CAFC Issues Another Precedential Decision on Standing

May 07, 2020

The Federal Circuit issued a precedential decision addressing standing requirements in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., No. 2018-2273, slip op. (Fed. Cir. April 23, 2020).<... Read more

USPTO Launches "IP Marketplace" Related to COVID-19

May 6, 2020

The USPTO created a web-based platform that identifies patents that may be useful in the creation of technologies to combat the coronavirus/COVID-19 disease (https://developer.uspto.gov/ipmarketplace/search/patents). The website lists various patents and patent publications, seven pages with about 24 per page, that include links to the patents or publications, Issue/Publication dates and other bibliographic information. There is also a column indicating if Licensing is available for the patents/patent applications listed. The patents and applications listed have been apparently asked by the patentee/patent applicant to be included (from the tab “About the Platform):<... Read more

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

April 28, 2020

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.<... Read more

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

April 27, 2020

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.<... Read more

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

April 17, 2020

The PTAB recently designated two decisions as precedential and one decision as informative with respect to 35 U.S.C. § 325(d). These cases discuss the Board's process for deciding when to use their discretion to deny institution because a Petition raises issues that the Patent Office previously considered in other proceedings (e.g., during prosecution, prior reexams).... Read more

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

March 30, 2020

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.... Read more

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

March 30, 2020

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®.... Read more

Patent Eligible Method of Treatment/Prevention Claim

March 23, 2020

特許適格性を満たす治療/予防方法クレーム の例<... Read more

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Pharma Claiming Practice Under Fire

February 28, 2020

The Federal Circuit has launched an assault on common claiming techniques in pharma and chemical patents. In October 2019 the Federal Circuit issued two opinions, the first was HZNP Medicines[1] involving the limitation “consisting essentially of” and the second, Idenix[2], striking at Markush Groups. This post concerns the HZNP decision. On February 25 the Federal Circuit denied HZNP’s request for a rehearing and rehearing en banc. According the Drug Patent Watch reported there were 244 drug patents using the language “consisting essentially of,” a number which seems low based on my experience.<... Read more