Bayer left hard up when CAFC reversed district courts final judgment with some stiff words for the lower court.

Adele Critchley | November 9, 2017

Bayer Pharma AG, Bayer Intellectural Property GMBH, Bayer Heathcare Pharaceuticals, inc., v. Watson Laboratories Inc., Activis Pharma, Inc.

November 1, 2017

Before Lourie, Moore and O’Malley.  Opinion by Moore

Summary:

The CAFC held that the district court clearly erred in finding that a skilled artisan would not have been motivated to arrive at claims 9 and 11 of the patent-in-suit.

The patent at issue is directed to a formulation of vardenafil and at least two sugar alcohols in the form of an uncoated oral disintegrating table (ODT). It was agreed by both parties that the claim covered an immediate-release formulation. Bayer markets a commercial embodiment of the patent under the name Staxyn, and its utility is erectile dysfunction.

Watson argued before the district court that the claims at issue would have been obvious to one skilled in the art based on multiple exemplary references showing motivation to (1)   create an ODT formulation; (2) select mannitol and sorbitol as sugar alcohols; and (3) make the ODT immediate release. The district court rejected each of Watson’s arguments, holding that Watson failed to meet its burden of proving by clear and convincing evidence that there would have been motivation. This determination rested largely on the court’s holding that it found Bayer’s expert (Dr. Wicks) testimony more credible than Watson’s expert (Dr. Jacobs) testimony. However, the CAFC held this decision failed to actually give credit to the important evidence of obviousness that Watson had presented.

Watson’s expert presented six prior art references suggesting that erectile dysfunction drugs would be good candidates for ODT formulations, but the judge ignored the presented evidence. The appeals court held that while “[I]t is well within the district court’s discretion to credit one expert’s competing testimony over another,” “…a district court cannot, through a credibility determination, ignore the wealth of evidence, especially as in this case where the expert [Bayer’s expert] did not even address it.”

The district court found it important that, according to Dr. Wicks, no ED ODT drug was on the market as of the patent’s priority date. To which, the CAFC held “it is unclear why the district court found [that] important,” since the obviousness analysis “is not limited to what products are forthcoming or currently available on the market.”

The CAFC held that there was clear error in the district court fact finding that there was no motivation to formulate ED drugs as ODTs, as this ‘is simply not accurate.’ For instance, Dr. Jacobs testified that the Chang reference submitted states that “drugs for [ED] would be good candidates for ODT formulation,” “he testified that numerous companies had already begun formulating ODT versions of ED drugs: Pfizer filed the Bell-Huff patent application directed to sildenafil ODT.” Dr. Wicks failed to address any challenges to the evidence provided by Watson.

Regarding Watson’s argument that it would have been obvious to make the ODT immediate release, the district court had disagreed with Watson favoring Bayer’s expert testimony again. Specifically, Bayer had argued that (1) a person of ordinary skill in the art would have expected vardenafil ODT to have a bitter taste, which would have discouraged him from creating a formulation that releases vardenafil in the mouth, and (2) a person of ordinary skill in the art would have been concerned with using an immediate-release formulation because it would be expected to increase bioavailability. The district court held that these two concerns result in a finding of teaching away.

Again, the CAFC disagreed with the district court. Specifically, “In assessing whether prior art teaches away, that “better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012).”   Thus, the fact one skilled in the art may prefer a delayed-release formulation to avoid the concerns of a bitter taste in the mouth and bioavailability, is not sufficient for a finding of ‘teaching away.’

Thus, the CAFC concluded that “Watson demonstrated by clear and convincing evidence that there would have been a motivation to formulate an ODT version of vardenafil. In fact, the prior art was explicit in the suggestion to make such a combination and the district court clearly erred in its fact finding to the contrary.”

Take-away:

Worth noting that the CAFC held that “While it may at times be unwise for a party to rely on numerous prior art references when challenging a patent on obviousness grounds,” this approach may not always be viewed as weak. Specifically, producing numerous references to support “a narrow point” can result in a strong case being formulated.

It is important to not focus on the commercial availability of products while failing to address relevant prior art. When addressing non-obviousness, it is imperative to consider the entire record and place the cited references under a proper analysis.

The teaching away inquiry does not focus on whether a person of ordinary skill in the art would favor one disclosed option over another, i.e., concerns and better alternatives are not sufficient for teaching away.

Additional Detail:

In 2003, the Food & Drug Administration (“FDA”) granted Bayer approval to market vardenafil hydrochloride trihydrate to treat erectile dysfunction (“ED”) under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched sildenafil under the name Viagra in 1998, and Eli Lilly launched tadalafil under the name Cialis in 2003. Levitra, Viagra, and Cialis are each formulated as tablets that are swallowed whole.

The patent-in-suit is U.S. Patent Number 8,613,950. It is directed to a formulation of vardenafil “in the form of an uncoated tablet which disintegrates rapidly in the mouth,” commonly referred to as an oral disintegrating tablet (“ODT”). Bayer markets a commercial embodiment of the ’950 patent, vardenafil ODT, under the name Staxyn.

Watson filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to market a generic version of Staxyn. Bayer filed the instant case asserting infringement of the ’950 patent. Claims 9 and 11, both of which depend from claim 8, are the only claims at issue:

Claims at issue:

8.  A drug formulation in the form of an uncoated tablet which disintegrates rapidly in the mouth and releases the drug in the mouth without swallowing the tablet comprising vardenafil hydrochloride trihydrate, and at least two sugar alcohols.

9.  The drug formulation according to claim 8, wherein said sugar alcohols are a mixture of sorbitol and mannitol.

11.  The drug formulation of claim 8, wherein at least one sugar alcohol is sorbitol.

The parties agree that claim 8’s requirement that the formulation “releases the drug in the mouth” means it is an immediate-release formulation.

Full Opinion

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