Amgen Wins Right to Market Mvasi™ — Federal Circuit Interprets BPCIA Provision Regarding Notice

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

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July 2, 2020

We appreciate your continued readership and wish to maintain your loyalty as we switch subscription software... Read more

FDA Seeking Comments on Orange Book Patent Listing

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

Final Rules on PTA Calculations in View of Supernus

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

Requirements Under COVID-19 Prioritized Examination Pilot Program

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

MCRO's Pyrrhic Victory

May 21, 2020

On May 20 the Federal Circuit for the second time found McRO’s patent for automatically generating animations to be patentable, this time reversing the district court’s finding of invalidity for lack of enablement. In its previous decision, McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016) (McRO I), the Federal Circuit reversed the district court’s holding that the claims were directed to a judicial exception, an abstract idea. In McRo I the Court had reversed based on its determination that the claims were to a genus limited to rules with certain common characteristics, a genus. Id. at 1313. In particular, the “rules are limiting in that they define morph weight sets as a function of the timing of phoneme sub-sequences.” Id. <... Read more

Biogen v. Banner Life Sciences -- The Limited Scope Of U.S. Patent Term Extensions (Hint: Metabolites Not Included)

May 12, 2020

Under 35 U.S.C. §156, a patentee can extend a patent’s term to restore part of the term consumed during the Food and Drug Administration’s (FDA) New Drug Application (NDA) approval process for a compound covered by the patent.<... Read more

CAFC Affirms Invalidation of Replacement Heart Valve Patent – Reiterates that Reasonable Expectation of Success is not Absolute Certainty for Success

May 08, 2020

           The Federal Circuit issued a public opinion in Boston Scientific Scimed, Inc., v. Andrei Iancu, No. 2018-2004 (Fed. Cir. May 6, 2020) (sealed opinion was previously issued on April 27, 2020), affirming the PTAB’s final written decision in IPR 2017-00060. The CAFC upheld that challenged claims 1-4 of U.S. Patent No. 8,992,608 to Boston Scientific are invalid as being obvious over prior art.<... Read more

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