Deferasirox – UK

On Nov. 10, 2022, the High Court (Patent Court) of England & Wales found deferasirox formulation patent invalid and not infringed by Teva.

 

Teva brought action for revocation of two patents, EP 2,964,202 and EP 3,124,018 owned by Novartis. These patents claim swallowable film-coated deferasirox formulation with certain excipients. Both patents have been upheld in the Opposition Division of the EPO with amended claims and appeals are pending. Novartis requested to amend the claims …

Bendamustine – USA

On Oct. 25, 2022, Delaware district court found defendants NDA non infringing as their products were not “ready to use”.

 

This is a patent infringement case under Hatch-Waxman Act brought by Plaintiff (Eagle pharmaceutical) against defendants (Slayback & Apotex). Defendants filed NDA for approval to manufacture and sell bendamustine
hydrochloride drug products based on plaintiff’s approved product, BELRAPZO® (bendamustine hydrochloride) Injection, I 00 mg/ 4 mL (25mg/mL). Eagle alleged in its complaint that defendants’ …

Eluxadoline – USA

On Oct. 20, 2022, Delaware Court denied Plaintiff’s motion to strike down “unclean hand” counterclaim and defense raised by Defendant.

 

Plaintiff (Allergan) sued defendant (Sun pharma) for infringement of patents related to product, Viberzi (Eluxadoline), as Sun filed ANDA to market generic version. Allergan initially sued Sun for infringement of US 9,675,587 and US 10,188,632 patents and then added later patents when they got issued subsequently. These patents are: US 11,007,179; US 11,090,291; US …

Sitagliptin – USA

On Sep. 29, 2022 Federal Circuit affirmed PTAB (Board) and found sitagliptin phosphate salt patent valid.

 

Petitioner (Mylan) on Oct 30, 2019 filed inter partes review (IPR) for claims 1–4, 17, 19, and 21–23 of US 7,326,708 patent. US’708 patent is assigned to Merck & it claims dihydrogenphosphate (DHP) salt of sitagliptin. On May 07, 2021, PTAB issued final written decision and found phosphate salt patent of sitagliptin valid. You can read the PTAB …

Eslicarbazepine – USA

On Sep. 15, 2022, Delaware court found some patents valid and infringed in Aptiom® Hatch-Waxman case.

 

Plaintiffs (Bial- Portela / Sunovion) sued defendant (Alkem) for infringement of five patents as defendant filed ANDA with USFDA to market generic version of APTIOM®. It is orally administered once a day in tablet form to treat epileptic seizures called partial-onset seizures. Plaintiff asserted claim 3 of US 10,675,287; claim 5 of US 10,695,354; claims 7 and 8 …

Treprostinil – USA

On Aug. 31, 2022, Delaware court found one patent invalid and other valid and infringed in Tyvaso® litigation.

 

United Therapeutics Corporation (“UTC”) sued Liquidia Technologies, Inc. for infringement of US 9,593,066; and US 10,716,793 because Liquidia filed NDA (LIQ861 / Yutrepia™) for treprostinil with P-IV certification. Tyvaso®, is an inhaled solution formulation of treprostinil approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. And LIQ861 is a …

Sucroferric oxyhydroxide – USA

On Aug. 18, 2022 , Delaware court found Velphoro® patent valid and infringed in a Hatch-Waxman litigation.

 

Plaintiffs (Vifor Fresenius) sued defendant (Teva) for infringement of US 9,561,251 patent as defendant filed ANDA seeking to launch generic version of Velphoro® (Sucroferric oxyhydroxide) chewable tablet. Velphoro is “a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.” The ’251 patent is directed to pharmaceutical compositions with …

Rifaximin – USA

On Aug. 17, 2022, New Jersey court granted Defendant’s motion to dismiss the complaint.

 

Plaintiff (Curia IP) is the assignee of patents related to mixtures of α and β polymorphic forms of rifaximin. These are US 9,186,355; US 10,556,915; US 10,745,415; and US 10,961,257 which have filing date in 2013 & 2014. Defendants (Salix pharma / Bausch / Alfasigma) markets XIFAXAN® product in USA since July 2004. Plaintiff claims that Defendants’ sale of XIFAXAN®, …

Methylphenidate – USA

On Aug. 16, 2022, New Jersey court gave mixed ruling in QuilliChew ER® Hatch-Waxman litigation.

 

Tris pharma (Plaintiff) sued Teva (Defendant) for infringement of five patents: US 9,545,399; US 9,844,544; US 9,844,545; US 11,103,494 and US 11,103,495. Teva filed ANDA seeking to produce and sell a generic version of QuilliChew ER®.  Tris alleges that Teva’s proposed generic product would infringe claims 22 and 24 of the ’399 patent; claim 37 of the ’544 patent; …

Rifaximin – USA

On Aug. 10, 2022, Delaware court ruled polymorph and one MoU patents invalid whereas other MoU patent as valid.

 

Norwich (Defendant) submitted ANDA to the USFDA for approval to market a generic version of Xifaxan (Rifaximin), 550 mg tablets. Salix (Plaintiff) markets Xifaxan in the USA. Salix sued Norwich for infringement of twenty-six patents. Before trial, Salix narrowed its case to U.S. Patent Nos. 7,612,199, 7,902,206 (“the Polymorph Patents”), 8,642,573 , 9,421 ,195, 10,335,397 …

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