Hindsight and Patentability

tube of cream

In order to get patent claims allowed and issued at the U.S. Patent Office (USPTO), a patent examiner has to be persuaded that an invention is non-obvious. Each issued patent is supposed to protect something significantly better than what has been invented before. But how much better? That’s the controversial question!

In practice, about 50% of applications are rejected and end without any patent being issued. Many rejections are on the basis of this fuzzy notion and law of non-obviousness found at 35 U.S.C. 103. Everyone seems to have his own deeply-felt opinion on the topic.

Examiners are not allowed to use a patent application as a road map to reject really great technical break-throughs. A finding of non-obviousness (a rejection) cannot be found on the basis of hindsight. In 2013, the Federal Circuit, provided guidance on avoiding the use of hindsight in Leo Pharmaceutical Products, Ltd v. Rea, 726 F.3d 1346 (Fed. Cir. 2013).

First, a little background. U.S. Patent No. 6,753,013 was assigned to Leo Pharmaceuticals. This ‘013 patent claimed a “storage-stable” pharmaceutical composition comprising a vitamin D analog, a corticosteroid and at least one solvent component for topical treatment of skin conditions such as psoriasis.

Galderma R&D, as a third-party, challenged the patent in a re-examination proceeding. During re-examination, the examiner rejected the claims as being obvious over 3 prior art references. The rejection was upheld on appeal to the Patent Board of Appeals and Interferences (BPAI).

The following is guidance taken from the Federal Circuit opinion.

  • The Board erred by collapsing the obviousness analysis into a hindsight-guided combination of elements. The record, disclosed several reasons that a person of ordinary skill in the art would not have been motivated to try, let alone make, the claimed invention of the ’013 patent because no scientist investigated the issue of how shelf-stable the mixture was.
  • The record showed that Turi, Serup, and Dikstein (the 3 references) described compositions for the same therapeutic purpose, but did not include a motivation to combine them.
  • In the face of strong objective indicia of nonobviousness, the Board erred by using hindsight to determine that the addition of Serup’s or Dikstein’s vitamin D analog to Turi’s formulation would have been obvious.
  • Even though the patented formulation was one of the available alternatives, the numerous known combinations indicated that these disclosures would not have rendered the claimed invention obvious to try.
  • There was a considerable time lapse between the references and the submission of the patent application.
    • It took over a decade—after Dikstein’s disclosure of the benefits of combining vitamin D and corticosteroid treatments into one formulation—for Dikstein’s formulations to be tested for storage stability.
    • It was twenty-two years after Turi and fourteen years after Dikstein that the solution was created to meet the long felt and unsolved need for a combined treatment of vitamin D and corticosteroid.
  • The record showed “extensive experimental evidence” of unexpected results that contradicted the Board’s obviousness finding.
  • Objective indicia “can be the most probative evidence of nonobviousness in the record, and enables the court to avert the trap of hindsight.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310 (Fed. Cir. 2010).
  • In this case, the objective indicia of nonobviousness were crucial in avoiding the trap of hindsight when reviewing a combination of known elements.

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