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W/ respect to @profmikecarrier and @charles_duan, pharma patent experts whose views I usually share, I disagree with their suggestion that @HHSgov’s patent infringement suit against Gilead over HIV PrEP “could unintentionally lead to higher drug prices.”/1 https://www.bloomberglaw.com/document/X80QLPN4000000?bwid=0000016e-8fd4-d013-a7ff-aff5e1e80001%26emc%3Dbhpnw_bf%3A1%26et%3DFIRST_MOVE%26link%3DeyJjdHh0IjoiSFBOVyIsImlkIjoiMDAwMDAxNmUtOGZkNC1kMDEzLWE3ZmYtYWZmNWUxZTgwMDAxIiwic2lnIjoibHFDU2tJOGU2cVlFOGo5M2hLaC9lRVNRZVM0PSIsInRpbWUiOiIxNTc0NjgzNzcyIiwidXVpZCI6Imd5YU1Ka2dOOURydDdSeFpXZFNOaVE9PXprZnd2Zm44TnYwZ1lLaTUxeE5VVWc9PSIsInYiOiIxIn0%3D%26qid%3D6822655
FULL DISCLOSURE: I represent @PrEP4All and have advocated for HHS and DOJ to assert their patents on PrEP against Gilead since this spring. See the summary @akapczynski and I recently published in @Health_Affairs /2 https://www.healthaffairs.org/do/10.1377/hblog20191118.218552/full/
As our HA Blog post states, I'm skeptical that method of treatment (MoT, aka method of use) patents in pharma add much value. While MoT patents spur preclinical and clinical development of new therapeutic uses, they are also an evergreening tactic. /3 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0049470
But I think reform of MoT patents can't and won't happen through litigation. While there are some interesting boundary Qs under 35 USC 101 and 103--e.g., MoT claims that recite & rely on a natural law, like Vanda--US v Gilead doesn't raise any such Qs. /4 https://www.scotusblog.com/case-files/cases/hikma-pharmaceuticals-usa-inc-v-vanda-pharmaceuticals-inc/
HHS's patents are run-of-the-mill MoT: relatively narrow in scope, address a medical need (HIV prevention) unmet by the prior art, don't rely on Baroque functional limitations or recitation of a natural law. For better or worse, CAFC has blessed such patents for decades. /5
US v Gilead seems to me unlikely to generate significant new law. It's unlikely to strengthen other MoT patents held by pharma and unlikely to affect drug prices--except, of course, the prices of Truvada and Descovy, which the govt could negotiate down to better fight HIV. /6
To meaningfully change the law on scope & impact of MoT patents, or eliminate them entirely, we need statutory reform. I would love a debate over adding categorical exclusions to the Patent Act against MoT and other types of evergreen patents: polymorphs, metabolites, REMS.../7
and I agree with @charles_duan that Coons-Tillis 101 reform bill would be bad for innovation & public health. Thanks to Mayo, 101 currently discourages evergreen MoT patents on dose adjustment based on diagnostic tests; Coons-Tillis would encourage them./8 https://www.judiciary.senate.gov/imo/media/doc/Duan%20Testimony.pdf
Finally IMHO those concerned about effects of MoT patents on competition & pricing should be thinking not just about validity but infringement. Validity of MoT patents is mostly settled law; infringement--e.g., skinny labeling for biosimilars--less so. /9 https://www.biosimilardevelopment.com/doc/what-is-skinny-labeling-and-will-it-work-for-biosimilars-0001
