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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
Pharmaceutical
UK-based Shield Therapeutics has provided an update on an ongoing patent dispute with Israeli generics giant Teva Pharmaceutical. 19 October 2020
Generics
Russian generics producers have designed alternative ways for the launch of their products in the domestic market, bypassing the patents of Western drugmakers, reports The Pharma Letter’s local correspondent. 13 October 2020
Biotechnology
Privately-held US biotech Allele Biotechnology and Pharmaceuticals has filed two patent infringement lawsuits – one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. 6 October 2020
Generics
US specialty pharma firm Collegium Pharmaceutical has announced a settlement agreement with the US subsidiary of Israel’s Teva Pharmaceutical Industries. 1 October 2020
Biotechnology
Denmark’s Genmab saw its shares drop over a tenth after it emerged the firm was locked in a legal battle over royalties for cancer drug daratumumab. 23 September 2020
Pharmaceutical
An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Matthew Birkett, partner, Hoffmann Eitle, on the granting of two patents for a single invention in the USA and Europe. 22 September 2020
Generics
Canada-based Bausch Health Companies and its gastroenterology business, Salix Pharmaceuticals, have agreed to resolve a set of outstanding intellectual property disputes with Sun Pharmaceutical. 22 September 2020
Pharmaceutical
The European Parliament at yesterday’s Plenary session called for the European Union to be more self-sufficient when it comes to medicines and medical equipment so that affordable treatments are available at any time. 18 September 2020
Generics
When US pharma major Bristol Myers Squibb acquired Celgene last year for $74 billion, one of the assets sure to offer an immediate return was Revlimid (lenalidomide). 17 September 2020
Pharmaceutical
Wealthy nations representing just 13% of the world’s population have already cornered more than half of the promised doses of leading COVID-19 vaccine candidates, Oxfam warned on Thursday as the health and finance ministers of G20 countries meet to discuss the global pandemic. 16 September 2020
Pharmaceutical
US pharma major Eli Lilly has secured a major win in its long-running patent dispute with Fresenius Kabi over Alimta (pemetrexed for injection), a lung cancer drug that generated global sales of around $2.13 billion in 2019. 16 September 2020
Biosimilars
Netherlands-incorporated generic major Mylan and US pharma giant Pfizer today announced that the companies have received final approval from the European Commission (EC) for the proposed combination of Mylan and Pfizer's Upjohn business, which will be called Viatris on completion. 15 September 2020
Biotechnology
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
Pharmaceutical
Stock in fish oil-based heart drug specialist Amarin fell precipitously on Wednesday, amid fears that key patents could be at risk. 3 September 2020
Generics
US pharma giant Merck & Co’s Indian subsidiary, which trades under the name Merck Sharp & Dohme, has sued an Indian company seeking to block it from ploughing ahead with its planned generic that Merck alleges would infringe its patent. 28 August 2020
Generics
The first generic version of Biogen’s main multiple sclerosis therapy, Tecfidera (dimethyl fumarate), is to launch in the USA. 20 August 2020
Biotechnology
Adcetris (brentuximab vedotin) is the market-leading drug in the world’s 7MM (the USA, France, Germany, Italy, Spain, the UK and Japan) markets and the main contributor to the market growth in Hodgkin’s lymphoma (HL) over the recent years. 19 August 2020
Pharmaceutical
The US District Court for the District of Delaware has upheld the validity of the Gilenya (fingolimod) dosage regimen patent, said Swiss pharma giant Novartis. 18 August 2020
Pharmaceutical
The High Court has handed down its second judgment in Merck KGaA v Merck Sharp & Dohme, the long-running dispute between two pharmaceutical companies regarding use of the MERCK trade mark. 3 August 2020
Biotechnology
After a run of positive announcements on the clinical side, mRNA therapeutics and vaccines developer Moderna Therapeutics has been struck with a patent blow, knocking 10% off its share price. 24 July 2020
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