A Whole Lot Of "Cobbl[e]"-ty Gook After Wertheim

• Published date: 28 December 2021
• Subject Matter: Intellectual Property, Media, Telecoms, IT, Entertainment, Patent, Media & Entertainment Law, Broadcasting: Film, TV & Radio
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Taylor K. Stark, Melanie Magdun, Amanda K. Murphy, Stacy Lewis, Sumaia Tabassum and Thomas L. Irving

Holding: In Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A., No. 20-2073 (Fed. Cir. 2021), the Federal Circuit issued an opinion ('Majority Opinion') affirming a decision of the Patent Trial and Appeal Board ('PTAB') holding all but one of the challenged claims unpatentable in IPR2019-00329. Judge Linn concurred-in-part and dissented-in-part ('Linn Opinion').

Background: Petitioner, Dr. Reddy's Laboratories ('DRL'), challenged Claims 1-5 and 7-14 of U.S. Patent No. 9,687,454 ('the '454 Patent') on anticipation grounds, citing the pre-grant publication of the original parent application from which the '454 patent claimed priority. Specifically, DRL asserted that the challenged claims, which issued from a fifth continuation of U.S. Patent Application 12/537,571 ('the '571 Application'), lacked written description support in the earlier '571 Application and thus, could not properly obtain the benefit of the '571 Application's effective filing date (August 7, 2009). Accordingly, DRL argued that the challenged claims were anticipated by the earlier publication of the '571 Application on February 10, 2011, as U.S. Patent Publication 2011/0033541 ('the '541 Publication').

The '454 Patent is directed to oral films that are designed to dissolve and release therapeutic agents. Claims 1, 7, 8, and 12 of the '454 Patent, which the majority highlighted as illustrative of all of the challenged claims, read as follows:

1. An oral, self-supporting mucoadhesive film comprising:

(a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;

(b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;

(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and

(d) an acidic buffer;

wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;

wherein the weight ratio of (b):(c) is about 4:1;

wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and

wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine C_max from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone C_max from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.

7. The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix.

8. The film of claim 7, wherein the film comprises about 48.2 wt % of the water soluble polymeric matrix.

12. The film of claim 1, wherein...