Sniffs Of Patentability In IPR: Anticipation, Obviousness, And Admissibility

• Jurisdiction: United States,Federal
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Subject Matter: Intellectual Property, Patent
• Author: Ms Taylor K. Stark, Stacy Lewis and Elliot C. Cook
• Published date: 04 May 2023

In Amphastar Pharms., Inc. v. Aegis Therapeutics, LLC, Amphastar filed a Petition for inter partes review ("IPR") of claims 1-20 of Aegis's U.S. Patent No. 10,682,414 ("the '414 patent"). The '414 patent is directed to intranasal epinephrine formulations and methods of treating anaphylaxis. Challenged claim 1 presents a method of treating a systemic allergic reaction in a mammal by administering a pharmaceutical nasal spray comprising epinephrine or an epinephrine-containing salt. IPR2021-01324, Paper 43, at *4. That claim reads as follows:

1. A method of treatment of a type-1 hypersensitivity reaction in a mammal comprising administering intranasally to the mammal in need thereof an aqueous nasal spray pharmaceutical formulation; wherein the aqueous nasal spray pharmaceutical formulation comprises

an anaphylaxis active ingredient, wherein the anaphylaxis active ingredient consists of between about 0.1 mg and about 2.4 mg of epinephrine, or a salt thereof in a single dose.

Claim 3, which depends from claim 1, reads as follows:

3. The method of claim 1, wherein:

intranasal administration of the single dose of the aqueous nasal spray pharmaceutical formulation to the mammal provides a plasma epinephrine concentration that is efficacious for the treatment of anaphylaxis.

The '414 patent's specification describes sample formulations and the results of two clinical studies. Id. at *4. The first of these studies compared epinephrine bioavailability after intranasal and intramuscular administration of formulations containing 0.3 mg epinephrine. Id. The second clinical study identified an optimized dosage for the intranasal administration of epinephrine-containing formulations and compared epinephrine bioavailability resulting from this optimized dose to the bioavailability resulting from an intramuscular dose. Id. The results of this second study indicated that "1.0 mg intranasal epinephrine can be formulated to be highly similar to or better than a 0.3 mg intramuscular injection of epinephrine." Id. at *5.

The Board instituted review on ' 102 and ' 103 grounds based on the Potta, Maggio, Munjal, and Srisawat references. Id. at *7.

Anticipation

The Board determined that Amphastar adequately demonstrated that Potta anticipates claims 1, 2, and 7-17, but not claims 3-6 and 18. Id. at *20.

Regarding claim 1, the Board found that Potta discloses the intranasal administration of aqueous spray pharmaceutical formulations to humans for systemic allergic reactions like...