech, Inc.  finding claims 1 and 32 of U.S. Patent No. 6,567,967 (the “‘967 patent”)  as being “not supported by substantial evidence.”

Synopsys sued ATopTech in 2013 for allegedly infringing the ‘967 patent. ATopTech subsequently filed two inter partes review (IPR) petitions (IPR2014-01150 and IPR2014-01159) challenging the validity of all claims of the ‘967 patent. The ‘967 patent aims to improve circuit performance by splitting large components into small subcomponents and optimizing the connections between subcomponents. Claim 1 requires “flattening each of said plurality of hierarchically arranged branches by eliminating superfluous levels of hierarchy above said atomic blocks.”  Claim 32 requires “determining optimal placement of each of the hard blocks, if any, within the predefined area.”  The Board found both claims either obviousness or anticipated in view of the Fields and/or Su references.

Continue Reading Federal Circuit Rejects Board’s Understanding of Prior Art

shutterstock_296971589Today, the Federal Circuit, vacated-in-part and remanded the Patent Trial and Appeal Board’s obviousness determination regarding a Securus Technologies patent directed to systems and methods for reviewing conversation data for certain events and bookmarking portions of the recording when something of interest is said, finding that the Board failed to provide any explanation for its decision with respect to certain challenged claims.

Continue Reading Federal Circuit to PTAB: No Short Cuts Allowed