Proposed Scheduling Order in AMRN Delaware Patent Case
The parties filed their proposed scheduling order (attached) yesterday in AMRN's patent infringement case against Hikma and Health Net. Hikma is the generic drug company that is selling its FDA-approved icosapent ethyl (generic Vascepa™), and Health Net is a health insurance company that is accused by AMRN of inducing infringement of certain patents that cover the use of Vascepa™, by diverting prescriptions for Vascepa™ to Hikma's generic version*. Two key dates in patent trials are the claim construction hearing ("Markman Hearing") and of course, the trial date. In the proposed scheduling order the claim construction hearing would be held on a date around the week of March 14, 2022, depending on the judge's availability. The trial would be held on a date after October 10, 2023 and likely in November or December of 2023, depending on the judge's availability.
It is noteworthy that there is a dispute between AMRN and Health Net regarding scheduling. Health Net has Motions currently pending to either dismiss their case altogether, or sever their case from the case against Hikma. As a reminder there is a hearing on all pending Motions scheduled for May 26, 2021 (See IQ Card for this litigation). In the proposed scheduling order, Health Net proposes that "[a]ll pretrial and trial deadlines concerning Plaintiff's claims against Health Net to be set following determination of the claims asserted against Hikma". This helps to clarify Health Net's likely plan for the litigation. Even if they don't win their Motion to Dismiss, if they can get their case severed from Hikma's, then they may file a Motion to stay their case until the Hikma case is decided. This would push any/much expense for the litigation for Health Net out for years, while the AMRN v. Hikma case is pending. Plus, if Hikma can knock out the patents on validity, then Health Net's case would almost certainly be dismissed. Or if Hikma loses its infringement case, then settlement of the AMRN v. Health net case might be more likely.
The proposed timing to get to trial around 3 years after AMRN filed its complaint against Hikma, is not too surprising. As we've indicated previously, the average time to trial in Delaware for a patent case is around 2.5 years, and this is a complex case. Although the District court in Delaware is a common venue for patent cases, it is not known as a fast court. In this situation, I think it works to AMRN's favor to be in a slower court. As the party filing this litigation, AMRN chose the district in which to bring this action, with full knowledge that Delaware is not known as a fast venue. Remember, AMRN filed the ANDA litigation against the generic companies in Nevada. Given the outcome of that case, it's not surprising that AMRN did not go back to Nevada. Of primary importance to AMRN would have been to choose the District in which it had the best chance of success on the merits.
I think the relatively slow timing of the Delaware court works in AMRN's favor in this case, which involves very complex patent issues for which the outcome is uncertain, and thus, of course, AMRN might ultimately lose. The most important of these complex issues would apply to other generic drug companies and insurance providers. Thus, this uncertainty of how this case will be decided for some years, may cause some generic companies to hesitate before entering the generic Vascepa™ market, and may cause Hikma to not commit as many resources to this Vascepa™ market while this case is pending. I doubt that this case will affect insurance companies covering generic Vascepa™ for all uses (i.e. adding Hikma's generic drug (and future generic versions of Vascepa) to its formularies at a lower cost tier), but they likely will at least analyze the risk vs. opportunity. In this situation where AMRN just received its expanded label in December of 2019 and then had to deal with the pandemic for over a year now, it would be helpful for AMRN to book more revenue in the coming few years and to establish the Vascepa™ brand in the market place.
*The practice of diverting prescriptions for a branded drug to a generic version for a patented use, is fairly common in these situations where there is more than 1 approved use for the branded drug, but only 1 of those uses is covered by an unexpired patent, and the generic drug has a "skinny label" that only includes the non-patented use. See the AMRN complaint for details about this process in the Vascepa™/Hikma situation.
#AMRN #patentlitigation #patent_litigation #Vascepa
