Biotech General Discussion

Last week, we received the official court scheduling order in the AMRN vs. Hikma and Health Net patent litigation in the District of Delaware. See schedule below*. The schedule has the trial starting on October 30, 2023, which was not surprising given the proposed schedule from the parties (See my prior free blog post HERE or full subscriber post HERE). Keep in mind that this schedule is not written in stone, but likely the trial will NOT occur any sooner. However, it could get pushed out. For example, a stay can be granted for various reasons, which could push out the trial date. As one example, a stay could be granted if the defendants file, and U.S. Patent Office (USPTO) grants, an IPR Petition to invalidate the patents asserted by AMRN in the USPTO instead of in this litigation proceeding. The defendant's have until 11/30/21 to decide whether to file an IPR Petition in the USPTO. There are numerous other reasons that a stay could be granted and/or the trial date can be extended.

It is also noteworthy that the court's scheduling order included a referral to a magistrate judge for the mandatory settlement conference that occurs in all patent lawsuits. In a post at a later date, we'll provide our comments on the likelihood that the AMRN vs. Hikma and Health Net case will settle within the next 12 months.

This most recent AMRN v. Hikma and Health Net is one of 3 active patent cases that we are watching that are highly relevant to AMRN's patent fight against generic competition, and thus AMRN's valuation. Currently, there is a lot of activity in all these cases, with important dates coming by the end of June for all of them. Here is a synopsis of these 3 U.S. patent cases we are watching closely, including the current status, key near-term dates, and some deeper analysis with respect to these upcoming activities:

1. AMRN's ANDA (generic drug) litigation against Hikma and other generic defendants (filed in Nevada on 8/24/18;

AMRN lost at the Dist. Ct. (patent held invalid); and

9/3/20 AMRN lost on appeal (Federal Circuit affirmed patent invalidity).

2/3 AMRN petitioned to the Supreme Court to reverse the appellate court ruling.

3/30 Sup Ct. requested Defendant's to file a Response

Although this was a little surprising and good news for AMRN, we still believe that there is a very low chance that the Supreme Court will agree to review (i.e. grant cert) AMRN's appellate loss.**

6/21 or 6/28 - Our best estimate for the timing of the Supreme Court's decision on whether to review this case (See **below about why this very surprising result would be very promising development for AMRN.)

2. AMRN (and Licensor Mochida) patent litigation against Hikma and Health Net (insurance company) (filed Oct. 2020 in Dist. Delaware)

11/5/20 Hikma launched generic Vascepa

11/30/20 AMRN filed patent lawsuit against Hikma

1/24/21 AMRN adds insurance company, Health Net", to lawsuit

5/23/21 Court will hear Motions to dismiss and Motion to sever (split case against Hikma from case against Health Net)

3. GSK v. Teva - A "skinny label" patent litigation that GSK brought against Teva for its generic version of GSK's cardiovascular drug Coreg® that is similar to AMRN's "skinny label" patent lawsuit against Hikma (Delaware case 2 above)

5/14/18 appeal filed

10/2/20 Fed Cir. Panel surprisingly reverses D. Ct. and rules in favor of GSK that Teva induced infringement. This was a good result for AMRN because it showed that a generic company could be found to induce infringement in a "skinny label" case with some similar facts to AMRN's current Del case. However, the Chief Justice of the Federal Circuit issued a long dissenting opinion and the case stirred a lot of comment and attention.

12/2/20 Petition for rehearing or en banc review filed by Teva

2/9/21 Teva's Rehearing request was granted

2/23/21 Oral hearing held related to rehearing

5/23/21 (estimate) Fed Cir panel rehearing decision (median Fed Cir precedential decision/opinion is 2.6 months from oral argument (See this article)) AMRN wants the Federal Circuit to affirm its earlier decision, which set a good precedent for AMRN, although these cases are very fact specific.

*Current schedule for AMRN v. Hikma and Health Net litigation

1. Joinder of Parties and Amendment of Pleadings due by 11/22/2021.

2. Fact Discovery completed by 8/18/2022.

3. Opening Expert Reports due by 9/19/2022.

4. Rebuttal Expert Reports due by 10/17/2022.

5. Reply Expert Reports due 11/16/2022.

6. Expert Discovery due by 12/16/2022.

7. Status Report due by 3/31/2022.

8. Dispositive Motions due by 3/30/2023.

9. Joint Claim Construction Brief due by 2/23/2022.

10. A Markman Hearing is set for 3/30/2022 at 01:00 PM before Judge Jennifer L. Hall.

11. Joint Proposed Pretrial Order due by 10/9/2023.

12. A Pretrial Conference is set for 10/13/2023 at 09:00 AM before Judge Richard G. Andrews.

13. A 5 day Jury Trial is set for 10/30/2023 at 09:30 AM in Courtroom 6A before Judge Richard G. Andrews. (*See Order for complete details).

Signed by Judge Jennifer L. Hall on 5/4/2021.

**Regarding litigation 1, AMRN is now attempting to get the Supreme Court to review the Appellate court's affirmation that AMRN's asserted patent (hypertriglyceridemia indication) are invalid. Although parties of a patent trial are entitled to an appeal of a District Court ruling, they are not, as a matter of right, entitled to a Supreme Court review of the appellate court's ruling. In fact, the Supreme Court only agrees to review (i.e. grants certiorari) for a small number of patent cases every year. We mentioned in past posts that we thought there was a remote chance that the Supreme Court would take up the AMRN ANDA case since the Federal Circuit (the patent appellate court) did not even find the case worthy of rendering a non-precedential opinion. However, in a bit of a surprise, on March 30, 2021 the Supreme Court requested that the defendant's file a Response to AMRN's Petition. The defendants previously waived their right to file a Response, which is fairly common when a defendant believes that a Petition does not have merit (Read law firm article on topic HERE). The Supreme Court's request that the defendants file a Response, apparently means that the Petition passed at least the first hurdle (Id. (see above article)). However, it does not necessarily mean that a grant is likely.

To analyze my initial assessment that there was a remote chance that the Supreme Court would review the appellate court's decision (grant cert), we analyzed 12 recent patent cases where the Supreme Court granted cert (Table 1). After this review, we continue to believe that AMRN's chances of getting the Supreme Court to review its loss at the Federal Circuit is very low. In all but one case, the Federal Circuit issued a full written opinion. And in that case, the Supreme Court issued a summary affirmation apparently because the Federal Circuit granted a decision around the same time on a similar issue. We do not find any pending patent cases at the Supreme Court where the Court is considering a similar procedural issue that is the focus of AMRN's Petition. Thus, we continue to believe that there is a very low likelihood that Supreme Court grant cert to AMRN and review the procedural issue at the heart of their loss at the Federal Circuit. If by this slim chance, the Supreme Court does grant cert, it should be seen very positively by the stock market because the Supreme Court overturns the decisions of the Federal Circuit around 68% of the time when it grants cert (See law firm article HERE). From a timing perspective, we believe that this decision by the Supreme Court should come down some time in late June.

#AMRN #Vascepa #patent_litigations #ANDA #icosapentethyl