Posts Tagged: "unexpected results"

Inherent obviousness necessitates specific motivation to modify lead compound in pharma process due to surprising, unexpected results

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill. The court pointed out “’the mere fact that a certain thing may result from a given set of circumstances is not sufficient’ to render the results inherent.” Millennium Pharmaceuticals, 2017 WL 3013204, at *6 (citations omitted by author). The court also held that it is never appropriate to consider “what the inventor intended when the experiment was performed,” even though Millennium “conceded as a matter of law that the ester is a ‘natural result’ of freeze-drying bortezomib with mannitol.” Id. Thus, hindsight reasoning should never be applied and, obviousness is “measured objectively in light of the prior art, as viewed by a person of ordinary skill in the invention.”

Federal Circuit Affirms ‘Teaching Away’ and ‘Unexpected Results’ that Support Non-obviousness

The Federal Circuit affirmed. The asserted claims were not obvious because, although the claimed amounts (0.01% bimatoprost and 200 ppm BAK) fell within the range disclosed in the prior art (0.001-1% bimatoprost and 0-1000 ppm BAK), Allergan “had produced ample evidence of teaching away and unexpected results, and that such evidence fully support[ed] a conclusion of non-obviousness.” For example: (1) BAK is a toxin and “should be minimized in ophthalmic formulations to avoid safety problems,” (2) BAK decreases permeability of bimatoprost, and (3) BAK causes hyperemia at high concentrations. Thus, the prior art “’criticize[d], discredit[ed], or otherwise discourage[d]’ the use of 200 ppm BAK in a bimatoprost formulation.”

How to Effectively But Safely Tell the Story of the Invention

I’m sure some patent litigators will blanch at what I’m suggesting about telling the “story” behind the invention in a patent application because of all the supposed “admissions” that will be made. But most patent litigators haven’t had to endure the frustration we patent prosecutors experience when try to get a “silk purse patent” based on a “sow’s ear description” because there’s no “story” told in the patent application about why the invention is patentable. Also, drafting a “litigation-proof” patent application (if one exists) is meaningless if you can’t get that patent application allowed because the “story” told doesn’t sell the patentability of the invention.