Takeaway: Motivation to combine in the face of an express teaching away must be found in the prior art itself; reliance on the teachings of the challenged patent to find a motivation to combine is impermissible hindsight.

In its Decision, the Board denied institution of inter partes review of claims 1-4 of the ‘285 patent because Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of any challenged claim. The ‘285 patent “is directed to drug dosage forms that have a coordinated release of an agent that raises the pH of a patient’s gastrointestinal tract to a safe level, followed by a non-steroidal anti-inflammatory drug (‘NSAID’), to reduce unwanted gastrointestinal side effects.”

Petitioner argued that the claims of the ‘285 patent “are not entitled to an effective filing date earlier than May 16, 2005, because the two applications filed before this date in the listed chain of priority on the face of the ’285 patent do not provide written description support for five features of the claims of the ’285 patent.” Thus, according to Petitioner, the earlier published and related Plachetka Publication was asserted to be prior art under 35 U.S.C. § 102(b) for being published more than two years before the earliest effective priority date of the ‘285 patent. The Board, however, disagreed, as “Petitioner’s arguments are rooted in its overbroad claim interpretations, and specifically, as to the application of the transitional term ‘comprising,’ and the claim terms ‘inhibits’ and ‘portion.’”

Turning to claim construction under the broadest reasonable interpretation, the Board first addressed the term “comprising therapeutically effective amounts of . . . naproxen surrounded by a coating.” The Board rejected Petitioner’s interpretation, agreeing with Patent Owner that “using the transitional term ‘comprising’ means that additional components may be present, but does not change the elements that are stated in the claim.” See Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285, 1305 (Fed. Cir. 2012). Petitioner’s interpretation “would encompass a composition where the vast majority of the naproxen, i.e., a therapeutically effective amount, would be outside of the coating.” In partially disagreeing with Patent Owner’s full definition, however, the Board found that “[a]lthough the claim term requires that a therapeutically effective amount of naproxen in a unit dosage form is surrounded by a coating, it does not exclude a unit dosage form that has an amount of naproxen outside of the coating that is not therapeutically effective.”

Regarding the “inhibits” and “portion” claim terms, both parties proposed an “ordinary meaning.” For the “inhibits” term, however, the Board disagreed with Petitioner’s “interpretation of the difference in breadth between ‘inhibit,’ ‘prevent,’ and ‘delay’[that] would lead to the conclusion that the claims of the ‘285 patent encompass a formulation that releases all of its naproxen slowly at any pH.” In sum, the “distinction between the ordinary meanings of these terms is not so vast to be able to reach such a conclusion,” and the Board did “not accept Petitioner’s argument that the claims of the ‘285 patent encompass a formulation that releases all of its naproxen slowly at any pH.” For the “portion” term, the Board disagreed with Petitioner that “the pre-2003 applications only disclose formulations that release all their esomeprazole immediately regardless of pH, while the ‘285 patent claims encompass formulations that delay release of most of its esomeprazole until reaching a particular pH.” Finally, for the term “unit dosage form,” the Board agreed with Patent Owner that the ‘285 patent “describes only oral dosage forms for administering the claimed formulations.” As such, because the Board construed “unit dosage form” to “require stability for oral administration,” the Board disagreed with Petitioner’s contention “that the pre-2003 applications require formulations that are orally administered while the claims of the ‘285 patent do not.” Based on the constructions of the foregoing, the Board found that Petitioner did not establish “that the claims of the ‘285 patent are not supported by at least the ‘216 application.”

The Board next turned to the asserted ground of unpatentability, obviousness over Depui, Phillips, Lundberg, and Clissod. Off the bat, the Board stated that “[w]hen the claims are construed properly, it is clear that the prior art does not teach the combination of the limitations set forth in the challenged claims of the ‘285 patent.” Petitioner “does not discuss these references or explain how one of skill in the art would combine the teachings from these references with the other cited references to arrive at the claimed invention.” The Board “agree[d] with the Patent Owner that Pilbrant teaches away from the claimed combination.” See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), cited in In re Mouttet, 686 F.3d 1322, 1333-34 (Fed. Cir. 2012). As such, the Board “agree[d] with the Patent Owner that Petitioner’s ‘[m]otivation to combine in the face of an express teaching away must be found in the prior art itself and reliance on the teachings of the ‘285 patent is impermissible hindsight.’”

Thus, the Board denied institution of the Petition.

Dr. Reddy’s Labs., Inc. v. Pozen Inc., IPR2015-00802
Paper 28: Decision Denying Instituting of Inter Partes Review
Dated: October 9, 2015
Patent: 8,557,285 B2
Before: Sheridan K. Snedden, Susan L. C. Mitchell, Robert A. Pollock
Written by: Mitchell
Related proceedings: Five district court proceedings in the United States District Court of New Jersey