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.
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.
In 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.
On 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.
In 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.
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.
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.
Today, 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.
On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit. See The Medicines Company v. Mylan, Inc., 2015-1113 (Fed. Cir. 2017). The patents-in-suit were U.S. Patent Nos. 7,582,727 (“the ’727 Patent) and 7,598,343 (“the ’343 Patent”). MedCo initiated a suit against Mylan, Inc. (“Mylan”) in response to Mylan submitting an Abbreviated New Drug Application (“ANDA”). Through submitting an ANDA request, Mylan wished to obtain approval from the Food and Drug Administration (“FDA”) for a generic drug that would directly compete against MedCo’s ANGIOMAX® product. To counter Mylan’s ANDA request, and keep their product exclusive, MedCo filed suit alleging that Mylan’s ANDA drug infringed claims in both the ’727 and ’343 Patents.
The district court held on summary judgment that Mylan’s drug did not satisfy the “efficient mixing” limitation of the ’343 Patent; however, following a 6-day bench trial found that Mylan’s drug did infringe the ’727 Patent because the asserted claims did not include an “efficient mixing” limitation. Mylan argued on appeal that the district court erred by not including the “efficient mixing” limitation as part of the “batches” limitation in the ’727 Patent.
On Tuesday, the U.S. Supreme Court heard oral argument 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, the Federal Circuit Court of Appeals, in an en banc decision, agreed with Lexmark and confirmed two important aspects of the patent exhaustion doctrine, namely that (1) a patentee can “sell a patented article subject to a single-use/no-resale restriction that is lawful and clearly communicated to the purchaser” without exhausting the patentee’s rights to that item, thereby permitting enforcement of the restrictions via an infringement suit; and (2) because foreign sales do not permit “the buyer to import the article and sell and use it in the United States,” an authorized foreign sale of a product does not exhaust a patentee’s U.S. patent rights to exclude associated with that product. The Supreme Court subsequently granted Impression Product’s petition to review these two holdings.