Genentech’s Cabilly II patent, which is directed generally to co-expression of recombinant antibody heavy and light chains in a single host cell, has been subject to a series of lawsuits since it issued in 2001.  The Cabilly patent is widely licensed in the industry and is thought to cover most, if not all therapeutic antibodies.  A succession of pharmaceutical companies have filed actions seeking declarations that their therapeutic antibodies do not infringe Cabilly II, and/or that it is invalid and unenforceable:  MedImmune (product: Synagis®; Centocor (ReoPro® and Remicade®); GlaxoSmithKline (Arzerra®); and Human Genome Sciences (“HGS”) (Benlysta®).  MedImmune and Centocor have settled with Genentech for undisclosed terms.  Medimmune’s suit went all the way to the Supreme Court on the issue of licensee estoppel, and to the Federal Circuit on MedImmune’s antitrust allegations.  Genentech also prevailed on U.S. Patent Office reexamination of Cabilly II.  GlaxoSmithKline’s and HGS’s suits are ongoing.

In the latest chapter, HGS filed a second lawsuit against Genentech in Delaware, alleging antitrust violations arising from the settlement of an interference proceeding between Genentech and Celltech.  HGS’s complaint alleges that “Genentech has engaged in a massive, years-long conspiracy to monopolize and restrain trade in the market and commit fraud on the District Court for the Northern District of California, on the U.S. Patent and Trademark Office (“PTO”), on competitors and customers in the market, and on the public—by entering into a collusive agreement to sacrifice U.S. Patent No. 4,816,397 ([Celltech’s] “Boss” patent) in favor of the Cabilly II patent and preserve the Cabilly II patent to maintain a monopoly that runs through 2018.” 

On March 15, Genentech filed a motion to dismiss the complaint, arguing that the HGS complaint is a “carbon copy” of MedImmune’s antitrust allegations, which were dismissed by a summary judgment which was later affirmed by the Federal Circuit.  In MedImmune, the Federal Circuit held that all of the alleged conduct was shielded from antitrust liability by the “Noerr-Pennington” doctrine because it constituted petitioning to the government. 

Because of the similarities between HGS’s and MedImmune’s complaints, it may be difficult for HGS to survive the pleading stage.  In its opposition filed April 1, HGS argues that it's entitled to its own day in court and shouldn't be "collaterally estopped" by MedImmune's failure to prove its claims.  Indeed, if HGS can survive the motion to dismiss, it might be able to discover information from Genentech and Celltech that would advance its antitrust claims and differentiate them from MedImmune’s.  In the meantime, it is certain that Genentech’s many Cabilly II licensees are watching these pending cases with great interest.