News & Analysis as of

Patent Invalidity Pharmaceutical Patents

Wilson Sonsini Goodrich & Rosati

Inventor’s Failure to Provide Material Information to the USPTO Results in an Unenforceable Patent

On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more

Sheppard Mullin Richter & Hampton LLP

Claiming A Range, Watch Out For The Presumption Of Obviousness

This Federal Circuit opinion analyzes the presumption of obviousness and the obviousness challenge based on prior art that describes a wider range of doses than what is claimed....more

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

A&O Shearman on

After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

A&O Shearman

Court of Appeal upholds invalidity of AstraZeneca's compound patent and clarifies the standard of plausibility

A&O Shearman on

On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more

Robins Kaplan LLP

Ingenus Pharms., LLC v. Nexus Pharms., Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Cyclophosphamide is an antineoplastic agent used to treat various cancers, including lymphomas, myeloma, leukemia, and breast carcinoma. The ’952 patent, issued to Plaintiffs in May...more

Robins Kaplan LLP

United Therapeutics Corp. v. Liquidia Techs., Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: UTC’s ’782 patent claims a method for treating pulmonary hypertension (“PH”). PH manifests in different varieties, including pulmonary arterial hypertension (“PAH”) and pulmonary...more

Venable LLP

Fresenius Kabi Files Two EYLEA® IPRs Prior to aBLA Filing Announcement

Venable LLP on

On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more

Venable LLP

Jury Finds Botox® Patent Claims Nonobvious and Awards Damages from Daxxify® Sales

Venable LLP on

On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...more

Goodwin

Fresenius Files Two IPRs Against Regeneron Aflibercept Patents

Goodwin on

On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more

Knobbe Martens

Combination Dosing Regimen Not Obvious Despite Overlapping Prior-Art Ranges

Knobbe Martens on

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more

Herbert Smith Freehills Kramer

The UPC – Two Years On

The Unified Patent Court – a one-stop-shop for European patent litigation – is now two years old. As it enters its third year of operation, we look at the approach that is becoming established in the new system, drawing out...more

DLA Piper

Purdue Appeals Federal Circuit Obviousness Decision to the Supreme Court

DLA Piper on

Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - July 2025

Venable LLP on

Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

Venable LLP on

Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

Venable LLP on

Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - July 2025

Venable LLP on

Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Haug Partners LLP

Federal Circuit Provides Further Guidance on Obvious Type Double Patenting For Patents Sharing Common Priority

Haug Partners LLP on

On June 9th, 2025, the Federal Circuit issued a decision in Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., affirming the district court’s grant of summary judgment of no invalidity for obviousness-type double patenting (OTDP)...more

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