Photo: Jason Doiy/ALM

Gilead Sciences Inc. has fired back at the explosive patent and antitrust class action filed against it earlier this year in the Northern District of California, contending that the suit's "overreaching extends to the point of absurdity."

Gilead's White & Case counsel formally asked U.S. District Judge Edward Chen to dismiss Staley v. Gilead Sciences on Wednesday. The suit was filed to great fanfare in May. Attorneys from Durie Tangri, Hilliard & Shadowen and others accused Gilead of entering into collusive licensing deals with other drug companies to extend its patent monopoly, "crippling this nation's ability to stop new HIV infections." The 139-page complaint also accused Gilead of holding back a life-saving drug, known as TAF, for more than a decade to maximize profits from its patents.

Gilead asked Chen in a motion signed by White & Case partner Heather Burke to ignore the rhetoric. "When the complaint is stripped of its pejorative characterizations and baseless conclusions, what remains is an account of lawful competition, including through joint ventures and other collaborations between Gilead and other pharmaceutical companies," Burke writes.

The joint ventures are the primary targets of the Staley complaint. It alleges that Gilead struck deals with competitors such as Bristol-Myers Squibb Co. and Johnson & Johnson Inc. to combine Gilead drugs with the other companies' more recently patented compounds into fixed-dose combinations. Then each company promised not to market or license generic versions of the other party's individual drugs. The Staley plaintiffs characterize the deals as "a private hiatus from competition" and illegal per se under recent Supreme Court decisions.

Gilead argues that the joint ventures are pro-competitive, because they increased patient choice and eased compliance. And they're shielded by the "ancillary restraints" doctrine, which Gilead says permits collaborators to include reasonable restrictions on competing against their joint venture. "Such arrangements cannot be expected to succeed unless each partner may confidently invest in and promote the venture without fear that another partner will act unilaterally to undermine it for its own benefit," Burke writes.

Bristol-Myers Squibb submitted its own separate motion to dismiss, saying consumers always had the option of separately buying Gilead's Truvada and Bristol-Myers' Sustiva, the component drugs that made up their fixed-dose combination called Atripla. "The Secretary of Health and Human Services celebrated Atripla as 'an important advance in our collective effort to deliver simplified therapy for people living with HIV,'" states Bristol-Myers' motion, which is signed by Arnold & Porter Kaye Scholer partner Daniel Asimow.

As for the TAF claim, Gilead notes that U.S. District Judge William Alsup dismissed "virtually identical" claims brought by the AIDS Healthcare Foundation (AHF) in 2017, finding that Gilead had the right to bring its products to market whenever it chose.

"Inexplicably," Burke writes, "the complaint recycles the dismissed AHF claims, even using the same contrived characterizations, such as faulting Gilead for keeping TAF 'on the shelf' and for 'gaming the system.'"