{"id":145088,"date":"2022-02-02T07:15:36","date_gmt":"2022-02-02T12:15:36","guid":{"rendered":"https:\/\/ipwatchdog.com\/?p=145088"},"modified":"2022-02-01T11:15:34","modified_gmt":"2022-02-01T16:15:34","slug":"two-pharma-biotech-cases-watch-2022","status":"publish","type":"post","link":"https:\/\/ipwatchdog.com\/2022\/02\/02\/two-pharma-biotech-cases-watch-2022\/id=145088\/","title":{"rendered":"Two Pharma and Biotech Cases to Watch in 2022"},"content":{"rendered":"

\u201cBased on the similarity of the questions presented to those that the Supreme Court declined to answer in Idenix v. Gilead<\/em>, Amgen\u2019s petition has a slim chance of success. Regardless, patent owners should be wary of asserting claims that characterize a monoclonal antibody purely on its function.\u201d<\/p>\n<\/div>\n

\"https:\/\/www.youtube.com\/watch?v=Jdf5EXo6I68\"<\/a>

Monty Python and the Holy Grail: “I’m Not Dead Yet.” Source: Youtube<\/a><\/em><\/p><\/div>\n

As we enter the second month of 2022, the old saying, \u201cIf at first you don\u2019t succeed, try, try again\u201d and the famous line, \u201cI\u2019m not dead,\u201d from Monty Python and the Holy Grail,<\/em> come to mind to describe two issues we\u2019ll be watching closely this year relating to litigation involving small and large molecule therapies.<\/p>\n

In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit\u2019s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court\u2019s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc<\/a>.<\/em>, 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.<\/p>\n

Another case we\u2019re watching concerns generics\u2019 ability to seek Food and Drug Administration (FDA) approval for less than all of the indications for which the reference drug is approved\u2014also known as a \u201cskinny label.\u201d\u00a0 For all the hubbub over the opinion in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.,<\/a> <\/em>7 F.4th 1320 (Fed. Cir. 2021), the district court\u2019s decision in Amarin Pharma, Inc. v. Hikma Pharms<\/a>. USA Inc., <\/em>No. CV20-1630-RGA-JLH, D.I. 97 (D.Del. January 4, 2022) shows that the skinny label may not be dead just yet.<\/p>\n

Enablement of Genus Claims in the Biotechnology Sector<\/strong><\/h2>\n

Last year, Amgen Inc. v. Sanofi-Aventis<\/a><\/em>, 987 F.3d 1080 (Fed. Cir. 2021), revived the discussion around enablement of genus claims in the biotechnology sector, this time specifically relating to antibody claims with functional limitations. At the district court, a jury found that the claims were not invalid for lack of enablement, but Judge Andrews granted Sanofi\u2019s JMOL, finding the claims at issue invalid. On appeal, the Federal Circuit discussed prior decisions on enablement of claims with functional limitations, finding that \u201c[w]hat emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.\u201d Amgen<\/em>, 987 F.3d at 1086. The Federal Circuit stressed the importance of considering the quantity of experimentation, and the full scope of the claims. Id<\/em>. As the panel stepped through the Wands factors<\/a><\/em> for enablement, it affirmed the district court\u2019s holding that Amgen\u2019s asserted claims to a genus of antibodies were invalid for lack of enablement as a matter of law.<\/p>\n

In November 2021, Amgen petitioned the Supreme Court for a writ of certiorari, presenting the following questions to the high court:<\/p>\n

[1.] Whether enablement is \u201ca question of fact to be determined by the jury,\u2019 \u2026 or \u201c a question of law that [the court] review[s] without deference,\u201d as the Federal Circuit holds.<\/p>\n

[2.] Whether enablement is governed by the statutory requirement that the specification teach those skillied in the art to \u201cmake and use\u201d the claimed invention \u2026 or whether it must instead enable those skilled in the art \u201cto reach the full scope of claimed embodiments\u201d without undue experimentation\u2014i.e, to cumulatively identify and make all or nearly all embodiments of the invention without substantial \u201c time and effort,\u201d \u2026.<\/p>\n

See<\/em> Case No. 21-757, November 18, 2021.<\/p>\n

Earlier last year, the Supreme Court denied certiorari in Idenix v. Gilead<\/em> (No. 20-380, January 19, 2021), which presented similar issues and left in place a Federal Circuit decision that many patentees believe created a heightened enablement standard for genus claims. There, a divided Federal Circuit panel held invalid claims directed to methods of treating hepatitis C using a genus that covered \u201ctens if not hundreds of thousands\u201d of 2\u2019-methyl-up nucleosides. In doing so, the majority focused on the undue experimentation factor to find that the specification \u201cdoes not provide enough meaningful guidance or working examples, across the full scope of the claim, to allow a POSA to determine which 2\u2019-methyl-up nucleosides would or would not be effective against HCV without extensive screening.\u201d\u00a0 941 F.3d at 1162.<\/p>\n

In the wake of Idenix<\/em>, branded pharmaceutical companies and trade organizations sounded the alarm over the death of genus claims for biotechnology inventions, whereas generic and biosimilar companies touted this result as a reaffirmation of the Court\u2019s reasoning in Wyeth & Cordis Corp. v. Abbott Labs<\/a>.<\/em>, 720 F.3d 1380 (Fed. 2013). As the law currently stands, genus claims that rely on functional or broad structural limitations to cover monoclonal antibodies (mAbs) can be invalid for lack of enablement where the specification does not provide further guidance.<\/p>\n

