AbbVie’s Pharmacyclics recently sued BeiGene for patent infringement. Both companies distribute Bruton’s tyrosine kinase (BTK) inhibitors for treatment of, among other indications, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Pharmacyclics sells Imbruvica® and BeiGene sells Brukinsa®. Will Pharmacyclics prevail, and if so, what will it gain?
Read MoreThe long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone. The case also represents another milestone in the changing landscape for patents covering biologic drugs. The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement. The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®. The takeaway is clear: as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.
Read MoreAmgen ($AMGN) is about to square off once again against Regeneron ($REGN) and Sanofi over whether Praluent® should be pulled from the market. Having prevailed at another jury trial earlier this year showing that Amgen’s PCSK9 protein patents are both valid and infringed, Amgen has renewed its bid for a court order enjoining Praluent® from the market. The injunction hearing is scheduled for June 2019. Over two years ago, Amgen prevailed after an earlier injunction hearing where the court ordered Praluent® to be barred from the market. Will Amgen be able to prevail again?
Read MoreAmgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences. Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent. The institution decisions are due before the trial: March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR. If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date. What are Coherus's invalidity arguments?
Read More