To clarify what I did, first read the documents recited in Paragraphs 5, 6, and 8 in the letter pasted below. Then ask someone like Sleven to post a link to the Amarin shareholders Petition for Writ of Certiorari in the U.S. Supreme Court.
June 4, 2025
D. John Sauer, Esq.
Solicitor General of the United States
Office of the Solicitor General
950 Pennsylvania Avenue, N.W.
Washington, D.C. 20530
Dear Solicitor General Sauer: I am sending materials to you that I sent last month to the FDA’s Office of Criminal Investigations, the FDA Commissioner, and FTC Chairman Ferguson. I want to make sure you are aware of the above materials in light of two invitations to you to respond in the related case of HIKMA et al. v. Amarin et al. currently pending in the U.S. Supreme Court. Both the HIKMA et al. Petition for Writ of Certiorari and its recent reply to Amarin’s response to the Petition have asked you to express your views on the issues there presented. None of the above papers filed by HIKMA et al. and Amarin et al. refer to the fraud issue discussed below. I also want to mention that I was the designated PTO representative that worked with Deputy Solicitor General Larry Wallace and Assistant to the Solicitor General Harriet Shapiro in preparation of briefs and oral argument in Diamond v. Chakabarty, 447 U.S. 303 (1980).
Issue No. 1
1. Enclosed with this summary letter is a copy of a Petition for Writ of Certiorari filed by Amarin Pharmaceutical Co. shareholders. Prices of Amarin stock shares quoted in the Petition should be adjusted to reflect a 1 for 20 Reverse Split earlier in 2025. E.g. $4.00 per share then is now $80 per share, or hypothetical $0.50 per share then is now $10 per share. I incorporate that Petition by reference here.
2. That Petition sought court review of detailed evidence of fraud by two generic drug companies (HIKMA and Dr. Reddy) in obtaining the FDA approval of their respective ANDA applications and labels for treating triglyceride levels exceeding 500 mg/decaliter in human patients with icosapent ethyl capsules.
3. The Supreme Court denied that Petition, apparently for lack of standing of Amarin shareholders to bring an intervention action before the Nevada District Court and the Court of Appeals for the Federal Circuit. The opinions and Orders of those two courts are set forth in Appendices A-C of the Petition. I am one of those shareholders. I am also a retired patent and trademark attorney, type I diabetic since 1956-57, and have career experience in patent and trademark law since 1961 in the PTO, Federal Judiciary, and private practice.
4. No court in the Federal judiciary has rendered a judgment with any rational opinion discussing the evidence of fraud set forth in the Petition.
5. I enclose a copy of the Supreme Court opinion in Hazel-Atlas Glass Co. v. Hartford Empire Co., 322 U.S. 238 (1944) referenced in the Petition. Hazel – Atlas is controlling authority applicable to any subsequent events in the present Amarin litigation, in my opinion.
6. Just as attorneys for Hartford created a document for signature by a supposedly disinterested industry official in support of the validity of its patent, 322 U.S. at 240-243, so also did attorneys for HIKMA and Dr. Reddy author and create “evidence” of unpatentability of six Amarin patents by omitting footnote explanations of data appearing in Table 3 of the Kurabayashi prior art reference and presented such manufactured “evidence” to the Nevada District Court in their jointly filed post-trial brief. The District Court Judge was misled and adopted that “evidence” verbatim to support her opinion invalidating the six Amarin patents. That Kurabayashi Table 3, sans explanatory descriptions of data in that Table, appears never to have been marked as an Exhibit during trial. It appears as “evidence” for the first time in their joint post-trial brief findings of fact, and in the subsequent Nevada District Judge order/opinion, pages 61A-62A of the Petition.
7. The two generic drug companies (HIKMA and Dr. Reddy) never publicly characterized their “evidence” in their post-trial brief as a simple mistake, and never asked that Nevada District Court Judge to correct her order/opinion as mistaken. I view their actions as deliberate with intent to deceive the Nevada Court.
8. The Office of Criminal Investigations (OCI) of FDA came into existence in the early 1990s as a result of investigations into criminal, fraudulent activities by eleven generic drug companies accompanying their submissions to FDA (ANDAs) for marketing approvals of their respective drugs. See FDA Compliance Policy Guide (CPG) 120.100 Fraud, Untrue Statements of Material Facts. Consistent with those guidelines, Hazel-Atlas and 18 USC 1001, I ask and expect the FDA to withdraw approval of the ANDAs that both HIKMA and Dr. Reddy filed for approval of their respective icosapent ethyl products, should evidence of fraud be found to exist. An FDA informed of the generics’ fraud discussed above would not have approved those ANDAs.
9. I have enclosed a copy of the slip opinion of the Federal Circuit Court of Appeals in HIKMA v. Amarin, 104 F. 4th 1370 (2024).
10. A Petition for Writ of Certiorari to review that decision was filed by HIKMA et al on February 14, 2025. Amarin et al filed its Brief in Opposition on May 15, 2025.
Issue No. 2
11. A separate issue arises with respect to Dr. Reddy.
12. I received a letter from CVS/Caremark and my insurance company.
13. Inasmuch as I am also a patient prescribed Vascepa since April 2013, I am directly affected by content of that letter effective July 1, 2024. I had received three bottles of Vascepa at a co-pay cost of either $9.00 0r $15.00 for years prior to July 1, 2024.
14. I received 3 bottles of Dr. Reddy’s generic icosapent ethyl on or about November 22, 2024 and retained one of those bottles. I returned two bottles for refund. I enclose photos of that one bottle and its label for information here, and for review by the FTC and/or Attorney General, DOJ.
15. Receipt of those three bottles occurred in response to a prescription written by my primary care provider to be Dispensed As Written for a three month supply of Vascepa.
16. The CVS pharmacy dispensed three bottles of Dr. Reddy’s product instead of the branded product. When instructed that the product to be dispensed was the branded product, CVS dispensed three bottles of the branded product.
I have receipts that reflect the co-pay cost to me of the above Dr. Reddy generic product and the Amarin branded product, both of which greatly exceed the co-pay cost of the branded Vascepa that I had paid for many years prior to July 1, 2024. E.g. a prescription for three bottles, three month supply of Vascepa filled 5/24/2024 shows that I paid $15. A prescription for three bottles, 360 capsules of Vascepa filled using a Good Rx coupon on 8/23/2024 was $705.52 copay cost to me. A prescription filled 11/22/2024 shows I received three bottles of Dr. Reddy product, 360 capsules, at a cost to me of $194.99. A new Dispense As Written prescription filled 11/26/2024 for Vascepa, three bottles, 360 capsules, cost $295.20. The latest Dispense As Written prescription for 360 capsules of Vascepa cost me $153.17 dated 4/15/2025.
17. I am aware of litigation brought by Express Scripts/Evernorth and CVS/Caremark (Teva and United Health/Optum also?) against FTC in W.D.MO (Kansas City). The suit involves the FTC investigation of the high cost of prescription drugs, an issue that plaintiffs disagree they are responsible for. I offer to be deposed as a witness on FTC’s behalf in that litigation.
18. I am also aware of antitrust litigation brought by Dr. Reddy against Amarin et al in Trenton, N.J. The issue involves exclusive supply contracts negotiated by Amarin et al related to inventory of Vascepa sufficient to meet anticipated demand.
19. A hearing in Trenton was held virtually on May 7, 2025 before the assigned judge. I have not seen or heard of a decision on the motion presented by Amarin to proceed on the pleadings with response by at least Apotex.
Sincerely,
AI
