Appeal of Examiner's Final Rejection of claims 18-20 reversed by PTAB
Attorney:
Diane Jones
August 4, 2025
Appeal of Examiner’s Final Rejection of claims 18-20 reversed by PTAB based on calculation of an effective human dosage from a “minimal risk of toxicity” dosage for a Cebus monkey rather than a calculation of “minimum pharmacologic activity in humans.”<... Read more
Eye Therapies, LLC. v. Slayback Pharma, LLC: How Prosecution History Can Alter Phrase Interpretation
Attorney:
David Inglefield
July 23, 2025
On June 30, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision regarding transitional phrase claim construction, reversing the decision of the Patent Trial and Appeal Board (PTAB) in Eye Therapies, LLC. v. Slayback Pharma, LLC. The PTAB had previously ruled the claims of U.S. Patent No. 8,293,742 (the ‘742 patent) unpatentable as obvious in a inter partes review brought by Slayback. During the inter partes review, the parties had disagreed on the construction of the transitional phrase “consisting essentially of” in the ‘742 patent. The Court found that the Board had incorrectly applied the conventional open construction of the transitional phrase, which was at odds with the prosecution record. This demonstrates how prosecution history can alter a phrase’s typical meaning.<... Read more
G1/24: Decision of the Enlarged Board of Appeal of the European Patent Office on Claim Interpretation
Attorney:
Matthew Hampton
July 15, 2025
On 18th June 2025, the Enlarged Board of Appeal of the European Patent Office issued Decision G1/24. During Appeal Proceedings (T0439/22) in the Opposition to European Patent No. 3076804B1 (Philip Morris Products S.A.) filed by Yunnan Tobacco International Co., Ltd, the following questions had been referred by the Board of Appeal (Referring Board) to the Enlarged Board of Appeal and subsequently found admissible by that Enlarged Board:<... Read more
US Synthetic Corp. v. International Trade Commission: Safeguarding Structure and Property Limitations in Composition-of-Matter Claims
Attorney:
David Inglefield
March 10, 2025
On February 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed the decision of the International Trade Commission (ITC) in US Synthetic Corp. v. International Trade Commission, issuing a precedential decision regarding subject matter eligibility important to the pharmaceutical and other life science industries. The ITC had previously ruled that US Synthetic’s composition of matter claims reciting measured properties of a composition were directed to a patent-ineligible abstract idea under 35 U.S.C. § 101. The CAFC found that the claims were indeed related to concrete structures, not patent-ineligible abstract ideas, and affirmed the lower court’s finding regarding enablement.<... Read more
The Muted Response of Pharmaceutical Companies to the Establishment of the Unitary Patent Court
Attorney:
Matthew Hampton
March 3, 2025
The Unified Patent Court (UPC) is an international court set up by participating European Union Member States to deal with the infringement and validity of both Unitary Patents1 and European patents. The Agreement on a Unified Patent Court (UPCA) entered into force on 1st June 2023 with the intention of obviating costly parallel patent litigation in the participating European Union Member States and thereby enhancing legal certainty for rights holders.<... Read more
Federal Circuit Reverses District Court's Invalidity Ruling on Written Description in Novartis v. Torrent
Attorney:
Xiaohua (Joyce) Guo, Ph.D.
February 18, 2025
In a precedential opinion issued on January 10, 2025, the United States Court of Appeals for the Federal Circuit reversed a district court’s ruling that had invalidated claims 1-4 of U.S. Patent No. 8,101,659 (“the ’659 patent”) for lack of written description.<... Read more
Patenting of Multi-Disciplinary Subject Matter – Personalized Medicine
Attorney:
Robert W. Downs
February 7, 2025
Personalized medicine is especially intriguing, as a problem with most drugs are the potential side effects. From a naive perspective, administering drugs may appear to be a trial and error process: take this for two weeks and come back with a follow up visit. If you have any side effects, contact me immediately. Wouldn’t it be nice if a drug had the effect it was meant to have without the possibility of side effects?<... Read more
The CAFC Backs the FTC View on Listing Device Patents in the Orange Book
Attorney:
Richard D. Kelly
January 14, 2025
On December 20 the Federal Circuit in Teva Branded Pharmaceutical Products R&D, Inc. (Teva) v. Amneal Pharmaceuticals (Amneal) affirmed the district court’s decision that medical devices were not listable in the Orange Book and Teva had improperly listed patents in the Orange Book and required Teva to remove them.<... Read more
Myrbetriq® Patent Invalidated On Grounds Not Asserted by Any Party Violating Party Presentation Principle
Attorney:
Richard D. Kelly
October 2, 2024
In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § 101 even though Sandoz had not asserted 101 as defense at any time during the case. The parties had agreed to limit the issue to claims 5, 20, and 25 and the defense to invalidity under 35 U.S.C. § 112. Neither party had notice that patent eligibility was an issue. In making his ruling Judge Bataillon relied upon a statement in Astellas post-trial brief that the “inventive concept of the ’780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.” Thus, because the claimed invention “reflects merely the discovery of the food-effect-resolving dissolution profile,” the district court deemed the asserted claims invalid as patent ineligible. Not only had the issue of patent eligibility not been raised by the defendant, but the claims were also to a specific composition. Recognizing the district court had gone on astray Sandoz moved the court to make additional findings of fact advising the court that the § 101 defense had not been raised as a defense and that the decision must be based on the language in the claims. The motion was denied.<... Read more
Finally, an ODP Decision in Favor of the Patentee
Attorney:
Richard D. Kelly
August 28, 2024
In Allergan USA, Inc v Sun Pharmaceutical Indus. Ltd, Appeal No. 2024-1061, August 13, 2024, the Federal Circuit reversed the district court’s holding that Allergan patent, U.S.P. 7,741,356 (‘356) was invalid for obviousness-type double patenting over USPs 11,007,179, 11,090,291, and 11,311,516. The relationship between the patents is shown below:
The ‘356 patent was entitled to significant PTA but because of the PTE it received, Allergan effectively disclaimed all but 487 days of the PTA. The total extension PTE plus PTA resulted in an expiration date of May 27, 2029, 15 years from the ‘356 issue date -- the maximum extension possible.<... Read more