Patents and Prior Art References: When is not saying something actually saying something?
By Melissa McCurdy, Standley Law Group LLP
As it’s first decision in the new year, the Court of Appeals for the Federal Circuit issued a precedential opinion in the Novartis Pharmaceuticals v. Accord Healthcare Inc. case.?The underlying facts in this case pertain to a patent (“the ’405 Patent”) assigned to Novartis Pharmaceuticals Corp. (“Novartis”) covering its Gilenya medication used to treat multiple sclerosis (“MS”).?Novartis sued HEC Pharm Co., Ltd. for Patent infringement after HEC filed its Abbreviated New Drug Application to try and bring its generic version of Gilenya to market.?The District Court found that the asserted claims of the ’405 Patent were infringed and not proven to be invalid.?HEC appealed arguing the District Court erred in finding the claims of the’405 Patent do not fail the written description requirement.?
The relevant claims of the ’405 Patent recite methods to treat MS with fingolimod at a daily dosage of 0.5 mg “absent an immediately preceding loading dose regimen.” The parties agreed on the definition of a loading dose being a dose which is higher than the daily dose which is usually given as the first dose.???A key question[1] was whether the ‘405 Patent contained adequate disclosure for the leading dose negative limitation.?The written description requirement is found in section 112 of the patent statute which provides that the patent’s specification must contain “a written description of the invention and of the manner and process of making and using it.?35 U.S.C. § 112(a). ?A specification that “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” has adequate written description of the claimed invention.?Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).?The test requires an objective inquiry into the specification as it would be conducted by one of ordinary skill in the art.?Id.?
HEC’s argument regarding the leading dose negative limitation was that the ’405 Patent specification contains no reference to or discussion of a leading dose whatsoever.?According to HEC, “silence alone cannot serve as a basis for a negative limitation”.?Notably, and as highlighted by the dissenting opinion, the Manual of Patent Examining Procedure “MPEP” states “The mere absence of a positive recitation is not a basis for an exclusion.”?MPEP 2173.05(i).?But, the CAFC found that the District Court properly relied upon the testimony of expert witnesses who testified as those of ordinary skill indicating that the ’405 Patent’s failure to reference a leading dose would have indicated that no leading dose should be included in the claimed treatment regimen.?The CAFC confirmed that in issued patents, negative limitations are like all other limitations and the critical inquiry under Section 112 is whether the specification adequately supports it to one of ordinary skill.?????
HEC also put forward the argument that the District Court’s written description decision contradicted its determination that the ’405 Patent was not anticipated by a key prior art reference (“Kappos 2006”). ?Kappos 2006, was an abstract “consisting of two paragraphs describing a planned critical trial and, with respect to dosing, states… that approximately 1.100 patients… are being randomized in a 1:1:1 ration to once-daily fingolimod in 1.25 mg, fingolimod 0.5 mg, or placebo, for up to 24 months.”??Here, the District Court found a skilled artisan would read the disclosure as silent on the presence or absence of a loading dose and therefore the negative leading dose limitation was not anticipated.?The CAFC found no clear error in this decision.?
?A review of the CAFC’s decision emphasizes there are differences between issued patents (which are presumed valid) and prior art references like Kappos 2006 (which are not presumed valid) which supported finding that the ’405 Patent supports the negative leading dose limitation while Kappos 2006 does not disclose it even though both are silent about it. ?And equally, if not even more important, expert testimony, provided as one of ordinary skill relating to the ’405 Patent, was provided which supported both findings.?This decision is a reminder that Patent specifications and issues relating to validity are not always as they appear on their surface: in many areas, what a patent or prior art reference actually says will require feedback from those with special expertise.?
The entire CAFC opinion in the Novartis Pharmaceuticals v. Accord Healthcare Inc. case is available via the link below:
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[1] HEC also challenged the District Court’s conclusion regarding the adequate written description of the asserted claims’ recitation of the “0.5 mg daily dose” of fingolimod, but the Court found that there was no clear error in the District Court’s decision on this issue, pointing out the parts of the ‘405 Patent which supported this aspect of the claims.?