During the week of August 20, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600, both denying institution of inter partes review.  A summary of the decisions follows:

Catalent Pharma Solutions, Inc. (“Catalent”) v. Patheon Softgels Inc. (“Patheon”), IPR2018-00421 (Decision Denying Institution Entered August 13, 2018).

In its petition, Catalent challenged claims 1-38 of U.S. Patent No. 9,693,978 (“the ’978 patent”) on anticipation and obviousness grounds. The ’978 patent is directed to oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules.

A key determination concerned claim construction of the term “about 5% lactic acid by weight of the fill material.” Catalent argued that the term “about 5%” should encompass between 2% to 8%. During prosecution, Patheon narrowed the scope of the claims from “lactic acid in an amount from about 0.2 to about 1.0 mole equivalents per mole of naproxen salt” to exclude a broader amount of lactic acid and recite “about 5% lactic acid by weight of the fill material.” The Board agreed with Patheon that the term “about 5%” should be given its ordinary meaning of “approximately 5%” and declined to adopt Catalent’s proposed construction, concluding that such a determination would improperly broaden the scope of the claims.

Catalent challenged the claims as anticipated and/or obvious based on references by Chen, Kim, and Schoenhard. The Board found that Catalent failed to establish that arriving at the claimed amount of lactic acid would have been a routine matter of choice and that Catalent’s expert relied on improper assumptions. In particular, Catalent’s expert chose a specific capsule size and shape and a specific amount of active agent for the basis of his contentions, but failed to adequately explain why that specific capsule was selected from numerous other conventional combinations. The Board determined that Catalent “appear[ed] to have arbitrarily selected dosages and capsule sizes so as to achieve the desired result of 5%[] lactic acid by weight of the fill material.” IPR2018-00421, Paper 9 at 24. Furthermore, Catalent’s expert erroneously referenced a capsule size that was impractical for human consumption. The Board found that “the unexplained picking-and-choosing activity” of Catalent’s analysis to reach their conclusions amounted to improper hindsight. Id. at 15. The Board further found that Catalent failed to establish that lactic acid would be a simple substitution for other acids, like citric acids, or that the amounts of each would be the same. Id. 17-19.

The Board concluded that Catalent failed to establish a reasonable likelihood of prevailing on any of the challenged claims of the ’978 patent and therefore denied institution of inter partes review.

Catalent Pharma Solutions, Inc. (“Catalent”) v. Patheon Softgels Inc. (“Patheon”), IPR2018-00422(Decision Denying Institution Entered August 13, 2018).

In another petition, Catalent challenged claims 1-19 of U.S. Patent No. 9,693,979 (“the ’979 patent”) on anticipation and obviousness grounds. The ’979 patent, like the ’978 patent discussed above, is directed to oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. The same references and similar grounds of unpatentability were presented by Catalent as were presented in its petition in IPR2018-00421.

For the same reasons as in IPR2018-00421, the Board denied institution of Catalent’s petition in IPR2018-00422. Accordingly, no trial was instituted against the claims of the ’979 patent.