Last week, the Federal Circuit heard oral argument in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, a case we have been tracking because it attracted seven amicus briefs. In it, Teva challenges a district court’s injunction requiring it to delist five patents from the Food and Drug Administration’s Orange Book. Judges Prost, Taranto, and Hughes heard the oral argument. This is our argument recap.
William M. Jay argued for Teva. He asserted that “[t]he district court erred in ordering these patents out of the Orange Book for three principal reasons.” First, he argued, “the district court concluded that these patents don’t claim the drug for which the applicant submitted the application,” but the “district court and Amneal don’t give the ordinary meaning of the word ‘claim’ or the statutory meaning of the word ‘drug.'” Second, he argued, the district court and Amneal’s reading “ask[s] this court to slice apart a New Drug Application and treat its boundaries as somewhere different than [Food and Drug Administration] itself treats them.” He explained that the “FDA treats a metered dose inhaler, including the inhaler parts, including the dose counter, as a drug,” and that it is “reviewed under the New Drug Application provisions of the statute.” He urged that “the parallel provisions in the listing statute should have the same treatment.” Third, he warned of “the consequences of Amneal’s interpretation, which would order genus patents and a patent on a single active ingredient in a combination two active ingredient product, out of the Orange Book.”
One judge questioned whether the court should agree with the FDA that it should choose the drug regime, even though a combination is not a drug, given that there is no regime for a “combination device-drug.” Jay responded that this view is “not consistent with both the listing statute and the drug statute of which it is a part or with the combination product statute.” He explained that the “FDA review[s] a combination product in a single application.” “In this case,” he continued, “because the active ingredient in a metered dose inhaler is primarily responsible for its effect on the human body . . . meter dose inhalers are to be reviewed as a drug.” The judge interrupted, however, to say it is still different to say “we will review it as a drug” and “it is a drug.” But “for purposes of review and for purposes of the listing statute,” Jay responded, “what matters is that it is part of a new drug application which FDA is reviewing for safety and efficacy.”
Later in the argument, Jay made clear his position that “these are drug product patents; they address components of the drug product, as FDA determines it; FDA determines that it is going to review all of this, including the dose counter, including the inhaler, and so on; it is no different than an active ingredient or a second active ingredient in a multiple active ingredient patent.”
In turn, Jay suggested that Amneal has no explanation for how its reading would allow the listing of, for example, “a genus claim that doesn’t name any active ingredient but draws the metes and bounds around a whole genus of active ingredients.” A judge then asked if this depends on whether “the genus is defined in a way that meets the relatively low threshold of having patentable significance.” Jay responded by saying, “perhaps standing alone.” But, he continued, Teva’s statutory interpretation is that, if “a patent claims a component of a drug product, then it’s a listable patent.” He argued that interpreting the statute to conclude that “the active ingredient in some way” must be claimed cannot be inferred from the statutory language. The analysis then, he continued, is “to apply the ordinary tools of claim construction and ask whether the patent claims, i.e., reads on, the the active ingredient.”
A judge later asked whether “a patent on a steering wheel” claims a car as a whole. Jay responded, “yes” in light of the statutory language. This answer, he said, is based on the use of the word “comprising,” because adding more elements is permissible. Moreover, he rejected the idea that “ordinary parlance” should be considered. He pointed to “the definition of ‘drug'” as including language suggesting “that a component of a drug is itself a drug.” Similarly, he argued, “if there were a like-statute for cars” that treated a component of a car as a car, then “under that framework a claim to a steering wheel that is used in a car” would claim a car.
Steven Maddox argued for Amneal Pharmaceuticals. He began by pointing out that the “patents do not claim or recite the NDA drug product or the active ingredient; they are device claims.” He explained that the question is whether Teva’s patents “meet the requirements of being drug product patents that claim the drug for which Teva submitted the NDA.” If so, he continued, then the patent “would be infringed by any portion of the NDA drug.” He further clarified that his main point here is “that the statute doesn’t say ‘a drug,'” but rather “it says the drug for which Teva submitted the NDA,” which is the albuletrol sulfate in aerosol inhalation form.
One judge asked why the application is for the actual inhaler, regardless of whether it is filled with the aerosol. In response, Maddox argued it is likely a result “of being a combination product.” He pointed out how Amneal’s position is that the drug product patent claims “must require the presence of at least the drug substance of the NDA drug in the claimed invention.” He argued that “[t]hat’s the floor, because that’s what ties it to the actual application [and] the drug for which the application was submitted.”
Another judge asked him about solving the genus problem. In response, Maddox argued that he’s “not sure if that problem needs a resolution.” He indicated the genus is not “specific to the drug that Teva applied for.”
Another judge, given that the drug regime is much more demanding and much more expensive to comply with compared to the device regime, asked “why shouldn’t somebody who is forced into the drug regime by a determination of the combination definition not get the full benefit of every other drug that’s under that regime.” Maddox responded by suggesting that, “if Congress wanted that to happen . . . Congress could have said so.” Instead, he explained, Congress asked, first, if there would be infringement and, second, if the patent claims “claim the NDA drug for which the application was submitted.”
A judge then posed a hypothetical. If the patent had listed albuterol, the judge asked, would this issue have never been litigated? Maddox responded by arguing that, “if albuterol was listed an active ingredient,” then, yes, there would be no dispute. The same judge further questioned him, asking “what if, instead of a specific list of different active ingredients,” the genus read “any drug that’s therapeutically effective to treat asthma?” Would that be listable, the judge asked. In response, Maddox argued that we “return to the plain meaning of claims,” asking “what do the claims require to be present?” He said, “if albuterol sulfate is not there, then it’s not listed.”
In his rebuttal, Jay argued against Amneal’s suggestion that the patent “has to specifically call out the name of the active ingredient” by suggesting this presents a genus problem. He asserted the court should adopt Teva’s “statutory interpretation that you have to claim in some way the active ingredient.” He maintained that, if the court follows that interpretation, “the court should reverse the district court and ask the district court to figure out whether these patents qualify under that standard.” He argued Teva’s “patents claim a genus of active ingredients, and albuterol sulfate is within that genus.” Alternatively, he argued, if the court disagrees, then “it’s a matter of claim construction, rather than statutory construction.” He suggested “the court should fix the statutory construction” and not adopt Amneal’s statutory construction, which “presents the genus problem.”
During the rebuttal, a judge highlighted that the statute’s “‘drug’ definition is not limited to active ingredients.” In response, Jay remarked, “that’s exactly the point.” He argued the distinction Amneal tries to draw between genuses “doesn’t come from anything in the statute.” Moreover, he said, the statue does not limit “drug” to “active ingredient.”
We will continue monitoring this case and report on developments.