Instruction to ‘Tell Your Doctor' of Pain Doesn't Induce an Infringing Use of Drug

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By Tony Dutra

May 6 — A drug label that tells a patient to “tell your healthcare provider” if the patient has a certain condition doesn't induce the physician to prescribe an infringing use of the drug, according to a 2-1 decision May 6 by the Federal Circuit.

The majority opinion said that “vague label language cannot be combined with speculation about how physicians may act to find inducement.”

The case came to the court on Takeda's appeal of a denial of a preliminary injunction that would have prevented launch of Hikma's Mitigare product for prophylactic—according to the label—treatment of gout.

Though the injunction denial was based on no “likelihood of success” by Takeda, the dissent took the majority's opinion as setting out a bright line rule that would prevent a finding of inducement based on off-label uses—regardless of the facts in this or other cases.

The Problem of Off-Label Uses

Drugs are often patented and those patents expire. Patent law rewards pharmaceutical firms for continued research into improved or new uses of expired or expiring drugs by granting new method-of-use patents with later expiration dates.

But use patents are often directly infringed only by doctors or patients. They are infringed by a competitive drug maker—the litigation target of the patent owner—only if the competitor induces doctors to prescribe or patients to choose on their own to follow the patented use.

A competitive drug maker needs Food and Drug Administration approval for instructions printed on the label of a drug it wants to market. According to Hatch-Waxman procedures, the FDA pays attention to patented use and tries to prevent one manufacturer's labels from including instructions that, if followed, would infringe another manufacturer's patents.

Even if the FDA does its job properly, the problem arising in this and other cases is that some doctors prescribe drugs, and some patients use drugs they have in their homes, for uses other than what is on the label. And those uses may be infringing.

The question presented here, then, is what the competitive drug maker can do or say about its FDA-approved uses without crossing the line into inducing uses that are not approved and are infringing.

Vague Label Instructions?

Takeda's patents are on methods of administering colchicine, known for centuries and so not patentable on its own, to treat gout. The patented methods cover a higher-than-normal dosage of colchicine on its own for flare-ups of gout (U.S. Patent Nos. 7,964,647 and 7,981,938) and co-administration with certain drug inhibitors for prophylaxis of gout (U.S. Patent Nos. 7,964,648; 8,097,655; and 8,440,722).

Hikma's Mitigare was approved for marketing for prophylaxis purposes without the drug inhibitors. But the FDA agreed to a label instruction that said, “If you have a gout flare while taking [Mitigare], tell your healthcare provider.” As to the co-administration use, the label warned of toxicity and said that such use “should be avoided if possible.”

Judge Sue L. Robinson of the U.S. District Court for the District of Delaware denied Takeda's motion for a preliminary injunction because the patent owner did not show a likelihood of success on the merits on its inducement claim, nor did it show a causal nexus between Hikma's infringement and irreparable harm to Takeda. The appeals court never got to the second question of harm.

Has to Encourage, Recommend or Promote Infringement

Judge Timothy B. Dyk wrote the opinion of the court, which was joined by Judge Todd M. Hughes.

The court's primary reference as to inducement of pharmaceutical patents was its holding that “where a product has substantial noninfringing 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,” in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365, 65 U.S.P.Q.2d 1481 (Fed. Cir. 2003).

The court also looked at other relevant precedents unrelated to pharmaceuticals and said that they generally required affirmative actions showing the intent to induce infringement. When “distilled” for application to the labelling requirement in the Hatch-Waxman context, the court said, precedent dictates that an inducement finding requires a showing that “[t]he label must encourage, recommend, or promote infringement.”

“This requirement of inducing acts is particularly important in the Hatch-Waxman Act context because the statute was designed to enable the sale of drugs for non-patented uses even though this would result in some off-label infringing uses,” the court said.

As to whether doctors would prescribe an off-label use of Mitigare for gout flares, Takeda argued that “tell your healthcare provider” would “inevitably” lead to such decisions. The court disagreed.

Takeda offered depositions of doctors who essentially said they would do just that, but Hikma—supported by a brief filed by the American College of Rheumatology—noted that doctors were more likely to prescribe alternative therapies for treatment of gout flares.

Doesn't ‘Necessarily Lead' to Infringement Here.

Takeda relied on but the court distinguished AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 97 U.S.P.Q.2d 1029 (Fed. Cir. 2010), where the inducement finding resulted from the FDA's insistence that the competitor use specific wording on the label.

In that case, “the patient did not have to consult anything outside of the label to infringe,” the court here said. “The instruction would ‘necessarily lead' to infringement.”

Takeda's arguments related to the co-administered patents were even weaker, according to the court's analysis, particularly given the many warnings against such use on the label.

The court thus affirmed the judgment that “Takeda had failed to meet its burden to show a likelihood of success on the merits.”

Dissent: Inducement Liability Fact-Specific

“The Hatch-Waxman Act is intended to encourage drug research and development, not to provide a disincentive by negating enforcement of improvement patents by the simple expedient of omitting the improvement from the label,” Judge Pauline Newman said in dissent. “With the removal of the patent incentive for improvements, the loser is the afflicted public.”

She characterized the court's ruling as “a simple, bright line rule of law” with the ultimate result that “the provider of a known drug product, with knowledge that it is likely to be used in direct infringement, can never be liable for induced infringement.”

Instead, Newman said, “These are fact-specific circumstances, and are not amenable to final disposition at a preliminary injunction hearing.”

She may well be right that this was a “final dispostion,” because the case returns to the Delaware district court where Hikma has already filed a motion to dismiss, largely for the reasons affirmed by the court here.

Takeda, undoubtedly though, will point to facts Newman brought up on its behalf in her dissent—the physicians' declarations and the FDA's original objection to Hikma's first proposed label. Takeda's response to Hikma's motion is due two weeks from the date of the Federal Circuit decision.

Jeffrey I. Weinberger of Munger, Tolles & Olson LLP, Los Angeles, represented Takeda. Charles B. Klein of Winston & Strawn LLP, Washington, represented Hikma.

To contact the reporter on this story: Tony Dutra in Washington at adutra@bna.com

To contact the editor responsible for this story: Tom P. Taylor at ttaylor@bna.com

Full text at http://www.bloomberglaw.com/public/document/Takeda_Pharmaceuticals_USA_v_Hikma_Americas_Inc_Docket_No_1501139.