• AMRN: Market Headwinds and Inherent Weakness of the Vascepa IP

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AMRN: Market Headwinds and Inherent Weakness of the Vascepa IP

 

Summary

Since having reported positive topline results from their REDUCE-IT trial in September of 2018, Amarin Corp.'s (NASDAQ: AMRN) stock price has risen over 700%. Much is assumed in this new valuation (~$10B MC fully diluted as of November 15, 2019), as the profitability of the Company is entirely dependent upon the potential commercial success of Vascepa. 

Lingering doubts as to the effectiveness of the therapy remain, however, due to the possibility that mineral oil had an adverse effect on the performance of the placebo group by hindering drug absorption. However, even more salient is the defensibility of the Company’s patent portfolio; we assail their patents and convincingly find each claim invalidated by prior art or otherwise not infringed by ANDA filers. Also provided is a section on barriers to expansion not given due weight by market participants and analysts.

 

TOTAL REPORT LENGTH: 203 pages; 64,511 words; 360 citations


 

Table of Contents: 

 

1. The Assailability of Amarin Corp.’s Patent Portfolio

                1.1 Obviousness and Prior Art

                1.2 The Doctrine of Inherent Disclosure

                1.3 The FDA Orange Book

                1.4 Background

                1.5 Invalidating Amarin’s Patents     

1.5.1 Did Amarin Insiders Commit Antitrust Violations by Submitting the ‘146 Patent to the Orange Book?

1.5.2 The ‘554 and '594 Patents and Doctrine of Equivalents

1.5.3 The ‘728, ‘677 and ‘652 Patents

1.5.4 The ‘727 and ‘086 Patents

1.5.5 The '920, '335, and Remaining Patents

                1.6 What Can Be Inferred from the Summary Judgement Ruling?

                1.7 The Epanova Double Standard

                1.8 Aren’t OTC Omega-3 Products Infringing?

                1.9 A Case in Point: Indivior Inc. v. DRL

                1.10 Acquiring Amarin Corp. Would be Detrimental

 

2. Factors Affecting Vascepa Market Penetration

                2.1 The Accessibility and Cost Savings of OTC EPA

                 2.2 Critique of Amarin’s U.S. ITC Complaint

                 2.3 Sales of Prescription OM3 in Similar Indications Present a Ceiling

                 2.4 The European Market: Why it Has Been Ignored

2.4.1 How the EU Market Could Be Lost Shortly After an Approval 

                2.5 The Threat of Epanova and Matinas BioPharma's MAT9001

                2.6 Can Amarin Control the Supply

                 2.7 Concluding Remarks

               

 


Reasons to Purchase the Report:

The Report will inform firms, individual investors, and other interested parties of the highly material drawbacks to an investment in or acquisition of Amarin Corp. and contrariwise, the potential profitability in adopting a short-sale positionas well as the vulnerabilities of Vascepa’s IP that may rightly be assailed.

 

The Report provides insights on the following pointers:

Patent Invalidation/Non-infringement: Detailed overview of where Amarin Corp. stands with their IP, as well as the state of and what to expect from their current patent litigations, divulging a preponderance of prior art references that inherently or explicitly invalidate each of Amarin’s patents covering Vascepa, or otherwise show them not infringed by ANDA filers. Also included is an overview on the current state of affairs in the courts and a timeline on due process.

Barriers to Entry: Comprehensive information as to the limitations of Amarin’s potential to achieve market penetration (US and EU) even should all go well in the courts and with FDA (and later, EMEA), including present and future competition, as well as other less well-known economic and regulatory hindrances. Also included is a critique of Amarin’s ITC complaint (UPDATED), including arguments they have in the process violated the Sherman Act, and may incur probing/lawsuit from FTC.

 

Consultation:

As part of the purchase of our reports, we make ourselves available to answer any and all questions on (or challenges to) our research, and commit to respond within 48 hours. We also update purchasers of our report on any relevant happenings that could impact the Company, including ongoing regulatory reviews, SEC/FTC developments, patent litigation developments (PACER), significant changes in SEC filings, and developments of direct competitors. 

 






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AMRN: Market Headwinds and Inherent Weakness of the Vascepa IP

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