Attorney:
Vincent K. Shier, Ph.D.
August 6, 2020
Much has been written lately about the USPTO's recent enforcement of its controversial interpretation of filing Requests for Continued Examination (RCE) in National Stage applications (i.e., applications under 35 U.S.C. §371) where the oath/declaration was not filed prior to filing the RCE. This post will not address the legal merits of the USPTO's position.... Read more
Attorney:
Richard D. Kelly
August 4, 2020
In March the Federal Circuit reversed a lower court decision finding Illumina’s patents (U.S.Ps. 9,580,751 and 9,738,931) for diagnosing Down’s Syndrome to be patent ineligible, 952 F.3d 1367 (Fed. Cir. 2020). On August 3, the Federal Circuit denied a petition for rehearing and rehearing enbanc but did issue a new decision adding the term “human-engineered” in several portions of the opinion discussing the separation of fetal DNA from maternal DNA which the inventors had discovered were of different sizes, fetal cell DNA is shorter than the maternal DNA. The inventors recognized that the DNA to be analyzed for genetic aberrations was that of the fetus. The problem was to isolate the small amount of fetal DNA from the maternal DNA so the fetal DNA could be analyzed for genetic aberrations. Prior to the invention there was no known way to distinguish and separate maternal DNA from the tiny fraction of fetal DNA present. The inventors found that by selectively removing DNA having more than 500 or 300 base pairs they could produce a sample where the fetal DNA content in the sample would be enriched and analyzed. The following claim is exemplary:<... Read more
Attorney:
Daniel J. Pereira, Ph.D.
July 28, 2020
The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts.... Read more
Attorney:
Marina I. Miller, Ph.D.
July 20, 2020
Electronic Communication Technologies, LLC (“ECT”) sued ShoppersChoice.com, LLC (“ShoppersChoice”), alleging that ShoppersChoice infringed claim 11 of U.S. Patent 9,373,261 (“the ’261 patent”). The district court granted ShoppersChoice’s motion for judgment on the pleadings that claim 11 was invalid under 35 U.S.C. § 101. ECT appealed. The Federal Circuit (“the Court”) affirmed the judgment of the district court.<... Read more
Attorney:
Richard D. Kelly
July 7, 2020
As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.... Read more
Attorney:
Lisa M. Mandrusiak
July 7, 2020
In 2013, the U.S. enacted the Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. § 262 to allow for abbreviated biologics license applications (“aBLA”) to be filed for complex products which are biosimilar to/interchangeable with FDA-licensed biologics.<... Read more
July 2, 2020
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Attorney:
Richard D. Kelly
June 29, 2020
The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.<... Read more
Attorney:
Vincent K. Shier, Ph.D.
June 24, 2020
Although long overdue, the U.S. Patent and Trademark Office (USPTO) released its Final Rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu (85 Fed. Reg. 36335-36342, June 16, 2020). Unfortunately, the Final Rule does not fully address Supernus.<... Read more
Attorney:
Marina I. Miller, Ph.D.
June 8, 2020
The USPTO has launched a new Covid-19 Prioritized Examination Pilot Program to help small and micro entities. The USPTO will accept requests for prioritized examination of up to 500 qualifying patent applications without requiring payment of certain fees associated with prioritized examination. Under this pilot, the USPTO will advance out of turn certain patent applications related to COVID-19 for examination, resulting in their prioritized examination. The USPTO aims to provide final disposition of patent applications in the pilot in one year or less after it grants prioritized status. <... Read more