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Patent on Taclonex Psoriasis Treatment Improperly Rejected in PTO Reexamination

Thursday, August 15, 2013
By Tony Dutra

The Patent and Trademark Office is no different from a district court in the requirement to assess objective indicia of nonobviousness in a patent reexamination proceeding, the U.S. Court of Appeals for the Federal Circuit ruled Aug. 12 (Leo Pharm. Prods., Ltd. v. Rea, Fed. Cir., No. 2012-1520, 8/12/13).

The court reversed the decision of the Board of Patent Appeals and Interferences, eight times using the word “hindsight” to characterize the board's faulty obviousness analysis. The court distinguished the board's role when it is reviewing an examiner's rejection of a patent application from the inter partes challenge at issue in this case.

The appeals court's criticisms can be seen as providing a detailed analytical structure for the renamed Patent Trial and Appeal Board, with its increased slate of post-issuance, inter partes challenge options created by the America Invents Act.

Patent Underlying Taclonex Ointment
Leo Pharmaceutical Products Ltd. owns a patent (U.S. Patent No. 6,753,013) on pharmaceutical compositions for the topical treatment of skin conditions such as psoriasis. Representative claim 1 originally identified three components: a vitamin D analog as component A; a corticosteroid as component B; and a particular set of solvents as component C.

Leo's commercial embodiment of the patent is the Taclonex ointment.

Tolmar Inc. and Perrigo Co. separately filed abbreviated new drug applications to sell generic forms of Taclonex ointment. Leo and Perrigo stipulated to dismissal in February 2012. Leo Pharma A/S v. Perrigo Israel Pharma Ltd., No. 1:11-cv-00963-RMB (S.D.N.Y.). Leo's infringement lawsuit against Tolmar was stayed pending the instant appeal, though co-defendant Teva Pharmaceuticals Industries Ltd., which supplies the active ingredient calcipotriene for Tolmar's product, was dismissed from the case. Leo Pharma A/S v. Tolmar Inc., No. 1:10-cv-00269-SLR (D. Del.).

Galderma R&D of Sophia-Antipolis Cedex, France, sought and the PTO instituted inter partes reexamination of the '013 patent on a challenge for obviousness. Galderma Laboratories LP makes the competitive Clobex spray product.

In reexamination, Leo amended Cclaim 1 to state specifically, “wherein said pharmaceutical composition is storage stable and non-aqueous.” Component C--the solvent--affects stability, and Leo had discovered that various aqueous options failed to address stability problems.

A 1977 patent issued to Joseph S. Turi--23 years before Leo's filing date--claimed a combination of components B and C. That left out the value of the vitamin D analog, which is to treat steroid-induced atrophy. Two other 10-year-old prior art references addressed that value by disclosing a combination of components A and B, but they did not discuss the stability problems.

The BPAI rejected the amended claims as obvious by using Turi as the primary reference and concluding that a skilled artisan would know to add the vitamin D analog to address the atrophy issue. Leo appealed.

Not Simply a Combination of Elements
Chief Judge Randall R. Rader, writing for a unanimous court, began by reversing the BPAI's construction of the term “storage stable.”

Essentially, the board looked through the specification to find a stability test, which the court held was “far short of its broadest reasonable meaning.” The court construed the term to “include a[ny] composition that maintains its stability during its shelf life for its intended use as an approved pharmaceutical product for sale and home use by ordinary customers.”

The court's primary reasoning for reversing, though, was based on errors in the board's approach. It first distinguished the invention here as “not simply a combination of elements found in the prior art.” The problem addressed by the patent, the court said, was storage stability of a composition containing both a steroid and a vitamin D analog, and nothing in the prior art that the board used to find obviousness disclosed or addressed that problem, let alone solved it.

The court looked at the three references in detail and concluded that they actually represented “divergent compositions with express disclaimers of the other's contents.” It thus characterized the board's “hindsight-guided combination of elements” analysis as inadequate for the purpose of finding a motivation to combine the teachings in the references.

That hindsight further informed the board's faulty judgment that the claimed combination would be obvious to try, the court said. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 U.S.P.Q.2d 1385 (2007) (86 PTD, 5/4/07), allowed for an obvious-to-try analysis in lieu of finding a motivation to combine, but, according to the court, “KSR did not create a presumption that all experimentation in fields where there is already a background of useful knowledge is 'obvious to try,' without considering the nature of the science or technology,” quoting Abbot Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352, 89 U.S.P.Q.2d 1161 (Fed. Cir. 2008).

The “background of useful knowledge” here had been published at least 10 years earlier, with no other party producing a storage stable formulation. “The problem was not known, the possible approaches to solving the problem were not known or finite, and the solution was not predictable,” the court said. The board erred in believing the solution was nothing more than “picking and choosing” from a list of combinations.

Inter Partes Proceeding Requires Full Analysis
The board's judgment was further “in the face of such strong objective indicia of nonobviousness,” the court said.

The court has chastised several district court rulings recently for establishing a case of obviousness and then considering these secondary considerations only as a possible rebuttal to a prima facie case (see, e.g.). The court extended that criticism to the board here, at least with respect to inter partes challenges:

When an applicant appeals an examiner's objection to the patentability of an application's claims for obviousness, the PTO necessarily has the burden to establish a prima facie case of obviousness which the applicant then rebuts. In re Mouttet, 686 F.3d 1322[, 1330, 103 U.S.P.Q.2d 1219 (Fed. Cir. 2012)(124 PTD, 6/28/12)]. However, during inter partes reexamination, the Board is reviewing evidence of obviousness--including objective indicia--submitted by two adversarial parties for the claims of an issued patent. Thus, the Board should give the objective indicia its proper weight and place in the obviousness analysis, and not treat objective indicia of nonobviousness as an afterthought.


In the instant case, the court said, the secondary considerations given inadequate weight by the board included “extensive experimental evidence” of unexpected results, the commercial success of Taclonex, and a “long felt but unsolved need.”

The court held that these objective indicia were the most probative evidence of nonobviousness with respect to Leo's amended patent claims. It thus reversed the board's determination.

Judges Kathleen M. O'Malley and Jimmie V. Reyna joined the opinion.

William E. Solander of Fitzpatrick, Cella, Harper & Scinto, New York, represented Leo. PTO Associate Solicitor Amy J. Nelson represented the office.


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