Late last month the Federal Circuit issued its opinion in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, a patent case that attracted seven amicus briefs. In this case, Amneal alleged that Teva delayed the entry of generic products into the market by improperly listing certain patents in the Orange Book. The District of New Jersey agreed and required Teva to delist its patents from the Orange Book. Teva appealed, and the Federal Circuit stayed the lower courts order pending its resolution of the appeal. Late last month, in an opinion authored by Judge Prost and joined by Judge Taranto and Hughes, the Federal Circuit lifted the stay and affirmed the district court’s delisting order. This is our opinion summary.
Judge Prost began her opinion for the panel by outlining the background of the case:
When a generic drugmaker applies to market a drug using the same active ingredient as a branded drug, the Food and Drug Administration (‘FDA’) cannot approve the generic company’s application if the . . . drug would infringe the brand-name manufacturer’s patent. The FDA checks for . . . infringe[ment] by looking at which patents the brand-name manufacturer listed in a publication called the Orange Book. . . . [B]y listing a patent as claiming a drug, the brand-name manufacturer can make the FDA withhold approval of the generic company’s application for thirty months. The brand-name manufacturer’s decision on which patents to list, then, can make the difference between the FDA granting the generic company’s application and the FDA withholding approval. . . . Amneal alleges that Teva improperly listed patents in the Orange Book and delayed entry of the generic products onto the market. The district court agreed with Amneal and ordered Teva to delist its patents from the Orange Book on the ground “that the Inhaler patents contain no claim for the active ingredient at issue . . .,” but instead, “are directed to components of a metered inhaler device.” The [New Drug Application (NDA)] product for which Teva listed the patents Amneal sought to delist is the ProAir® HFA Inhalation Aerosol . . . . Although the FDA approved Teva’s ProAir® HFA as a drug, [it] cotains both drug and device component . . . . Teva lists non-expired patents in the Orange Book for its ProAir® HFA. Five are relevant here . . . . These patents are similar but not identical to in claimed subject matter. . . . [They] relate to improvements in the device parts of the inhalers––specifically, the dose counter––although their specifications make some reference to active ingredients being used alongside the dose counter. [C]laims in these patents focus on the device components of the inhaler––specifically, the dose counter and the inhaler canister. . . . None of the claims in the five asserted patents explicitly require the presence of an active drug, let alone any specific active drug. Amneal filed an [Abbreviated New Drug Application (ANDA)] seeking approval to market a generic version of Teva’s ProAir® HFA that uses the same active ingredient. . . . Amneal filed a paragraph IV certification asserting that it did not infringe the nine patents. . . . Teva sued for infringement of . . . the five patents identified above. Amneal filed . . . counterclaims seeking an order requiring Teva to delist the five patents that it asserted against Amneal. Amneal alleges that Teva’s infringement suit ‘triggered. 30-month stay of final FDA approval of Amneals ANDA.’ . . . . Teva moved to dismiss . . . . Amneal cross-moved for a motion for judgment on the pleadings on the ground that Teva improperly listed the asserted patents. . . . The district court concluded that Teva’s patents ‘do not claim the drug for which the applicant submitted the application’ and thus ordered Teva to delist its patents from the Orange Book. Teva timely appealed the district court’s interlocutory delisting order . . . . Shortly after Teva filed its appeal, we issued a stay of the district court’s order pending our review.
Judge Prost began her analysis for the Federal Circuit by explaining that “[s]tatutory interpretation is an issue of law that” the court reviews “de novo.” Beginning “with the language of the statute,” she continued, the panel looks to “the specific context in which that language is used, and the broader context of the statute as a whole.”
Next, Judge Prost summarized Teva’s arguments. Teva, she explained, “argues that the district court erred by interpreting the listing provision to permit the listing of only a small class of patents claiming at least the active ingredient.” Teva asserts, she continued, “that a patent can . . . be listed in the Orange Book if the claimed invention is found in any part of its NDA product.” Additionally, she continued, “Teva . . . argues that, even if we reject its statutory arguments, we must remand for the district court to construe the claims.”
Judge Prost concluded “that Teva’s patents do not qualify for listing because they do not claim the active ingredient.” On this issue, Judge Prost began by “rejecting Teva’s interpretation of the word ‘claims’ in the listing and counterclaim/delisting provisions.” While Teva asserted that “‘claims’ is effectively coterminous with the products that infringe a patent,” she rejected this interpretation. She reasoned that the “listing provision identifies infringing and claiming as two different requirements.” Despite the fact that “claim” and “infringe” “have a meaning ‘peculiar to patent law,'” she highlighted that they still “have different meaning.” Claims, she explained, “identif[ies] the invention,” while infringement “occurs when others make, use, or sell the invention without authorization.”
Judge Prost identified four principles differentiating “infringing [a] claimed invention” and “claiming an invention.” First, “claims and infringements have different analytical focal points.” Infringement “is assessed by examining a particular thing . . . that exists out in the world” while, in contrast, she explained, a claim is assessed by “examining the intrinsic meaning of the written patent document.” Second, infringement can occur “without literally meeting all of the claim elements.” Third, an infringing product, she highlighted, often “contain[s] additional features beyond what the patent claims.” Lastly, “a written description of the invention,” she discerned, “does not apply to the entirety of an infringing product,” but instead “applies to what the patent discloses and claims as ‘the invention.'”
Teva’s counterarguments, Judge Prost explained, were “unpersuasive.” First, while Teva asserted that precedent showed “that the patents that claim the drug are the same as the patents that the approved drug would infringe,” she rejected that interpretation. She highlighted how the cited precedent did not “interpret the listing provision.”
In summary, Judge Prost concluded, a patent claims a drug “when it particularly points out and distinctly claims the drug––not simply when the claim could somehow be interpreted to read on the drug.”
Next, Judge Prost addressed Teva’s second argument, regarding “how much of the drug for which the applicant submitted the application a patent must claim to be listed.” Teva’s argument, she explained, depends on combining the definitions of “drug” and “assert[ing]that the [statute] defines any part of something used to treat a disease as a drug.” If true, she continued, Teva’s listing in the Orange Book is permissible because the “patent claims any part of the drug, even if it only claims device parts.”
Judge Prost rejected Teva’s contention. She highlighted that the “broader statutory context” suggests that “for a patent to ‘claim[] the drug . . . ,’ such a patent must claim at least the active ingredient identified in the application.” As a result, she concluded, “[t]o list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved.” To “claim that drug,” she continued, the patent must “claim at least the active ingredient.” Therefore, Teva’s patents “claiming just the device components of the product approved in [the] NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.”
Finally, Judge Prost addressed Teva’s last argument that “its patents do claim an active ingredient.” She rejected Teva’s contention because a “claim requiring the presence of ‘an active drug’ is far too broad to particularly point out and distinctly claim the drug approved in Teva’s NDA.” In fact, she noted, “Teva’s construction permits the presence of any active ingredient in any form.”
As a result of Judge Prost’s analysis, the panel lifted its stay and affirmed the district court’s order requiring Teva to delist its patents.