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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
Belgium’s General Association of the Pharma Industry, known as pharma.de, has emphasized the importance of intellectual property (IP) in stimulating creativity and innovation in the pharmaceutical industry. 28 April 2025
Biotechnology
California-based biotech Halozyme Therapeutics yesterday revealed it has filed a patent infringement lawsuit against US pharma giant Merck & Co in the US District Court in New Jersey. 25 April 2025
Biotechnology
South Korean vaccine developer SK bioscience has won a final ruling in a patent dispute with Moderna over key technologies used in the manufacture of mRNA vaccines. 23 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Biosimilars
The US Court of Appeals for the Federal District has ruled against Sandoz in patent litigation concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept). 2 July 2020
Generics
A recent Intellectual Property Appellate Board (IPAB) order has resulted in the generic version of anti-cancer drug Ibrutinib becoming illegal once again, leaving patients with no option but to go back to buying Ibrutinib, sold under the brand name Imbruvica at $5,283. The revoked patent has granted a fresh lease of life to the on-going litigation between Big pharma and domestic drug companies, reports The Pharma Letter’s India correspondent. 25 June 2020
Generics
Mumbai-based drugmaker BDR Pharmaceuticals has sought the drug controller’s approval to manufacture and sell a generic version of remdesivir without entering into a licensing pact with Gilead Sciences, prompting the patent-holder to flag its concerns with the government. 24 June 2020
Biotechnology
UK-based Kymab has won another court ruling, this time in its home country, in its global patent dispute with US biotech Regeneron. 24 June 2020
Generics
The US District Court for the Northern District of West Virginia has invalidated biotech major Biogen's Tecfidera (dimethyl fumarate) patent, US Patent No 8,399,514, for lack of written description, Netherlands-headquartered generics firm Mylan announced late yesterday, reversing what had been a string of past victories over this patent for Biogen. 19 June 2020
Generics
The US District Court for the District of New Jersey has ruled in favor of the Israel-based generics giant Teva in a patent infringement lawsuit regarding a generic version of Narcan (naloxone HCl) nasal spray for the treatment of opioid overdose. 8 June 2020
Biotechnology
US biotech Regeneron Pharmaceuticals has failed to invalidate a fifth Kymab patent, covering genetically-modified mice used to produce human antibody therapeutics. 3 June 2020
Pharmaceutical
Chugai Pharmaceutical says it has filed a patent infringement lawsuit with the Tokyo District Court and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the generic drugs of an osteoporosis agent, active vitamin D3 derivative Edirol (eldecalcitol) against Sawai Pharmaceutical and Nichi-Iko Pharmaceutical. 1 June 2020
Pharmaceutical
A new technology access pool for COVID-19 has been launched by the World Health Organization (WHO), together with 30 countries and multiple international partners and institutions. 29 May 2020
Biotechnology
Contrary to conventional wisdom that says the coronavirus pandemic will generally benefit biopharmaceutical companies, a new Pioneer Institute study finds that many companies will emerge from the pandemic commercially weaker, dealing with delays in new product launches and with fewer resources to invest in research and development. 21 May 2020
Pharmaceutical
Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and its licensor AlfaSigma, have agreed to resolve the outstanding intellectual property litigation with Sandoz, regarding Xifaxan (rifaximin) 550mg tablets. 6 May 2020
Generics
India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of sufficient measurable improvements to its Intellectual Property framework. 4 May 2020
Pharmaceutical
The Indian government has been urged by cancer healthcare groups to revoke the patent for US biotech major Gilead Sciences’ potential anti-COVID-19 treatment remdesivir. 29 April 2020
Pharmaceutical
New research from the OECD highlights the scale of pharmaceutical and medical products counterfeiting - a global problem that has been exacerbated by the COVID-19 pandemic. 21 April 2020
Biotechnology
A UK High Court ruling has invalidated patents held by San Francisco-based FibroGen, clearing the way for Akebia Therapeutics to proceed with a new class of medicine to treat anemia. 20 April 2020
Pharmaceutical
US drug developer Lipocine today announced that the US Food and Drug Administration denied the Citizen Petition filed by Clarus Therapeutics on October 2, 2019. 17 April 2020
Pharmaceutical
A Supplementary Protection Certificate (SPC) is an extremely valuable prize for the pharmaceutical patent owner as it extends the patent life of an authorised medicine for up to five years at a time when a successful drug is likely to be well established and at the top of its earning power. 14 April 2020
Biotechnology
Privately-held US biotech EpiVax yesterday announced its partnership with GAIA Vaccine Foundation (GVF) to crowd-source funds for the COVID-19 project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership. 8 April 2020
Pharmaceutical
Fish oil-based drug Vascepa (icosapent ethyl) could make a smaller splash than Amarin had hoped, after a US court nixed part of its patent estate. 31 March 2020
Biotechnology
As the world watches aghast, the novel coronavirus continues to spread its tentacles around the globe, with cases of COVID-19 rising to nearly 375,000 on Tuesday, an increase of 75,000 from the day before. 25 March 2020
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