Weekly Patent Litigation Round-Up

Weekly Patent Litigation Round-Up

Delaware judge deals Biogen another blow in Tecfidera patent fight

A federal judge in Delaware on Wednesday dealt another setback to drug company Biogen Inc in its effort to keep generic versions of its multiple sclerosis treatment Tecfidera off the market through patent litigation. Handing a win to Novartis AG unit Sandoz and other generic drug companies, U.S. District Judge Maryellen Noreika said a Biogen patent on a Tecfidera dosing regimen was invalid because it did not sufficiently describe the claimed invention…



Mylan and Development Partner, Synthon, Win Significant European Patent Office Ruling Related to Copaxone® 40mg/mL

HERTFORDSHIRE, England and PITTSBURGH, Sept. 15, 2020 /PRNewswire/ –Mylan N.V. (NASDAQ: MYL) today announced that the Technical Board of Appeal of the European Patent Office (EPO) has held that Yeda Research and Development Company, Ltd.’s European Patent no. 2 949 335 related to Teva’s Copaxone® 40 mg/mL three times weekly product is invalid and revoked across Europe. With the EPO’s decision, Mylan has once again overcome Teva’s attempts to restrict MS patients’ access to safe and affordable alternatives. Over the course of the last eleven years, Mylan has successfully defeated Teva’s four waves of U.S. patent litigation, eight Citizen Petitions, injunction proceedings in India, and more than 15 regulatory challenges, patent litigations or commercial actions across Europe. The EPO’s positive ruling will allow Mylan to immediately return to the market and accelerate commercialization in other markets across Europe…



Fresenius Faces French Damages Over Alimta

Fresenius Kabi must pay Eli Lilly €28m in damages after a French court of first instance found that the generics firm’s pemetrexed infringed intellectual property protecting the Alimta chemotherapy brand. The German firm has commented on possible next steps..



IPAB allowed an appeal and granted a patent to pfizer for tofacitinib and its salts

The IPAB  allowed  an appeal and granted a patent to Pfizer for Tofacitinib and its salts (application 991/MUMNP/2003. This application claimed the compound 3-{(3R, 4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile and pharmaceutically acceptable salts thereof (Tofacitinib and its salts) and was refused by the patent office on various grounds, including anticipation by prior claiming and section 3(d). The main prior art cited by the controller for novelty was Document WO 0142246(D1) that claimed and disclosed the compound 3-(4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl)-3-oxo- propionitrile. The ground of anticipation by prior claiming was not raised in the hearing notice and for section 3(d) no known substance was identified.



Ibrutinib Patent Revocation: IPAB Says the Stay is Here to Stay

Latest in the Ibrutinib patent saga is IPAB’s order maintaining the interim stay over the revocation of the anti-cancer drug patent. This comes at an interesting time, as a recent report by I-MAK suggests that US-based Biopharma Company AbbVie might be attempting to build a patent wall around Imbruvica (Ibrutinib’s market brand), having secured 88 patents out of 165 applications filed. Imbruvica currently generates a whopping $4.5 billion a year for AbbVie. In India, Pharmacyclics LLC (owned by AbbVie) had been granted the patent in 2014 (IN 262968), against which Laurus Labs had filed a post-grant opposition under Section 25(2) of the Patents Act, 1970 the next year. The hearing was scheduled in November 2017, but was adjourned and rescheduled to 25th September 2019, before being ultimately held on 22nd November. Consequently, the patent was revoked on grounds of lack of inventive step in March 2020.…



Dr Reddy’s announces settlement of Revlimid capsules patent litigation with Celgene in US

Dr Reddy’s Laboratories announced the settlement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb relating to patents for REVLIMID (lenalidomide) capsules. In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Dr Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the US beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages are confidential. Dr Reddy’s is also licensed to sell generic lenalidomide capsules in the US without volume limitation beginning on January 31, 2026.…


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