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Generics
In what is not exactly a win-win situation for the Indian generic firms, a recent federal court ruling in Delaware, USA, has determined that MSN Pharmaceuticals has not infringed on a key patent (Novartis' US Patent No 11,096,918) related to Novartis' blockbuster heart failure drug, Entresto (sacubitril/valsartan). 18 July 2025
Generics
The number of patent disputes in the Russian pharmaceutical industry has almost doubled in the last several years, while these figures continue to grow these days, The Pharma Letter’s local correspondent reports. 16 July 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries together with its subsidiaries announced that further to its intimation dated April 10, 2025, Sun and Incyte Corporation have entered into a settlement and license agreement regarding litigation related to Leqselvi (deuruxolitinib). 15 July 2025
Biotechnology
China-based biotech CARsgen Therapeutics has strengthened its grip on intellectual property in the CAR-T space after a US rival dropped its legal challenge to one of the company’s cornerstone patents in Europe. 14 July 2025
Pharmaceutical
Pharmaceutical companies are heading toward a steep patent cliff that could strip more than $230 billion in US drug sales between 2025 and 2030, according to a new report from analytics firm GlobalData. The industry is preparing for a wave of revenue loss as leading drugs lose exclusivity and face generic and biosimilar competition. 4 July 2025
Pharmaceutical
As pressure builds around drug pricing and access, US trade group PhRMA is pushing back against criticism of pharmaceutical patents. In a recent blog post, the organization argued that intellectual property protections are essential to biopharmaceutical innovation and key to sustaining the American economy. 1 July 2025
Generics
US insurance giant Cigna has taken fresh legal action against Bristol Myers Squibb, accusing the drugmaker of manipulating the patent system to preserve its monopoly on the multiple myeloma treatment Pomalyst (pomalidomide). 26 June 2025
Pharmaceutical
See-sawing global tariffs, a US regulator in flux and a possible end to US drug price premia are not, apparently, enough to stymie pharmaceutical industry growth. 24 June 2025
Generics
The revision of the European pharmaceutical legislation, the reform of the Supplementary Protection Certificate (SPC) system and the review of the SPC manufacturing waiver are now fundamental reforms to stimulate a strong off-patent pharmaceutical industry in Europe whose medicines account for the vast majority of those dispensed in Europe, trade group Medicines for Europe announced today. 24 June 2025
Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Pharmaceutical
The European Council of Minister last week said it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the European Union’s (EU) pharmaceutical sector fairer and more competitive. 9 June 2025
Generics
Japanese drugmaker Eisai said yesterday that it has received a favorable decision regarding the lawsuit filed in the US District Court for the District of New Jersey in November 2019 against generic drug manufacturer Shilpa Medicare, which submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima (lenvatinib), for infringement of US Patent No 11,186,547. 30 May 2025
Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Generics
Russian drugmaker Geropharm has received a compulsory license from the Russian state to produce a generic of Ozempic (semaglutide) developed by Denmark’s Novo Nordisk. As in case of Ozempic, Geropharm’s generics are used to treat diabetes, as well as for weight loss, reports The Pharma Letter’s local correspondent. 28 May 2025
Biotechnology
South Korean vaccine maker SK Bioscience has secured a final court victory over US pharma major Pfizer in a long-running patent dispute concerning exports of its 13-valent pneumococcal conjugate vaccine, SKYPneumo (pneumococcal 13-valent conjugate vaccine). 21 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Generics
India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion. 13 May 2025
Pharmaceutical
Trade group the Association of the British Pharmaceutical Industry (ABPI) has spoken out against a new free trade agreement signed by the UK government with India. 7 May 2025
Pharmaceutical
The Russian drugmaker Akrikhin has filed a lawsuit against UK pharma major AstraZeneca to the Moscow Intellectual Property Court asking to recognize its right to use formulas from two patents of Astra Zeneca for production of Forxiga (dapagliflozin), a drug for the treatment of diabetes and cardiovascular diseases, The Pharma Letter’s local correspondent reports. 1 May 2025
Generics
The Russian Ministry of Economy has prepared a draft order that will limit the ability of pharmaceutical companies to patent other forms of already known chemical compounds in Russia, according to recent statements by some senior state officials and local media, reports The Pharma Letter’s local correspondent. 17 February 2021
Biotechnology
The US Court of Appeals for the Federal Circuit has upheld the decision by the US District Court for the District of Delaware that Amgen's asserted patent claims directed toward PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies are invalid based on lack of enablement. 15 February 2021
Pharmaceutical
The US Patent and Trademark Office (USPTO) recently issued a US Patent Term Extension (PTE) certificate for Ibrance (palbociclib), US pharma giant Pfizer announced on Friday. 8 February 2021