Three amicus briefs have been filed<\/a><\/em> in support of Amgen\u2019s petition, and Sanofi\u2019s response is currently due March 14, 2022. Based on the similarity of the questions presented to those that the Supreme Court declined to answer in Idenix v. Gilead<\/em>, Amgen\u2019s petition has a slim chance of success. Regardless, patent owners should be wary of asserting claims that characterize a mAb purely on its function.<\/p>\n

Skinny Labels Aren\u2019t Dead Yet<\/strong><\/h2>\n

Another case we\u2019ve been watching closely is Amarin\u2019s litigation against Hikma and Health Net, concerning Hikma\u2019s \u201cskinny-label\u201d generic of Amarin\u2019s Vascepa\u00ae (icosapent ethyl). Amarin\u2019s Vascepa\u00ae is FDA-approved for both the treatment of severe hypertriglyceridemia (the \u201cSH indication\u201d) and cardiovascular risk reduction (the \u201cCV indication\u201d), but only the CV indication is covered by Amarin\u2019s patents. In November 2020, Hikma launched its FDA-approved generic product with the CV indication carved-out from its label (under 21 U.S.C. \u00a7\u00a0355(j)(2)(A)(viii)). Soon after, Amarin filed a patent infringement case in Delaware district court alleging that Hikma nonetheless induces infringement of its SH indication patents based. Case No. CV 20-1630-RGA-JLH.<\/p>\n

Amarin\u2019s infringement case was based on the Federal Circuit\u2019s decisions in GSK v. Teva<\/em>, which found that Teva induced infringement of GSK\u2019s method-of-treatment patent despite having a skinny label that lacked the indication at issue. See<\/em> Case No. 2018-1976 (opinion dated October 2, 2020, and re-hearing opinion dated August 5, 2021). In both decisions, the majority found Teva liable for induced infringement based on its label along with press releases and other marketing materials. However, in its re-hearing opinion, the majority addressed concerns from Teva and amici by stressing that its opinion was fact specific and did not change the law permitting generic drug companies to avoid induced infringement by carving indications out of their labels. Judge Prost again dissented, arguing the new opinion left concerns of significant risk and uncertainty for generic filers that carve out indications from their labels.<\/p>\n

Hikma moved to dismiss Amarin\u2019s complaint under Rule 12(b)(6). In opposition, Amarin argued that Hikma\u2019s label teaches CV risk reduction because Hikma\u2019s label includes a warning concerning side effects for patients with CV disease and because Hikma\u2019s label does not affirmatively state not to use its product for the CV indication. In August 2021, Magistrate Judge Hall recommended denying Hikma\u2019s motion, finding Amarin\u2019s allegations plausible based on the lack of a factual record. Case No. CV 20-1630-RGA-JLH, D.I. 64 (D. Del. August 3, 2021).<\/p>\n

Following the re-hearing opinion in GSK v. Teva<\/em>, Judge Andrews rejected Amarin\u2019s arguments and the Magistrate\u2019s recommendation and granted Hikma\u2019s motion to dismiss. In doing so, Judge Andrews focused on the following factors:\u00a0 (i) the warning in Hikma\u2019s label to patients with CV disease was not an instruction or encouragement, (ii) there is no precedent requiring Hikma to include an affirmative statement in its label to discourage the use of its product for the patented indication, and (iii)\u00a0Hikma\u2019s public statements about Vascepa\u00ae sales and that its product is a generic equivalent to Vascepa\u00ae did not rise to the level of inducing acts. Case No. CV 20-1630-RGA-JLH, D.I. 97 (D. Del. January 4, 2022).<\/p>\n

However, Judge Andrews permitted Amarin\u2019s case against Health Net (an insurance company that provides coverage for Vascepa\u00ae and Hikma\u2019s generic product) to go forward. Amarin alleges that Health Net\u2019s formulary placement of Hikma\u2019s generic as being interchangeable with Vascepa\u00ae for all indications induces infringement of Amarin\u2019s patents covering the CV indication.<\/p>\n

We\u2019ll be watching this case closely, as insurers are not typically implicated in Hatch-Waxman litigation. We also expect Amarin to appeal the dismissal of its case against Hikma, and it will be interesting to see whether the Federal Circuit adheres to the promise it made in its GSK v. Teva<\/em> re-hearing opinion to conduct a fact-specific analysis in each case.<\/p>\n","protected":false},"excerpt":{"rendered":"

As we enter the second month of 2022, the old saying, \u201cIf at first you don\u2019t succeed, try, try again\u201d and the famous line, \u201cI\u2019m not dead,\u201d from Monty Python and the Holy Grail, come to mind to describe two issues we\u2019ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit\u2019s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court\u2019s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.<\/p>\n","protected":false},"author":110334,"featured_media":145090,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[7202,82,6998,228,3,38597,37020,586],"tags":[8285,328,553,73532,8730,5531,31871,49,33,107,8742,34,1292,1241,248],"yst_prominent_words":[16260,15330,53017,31149,19681,15331],"acf":[],"_links":{"self":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts\/145088"}],"collection":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/users\/110334"}],"replies":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/comments?post=145088"}],"version-history":[{"count":0,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/posts\/145088\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/media\/145090"}],"wp:attachment":[{"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/media?parent=145088"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/categories?post=145088"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/tags?post=145088"},{"taxonomy":"yst_prominent_words","embeddable":true,"href":"https:\/\/ipwatchdog.com\/wp-json\/wp\/v2\/yst_prominent_words?post=145088"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}