"Show More Of You": Amgen V. Sandoz, Battling It Out On Amgen's Otezla' Drug

• Published date: 20 January 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Ms Jill MacAlpine, Paul W. Browning, Melissa Santos, Hira Javed, Stacy Lewis and Thomas L. Irving

Holding

In the Hatch-Waxman patent infringement case Amgen, Inc. v. Sandoz Inc., Civ. Action No. 3:18-cv-11026, Judge Shipp of the District Court of New Jersey held in favor of Amgen in part and for Defendants in part.

Background

Amgen sued Dr. Reddy's Laboratories, Sandoz, and Zydus Pharmaceuticals for infringement of five patents: U.S. Pat. Nos. 7,427,638 ("the '638 patent"), 8,455,536 ("the '536 patent"), 10,092,541("the '541 patent"), 7,893,101 ("the '101 patent"), and 8,093,283 ("the '283 patent"). The asserted patents relate to using stereomerically pure apremilast and crystal forms thereof to treat psoriasis. Amgen sells oral apremilast tablets under the name Otezla^', the "Show More of You" tablets, as touted in the Otezla^'television commercials.

The '638 Patent

The district court found that the '638 patent was not shown to be invalid. Defendants had stipulated to infringement, so judgment was entered in favor of Amgen. Score 1 for Amgen.

Asserted claims 3 and 6 respectively read:

[t]he pharmaceutical composition of claim 2 wherein said pharmaceutical composition is suitable for oral administration to a patient.

[t]he pharmaceutical composition of claim 5 wherein the amount of stereomerically pure [apremilast] is from 10 mg to 200 mg.

The primary reference relied upon by Defendants for their obviousness challenges was U.S. Patent No. 6,020,358, a Celgene patent with inventors common to the '638 patent. The reference patent discloses seventeen examples, all of which are racemic mixtures, including a racemic mixture of 50% apremilast and 50% of its enantiomer. The reference patent states "[b]oth the racemates of these isomers and the individual isomers themselves . are within the scope of the present invention." Furthermore, the prior patent asserted that:

The racemates can be used as such or can be separated into their individual isomers mechanically as by chromatography using a chiral absorbant. Alternatively, the individual isomers can be prepared in chiral form or separated chemically from a mixture by forming salts with a chiral acid, such as the individual enantiomers of 10-camphorsulfonic acid, camphoric acid, ?-bromocamphoric acid, methoxyacetic acid, tartaric acid, diacetyltartaric acid, malic acid, pyrrolidone-5-carboxylic acid, and the like, and then freeing one or both of the resolved bases, optionally repeating the process, so as obtain either or both substantially free of the other; i.e., in a form having an optical purity of >95%.

Id. at *23-24 (internal citation omitted).

Defendants contended that it would have been obvious to resolve the racemate comprising apremilast. In assessing the obviousness of apremilast, Defendants contended that a lead compound analysis was not applicable. The district court agreed, noting the Federal Circuit's direction with respect to analyzing obviousness of purified and racemic compounds:

Where a claimed composition is a purified form of a mixture that existed in the prior art and "if the prior art would provide a person of ordinary skill in the art with reason to believe [it had desirable properties], the purified compound is prima facie obvious over the mixture even without an explicit teaching that the ingredient should be concentrated or purified."

Amgen at * 21 (quoting UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313, 1323 (Fed. Cir. 2018).

[I]f it is known that some desirable property of a mixture derives in whole or in part from a particular one of its components, or if the prior art would provide a person of ordinary skill in the art with a reason to believe that this is so, the purified compound is prima facie obvious over the mixture even without an explicit teaching that the ingredient should be concentrated or purified.

Amgen at *26 (quoting Aventis Pharma Deutsch/and GmbH v. Lupin, 499 F.3d 1293, 1301 (Fed. Cir. 2007)).

The district court found that the Defendants failed to meet their burden to show that the prior art would have provided a person of ordinary skill in the art ("POSITA") with the motivation to resolve...