Celgene Corp. v. Peter, Appeal Nos. 2018-1167, -1168, -1169 (Fed. Cir. July 30, 2019)

Celgene owned two patents that pertained to methods of safely distributing potentially hazardous drugs.  The patents were challenged in an inter partes review (IPR) as obvious over the prior art.  The Board determined that the patents were obvious.


Continue Reading Inter Partes Review of Pre-AIA Patents is Constitutional

Cited Statutory Sections: 101 and 103

This appeal concerned 10 inter partes reviews (IPRs) filed by petitioners Neptune Generics, Fresenius Kabi USA and Mylan Laboratories against all of the claims of U.S. Patent No. 7,772,209, which is owned by Eli Lilly & Co. The ’209 patent concerns methods of administering pemetrexed disodium, an antifolate chemotherapeutic agent, in combination with folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12. The co-administration of the folic acid and the MMA lowering agent was represented as reducing the toxicity of the antifolate chemotherapy.


Continue Reading Neptune Generics, LLC v. Eli Lilly & Co., No. 2018-1257 (Fed. Cir. Apr. 26, 2019).

In an inter-partes review proceeding (IPR), a challenger can rely only on patents and printed publications to challenge the validity of a patent claim. In contrast, in a post grant review (PGR) proceeding, a challenger can rely on any ground related to patentability, including prior sale, to challenge a patent claim.  In particular, 35 U.S.C. §102(a)(1) bars a person from receiving a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”
Continue Reading Supreme Court Holds That AIA On-Sale Bar Applied to Secret Sales

A number of significant changes occurred in 2018 at the U.S. Patent and Trademark Office (USPTO). To begin with, in February 2018, a new USPTO Director took office.  Director Andrew Iancu, a former patent litigator with law firm experience, appears to have brought a different perspective than that of his corporate predecessors – Michel Lee (Google) and David Kappos (IBM) – to the job at the helm of the USPTO.  In his Senate confirmation hearings, Iancu made it clear that he felt that better balance was needed in the administrative review of issued patents by the USPTO under the America Invents Act (AIA).   He pledged to assess “improvements in the AIA trial standards and processes.”  Iancu identified “institution decisions, claim construction, the amendment process, and the conduct of hearings” as areas that warranted study.  In fact, Director Iancu did a lot more than study these aspects of practice before the Patent Trial and Appeal Board (PTAB) in 2018.
Continue Reading Year in Review: Changes in PTAB Practice in 2018

In a final rule published in the Federal Register on October 11, 2018, the U.S. Patent and Trademark Office (USPTO) took a remarkable step of acknowledging unfairness in the way its Patent Trial and Appeal Board (PTAB) has been conducting trials for the past six years. The rule change will apply to all of the

On May 23, 2018, in XY, LLC v. Trans Ova Genetics, L.C., CAFC held that its affirmance of PTAB’s invalidity decision regarding certain claims of a patent owned by XY in a separate appeal involving a different defendant must be given “immediate issue preclusive effect” with respect to the same claims in the present

On May 9, 2018, U.S. Patent and Trademark Office (PTO) issued a notice of proposed rule for changing the standard for construing claims in unexpired patents in inter partes review (IPR), post-grant review (PGR), and transitional covered business method (CBM) proceedings from current broadest reasonable interpretation (BRI) to the same claim construction standard that is

The U.S. Supreme Court’s decision this week in SAS Institute v. Iancu has upended a major provision of the U.S. Patent and Trademark Office (PTO) regulations for inter partes and post grant review proceedings conducted by its Patent Trial and Appeal Board (PTAB).  By concluding in a 5-4 decision that the agency lacks the authority

In a recent decision, the Court of Appeals for the Federal Circuit (CAFC) affirmed decisions in two inter-partes review (IPR) proceedings that patents owned by ICOS Corporation directed to tadalafil formulations (used in the erectile dysfunction drug, Cialis, and the pulmonary arterial hypertension drug, Adcirca) were invalid as obvious. (CAFC Decision Nos. 17-1071 and 1018,

In an inter partes review (IPR) proceeding, a patent owner may file one motion to amend the patent in one or more of the following ways: (a) cancel any challenged patent claim, or (b) for each challenged claim, propose a reasonable number of substitute claims.  35 U.S.C. §316(d).  1290.  With regard to substitute claims, the