On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major changes to USPTO practice or procedure” but instead “incorporat[e] guidance from the Amgen decision…
As we previously reported, on February 11, 2021, a three-judge panel of the Federal Circuit affirmed the District Court for the District of Delaware’s grant of Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165…
On August 28, 2019, the District Court for the District of Delaware issued an opinion related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab). After a jury found that two of the five asserted…
On February 25, 2019, a jury in the District of Delaware made findings related to the validity of two of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) covering its cholesterol-lowering drug Repatha® (evolocumab). The jury found Sanofi and Regeron failed to demonstrate that at least some claims of the…
On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…
Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims. Many patents covering biological products contain antibody claims. A major focus of the USPTO memorandum is the Federal Circuit’s decision in Amgen v….
In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanded the appeal to the district court for a new trial on the defendants’ written description…
The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here: 15-1039 SANDOZ INC. V. AMGEN INC., ET AL. 15-1195 AMGEN INC., ET AL. V. SANDOZ INC. The motion of Apotex, Inc., et…
We reported last week that a permanent injunction against the sale of Praluent® (alirocumab) was issued in Amgen v. Sanofi/Regeneron. The day after the court’s order, defendants filed a motion to stay the injunction while the decision is appealed to the Federal Circuit. Yesterday, Judge Robinson denied defendants’ motion to stay, noting that in the order…
For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes with Amgen’s Repatha® (evolucumab). Both products are monoclonal antibodies that target PCSK9 to lower the levels…