Federal Circuit Scratches Patent Office Inter Partes Reexam Obviousness Determination | Practical Law

Federal Circuit Scratches Patent Office Inter Partes Reexam Obviousness Determination | Practical Law

In Leo Pharmaceutical Products, Ltd. v. Rea, the US Court of Appeals for the Federal Circuit reversed the US Patent and Trademark Office's obviousness determination in an inter partes reexamination proceeding concerning a patent directed to pharmaceutical compositions for the topical treatment of certain skin conditions, such as psoriasis.

Federal Circuit Scratches Patent Office Inter Partes Reexam Obviousness Determination

by Practical Law Intellectual Property & Technology
Published on 13 Aug 2013 • USA (National/Federal)
In Leo Pharmaceutical Products, Ltd. v. Rea, the US Court of Appeals for the Federal Circuit reversed the US Patent and Trademark Office's obviousness determination in an inter partes reexamination proceeding concerning a patent directed to pharmaceutical compositions for the topical treatment of certain skin conditions, such as psoriasis.
Ruling that the US Patent and Trademark Office (USPTO) had engaged in a hindsight obviousness analysis, the US Court of Appeals for the Federal Circuit on August 12, 2013 issued an opinion reversing the USPTO's obviousness determination in Leo Pharmaceutical Products, Ltd. v. Rea. Specifically, the Federal Circuit determined that the claimed invention was not obvious primarily because:
  • The inventors recognized and solved a problem that:
    • the prior art did not recognize; and
    • was not solved for over a decade.
  • The objective evidence of nonobviousness was compelling.

The Invention

The appeal in this case arose from an inter partes reexamination proceeding concerning a patent owned by Leo Pharmaceutical Products, Ltd. covering pharmaceutical compositions for the topical treatment of certain skin conditions, such as psoriasis. Specifically, the claimed invention relates to a single, storage stable pharmaceutical product comprising:
  • A vitamin D analog.
  • A corticosteroid.
  • A solvent including polyoxypropylene 15 stearyl ether (POP-15-SE).
Previous combination formulations were not storage stable. Therefore physicians prescribed a two-drug regimen that required patients to apply one drug in the morning and another at night. The inventors discovered that a new set of solvents, including POP-15-SE, solved the storage stability problem and allowed the vitamin D analog and the corticosteroid to coexist in a single pharmaceutical product.

Nonobviousness Analysis

The USPTO relied on the combination of three prior art references and discounted Leo's objective evidence of nonobviousness to determine that the claimed invention was obvious.

Prior Art

The main reference discloses pharmaceutical compositions comprising a steroid contained within a solvent, POP-15-SE, but does not teach the use of vitamin D. Both of the secondary references disclose dermatological compositions comprising a vitamin D analog and a corticosteroid or steroid.
The Federal Circuit emphasized that:
  • The claimed invention is not just a combination of prior art elements but is based on the inventors' recognition of and solution to certain formulations' storage stability problem.
  • Several medical research articles discouraged the combination of a vitamin D analog with a corticosteroid because of stability problems.
  • Neither of the secondary references recognized or disclosed the stability problem and therefore there was no reason for one of ordinary skill in the art to improve those formulations by using the main reference teaching.
  • The main reference:
    • was available for 22 years before the application for the patent at issue was filed and there was no evidence that anyone sought to improve that formulation by adding vitamin D; and
    • disclaims the use of the secondary references' formulations' solvents.
The Federal Circuit also concluded that the claimed invention was not obvious to try because:
  • There were more than eight different classes of additives and more than ten different categories of composition forms available.
  • The prior art did not provide direction.
  • There was no expectation of a successful result.
  • The elapsed time between the prior art and the filing date of the application for the patent at issue was significant.

Objective Indicia of Nonobviousness

The Federal Circuit reiterated that consideration of the objective indicia of nonobviousness is part of the whole obviousness analysis. It then concluded that the evidence of nonobviousness in this case was compelling based, in part on:
  • The unexpected storage stability achieved by the combination of known elements.
  • The fact that the claimed invention is the first FDA-approved drug to combine vitamin D and corticosteroids in a single formulation for topical application.
  • The intervening time between the prior art's teaching of the components and the preparation of the successful composition.
Court document: