In CareDx, Inc. v. Natera, Inc., the U.S. Court of Appeals for the Federal Circuit held that CareDx’s patent claims to methods of detecting organ transplant rejection were invalid as patent ineligible under 35 U.S.C. § 101.1 Affirming the district court, the Federal Circuit determined that CareDx’s claims “are directed to a natural law together with conventional steps to detect or quantify the manifestation of that law,”2 relying on “admissions” in the patents themselves that the claims recited only “conventional” techniques.’Read More
On 1 February 2022, the Federal Circuit released its decision in Qualcomm v. Apple1 providing guidance on the treatment of Applicant Admitted Prior Art (AAPA) under 35 U.S.C § 311(b) in Inter Partes Review (IPR) proceedings. In doing so, the Federal Circuit vacated two IPR decisions2 of the Patent Trial and Appeal Board (PTAB) where the PTAB had found several claims of U.S. Patent No. 8,063,674 (“the ’674 patent”) unpatentable under 35 U.S.C. § 103. In doing so, the Federal Circuit remanded the case to allow the PTAB to address the specific issue of whether the AAPA cited by Apple improperly formed the “basis” of Apple’s § 103 challenge or was simply ancillary.Read More
On 23 December 2021, the Patent Trial and Appeal Board (“the Board”) instituted inter partes review (IPR) of U.S. Patent No. 7,725,759 B2 (“the ’759 patent”). See OpenSky Indus., LLC v. VLSI Tech. LLC IPR2021-01064, Paper 17 (Dec. 23, 2021). Petitioner OpenSky Industries, LLC (“OpenSky”) relied on expert declarations of Dr. Sylvia D. Hall-Ellis and Dr. Bruce Jacob originally filed by Intel Corporation in two other IPR proceedings (“Intel IPRs”).1 Indeed, the declaration included the same coversheet that accompanied the declaration in the Intel IPR. The Board analyzed OpenSky’s Petition under §314(d) and §325(d), declining to deny institution, finding, in part, that since Fintiv and General Plastic did not warrant discretionary denial, the arguments, which were almost identical to those made in the Intel IPRs, deserved to see their day in court at the PTAB.Read More
Last year, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit confirmed that 28 U.S.C. § 1400(b) is the sole venue provision for domestic defendants in Hatch-Waxman actions.1 On Friday 5 November 2021, the Federal Circuit provided even greater clarity on venue rules in such cases, concluding that, for venue purposes, only submission of the ANDA qualifies as an act of infringement, not any action related to the submission.2Read More
The High Court of Australia’s recent decision Calidad Pty Ltd v Seiko Epson Corporation  HCA 41 (Calidad) has more closely aligned Australian patent law with its U.S. and European counterparts. Key takeaways from this decision are:
- the ‘doctrine of exhaustion of rights’ has replaced the ‘implied licence doctrine’;
- a patent owner’s exclusive rights are extinguished by the first sale of the patented goods;
- innovators have greater scope to reuse products without risking patent infringement; and
- patentees seeking greater control over post-sale use should do so through contract law.
In a 2-1 split decision on Wednesday, July 22, 2020, the Federal Circuit confirmed that the Patent Trial and Appeal Board (“PTAB“) had the authority to reject substitute claims under 35 U.S.C. §§ 101 and 112, statutory grounds not available to the PTAB for evaluating patentability of granted patent claims in inter partes review (“IPR“). (Uniloc 2017 LLC, v. Hulu, LLC et al., Case No. 2019-1686, slip op. at 3 (Fed. Cir. July 22, 2020).)Read More
The PTAB’s Precedential Opinion Panel (“POP”) issued a decision in Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, on Friday, December 20, 2019. The issue at hand: “What is required for a petitioner to establish that an asserted reference qualifies as ‘printed publication’ at the institution stage?” Hulu v. Sound View, IPR2018-01039, Paper 29 at *2 (P.T.A.B. December 20, 2019).
This decision provides clarity on an issue that was often addressed inconsistently across panels regarding the “requirements for institution involving issues of public accessibility of an asserted ‘printed publication.’” Id. at 2.Read More
Effective 1 July 2019, the EU adopted a regulation by introducing a supplementary protection certificate (SPC) manufacturing and stockpiling waiver. This waiver also applies for biosimilar versions of SPC-protected medicine during the term of the SPC.Read More