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Pharmaceutical
As advocates for a World Health Organization proposal to temporarily waive intellectual property protections for COVID-19 vaccines try to win more support from developed countries, one obstacle to reaching consensus is whether compulsory licenses will require pharmaceutical companies to divulge trade secrets, say experts reported by Law360, a LexisNexis which is providing free access to its coronavirus coverage in an effort to ensure the legal community has accurate information. 26 May 2021
Biosimilars
The US Supreme Court has denied the petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), sold by US biotech major Amgen. 18 May 2021
Pharmaceutical
The mere notion of the US government supporting any policies that might encourage pharmaceutical patents to be ignored would have seemed inconceivable only 18 months ago. 17 May 2021
Biosimilars
US pharma major AbbVie has answered back in its latest row over Humira (adalimumab), the inflammatory diseases drug that it continues to sell without competition in the USA. 14 May 2021
Biotechnology
Finland-based biotech Faron Pharmaceuticals today revealed that it has signed a sub-license agreement for the rights to US patent US9,376,478, which currently extends to 2033. 14 May 2021
Pharmaceutical
Amid growing demand for waiving intellectual property rights (IPR) over COVID-19 vaccines and even granting Compulsory License to drug firms to manufacture the vaccines to tide over the shortage, indigenously developed coronavirus vaccine maker from India, Bharat Biotech, has welcomed other pharma companies to manufacture its Covaxin. 14 May 2021
Generics
The UK’s Competition Appeal Tribunal (CAT) has upheld the CMA decision that pharma major GlaxoSmithKline (LSE: GSK) and some generic suppliers of the anti-depressant paroxetine broke competition law. 12 May 2021
Biosimilars
Privately-held Icelandic biopharmaceutical company Alvotech, which is seeking to become one of the leaders in the biosimilar monoclonal antibody market, has made a statement this week by filing a lawsuit against AbbVie. 12 May 2021
Pharmaceutical
To the surprise of many, the US government has backed a World Trade Organization (WTO) proposal to disclaim certain intellectual property (IP) rights to coronavirus vaccines, after previously opposing it. 6 May 2021
Pharmaceutical
US biotech Gilead Sciences has filed a lawsuit with the Russian Supreme Court challenging the decision of the Russian government to issue a license to the domestic drugmaker Pharmsynthez for the manufacture of its original anti-COVID-19 drug remdesivir without its consent, reports The Pharma Letter’s local correspondent. 27 April 2021
Pharmaceutical
The US Patent and Trademark Office (USPTO) has determined that three US composition of matter patents covering latanoprostene bunod, commercialized as Vyzulta, (latanoprostene bunod ophthalmic solution), 0.024%, are eligible for patent term extension, potentially through to 2030, says French eye-care specialist Nicox. 22 April 2021
Pharmaceutical
The government must support a patent waiver for COVID-19 vaccines and treatments to protect the UK’s own vaccination program, according to public health experts from the Independent SAGE group. 16 April 2021
Pharmaceutical
Last week, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments to the National Institute of Standards and Technology (NIST) regarding the proposed rulemaking on implementing regulations of the Bayh-Dole Act. 12 April 2021
Generics
Global drugmakers who are trying to minimize their losses from the ever-growing turnover of generics of their original drugs in Russia, have called on the country’s federal government to update the existing register of drugs and patents – in a move to provide them with a better opportunity to protect their patent rights in Russia, according to recent statements by representatives of producers and local media, reports The Pharma Letter’s local correspondent. 30 March 2021
Generics
As the call for compulsory licenses on two new tuberculosis (TB) drugs gets louder in India, the Bombay High Court has directed the government to decide on the representations made seeking non-commercial licenses for the two patented life-saving anti TB drugs: bedaquiline and delamanid, which offer fresh hope to multi-drug resistant (MDR) or extensive-drug resistant (XDR) TB patients. 30 March 2021
Pharmaceutical
The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals and Kindeva Drug Delivery, determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid. 3 March 2021
Biosimilars
Russian drugmaker Geropharm plans to become one of the leading players in the domestic insulins market within the next several years, with the possible launch of a biosimilar of ultra-long-acting insulin, produced by the Danish diabetes care giant Novo Nordisk, as well as a further expansion of its portfolio. 2 March 2021
Pharmaceutical
In recent weeks there has been much criticism around the availability of COVID-19 vaccine supplies to less developed countries, with various consumer groups and some European governments calling for countries to ignore patent protection to allow local drugmakers to manufacture the vaccines, and accusing the western world of hording. 24 February 2021
Generics
Russia needs a total overhaul of its patent regulation system with regard to pharmaceuticals, with the aim to ensure access for the local population to cheaper drugs, according to recent statements by local pharma analysts and some domestic media, reports The Pharma Letter’s local correspondent. 23 February 2021
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical announced today that it has refiled a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, regarding the generic drugs of an osteoporosis agent, active vitamin D3 derivative Edirol capsule 0.5 g / 0.75 g (eldecalcitol). 17 February 2021
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
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