PTO Expands the Scope of the Immunotherapy Pilot Program

The PTO’s Cancer Immunotherapy Pilot Project, begun in 2016, has been deemed a success. It permitted an applicant claiming a method to treat cancer using immunotherapy to file a petition to accelerate issuance of the first Examination Report. When the program expires, on Jan. 31st, it will be replaced by a structurally similar program entitled “the Cancer Moonshot Expedited Examination Pilot Program” which will broaden the scope of qualifying technologies, to include certain product or apparatus “use” claims.  87 C.F.R. 75608, Dec. 9th 2022.

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Moderna to Pfizer: “The Pandemic is Over”

On August 26th, Modernatx, Inc. and Moderna US, Inc. sued Pfizer and Biontech SE,  (Case 1:22-cv-11378 [D. Mass.]) for treble damages and attorney’s fees related to the alleged direct or indirect infringement of three of Moderna’s patents with claims directed to the mRNA vaccines developed by Moderna to prevent or lessen the symptoms of COVID-19 infections. The patents in suit are U.S. Pat. Nos. 10,898,574; 10,702,600 and 10,933,127. Claim 2 of the ‘574 patent is directed to lipid nanoparticles comprising an mRNA encoding a polypeptide, wherein the mRNA comprises one or more uridines, where substantially all of the uridines are modified. This is my compressed version of this patent claim, since the events leading to filing this suit are more interesting at this stage.

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Tillis Bill Tries to Fix Section 101

This recently introduced bill would replace section 101 with a lot of text. The commentators are all commentating, but I have yet to read whether or not the “outlaw” status of claims to diagnostic methods—led by varying interpretations of Mayo v. Prometheus—has been clearly lifted by this bill. Here are the relevant parts, at least setting up the discussion on this point.

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CareDx v. Natera – The Broad Road to Patent Ineligibility

In CareDx v Natera, Appeal No. 2022-1027, (Fed. Cir., July 18, 2022), a three judge panel of Judges Lourie, Bryson and Hughes, affirmed the district court’s finding that the claims of U. S. patent nos. 8703652, 9845497 and 10329607 are invalid for failing to survive the Alice/Mayo test for patent eligibility. I subtitled this post using Matthew 7:13-14: “Enter through the narrow gate. For wide is the gate and broad is the road, that leads to destruction.” The appeal to the Federal Circuit, which I wrote about on October 15, 2021, never got on the narrow road that leads to viable diagnostic claims. It may not have been possible to overcome the obstacles that blocked the road, but CareDx managed to hit them all, and ended up with three invalid patents on natural phenomena.

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