In 2015 the US Federal Circuit resolved the biosimilars case of Amgen v Sandoz. But the parties did not stop there, meaning the Supreme Court could potentially review it. LSIPR looks at the consequences of a possible review.
It is likely that many patent applications directed to CRISPR technology will be filed in India, says Hemant Singh of Inttl Advocare, who analyses some of the early applications and the rules on patentability.
CRISPR is only part of the gene editing story, and by studying the patents associated with all of the various methods, a much clearer picture of the entire field can be generated, says Tony Trippe, senior patent analyst for Thomson Reuters.
The Indian government has invited public comments on draft regulatory guidelines for biosimilars, while patent law in this area has still to take shape. Sameer Sah, Nisha Austine and Jahnvi Shah of Khaitan & Co report.
The BPCIA requires a biosimilar applicant to notify the reference product sponsor of its drug no later than 180 days before the first commercial marketing date. Darryl Woo, Erin Ator Thomson, Janice Ta and Wendy Wang of Vinson & Elkins report on some of the pressing issues in this area.
In March, Merck unsuccessfully tried to invalidate a patent owned by Bristol-Myers Squibb covering metastatic skin cancer treatment. Ernest Linek of Banner & Witcoff reviews the arguments and the court’s ruling.
No patent application directed to CRISPR has yet fallen foul of the EU’s Biotech Directive on the basis of the human embryo use exception, but the technology is still in its nascent stage. Ashley Roughton of Nabarro reports.
Despite a large body of EPO case law accepting second medical use claims that recite a novel technical effect, all eyes are on how courts in EPC member states will deal with infringement cases arising from such patents. Joachim Wachenfeld and Oswin Ridderbusch of Vossius & Partner report.
The European Commission is considering whether ‘export waivers’ should be introduced in order to partly relax the rules on supplementary protection certificates. Gareth Morgan of Olswang explains more.
Following several high-profile decisions by the US Supreme Court making it harder to patent biotech inventions, parties should follow several best practices to give their products the best chance of being patented. Kathryn Hull of Gordon Rees provides some tips.