by Dennis Crouch In a significant win for the generic pharmaceutical industry, the Federal Circuit recently affirmed that legal expenses incurred defending Hatch-Waxman patent litigation can be deducted immediately as ordinary business expenses rather than capitalized. The decision in Actavis Laboratories FL, Inc. v. United States, No. 2023-1320 (Fed. Cir. Mar. 21, 2025), affirms the earlier ruling by Court of Federal Claims Judge Ryan Holte in favor of Actavis.  The U.S. Government will now need to issue a tax refund of about $12 million just for 2008-2009. To continue reading, become a ..read more

In a decision newly designated as "informative" by the USPTO, the Patent Trial and Appeal Board (PTAB) provided important guidance on the procedural requirements for inter partes review (IPR) petitions, particularly consistency between IPR proceedings and parallel litigation. Cambridge Mobile Telematics, Inc. v. Sfara, Inc., IPR2024-00952, Paper 12 (P.T.A.B. Dec. 13, 2024). In its decision, the Board exercised discretion to deny the petition because the petitioner failed to properly address claim construction, particularly whether the claim terms were means-plus-function under 35 U.S.C. §112(f ..read more

by Dennis Crouch The Federal Circuit's short precedential decision in Realtek v. ITC & DivX addresses ITC sanctions proceedings. The alleged bad act here involves patentee DivX who arguably altered its infringement theory against Realtek midstream and then ultimately dismissed its complaint against the Taiwanese semiconductor company after that pathway was also cut off. Realtek thought that the ITC should sanction the patentee, but the ITC refused.  The Federal Circuit recently dismissed the appeal -- holding that the court had no power to review this abuse of discretion claim. Althou ..read more

Guest post by Professors Jonathan S. Masur (Chicago Law) and Lisa Larrimore Ouellette (Stanford Law). This blog recently covered the Federal Circuit’s important decision in In re Entresto (Novartis Pharmaceuticals v. Torrent Pharma), 125 F.4th 1090 (Fed. Cir. 2025), which upheld patent claims even though they covered after-arising technology that was not described or enabled in the specification. As Dennis noted, the Federal Circuit appeared to depart from well-established prior law on the subject. But as we explain in our forthcoming article, Disclosure Puzzles in Patent Law, we believe the c ..read more

by Dennis Crouch In an unprecedented move, the Secretary of Commerce is terminating all current appointments to the Patent Public Advisory Committee (PPAC) and Trademark Public Advisory Committee (TPAC), effectively removing the entire membership of both committees.  New members will apparently be appointed shortly, with the USPTO planning to proceed with previously scheduled public committee meetings in May 2025.  The statute requires that "any vacancy on an Advisory Committee shall be filled within 90 days after it occurs." Although my memory is sometimes faulty, I believe that thi ..read more

by Dennis Crouch I'm delivering a U.S. patent law year-in-review for the past year or so.  Here are Nine of the topics that deserve some focus. 1. The New USPTO under President Trump: The greatest ongoing issue is the about-face from President Trump to President Biden. The ultimate direction and outcome will become more clear as we move through 2025, but there have already been dramatic shifts, especially focused on workforce RTO and RIF and elimination of non-core USPTO activities. Meanwhile backlog is growing again. 2. The Only Federal Circuit En Banc Decision – LKQ v. GM: Shifts in des ..read more

The Supreme Court has denied BMC Software's petition for writ of certiorari -- formalizing the Fifth Circuit decision that nullified a $1.6 billion judgment against IBM.  The appellate court had overturned the district court's breach of contract finding and its subsequent large damages award. This case involves two large companies, each with billions of dollars in annual revenues. But, the setup will be familiar to so many innovative companies across the nation that are forced by market realities to do business with the very competitors that are likely to be their undoing. Small businesse ..read more

By Dennis Crouch The Federal Circuit has affirmed the denial of a preliminary injunction against Amgen's biosimilar version of Regeneron's blockbuster drug EYLEA (aflibercept). Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 2024-2351 (Fed. Cir. Mar. 14, 2025) (Lourie, J.). This latest ruling stands in contrast to the court's January 2025 decisions upholding preliminary injunctions against Samsung Bioepis and Formycon, effectively blocking their biosimilar launches. All three cases are part of consolidated multi-district litigation in the Northern District of West Virginia. Each appeal invo ..read more

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post ..read more

The Federal Circuit recently heard oral arguments in the much-anticipated en banc review of EcoFactor, Inc. v. Google LLC, a case focusing on how courts evaluate expert testimony on patent damages.  And, in particular, when a court should step-in to bar expert testimony that does not have sufficient factual basis for its conclusions.  The arguments focused on whether EcoFactor's damages expert improperly derived royalty rates from license agreements that contained performative non-binding "whereas" clauses stating EcoFactor's belief about rates, while the operative provisions specifi ..read more