Kirkland & Ellis attorneys Shaoyao Yu, Jeanna Wacker and Tasha Francis Gerasimow discuss various issues that will shape litigation strategies this year for participants in the pharmaceutical patent space, including several rulings from the Federal Circuit and new state laws.
Last year saw significant legal actions in the pharmaceutical sector that will shape the patent landscape this year, including new developments in induced infringement, continued scrutiny of written description and enablement support for patent claims, and increased state legislative efforts to curb anticompetitive agreements.
Litigating Induced Infringement
First, let’s start with the U.S. Court of Appeals for the Federal Circuit’s second decision in August 2021 in GlaxoSmithKline LLC v. Teva Pharms. USA Inc., which shed new light on litigating induced infringement in 2022. This case involved Teva’s generic version of GSK’s Coreg® drug, and a key issue is whether Teva’s skinny label, where it attempted to carve out the patented indication for congestive heart failure, nonetheless induced infringement.
The court held that Teva’s skinny label failed to fully carve out the patented indication, and that substantial evidence supported the jury’s finding of induced infringement. The court denied en banc review in February.
Following this ruling, brand manufactures are likely to use GSK as a road map in litigating induced infringement claims this year, especially when the generic’s label does not expressly include the infringing indication.
Specifically, brand manufacturers may be able to show inducement by demonstrating that doctors interpret the label as encouraging infringement, or by evidence outside the label, such as marketing materials promoting the generic as equivalent to the brand drug, press releases encouraging doctors to prescribe the generic drug for the patented use, and the generic’s knowledge that they will profit from infringing sales even if the patented use is not explicitly included in their label.
Generic companies, on the other hand, may consider expressly disclaiming patented indications in promotional materials to avoid induced infringement liability.
Written Description and Enablement Challenges
Second, pharmaceutical patents could face rigorous written description and enablement challenges, especially those concerning a broad genus, or ranges versus specific amounts.
In 2021, the Federal Circuit issued several decisions invalidating claims for failing Section 112 requirements.
For example, in Amgen Inc. v. Sanofi, Aventisub LLC, the court affirmed the district court’s decision that Amgen’s claims directed to a genus of antibodies defined by functional limitations were not enabled, because the “functional limitations here are broad, [but] the disclosed examples and guidance are narrow.”
In Juno Therapeutics Inc. v. Kite Pharma Inc., the court reversed a $1.2 billion jury verdict for Juno Therapeutics and Sloan Kettering Institute for Cancer Research. The court invalidated functional genus claims for lack of written description, finding the patent failed to disclose “representative species or common structural features to allow a [POSA] to distinguish between scFvs that achieve the claimed function and those that do not.”
The court also scrutinized whether claims drawn to ranges versus specific amounts meet Section 112 requirements.
For example, in Biogen Int’l GMBH v. Mylan Pharms. Inc., the Federal Circuit invalidated method claims of administering “a therapeutically effective dose” of drug for lack of written description “because the specification’s only reference to [the claimed dose] was part of a wide dosage range and not listed as an independent therapeutically efficacious dose.”
In Indivior UK Ltd. v. Dr. Reddy’s Lab’ys S.A., the court found the weight range limitations in claims of orally dissolvable films lack written description, because the specification did not describe the claimed range, but “only specific, particular examples.”
Going into 2022, the court continued its examination in Novartis Pharms. Corp. v. Accord Healthcare Inc., this time finding the claimed dose was supported by written description, because the specification disclosed “literal description of the [claimed] dose” and “all described ranges included the [claimed dose].”
Finally, pharmaceutical companies could face increasing anticompetitive scrutiny by state legislation sanctioning “pay-for-delay” settlements between generic and brand companies.
The first of these laws, California AB 824 prohibits settlements where a generic or biosimilar company agrees to delay its market entry in exchange for “anything of value” and imposes civil penalties of $20 million or more for violations. In December 2021, the Eastern District of California granted a preliminary injunction against AB 824, finding the plaintiff is likely to succeed in showing AB 824 violates the Dormant Commerce Clause. However, the court on Feb. 15 partially reinstated the law.
Despite this backdrop, other states have introduced similar bills in 2021 to sanction anticompetitive settlements in the pharmaceutical field, such as Connecticut, Illinois, Minnesota, New York, and Oregon, which are all pending as of March 2.
These legal developments will continue to shape litigation strategies in 2022. Participants in the pharmaceutical space should prepare for increased induced infringement litigation, stay cognizant of Section 112 developments, and monitor legislative scrutiny of pay-for-delay agreements as they enter into litigation and settlements in 2022.