In Biogen International GmbH v. Mylan Pharmaceuticals, Inc., the United States Court of Appeals for the Federal Circuit, which has exclusive jurisdiction over patent appeals,[1] affirmed the district court’s invalidation of Biogen’s patent for a multiple sclerosis (MS) treatment.[2] In its decision, the majority communicated its preference for specific written descriptions and its dislike of amendments which mold a broad specification to better support a later claim.[3] Going forward, inventors should be wary of piling wide-ranging data into their specifications with the hope of re-forming their data to fit more specific applications later. The requirement for a more focused specification set forth in Biogen v. Mylan lowers the bar for competitors seeking to invalidate existing patents, benefiting generic pharmaceutical companies like Mylan.
Specificity & Dosage
Biogen’s specification described a 480 mg dose of dimethyl fumarate (“DMF480”) to treat MS, but the majority held that a single reference to DMF480 in the entire specification was insufficient to satisfy the written description requirement.[4] Biogen further argued that DMF480 was linked to a 720 mg dose, which was known to be effective, thereby allowing a skilled artisan to recognize the merits of a DMF480 treatment.[5] However, the court rejected this contention as too general, noting that the 720 mg dose was similarly linked to ineffective 100, 200, and 1000 mg doses.[6] By highlighting the attenuated connection between DMF480 and proof of efficacy in the specification, the majority communicates that it will invalidate patents whose specifications do not describe the claimed invention with particularity.
The dissent also considered specificity but would have accepted an exact reference to DMF480—albeit as the end of a range—as specific enough.[7] Seemingly in agreement with the majority, the dissent did observe that listing a range (e.g. 100-720 mg) which happened to include DMF480 would be insufficient.[8] Thus, the majority’s concern about specificity may extend to other judges given the right facts.[9]
Amendments & Inventorship
The majority also discourages amendments which reframe specifications to better support claims.[10] Here, the original specification focused on drug discovery, not treating MS.[11] When Biogen discovered that these drugs could treat MS, it amended the patent, adding a new inventor whose research involved DMF480.[12] The court, however, focused on the original inventor’s testimony, in which he stated that he did not believe his research could lead to a clinical treatment for MS.[13] Emphasizing this discrepancy reiterates the district court’s role as fact-finder and cautions others against using amendments to manipulate specifications.[14] Indeed, the majority rejected this attempt to claim an earlier priority date through amendment, reiterating that the written description must demonstrate the invention “as of the filing date.”[15] This focus on the patentholder’s understanding of the invention as of the filing date discourages premature filing of specifications, later molded by amendments to fit a desired purpose.
Implications on Filing Strategies
Overall, Biogen signals a higher bar for meeting the written description requirement.[16] In the pharmaceutical context, if proper dosage is unclear as of the filing date, an understanding of the treatment sufficient to write a precise specification may also be lacking.[17] In other industries, too, inventors must “sufficiently disclose” their invention when initially filing their patent application.[18]
Biogen’s stricter specification standards yield a filing conundrum. On one hand, inventors can file broad specifications, securing the patent before their competition. However, after Biogen, such patents will likely be invalidated for an insufficiently detailed specification. In the pharmaceutical industry, generic competitors will likely be emboldened to engage in Abbreviated New Drug Application (ANDA) litigation.[19] Through the ANDA process, generic drug companies file with the FDA, asserting that the patent for the brand name drug does not cover the generic.[20] Then, the brand name drug manufacturer sues the generic manufacturer for patent infringement, delaying FDA approval of the generic drug.[21] Because the brand’s patent is more likely to be invalidated for an overly broad written description following Biogen, generic manufacturers like Mylan are likely to become more successful.[22]
On the other hand, inventors can heed the majority’s message, develop a thorough understanding of their invention, and then write a precise specification.[23] Still, while this fine-tuning occurs, a competitor can file with sufficient detail, causing the more thorough inventor to lose the investment they made gathering additional data. Therefore, inventors must strike a balance between waiting too long for specifics and filing too soon without precision. While Biogen suggests that dosage and efficacy are essential aspects of the specification, side effects are not discussed, so it may be worthwhile for applicants to file without this data.
There is no bright line rule to determine what constitutes the proper level of specificity—as demonstrated by the dissent finding Biogen’s specification sufficiently detailed—making the future uncertain.[24] Nevertheless, generics are a profitable and growing industry, and Biogen v. Mylan is part of a trend of generic-friendly Federal Circuit decisions.[25] Altogether, Biogen v. Mylan prevents inventors from patenting treatments they do not flesh out. The Federal Circuit thereby incentivizes inventors to understand their inventions thoroughly—not just “call dibs” on swaths of potential discoveries.
[1] 28 U.S.C. § 1295(a)(1).
[2] Biogen Int’l GmbH v. Mylan Pharms., Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021), reh’g denied, 28 F.4th 1194 (Fed. Cir. 2022), cert. denied, No. 21-1567 (Oct. 3, 2022).
[3] Id. at 1333–46.
[4] Id. at 1335–36, 1338–40.
[5] See id. at 1344.
[6] Id. at 1343–44.
[7] See id. at 1351 (O’Malley, J., dissenting).
[8] Id.
[9] See id. at 1341 (majority opinion); see, e.g., Biogen Int’l GmbH v. Mylan Pharms. Inc., 28 F.4th 1194, 1196 (Fed. Cir. 2022), cert. denied, No. 21-1567 (Oct. 3, 2022).
[10] Biogen, 18 F.4th at 1338-40.
[11] Id. at 1338.
[12] Id. at 1339.
[13] Id. at 1339–40.
[14] See id. at 1341–42.
[15] See id.
[16] Robert E. Colletti & Tiffany Jang, Federal Circuit Denies Rehearing in Biogen v. Mylan: Dissent Raises Four Written Description “Points of Error” That En Banc Court Should Have Corrected, Haug Partners LLP (Apr. 1, 2022), https://haugpartners.com/article/federal-circuit-denies-rehearing-in-biogen-v-mylan-dissent-raises-four-written-description-points-of-error-that-en-banc-court-should-have-corrected.
[17] See Biogen, 18 F.4th at 1343.
[18] See id. at 1343-44.
[19] See Colletti & Jang, supra note 17.
[20] See Biogen, 18 F.4th at 1336.
[21] See id.
[22] See Rani Mehta, Pharma Refines Tricks to Tackle Section 112 but Left Frustrated, Managing IP (Oct. 14, 2022), https://www.managingip.com/article/2aqyclfk75re0mzg379q8/pharma-refines-tricks-to-tackle-section-112-but-left-frustrated.
[23] See Colletti & Jang, supra note 17.
[24] See id. at 1351 (O’Malley, J., dissenting); see also Biogen, 28 F.4th at 1198–1200.
[25] Laura Wood, Global Generic Drugs Market to Grow by $176.25 Billion During 2023-2027, Business Wire (Jan. 13, 2023, 8:08 AM), https://www.businesswire.com/news/home/20230113005245/en/Global-Generic-Drugs-Market-to-Grow-by-176.25-Billion-During-2023-2027—ResearchAndMarkets.com; see Mehta, supra note 23.