A reference can be a background reference for evidence of motivation to combine even if not sufficient on its own to support a rejection

Bernadette McGann | June 13, 2017

Novartis Ag, Mitsubishi Parma Corp. v. Torrent Pharmaceuticals Limited, Apotex Inc., Mylan Pharmaceuticals Inc.

April 12, 2017

Before  Taranto, Chen and Stoll.  Opinion by Chen.

Summary

The CAFC held that the Board correctly used Sakai as evidence to support its motivation to combine Chiba and Aulton, even though the Board dismissed challenges of patentable based on Sakai.

Details

U.S. Patent No. 8,324,283 (hereinafter ‘283) is directed towards a solid pharmaceutical composition for treatment of autoimmune diseases, such as multiple sclerosis.  Claims 1 and 19 are the only independent claims.  “[c]laim 1 is directed towards a solid oral composition comprised of the combination of one of a handful of S1P receptor agonists and any sugar alcohol, whereas claim 19 is directed towards the specific combination of fingolimod and  mannitol in a solid oral composition.”  Id. at 4.

Torrent initialed an inter partes review (hereinafter IPR) of ‘283, challenging the patentability of the claims on three bases 1) as obvious over Chiba and Aulton, 2) as anticipated by Sakai and 3) as obvious over Chiba and Sakai.  Chiba disclosed treating autoimmune diseases, such as MS, with an immunosuppressive compound like fingolimod, via oral administration.  Id. at 6.  Aulton disclosed tablets and capsules to administer drugs orally and recommends mannitol as a commonly used, but expensive, excipient.  Sakai disclosed a liquid pharmaceutical composition for treatment of autoimmune diseases wherein fingolimod is an active ingredient and may further comprise saccharide.  The Board granted Torrent’s petition and instituted a trial for review of patentable only on the first ground, i.e. Chiba and Aulton.  The Board dismissed the 2nd & 3rd challenges since Sakai did not disclose a solid composition for oral administration, and noted that “Sakai does not identify mannitol as a ‘conventional excipient’ in solid pharmaceutical compositions, and Sakai’s stated reasons for using mannitol in liquid pharmaceutical compositions are inapplicable to its potential use in connection with solid pharmaceutical compositions.” Id. at 8.

Board held that Chiba and Aulton, in combination, strongly suggested the solid pharmaceutical composition of ‘283.  To further support their conclusion, the Board cited “additional evidence of the reason to combine fingolimod and mannitol.”  Id. at 9.  One of the additional evidence cited was Sakai.  “The Board explained that even though Sakai did not ‘teach that mannitol is a conventional excipient for use in solid pharmaceutical compositions,’ id., the record evidence relating to Dr. Byrn’s article (Novartis’ own expert), which was debated by the parties, supported a finding that ‘Sakai’s teaching would have been relevant to the decision on which excipient to use in formulating a solid oral dosage form of fingolimod.’ id. Id. at 9.  “The Board concluded its motivation to combine analysis:

Given (1) the knowledge in the art that mannitol provided advantages in formulating tablets generally, (2) Chiba’s teaching that a person of ordinary skill in the art would have been able to identify or easily determine excipients that would have been compatible with fingolimod, (3) Aulton’s teaching that mannitol was a diluent commonly used in the most common form of pharmaceutical manufacture, (4) Sakai’s teaching that mannitol and fingolimod should be combined in the liquid phase, and (5) Dr. Byrn’s statement that liquidphase compatibility was relevant to the prediction of solid-phase compatibility, we conclude that Petitioners have shown a reason to combine the teachings of Chiba and Aulton.

Id. at 10.

Novartis appealed and argued that 1) Board violated the Administrative Procedure Act (hereinafter APA) by relying upon Sakai without providing Novartis proper notice and a chance to be heard, 2) erred with regards to the analysis of the motivation to combine evidence and 3) erred on treatment of Novartis’ evidence of nonobviousness.

