Publications

CAFC Issues Another Precedential Decision on Standing

USPTO Launches "IP Marketplace" Related to COVID-19

Supreme Court Holds Proof of Willfulness is Not a Precondition to an Award of Profits under Section 43(a)

USPTO Decides an "Inventor" as a "Natural Person"

The USPTO has published an apparently January 2020 Commissioner Decision effectively precluding the filing of patent applications where the invention was made solely by artificial Intelligence (AI). This decision has implications in the pharmaceutical industry where the use of AI to identify new compounds or uses for old compounds is utilizing AI. It also provides some guidance as to how the problem may be avoided.

How AI-Related Life Sciences Patents Are Examined In Japan

Law360

Obviousness of Compounds Having "Significant Structural and Functional Similarities" With Known Compounds

Mylan Pharmaceuticals Inc. and others ("Mylan") appealed from the District Court's grant of summary judgment that claim 8 of U.S. Patent 8,552,025 owned by Valeant Pharm. Int'l, Inc.was not invalid. Valeant Pharm. Int'l, Inc. v. Mylan Pharm., Inc., No. 2:15-cv-08180 (SRC), 2018 WL 2023537 (D.N.J. May 1, 2018). The Court of Appeals for the Federal Circuit ("the Court") reversed the decision of the district court.

SCOTUS Reverses The Federal Circuit Again: IPR Time-Bar Determinations Are Not Judicially Reviewable

PTAB Issues Two New Precedential and One Informative Opinions on Section 325(d)

"A Method of Preparation" and Patent Eligibility Under Section 101

Before LOURIE, MOORE, and REYNA, Circuit Judges. Illumina, Inc. and Sequenom, Inc. ("Illumina") filed suit against Ariosa Diagnostics, Inc., Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc. ("Roche") alleging infringement of U.S. Patents 9,580,751 and 9,738,931. Roche moved for summary judgment that the asserted claims were invalid under 35 U.S.C. § 101. The district court granted Roche's motion holding that the claims of the '751 and '931 patents were directed to ineligible subject matter. Illumina appealed. The Federal Circuit ("the Court") reversed the district court's grant of summary judgment and remanded for further proceedings.

Listing the Medical Device Part of a Combination Product in the Orange Book May Trigger Antitrust Liability

A patent listing in the Orange Book provides the innovator drug company with a potent tool for excluding generic competitors who wish an ANDA application or 505(b)(2) drug approval applications relying upon the innovator's efficacy and safety data. If a patent is listed in the Orange Book the generic applicant must provide notice to the NDA holder and the patentee (if different) of the application's filing. The patentee then has 45 days to initiate litigation which would cause a 30-month stay of the FDA approval of the generic drug. Normally patents to a drug's packaging are not listable in the Orange Book, however, an exception exists for packaging which also functions as the drug's applicator. Sanofi took advantage of this provision to list U.S.P. 8,556,864 (‘864 patent) which was directed to the drive mechanism used in its injector pen for its Lantus® insulin product. The product plus injector was sold as Lantus Solostar®.