by Dennis Crouch
The asserted patents in this case cover a combination dosing of (1) a pain-relief drug (NSAID) with an enteric coating (released in acidic environment) and (2) an uncoated PPI. U.S. Patent Nos. 6,926,907 and 8,557,285.
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.
Claim 1 of the ‘285.
The defense raised a written description issue – arguing that the original patent filings did not support the “therapeutically effective” limitation. The district court sided with the patentee, but the Federal Circuit reversed on appeal and held the claims invalid. In particular, the Federal Circuit found that PHOSITA could not tell from the patent document that the compound was “therapeutically effective” as claimed.
Obviousness – Written Description Interplay: The amount of written description needed varies from patent to patent depending upon a number of factors — including the level of skill in the art. An invention that far-exceeds the state-of-the-art will need more description in order to show possession of the invention.
In this case, the patentee won its obviousness argument by showing PHOSITA would not have reasonably expected the combination to work. As such, that means that the claim elements must be fully described in the specification.
The Court also explained that the written description requirement does not always require proof that a claimed drug treatment is effective. The difficulty for the patentee here, is that the treatment’s effectiveness is particularly claimed.
The Patentee has now petitioned the Federal Circuit for rehearing en banc and explained the holding as follows:
The panel accepted Defendants’ argument that, if the prior art would have led a skilled artisan to be skeptical that uncoated PPI would work, the patents must lack written description because they allegedly lack experimental data or a detailed theory to overcome this teaching away and persuade the skilled artisan the uncoated PPI in the claimed invention would be effective. The panel stated, for example, that the inventor failed to show possession of the claimed invention because a skilled artisan “would not have expected uncoated PPI to raise gastric pH.”
The petition argues that this approach is improper:
The panel improperly enacted a new written description standard requiring either experimental data or a detailed theory of why the invention will work, at least for inventions that overcome obviousness based on skepticism in the field or a lack of reasonable expectation of success. In doing so, the panel’s opinion contradicts the very cases it cites, which hold that written description does not require experimental data, working examples, a detailed theory of why the invention will work, or an actual reduction to practice. . . .
This opinion creates a heightened written description standard that contradicts this Court’s precedents stating that a patent specification must only show that the inventor had possession of the claimed invention and does not need to disclose data
Citing Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015) and Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir. 2014).
Following the en banc petition, the Federal Circuit requested a response from Dr. Reddy’s who filed a short brief arguing primarily that Nuvo created a false “parade of horribles” that mischaracterize the Federal Circuit’s opinion.
- Alan Pollack (Windels Marx) is handing the appeal for Dr. Reddy’s
- Stephen Hash (Baker Botts) is representing Nuvo Pharma.