Pharma IP Circle

On Apr. 05, 2024, Federal Circuit vacated PTAB’s decision in an IPR and remanded the case for the PTAB to dismiss the  proceedings as the case got moot.

 

Sumitomo Pharma Co., Ltd. owned a patent (U.S. Patent No. 9,815,827) titled “Agent for Treatment of Schizophrenia,” which detailed dosing regimens for treating certain psychotic disorders with lurasidone, a pharmaceutical compound. The patent specifically claimed dosing regimens that treated schizophrenia without causing clinically significant weight gain, …

On Jan. 11, 2024, New Jersey district court granted Plaintiff’s motion to dismiss counterclaim of inequitable conduct put forth by Defendants.

 

This is with respect to Hatch-Waxman litigation concerning Cannabidiol (Epidiolex) oral solution. It is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Various defendants filed ANDA and Jazz (Plaintiff) sued them for infringement of …

On Dec. 20, 2023, Federal Circuit affirmed PTAB decision that claims 1–8 of US 10,716,793 are unpatentable.

 

United Therapeutics Corporation owns the ’793 patent, which is directed to methods of treating pulmonary hypertension comprising inhalation of treprostinil with single dose from 15 micrograms to 90 micrograms delivered in 1 to 3 breaths. Dependent claims mention specific dry powder and particle size. Liquidia Technologies, Inc. petitioned for IPR of all claims of the ’793 patent, …

On Dec. 07, 2023, Federal Circuit affirmed district court’s judgment of non-infringement of method of use patents and infringement of process patent.

 

Lundbeck / Takeda (Plaintiffs) market Trintellix® (Vortioxetine) for the treatment of major depressive disorder (“MDD”) in adults. Defendants Lupin, Macleods, Sandoz, Sigmapharm, Zydus, Alembic, and Lek pharma filed ANDA with USFDA to market generic version of Trintellix®. District court held that defendants’ ANDA did not infringe two patents US 9,278,096 (use of …

On Nov. 07, 2023, Federal Circuit dismissed appeal of Allgenesis Biotherapeutics because it failed to establish sufficient injury in fact.

 

Cloudbreak Therapeutics owns US 10,149,820 patent, related to compositions and methods for treating pterygium. Allgenesis petitioned for IPR of all claims of US’820. Cloudbreak disclaimed genus claims leaving only claims 4 and 5, which more narrowly claim the use of nintedanib. The Board issued a final written decision holding Allgenesis failed to show claims …

On Aug. 15, 2023, Delaware district court found Lonsurf®patent valid and infringed.

 

This is an Hatch-Waxman litigation related to Lonsurf® [combination of trifluorothymidine (FTD) & tipiracil – called TAS-102 therapy] product, marketed by Taiho pharmaceuticals. USFDA approved Lonsurf® for treating adult patients with metastatic colorectal cancer who have already received certain other prior treatments. Defendants (Aurobindo / Accord / MSN Pharma / Natco) filed ANDAs with the FDA to market generic version. Taiho alleged …

On Aug. 16, 2023, Delaware district court found Brivaracetam compound patent valid and infringed.

 

This is an Hatch-Waxman litigation related to Briviact® product, marketed by UCB. USFDA approved Briviact® for the treatment of partial-onset seizures in epilepsy patients one month of age or older. UCB sells Briviact® in 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg tablets, a 50 mg/5 mL single-dose intravenous solution, and a 10 mg/mL oral solution. Defendants …

On Apr. 19, 2023, Federal Circuit affirmed District Court which found some Apremilast patents valid and invalid.

 

This is a Hatch-Waxman litigation. Amgen markets apremilast, which is used for treating psoriasis and related conditions, under the brand name Otezla®. US 7,427,638 (composition with stereomerically pure apremilast), US 7,893,101 (crystalline polymorphic forms) and US 10,092,541 (method of treatment using dose titration of apremilast) are listed in Orange Book. Many generic filers including Sandoz / Zydus …

On Apr. 12, 2023, Federal Circuit affirmed district court’s decision that asserted claims of US 10,130,589 are invalid.

 

Background:

The US’589 patent is listed in Orange Book for Neupro® (Rotigotine) film/patch, which is used to treat Parkinson’s disease. The technology at issue relates to transdermal therapeutic systems (TTSs), which deliver drugs through the patient’s skin and thus avoid complications with oral treatments. These patches contain drugs in an “amorphous,” form as crystalline form …