It is important at the initial stages of drafting an application to distill down the points of novelty, determine why the claimed invention is nonobvious over the prior art and ensure that there is a complete and enabling disclosure.
U.S. patent law establishes requirements that inventors and applicants must satisfy to obtain a patent, which include utility, recitation of patent eligible subject matter, novelty, nonobviousness, an adequate written description, enablement and the best mode of practicing the invention. Biogen International GmbH v. Mylan Pharmaceuticals, Inc., No. 1-17-cv-116, 2020 WL 3317105 (N.D. W. Va. June 18, 2020), presents an example of tensions between the nonobviousness and written description requirements. At issue were claims in U.S. Pat. No. 8,399,514 (the ’514 patent), drawn to methods of treating multiple sclerosis (MS) via the administration of about 480 mg of dimethylfumarate (DMF) and/or monomethylfumarate (MMF) twice daily (BID). The ’514 patent is associated with the drug Tecfidera® for the treatment of MS. Mylan sought to file an Abbreviated New Drug Application (ANDA) under Paragraph IV of the Hatch-Waxman Act to market a generic bioequivalent and sought certification that the relevant patents are “invalid or will not be infringed by the manufacture, use, or sale of the new generic drug for which the ANDA is submitted.” Biogen sued Mylan within the 45-day timeframe for infringement.
The prosecution history guided the court’s decision. The research program that led to the discovery of the method of DMF/MMF administration and the development of Tecfidera® had studied the activation of the nuclear factor erythroid 2-related factor 2 (NRF2) pathway and screened compounds other than DMF that could activate said pathway. Findings related to activation of the NRF2 pathway were included in a U.S. provisional application and a PCT application. Biogen filed the provisional application drawn to the NRF2 studies on February 8, 2007, prior to the start of Phase III trials for Tecfidera®, and filed the PCT application February 7, 2008, claiming priority to the provisional. Biogen entered the U.S. national phase from the PCT application on August 7, 2009. Following the conclusion of the Phase III trials leading to the discovery of the effective dosage, Biogen filed a second provisional application on May 26, 2011, containing the data from the Phase III trials and subsequently amended the U.S. national phase application to replace the original title “Nrf2 Screening Assays and Related Methods and Compositions” with “Treatment for Multiple Sclerosis.” That application further replaced all previously listed claims drawn to methods for screening drug compounds for their ability to activate the NRF2 pathway with new claims reciting methods for treating MS with a 480 mg per day dose of DMF (BID) and added a new inventor. Biogen did not amend the specification of the U.S. national phase application to maintain the February 8, 2007, priority date. Biogen subsequently abandoned the national phase application in favor of a continuing application, which included all amendments to the national phase application and maintained the specification of the provisional application.
During prosecution of the continuing application, the USPTO twice rejected the claims as obvious. Biogen rebutted each instance with the assertion that the 480 mg per day dose of DMF (BID) exhibited unexpected efficacy in treating MS to overcome the obviousness rejections leading to allowance and issue of the ’514 patent. Mylan previously challenged the 480 mg per day dosage as the result of optimization within an established effective range, which is usually obvious, in an inter partes review proceeding (IPR) in which Biogen prevailed, collaterally estopping Mylan from reasserting obviousness in a subsequent action. See generally Mylan Pharm., Inc. v. Biogen MA, Inc., IPR2018-01403, 2020 WL 582736 (PTAB. Feb. 5, 2020).
Mylan contended the ’514 patent was invalid for failing to meet the written description requirement because the specification bore no resemblance to the claimed invention, failed to teach that a person of ordinary skill in the art (POSA) would not have expected the 480 mg per day dose of DMF to effectively treat MS, and that the specification failed to adequately describe the claimed invention. Mylan argued that the specification was merely a combination of selectively plucked disclosures corresponding to the claim elements, as Biogen tacked on claims to a specification covering a completely different invention conceived by a different inventor four years prior to the Tecfidera® Phase III trial results that revealed the effectiveness of the 480 mg per day dose of DMF, adding doubt that the inventors actually possessed the claimed invention.
The court agreed with Mylan, finding that Biogen attempted to satisfy the written description requirement by selecting specific words from the specification corresponding to the different elements of the invention, thus failing to adequately describe the invention. The court relied on Nuvo Pharmaceuticals (Ireland) Designated Activities Co. v. Dr. Reddy’s Laboratories, Inc., 923 F.3d 1368, 1380 (Fed. Cir. 2019), holding that the written description requirement is not met simply because “the claim language appears in ipsis verbis in the specification.” The court noted that the methods in the specification drawn to the administration of DMF and MMF were overly broad in reciting treatment of a general neurological disease with DMF and/or MMF and failed to specifically mention treating MS with a 480 mg per day dose of DMF (BID). Thus, the methods recited in the specification would neither lead a POSA to the treatment of MS specifically nor provide a link to a therapeutically effective amount of DMF being about 480 mg per day (BID). Dose recitations in the specification did not suggest 480 mg per day (BID) as an effective amount of DMF, only indicating that doses could be from 0.1 g to 1 g, 200 mg to about 800 mg, 480 mg to about 720 mg or about 720 mg per day, leading a POSA to be drawn to about 720 mg per day as the effective dosage. A POSA would not have expected a 480 mg per day dose to be an effective dose in 2007 as the conclusion of Phase III trials occurred four years later. Because the specification failed to establish possession by failing to adequately describe the claimed invention, the court held the claims of ’514 patent to be invalid for lack of written description.
Biogen’s crafty prosecution strategy avoided four years of potential prior art based on the 2011 discovery of the claimed dosage regimen by claiming priority to the 2007 provisional application. Although Biogen’s arguments of unexpected results may have helped overcome obviousness in prosecution and an IPR, the failure of the specification to direct and teach that administration of 480 mg per day of DMF was effective at treating MS was detrimental.
Thus, it is important at the initial stages of drafting an application to distill down the points of novelty, determine why the claimed invention is nonobvious over the prior art and ensure that there is a complete and enabling disclosure. In drafting, the practitioner should implement a “hook,” or more specifically, highlight an aspect of the underlying invention that draws the examiner’s attention during prosecution, or the attention of a court should the resulting patent face future litigation. While breakthrough discoveries may set off a race to obtain patent protection, applicants should not rely on prior pending disclosures that only tangentially relate to the discovery to facilitate a prosecution strategy. Applicants should ensure that the content of the disclosure provides adequate basis and support for arguing against an art rejection to properly inform and disclose the novel and nonobvious distinctions over the prior art and to demonstrate to the public that the inventors and/or applicants have actual possession of the claimed invention.
Perhaps in error to Biogen’s favor, the court appeared to be confused as to the proper threshold criteria for determining whether a patent satisfies the written description requirement under 35 U.S.C. § 112 in applying the “person of ordinary skill in the art” standard―which is only recited in 35 U.S.C. § 103―to a written description analysis. The POSA is a hypothetical legal construct used as the standard by which obviousness is determined, whereas the “person skilled in the art” as recited in 35 U.S.C. § 112 refers to actual people within the general public having skill in the art. Practitioners should be reminded that the former is a hypothetical person who does not seek to innovate, but only follows conventional wisdom contained in the prior art, whereas the latter refers to a real person skilled in the art for whom the specification has to be understandable for enablement. Because the latter is a higher standard to meet, it is important that practitioners apply the correct standards in evaluating obviousness or determining enablement; the POSA should not have the benefit of the content matter of the specification whereas the person skilled in the art should have such benefit.
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