In the AIPLA Spring 2025 newsletter, Nath, Goldberg & Meyer ‘s Joshua Goldberg and Leia Dingott discuss how Court of Appeals for the Federal Circuit (CAFC) affirmed the decision by the U.S. District Court in New Jersey, which ordered the delisting of five U.S. Patents owned by TEVA on the ground “that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate,” but instead “are directed to components of a metered inhaler device.” Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964, — F. Supp. 3d –, 2024 WL 2923018, at *6, *7 (D.N.J. June 10, 2024) (“Delisting Order”). Accordingly, moving forward, patents for a medical device product are only Orange Book listable in the U.S. if they include claims directed to the active drug ingredient.
In its decision, the CAFC gave a thorough background explaining how the U.S. Food and Drug Agency (FDA) approves applications to market drugs and how the Orange Book is used. The CAFC explained that the FDA requires a company to submit a new drug application (NDA) before the company can market the drug. The NDA must include full reports showing that the drug is safe and effective, a full description of the components and manufacturing process for the drug, proposed labelling for the drug, and information on patents claiming the drugs as explained in the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 21 U.S.C. § 355(a), (b). The FDA will approve the drug if the reports show that the drug is safe and effective. Id. § 355(d).
The CAFC continued to explain that before 1984, a company seeking approval for a generic drug containing the same active ingredient as the brand-name drug manufacturer had to file its own NDA with its own clinical trials, even though the FDA had already determined that the active ingredient in the drug was safe and effective. See United States v. Generix Drug Corp., 460 U.S. 453, 454, 461 (1983). The CACF explained that a full set of trials to prove that the generic was safe and effective was costly, time consuming, and often involved infringement of one or more patents for the name brand drug. Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 863 (Fed. Cir. 1984), superseded by statute, Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1358 (Fed. Cir. 2003).
The Hatch-Waxman Act, which was enacted in 1984, changed the approval process for generic drugs to bring generics to market faster. See Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585. The Hatch-Waxman Act introduced an Abbreviated New Drug Application (ANDA), which allowed a company with a proposed generic product to show bioequivalence to a name brand drug as shown in an approved NDA rather than having to conduct and submit separate clinical trials to show safety and efficacy. See 21 U.S.C. § 355(j). Congress also created a safe harbor granting immunity from patent infringement when the activity was “solely for uses reasonably related to the development and submission” of information to the FDA. 35 U.S.C. § 271(e)(1). The provision overturned the Roche decision from 1984.
The Hatch-Waxman Act also included a patent-term extension (PTE) for patents claiming an FDA-approved product because obtaining FDA approval often takes longer than getting a patent granted by the USPTO. See 35 U.S.C. § 156(a).
The changes brought by the Hatch-Waxman Act sped up the process for generics getting approved but did not deal with the litigation risk that the generic company took by marketing a drug covered by an NDA holder’s patent. Therefore, Congress created a new act of infringement to resolve patent disputes pre-approval. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990). The new provision made submitting an ANDA a technical act of infringement. 35 U.S.C. § 271(e)(2)(A). One remedy for an eventual finding of infringement is setting the effective date of approval no earlier than the date that the brand’s patent would expire. Id. § 271(e)(4)(A).
Congress also prohibited the FDA from approving an ANDA that would infringe a “listed patent”, i.e., any patents submitted by the NDA holder to the FDA for inclusion in the Orange Book (aka Approved Drug Products with Therapeutic Equivalence Evaluations). To be included in the Orange Book, the NDA holder must submit “the patent number and expiration date of each patent” related to the drug for which approval is requested to the FDA. 21 U.S.C. § 355(b)(1)(A)(viii).
A generic company submitting an ANDA must include, as a part of their application, an appropriate patent certification for any patents listed in the Orange Book for the relevant NDA drug product. There are four certifications that the generic applicant can make as part of their ANDA: 1) “such patent information has not been filed.” Id. § 355(j)(2)(A)(vii)(I); 2) “such patent has expired.” Id. § 355(j)(2)(A)(vii)(II); 3) “the date on which such patent will expire.” Id. § 355(j)(2)(A)(vii)(III); and 4) “that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.” Id. § 355(j)(2)(A)(vii)(IV).
For certifications 1 and 2, the FDA may approve the ANDA immediately, as there is no potential patent infringement of a listed patent. For certification 3, the FDA may wait until the relevant patent(s) expire before approving the ANDA. For certification 4, the process is more complicated. The generic applicant sends the patent owner a Paragraph IV notice that gives the patent owner 45 days to file an infringement suit for the technical act of infringement of filing the ANDA. Id. § 355(j)(5)(B)(iii). If the patent owner files an infringement suit within 45 days of the notice, the approval of the ANDA shall be effective after a thirty-month period from the date of the notice. Id. If the patent owner does not sue, then the approval may be effective after the 45 days have lapsed.