Generics
Russian drugmaker Pharmsynthez has begun production of a remdesivir generic, the drug that was originated by the US biotech Gilead Sciences (Nasdaq: GILD) and marketed under the Veklury brand, reports The Pharma Letter’s local correspondent. 2 February 2021
Pharmaceutical
French pharma major Sanofi appears to have the opportunity to restore exclusive rights on insulin glargine in Russia as the Russian Intellectual Property Court has overturned a lower court decision to revoke Sanofi's patent for the drug, trade name Lantus, on the basis of a judicial claim submitted for the Russian drugmaker Geropharm a while ago, reports The Pharma Letter’s local correspondent. 26 January 2021
Generics
Hyderabad, India-based Natco Pharma is seeking to file a compulsory licensing application for a generic version of Eli Lilly's arthritis drug baricitinib, in a move that could potentially lead to a legal battle over intellectual property rights (IPR), reports The Pharma Letter’s local correspondent. 23 December 2020
Biotechnology
The global pharma industry has highlighted what it called the “unprecedented pace” of progress in the fight against COVID-19, while insisting that forthcoming vaccines have been tested to the same high standards as usual. 8 December 2020
Pharmaceutical
The Association of Foreign Pharmaceutical Manufacturers (AIPM), a trade association which unites more than 60 global drugmakers operating in the Russian market, has appealed to the country’s Federal Antimonopoly Service (FAS) to limit participation of a drug with the international non-proprietary name (INN) insulin glargine in tenders for public procurements in the Russian pharmaceutical market, according to recent statements by an official spokesman of the Association and some local media reports. 1 December 2020
Pharmaceutical
An intense debate is going on in India on whether patented drugs should be selected and identified for inclusion in the National List of Essential Medicines (NLEM) 2020, which is being finalized by the Expert Committee constituted by the Ministry of Health. 27 November 2020
Generics
The European Commission has fined the pharmaceutical companies Israel-based Teva Pharmaceutical Industries 60.5 million euros ($72 million) for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil, after Cephalon's main patents had expired. 26 November 2020
Pharmaceutical
The US regulator has turned down a submission from North Carolina, USA-based Liquidia Technologies to market LIQ861 (treprostinil) for pulmonary arterial hypertension (PAH). 26 November 2020
Pharmaceutical
A much awaited Pharmaceutical Strategy for Europe was adopted today by the European Commission. 25 November 2020
Generics
American pharma giant Pfizer and its group companies have filed a petition in a US court against Aurobindo Pharma and Dr Reddy’s Laboratories, alleging the Indian generic drugmakers were planning separately to come out with generic versions of its blockbuster drug Ibrance (palbociclib) before expiration of its patent. 25 November 2020
Generics
As Indian companies focus on anti-diabetes, Court rejects AstraZeneca's plea on diabetes drug patent
Indian drug company, Laurus Labs is set to boost capacity with a $202 million infusion, underscoring the inherent advantages of Indian pharmaceutical firms that focus on molecules in diabetes, ophthalmology, and cardiovascular therapy. While three out of the top seven largest-selling drugs in the country are now anti-diabetes, the therapy is registering a robust double-digit growth year-on-year, reports The Pharma Letter’s India correspondent. 23 November 2020
Pharmaceutical
Lawsuits for patent infringement require a showing that an accused product or process includes each and every element of an asserted claim, write Jonathan Roses, counsel, Wolf, Greenfield & Sacks, and Alexander Lee, associate, Hoffmann Eitle, in an Expert View piece. 20 November 2020
Biosimilars
The Indian pharmaceutical industry sees US President-elect Joe Biden’s proposed plan to expand Obamacare and reduce middlemen as positive steps. Looking to benefit from the Biden presidency on the back of an increased push for generic prescriptions and biosimilar strategy, Indian drugmakers expect the accent on localization to continue, reports The Pharma Letter’s India correspondent. 12 November 2020
Generics
Pharmasynthez, one of Russia’s leading drugmakers, has asked for permission to begin production of a generic of remdesivir, an original drug from US antivirals giant Gilead Sciences, reports The Pharma Letter’s local correspondent. 10 November 2020
Generics
A new white paper has explored the misuse of certain intellectual property (IP) tools that block generic and biosimilar medicines for the first time since the findings of the European Commission Pharmaceutical Sector Enquiry in 2009. 6 November 2020
Biotechnology
The European Patent Office (EPO) Technical Boards of Appeal has ruled in French pharma major Sanofi and US partner Regeneron Pharmaceutical’s favor, invalidating certain claims of Amgen’s European patent (EP 2 215 124) directed to PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies relevant to Praluent (alirocumab). 30 October 2020
Pharmaceutical
Jonathan Roses, counsel Wolf, Greenfield & Sacks and Matthew Birkett, partner, Hoffmann Eitle, provide an Expert View on general treatment of salt and polymorphic forms in the US Patent and Trademark Office, the European Patent Office and the courts. 23 October 2020
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