Docket Nos. 2015-2029, -2030, -2032
IPR2014-00377, IPR2014-00378, IPR2014-00379
PROST, NEWMAN, LOURIE
March 24, 2016
Brief Summary: Board decisions affirming the patentability of Depomed’s patents because Purdue failed to show patents would have been obvious by a preponderance of the evidence (motivation to combine not shown).
Summary: Purdue appealed from final USPTO written decisions in three IPRs (Purdue I, II and III) affirming the patentability of Depomed’s US 6,340,475 and 6,635,280 encompassing “controlled-release oral drug dosage form[s]” where the drug has particular characteristics (particular solubility in water, “at least one ionized group in the pH range 5 through 8) in a polymeric matrix and methods of administration. The Board found the prior art “Baveja discloses most of the limitations of independent claims 1 and 43 of the ‘475 and ‘280 patents, except for the ‘swelling’ and ‘substantially intact’ limitations” and rejected Depomed’s teaching away arguments. The Board also found prior art “Shell discloses the limitations that are missing from Baveja” but that “Purdue failed to establish a reason to combine the prior art to achieve the claimed invention with a reasonable expectation of success”, “failed to explain persuasively ‘how or why’ a person of ordinary skill in the art would have combined the ‘swelling’ and ‘substantially intact’ features of the Shell formulation with the Baveja formulation” (e.g., how those features “would not affect the other desired properties of the Baveja formulation, such as the drug release profile”), and “improperly used hindsight by defining the problem with a recitation of the challenged claims”. Purdue argued the Board deviated from KSR’s “expansive and flexible approach that accounts for the interrelated teachings of the prior art and the nature of the problem to be solved”, that “its definition of the problem to be solved came directly from Shell, not from the challenged claims”, and that “Baveja and Shell demonstrate actual success”. Depomed argued “Purdue’s generic and conclusory statements of interrelated teachings of the prior art are indicative of the fact that Purdue presented no credible evidence on a motivation to combine the prior art.” The FC panel agreed with Depomed that the Board applied the correct legal standard. It found “the Board correctly determined that each limitation of the challenged independent claims was known in the art”, “Baveja does not teach away from the claimed dosage form” (In re Mouttet, FC 2012 (alternatives do not “mean that an inferior combination in inapt for obviousness purposes”) but failed to show “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does” (KSR; Par Pharm., FC 2014). It found Purdue “failed to demonstrate to the Board that the problem was known in the art or that Purdue’s formulation of the problem was derived directly from the prior art, rather than from the challenged claims” (Insite Vision, FC 2015 (“Defining the problem in terms of its solution reveals improper hindsight in the selection of the prior art relevant to obviousness.”)) It also agreed a reasonable expectation of success was not shown, as “both parties’ experts testified on the large number of formulation considerations in play when designing a drug formulation.” Thus, the Board’s decision was affirmed.