Some argue that this 30-month stay in approval may entice patent owners to improperly list patents in connection with their NDA. The FDA does not police the patents listed in the NDA on the basis of not having sufficient patent-law expertise to determine the listability of any submitted patent information. This was an important issue addressed by the CAFC in their decision.
The CAFC then discussed TEVA’s NDA for ProAir® HFA Inhalation Aerosol, described in NDA No. 021457, Amneal’s ANDA with a Paragraph IV certification indicating Amneal’s belief their proposed generic product would not infringe any claim of any patent listed in the Orange Book for this product, and the District Court’s delisting order.
TEVA listed patents for a metered dose inhaler that can be used with albuterol sulfate in the Orange Book. However, none of the patents listed by TEVA specifically claim an active ingredient, only a medicament canister. While the FDA did approve the NDA as a drug because of the active ingredient used in the final product, the CAFC explained that a device-drug combination product does not become a drug just because it is regulated as a drug.
Amneal submitted an ANDA to obtain approval for a similar device with a Paragraph IV certification, arguing that the nine patents listed by TEVA would not be infringed by their proposed generic device. TEVA then sued Amneal for infringement on, ultimately, five of the Orange Book listed patents. Amneal, in turn filed counterclaims against Teva, including a request for an order that TEVA be required to delist the five patents, which did not include claims for an active ingredient as required for listing in the Orange Book.
The CAFC performed a statutory interpretation de novo as an issue of law. In the review, the CAFC focused on the language of the relevant statute and the broader context of drug approval to determine the meaning in the relevant statute.
TEVA argued that their patents were properly listed in the Orange Book because the patents “claim the drug” by reading on, or referring generally to, the drug. In other words, TEVA argued that a patent claims a drug if the patent would be infringed by use of the drug. The CAFC rejected this interpretation. The CAFC explained that TEVA’s interpretation would allow far more patents to be listed in the Orange Book and goes directly against the plain language of the relevant statute. The CAFC pointed out that the listing provision of the relevant statute identifies “infringing” and “claiming” as two distinct requirements. The CAFC asserted that it would have been redundant of Congress to include two different clauses for the same requirement. The Court also referred to the patenting statutes, specifically 35 U.S.C. § 112, which defines the written description and claim requirements in a patent application. When the claims and specification are read together the claims define the invention. Therefore, the CAFC concluded that claims are of primary importance and identify the “invention.”
Infringement, on the other hand, is governed by a different statute (35 U.S.C. § 251) and occurs when someone other than the inventor makes, uses, sells, or imports the claimed invention without authorization. Claims are given their ordinary meaning based on the words used inside the patent document itself. Further, someone can infringe a patent without meeting all the claim elements when there is equivalence between the elements of the accused product or process and the claimed elements of the patented invention. A product that infringes a patent claim can also include more than the elements of the claim.
Referring again to the written description requirement with respect to the relevant patents, the CAFC gave an example from oral arguments to illustrate the difference between claims and infringement. A large item such as a car can infringe a patent for a steering wheel even if the patent application did not describe the car itself.
Lastly, the CAFC described that the interpretation outlined in the opinion contrasts with the Patent Term Extension (PTE) provisions of the Hatch-Waxman Act, which extends the term of a patent that “claims a product.” 35 U.S.C. § 156(a)(4). The CAFC concluded its statutory analysis by stating that both relevant statutory provisions and case law establish that what a patent claims and what infringes a patent are distinct concepts. What is claimed in TEVA’s patents are distinct from what may infringe TEVA’s patents.
Next, the CAFC discussed whether the device itself was a drug, or whether an actual chemical must be claimed in the patent. The CAFC again turned to statutes and case law to determine that medical devices and chemical compounds, or drugs, have distinct approval pathways under U.S. law and cannot be conflated as the same thing. Patents listed in the Orange Book are required to include at least one claim directed to an active ingredient, while all TEVA’s asserted patents for a metered dose inhaler device do not include any claims for the active drug ingredient, albuterol sulfate. The CAFC concluded TEVA’s argument that a claim requiring the presence of “an active drug” was far too broad to particularly point out and distinctly claim the drug approved in TEVA’s NDA as required by 35 U.S.C. § 112.
Accordingly, the CAFC affirmed that Teva is required to delist the patents at issue from the Orange Book for the ProAir® HFA Inhalation Aerosol, and lifted the stay, thereby permitting Amneal to launch their generic product.