The CAFC held that the Board did not violate the notice and be heard provisions of the APA.  Novartis argued that the Board ruled Sakai out entirely when the Board denied institution of the two proposed grounds of unpatentability based on Sakai.  Further, Novartis argued that had it had proper notice that the Board would rely upon Sakai, it would have submitted a “vastly different” response.  The CAFC held that the Board merely declined Sakai as an anticipatory reference and a primary obviousness reference.  The CAFC held that the Board was correct in holding that the disclosure of Sakai would be relevant to a skilled artisan in achieving a solid oral dosage formation of fingolimod and an excipient, such as mannitol.  Moreover, “Sakai merely reinforced its finding that the person of ordinary skill in the art would have expected mannitol to be compatible with fingolimod because Sakai discloses a stable combination of these two ingredients suitable for long-term preservation.  The Board’s discussion of Sakai…was not inconsistent with its review of Sakai in the Institution Decision.”  Id. at 13.

The CAFC dismissed Novartis’ claim of “surprise” regarding Sakai and noted that Sakai was debated by the parties at length throughout the proceeding and in the same context as was presented in the Board’s Final Written Decision.  In addition, in Torrent’s petition for IPR, several references, including Sakai, were cited to support the motivation to combine Chiba and Aulton.  Throughout the proceeding, “the relevance of Sakai’s compatibility-disclosure to support a motivation to combine Chiba and Aulton was an ongoing, debated issue that Novartis addressed directly, on multiple occasions”, including within Novartis’ own Patent Owner’s Response.  Id. at 14.  Both the Petitioner’s and Novartis’ experts discussed Sakai and its applicability to the motivation to combine Chiba and Aulton.

Next, Novartis argued that the Board erred by failing to take into consideration the prior art as a whole, including the critical evidence of mannitol and its disadvantages as an excipient for solid composition.  The CAFC quickly dismissed this argument, holding that the Board took proper consideration of Novartis’ argument regarding motivation to combine and even noted a negative of mannitol, i.e. expense.  “[t]here is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument.” Id. at 19 and 20.

The CAFC held that there was substantial evidence to support the Board’s finding of obviousness. The CAFC then addressed Novartis’ arguments regarding the Boards’ treatment of their objective indicia of nonobviousness.

Regarding Novartis’ unexpected results argument, the Board held that there was no unexpected results with regards to independent claims 1 and 19 because these claims did not recite a dosage limitation and therefore, the evidence of unexpected results, which included a low dose feature, was not commensurate in scope with the claims.  To the CAFC, Novartis argued that the Board erred because the Board did not reassess the unexpected results argument for the dependent claims reciting a low dosage limitation.  The CAFC noted that Novartis’ argument on appeal differs from the argument presented to the Board.  To the Board, Novartis argued that “mannitol unexpectedly is stable with fingolimod throughout the full dosage range.Id. at 23.  Novartis did not identify the dependent claims at issue now or discuss specific dosages or concentrations.  The CAFC held that Novaris did not distinctly argue an unexpected result specific to any of the dependent claims and therefore waived this argument.

Next, Novartis argued that the Board failed to give sufficient weight to their evidence of commercial success, industry praise and meeting a long-felt but previously unsolved need.  Novartis argued that “as a matter of law, a feature that is known in the art but not actually available to the market-i.e., in commerce-cannot be used to disprove Novartis’ attempts to establish a nexus based on that claimed feature.” Id. at 24. The CAFC held that there must be a nexus between the evidence and the merits of the claims.  The CAFC held that Novartis’ evidence is based solely on being the first commercially-available solid oral MS treatment, and there is no nexus to the merits of the claims.  The CAFC agreed with the Board that the evidence was not probative of the nonobviousness inquiry.

The CAFC affirmed the Board’s decision.

Takeaways

  • When possible, present separate arguments directed towards each dependent claim.
  • When establishing nonobviousness by arguments of commercial success &/or solving a long felt need, there must be a nexus between the merits of the claims and the success. Success alone will not satisfy this burden.
  • A reference, which is insufficient for an anticipation rejection or as a primary reference in an obviousness rejection, may nonetheless be cited as evidence to support a motivation to combine two or more different references in a prima facie case of obviousness.

Full Opinion

 

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