As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the legislature passed that legislation by a vote of 47-0-2 and Governor Pete Ricketts signed the bill into law, making Nebraska…
The U.S. Supreme Court granted Oil States Energy Services’ petition for a writ of certiorari seeking review of the constitutionality of post-grant review proceedings by the USPTO’s PTAB. Oil States appealed to the U.S. Supreme Court after the Federal Circuit decided to uphold the PTAB’s invalidation of claims in a…
With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For an in-depth analysis of patent dance strategies employed by biosimilar applicants to date, check out this article in Bloomberg’s Life Sciences…
We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without prejudice, which Amgen argued was unnecessary given the court’s prior order of dismissal without prejudice. This morning,…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
Law360 has published an article by three of our contributing editors here at Big Molecule Watch. As suggested by the title, “The Biosimilars Litigation Landscape for 2017,” the article provides an analysis of the expected BPCIA litigation activity, including potential new litigations, in 2017. Click here for a link to…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a new trial regarding written description and enablement of the asserted claims of the patents-in-suit. On March 16, 2016, after a trial,…
As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are appealing the district court’s judgment to the Federal Circuit. Meanwhile, Celltrion’s partner Pfizer announced last week that it will begin shipping…
Today, the USPTO released a notice of proposed rulemaking (set to be published on October 3 in the Federal Register) setting and adjusting patent fees (including fees for post-grant proceedings) during fiscal year 2017.
The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications about unapproved uses of their approved/cleared medical products, including biologics. The public hearing will be held on November…