New Developments in Obviousness-Type Double Patenting and Original Patent Requirements — Patents: Post-Grant Podcast
Inter Partes Review: Validity Before the PTAB
Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more
We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more
Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more
Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc....more
On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more
In Incept v. Palette Life Sciences 21-2063, 21-2065 (Fed. Cir. Aug. 16, 2023), the case addresses the Board’s anticipation and obviousness determinations in two IPRs (IPR2020-00002 and IPR2020-00004), where the Board held the...more
The Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board (PTAB or Board) finding that a combination of prior art references requires only an implicit indication of a reasonable expectation of success. ...more
In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more
This case is an appellate review of the district court’s findings regarding patent obviousness and priority date. Background Amgen produces and markets apremilast, a medication for the treatment of certain types of psoriasis...more
On August 22, 2023, the Federal Circuit affirmed an IPR Final Written Decision holding claims to deuterated derivatives of ruxolitinib unpatentable as obvious and rejected the patentee’s argument that a skilled artisan would...more
The Federal Circuit reversed a Patent Trial and Appeal Board (“Board”) decision finding the challenged claims of Sanofi-Aventis’ ’614 patent unpatentable as obvious....more
This case addresses obviousness under 35 U.S.C. § 103 in relation to a method of increasing prostacyclin release to reduce hypertension in a patient. In particular, this case discusses issues relating to motivation to...more
Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more
Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more
Procedural History - Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc. is an appeal from a final written decision in an inter partes proceeding (“IPR”) of the Patent Trial and Appeal Board (“PTAB”) that found...more
Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., No. CV 20-5426 (SRC), 2022 WL 17352334 (D.N.J. Dec. 1, 2022) (Chesler, J.) Drug Products and Patent(s)-in-Suit: Duobrii® (halobetasol...more
Case Name: Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., No. 20-8966 (SRC), 2022 WL 17959811 (D.N.J. Dec. 27, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Vyvanse® (1-lysine-d-amphetamine dimesylate); U.S....more
The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) Final Written Decision (FWD) in an inter partes review (IPR) that Mylan Pharmaceuticals failed to show the claims of U.S. Patent No. 7,326,708 were...more
In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more
Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more
The US Court of Appeals for the Federal Circuit found a method of treatment claims pertaining to topical formulations to be obvious, applying the presumption of obviousness of overlapping ranges theory. Almirall, LLC v....more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more
Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more