On 20 May US District Judge David Folsum issued orders believed by others to favor the arguments of Lec Tec, the plaintiff. Judge Folsum issued a Markman ruling, resulting from a hearing process by which the judge rules on interpretation of patent claims, otherwise known as a "claim construction hearing". Claim construction findings can indicate a likely outcome for any patent infringement case along with related motions for summary judgment. In this case Folsum ruled on the claim language around the patch's "non-occlusiveness" and around the "curing" process used during manufacture in both interpretations favoring Lec Tec. Second, he denied the defendants' motion for summary judgment on non-infringement, but granted their motion on invalidity. Typically patents, such as these, that have gone through a second (re)examination process by the US Patent Office have their validity strengthened. Subject to legal interpretation by patent counsel these judicial orders would seem to favor Lec Tec. The earlier withdrawal and settlement of three defendants, including J&J, would suggest this may be the case. The persistence of the remaining defendants could suggest a delay in their development of technologies outside these patent claims, buying time to an NDA approval, or significant exposure to retrospective and prospective royalties.
Fourth, industry rumors suggest J&J plans a launch of a new line of topical pain patches, perhaps in the 4Q10, or soon thereafter. This new line may represent adoption of an alternative patch technology outside the patent claims of Lec Tec thereby avoiding forward licensing royalties to Lec Tec, and/or possibly an NDA approved product. Note: FDA's creeping quality control investigations into J&J may yet extend to its Asian pain patch suppliers, or at least to its oversight of quality assurance at third-party manufacturers.
As we had predicted one year ago these timelines will intersect towards January, 2011. Eventually non-traditional forms of topical pain products like wraps, sleeves, etc. may fall by the wayside absent additional individual NDA's material to their form. Salonpas and J&J look to be advancing forward as they work around regulatory uncertainty and sidestep patent infringement exposure. Chattem, fighting a rearguard action with Lec Tec, will in the meantime be singularly focused on proving it can launch Sanofi's (SNY) allergy medicine Allegra into the OTC market in 1Q2011 against entrenched category leaders, Claritin (MRK), Zyrtec (JNJ) and cheaper storebrand options. Donald K. Riker, Ph.D. Dr. Riker is the President & Founder, On Point Advisors, LLC, a healthcare consultancy, and Editor-in-Chief, OTC Product News dedicated to the over-the-counter healthcare industry. He is the former Vice President R&D & Chief Scientific Officer, Chattem, Inc. and Associate Director & Fellow, Personal Healthcare, Procter & Gamble. Dr. Riker is an elected member of several medical and scientific organizations, The Licensing Executive Society, and the Association of Healthcare Journalists.