Amarin Corp Plc (AMRN)

[dogn]

IP watchdog article by Zachary Silbersher

MARCH 23, 2022

Above my pay grade.
Point of following unclear to me: “Amarin Pharmaceuticals recently asserted a handful of patents, which were invalidated during litigation, even though Amarin allegedly previously characterized the prior art to both the FDA and investors as seemingly anticipatory of the very patents it subsequently sought to defend in court.”

“For years, there has been a chorus of voices lamenting that brand pharmaceutical companies are delaying entry of lower-cost generic drugs with patents that do not, in fact, embody years of expensive R&D. Getting the data right is therefore just as important as getting the conclusions right about what that data actually means.”

“The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.”

“First, generic competition is not stifled by patents only because of increased litigation costs. Generic pharmaceutical companies are essentially in the litigation business. Their business plans are predicated upon being sued for patent infringement and overcoming those suits to achieve the earliest entry date possible. There exist entire statutory schemes, including the Hatch-Waxman Act for small-molecule drugs, and the Biologics Price Competition and Innovation Act for biologic drugs, that set forth how and when brand pharmaceutical companies can sue prospective generics and biosimilars for patent infringement before they enter the market. These lawsuits are, somewhat counter-intuitively, triggered by the generics themselves, namely through filing abbreviated new drug applications (ANDAs) and Paragraph IV certification letters. Indeed, generics and biosimilars are one of the few types of defendants in patent litigation—or any litigation for that matter—who know they are going to be sued, and when, even before the plaintiff does.”
“Indeed, a problem exists when the bulk of the R&D behind a drug is finished and the brand pharmaceutical companies nevertheless squeeze out an additional patent with a far off expiration date that permits the brand to continue litigating against generic entry. There are numerous examples of this. Novartis is currently asserting a patent covering its blockbuster Gilenya that purports to cover taking the chicken pox vaccine to immunize against chicken pox. Amarin Pharmaceuticals recently asserted a handful of patents, which were invalidated during litigation, even though Amarin allegedly previously characterized the prior art to both the FDA and investors as seemingly anticipatory of the very patents it subsequently sought to defend in court.”
https://www.ipwatchdog.com/2022/03/23/hudson-institute-memo-draws-wrong-conclusions-discrepancies-maks-data/id=147816/