Amgen patents on Repatha invalid, judge rules in reversal
A federal judge on Wednesday ruled two patents held by Amgen on its cholesterol drug Repatha are invalid, reversing a February jury verdict that had upheld the California biotech’s claims in its legal battle with rivals Sanofi and Regeneron. Judge Richard Andrews’ decision will not remove Repatha from market, and Amgen said it plans to appeal. Still, it’s a setback that strengthens the position of Sanofi and Regeneron, which sell the competing drug Praluent. Both Repatha and Praluent are antibodies that lower cholesterol by binding to a protein called PCSK9..…
Delhi High Court Revoked the Patent on Novartis’ Ceritinib
The Court suspended the earlier interim relief granted to Novartis, which had restrained the manufacture and sale of the generic version of the cancer drug by Natco Pharma. It was only end-May the Delhi High Court had restrained Natco from carrying out any fresh manufacture of drugs comprising the API ceritinib, a non-small cell lung cancer (NSCLC) treatment. The Court’s May decision came on a plea filed by Novartis seeking an order restraining Natco from manufacturing and selling ceritinib. The Swiss company submitted that, in March 2019, it came across Natco’s product under the trademark Noxalk at a pharmaceutical conference in Kolkata.…
Del HC Vacates Interim Orders Restraining Dr. Reddy’s & Ors. from Selling AstraZeneca’s Ticagrelor
On 8th August, the Single Bench of the Delhi High Court vacated the interim orders granted in favour of AstraZeneca (‘plaintiff’) preventing Micro Labs, Natco Pharma and Dr. Reddy’s Laboratories (‘defendants’) from selling, marketing or dealing with TICAGRELOR (an effective platelet aggregation inhibitor) or any other product violating the plaintiff’s registered patents- IN 907, IN 984 and IN 674. The case relates to two important issues, namely, selection patents and the difference between coverage and disclosure in a patent. The interim applications dealt with in the instant case were IA 3986/2018 in CS (Comm.) 749/2018, IA 4771/2018 in CS (Comm.) 792/2018, IA 9332/2018 filed in CS (Comm.) 1023/2018 filed by the plaintiffs, and IA 5096/2018 in CS (Comm.) 749/2018 filed by the defendants seeking vacation of the interim orders..…
Parties Agree That Mylan’s Pegfilgrastim Biosimilar Does Not Infringe Amgen’s Patent
Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania. In the status report, they agree that Amgen cannot maintain a claim of infringement against Mylan with respect to US Patent Number 8,273,707, which covers a process for purifying proteins by mixing a protein preparation with a solution involving 2 salts. This latest development stems from an earlier decision in another case related to the same patent; in March 2018, a Delaware court dismissed a lawsuit brought by Amgen over a different biosimilar developer’s alleged infringement of this same patent; in that case, Amgen alleged that Coherus BioSciences infringed on its patent because Coherus’ biosimilar pegfilgrastim, later approved as Udenyca, mixed salts that, in combinations, were equivalent to Amgen’s patented combinations. According to the court, Amgen had previously acknowledged that Coherus did not literally infringe on the patent..
Baxalta Loses Motion for Patent Infringement Retrial Against Bayer
A federal court in Delaware has denied Baxalta’s request for a new trial in a suit brought by Bayer over patent infringement by Baxalta’s hemophilia A drug Adynovate. The Takeda subsidiary sought a new trial on the grounds that its clotting factor VIII drug could not infringe on Bayer’s patent for factor VIII because the patent was invalid. Bayer sued Baxalta and Nektar Pharmaceuticals in 2016 alleging that they infringed on its patent by making, selling and importing Adynovate. Nektar had worked with Bayer on its version of the drug, but also helped Baxalta develop Adynovate, according to Bayer’s complaint. The FDA approved Jivi, Bayer’s factor VIII hemophilia A treatment, in August 2018. In a trial held earlier this year, a jury found that Baxalta did infringe on Bayer’s patent, and the company was ordered to pay $872 million in royalties and $155 million in damages.…
Purdue Pharma proposes $12B settlement to clean up opioid mess — report
After months of negotiations with states and federal plaintiffs accusing it of instigating the opioid crisis through aggressive and deceptive marketing tactics, Purdue Pharma is ready to pay $10 to $12 billion to settle it all. The potential deal would cover hundreds of lawsuits being waged against the company by states, cities, towns and tribes, which is being overseen by United States district judge Dan Polster in Cleveland, alongside cases involving other prescription opioid makers. As part of the deal, the Sackler family — who had been charged with building a “multibillion-dollar drug empire based on addiction” — will give up ownership in Purdue..