The Patent Trial and Appeal Board recently found that all claims of U.S. Pat. 8,324,283, covering the multiple sclerosis treatment Gilenya, are invalid as obvious over prior art.1 The Board concluded2 that:
i. the Petitioners (Torrent Pharmaceuticals Ltd, Apotex, Inc. and Mylan Pharmaceuticals Inc.) established by a preponderance of the evidence that the claims would have been obvious over Chiba (as teaching immunosuppressive drug fingolimod) in view of Aulton (as teaching the use of mannitol and Mg stearate in orally administered drugs); and
ii. the Patent Owners (Novartis AG and Mitsubishi Pharma Corp.) failed to establish by a preponderance of the evidence that proposed amended claims 33-64 are patentable.
Under the standard of broadest reasonable construction in light of the ‘283 specification, the PTAB construed “solid pharmaceutical composition suitable for oral administration” as “solid composition capable of delivering a pharmaceutical effect when administered orally;” “is stable” to mean “meets stability requirements of a test by FDA for approval;” “a pharmaceutical composition that “has substantially uniform distribution…throughout the composition” as one that “meets content uniformity requirements for active ingredients in solid oral unit dosage forms as defined by the [United States Pharmacopeia];” and “rough particle surface” to be a particle “with higher surface area than a sphere of a diameter equal to the average diameter of the particle in question.”3
Relying heavily on a reference that was cited by the Petitioners, but not relied on to institute the inter partes review, and taking into account the knowledge in the art regarding mannitol and admissions by the Patent Owner’s own declarant, the Board concluded: (a) that it was irrelevant that Petitioners failed to establish the inventors’ actual subjective reason for combining mannitol and fingolimod;4 and (b) that the Petitioners established that a person of ordinary skill in the art would have had a reasonable expectation of success in combining fingolimod and mannitol.5
The Patent Owners argued that that objective indicia of nonobviousness established that the claimed solid oral dosage form of mannitol and fingolimod would not have been obvious to a person of ordinary skill in the art.6 However, the Board disagreed stating that:
a. even if the stability of the mannitol-fingolimod combination at low doses was unexpected, it was insufficient to support a finding of unexpected results as the evidence of unexpected results was only across a tiny portion of the unlimited dose range in the claims;7
b. because the prior art contained solid oral multiple sclerosis treatments, the claimed fingolimod dosage form was not necessary to satisfy any long-felt need for a solid oral multiple sclerosis treatment;8
c. there was no nexus between the claimed invention and the industry praise because what was praised about Gilenya was not the specific formulation recited in the claim, but rather the general fact that Gilenya was a solid oral multiple sclerosis medication;9 and
d. because of the lack of any evidence of Gilenya’s expected sales to which the actual sales of Gilenya can be compared, and because Gilenya’s market share model was flawed, the Patent Owners did not carry the burden of production necessary to trigger Petitioners’ burden to explain Gilenya’s commercial success as being due to factors extraneous to the claimed invention.10
Finally, in response to the Patent Owners’ motion to amend, in which claims 33-64 were proposed, the Board determined that the Patent Owners had not carried the burden of demonstrating the patentability of any of the proposed claims.11
2 Id. at 3.
3 Id. at 6-9
4 Id. at 18-19.
5 Id. at 20.
6 Id. at 21.
7 Id. at 22-23.
8 Id. at 25.
9 Id. at 26
10 Id. at 30.
11 Id. at 40 (the Board provided a detailed analysis highlighting that the proposed claims are obvious in view of the Chiba and Aulton at 40-46).