The Hatch Waxman Act and Induced Infringement

Oral argument was recently heard before the Federal Circuit in the appeal of AstraZeneca Pharms. LP. v. Aurobindo Pharma Ltd. AstraZeneca, along with IPR Pharmaceuticals, Inc., and The Brigham and Women’s Hospital, Inc., (“Plaintiffs) sued ten generic drug companies alleging infringement of US Patent Nos. 6,858,618 (“the ‘618 patent”) and 7,030,152 (“the ‘152 patent”) under the Hatch-Waxman Act. These patents claim methods of treatment using rosuvastatin calcium, which Plaintiffs market as Crestor®.

The ten generic drug companies had filed abbreviated new drug applications (“ANDA”) with the U.S. FDA seeking to market generic versions of the drug to treat nonfamilial hypercholesterolemia, homozygous familial hypercholesterolemia or hypertriglyceridemia, uses which were not covered by the two method of use patents, but were FDA approved uses.

Plaintiffs alleged that Defendants’ generic tablets, if approved by the FDA, will be prescribed and administered to human patients according to the Crestor® label to treat heterozygous familial hypercholesterolemia (“HeFH”) and for the primary prevention of cardiovascular disease, which uses will constitute direct infringement of the ‘618 and ‘152 patents, respectively. As noted, the ANDA filed by the Defendants did not embody a use claimed in the patents. Plaintiffs alleged the claimed uses will occur nonetheless because the generic label will mirror the Crestor® label, and will be uses that Defendants know or should know will occur. Therefore, Defendants will actively induce, encourage, aid and abet this prescription and administration, with knowledge and specific intent that these uses infringe Plaintiffs’ rights under the ‘618 and ‘152 patents.

The issue before the district court hinged on standing to sue under 35 U.S.C. § 271(e)(2)(A), i.e., whether a cause of action was made out with respect to Defendants’ proposed uses relative to the patents’ claims. The relevant language of 35 U.S.C. § 271(e)(2)(A) is:

2) It shall be an act of infringement to submit –

(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent.

Before the Delaware District Court, Defendants moved to dismiss for lack of subject matter jurisdiction, arguing that the Hatch-Waxman Act created an infringement claim only if the generic manufacturer sought approval for the specific methods of treatment claimed by the patent. According to Defendants, Plaintiffs case under 35 U.S.C. § 271(e)(2)(A) lacked merit because of the generics’ non-infringing uses. The district court agreed with Defendants and Plaintiffs appealed.

In oral arguments before the Federal Circuit in November, Plaintiffs argued that the mere filing of an ANDA for rosuvastatin calcium tablets was an act of infringement under the Hatch Waxman Act even though the ANDA was for non-infringing uses of the drug. Plaintiffs also urged that there was enough evidence in the generic manufacturer’s proposed labeling and elsewhere to support the likelihood of induced infringement.

Chief Justice Rader and Justice Moore pointed out several times during oral arguments that in order for 35 U.S.C. § 271(e)(2)(A) to apply, it requires that the ANDA seek approval for the use of a drug which is claimed in a patent. In this case, the ANDA does not seek approval for a patented use. The Justices cited the Warner-Lambert Co. v. Apotex Corp. decision, which held that “where a product has substantial non-infringing uses, intent to induce infringement cannot be inferred even when the [alleged inducer] has actual knowledge that some users of its product may be infringing the patent.” Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003). “[I]nducement requires that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another’s infringement.” DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc in relevant part). Plaintiffs argued that Warner Lambert did not apply to the facts at hand.

Chief Justice Rader also indicated to Defendants’ counsel that due to the limited uses in the ANDA, there was a substantial likelihood the generics would induce infringement. He raised the question as to whether the generic companies could win an inducement to infringement suit.

A decision for AstraZeneca would strengthen method of treatment patents for prescription drugs and expand the reach of Hatch-Waxman. Gibbons P.C. will stay tuned to this development.