Apotex v. Wyeth is a relatively simple and straightforward nonobviousness decision in the pharma space (albeit non-precedential). The Wyeth patent at issue here claims the compound that includes tigecycline mixed together with an acid as well as lactose. Although not claimed, the specification indicates that the mixture is beneficial because it helps tigecycline avoid degradation. At the time of the invention (2005) tigecycline was a known tetracycline known to act as a broad spectrum antibiotic that degrades rapidly at a neutral PH.
The key prior art in the obviousness case was a Chinese patent publication that discloses minocycline mixed with both lactose and an acid in order to avoid degradation. Minocycline is a closely related tetracycline that is both structurally similar and operates by similar action. (Tigecycline is a derivative of minocycline).
In both the Inter Partes Review proceedings and the appeal, the courts found insufficient motivation to combine the cited references by substituting the tigecycline into the minocycline compound. Importantly here, the courts made this determination as a factual finding that “a skilled artisan would [not] have had a reason to combine the references.”
Apotex (the challenger) argued that the similarity between the two forms of tetracycline and the fact that tigecycline was “known to work where other antibiotics have failed” both pushed toward a finding of a motivation to combine. The courts however rejected this argument – finding that the structural similarities did not create “a potential motivating factor for a skilled artisan to substitute tigecycline for minocycline.”
[W]hile tigecycline is closely related to minocycline structurally and in terms of benefit, the Board did not err in concluding that there was insufficient basis in the record to show that it would have been obvious to a skilled artisan to substitute tigecycline in the prior art minocycline composition.
Although not mentioned by the courts, I would think it would also be important motivation to consider that – at the time of the invention here – tigecycline was not just some random minocycline derivative – rather tigecycline was being considered as an important last-resort MRSA treatment and under consideration for fast-track FDA approval.
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A first thought that comes to my head in this case is whether the outcome here stems from the fact that this is a pharmaceutical case rather than one focusing on electronics or mechanical engineering. Perhaps not, the court does explain here the lack of assurances (pre-invention) that the claimed mixture would substantially reduce degredation. That factual-setup can be distinguished from a case like KSR where a good engineer could give pre-assurances that they could get the combination to work.
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One aspect of the decision involves underlying distinctions between the ultimate question of obviousness (an issue of law) and the factual underpinnings (such as motivation to combine references). Here, of course, once the facts were determined, the question of law was instantly answered.
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 U.S. Patent No. 7,879,828, claim 1 taken as typical.
 Chinese Patent Pub. No. 139055A.
 See In re Hyon, 679 F.3d 1363 (Fed. Cir. 2012).