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
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
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
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
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
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
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
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
January 13, 2020
Last month, the Federal Circuit affirmed the District Court of Delaware's decision in Persion Pharmaceuticals v. Alvogen invalidating as obvious two Persion patents claiming methods of treating pain in patients with hepatic impairment (compromised liver functionality) using hydrocodone. Important to the Federal Circuit's decision was the concept of "inherency."... Read more
January 3, 2020
Multiple companies (collectively "Techtronic Industries" or "TTI") appealed from a final determination of the United States International Trade Commission (the "Commission") that their imported product (garage door opener products) infringed the claims of U.S. Patent 7,161,319 (the "319 patent").... Read more