Item 8.01 Other Events
As expected and consistent with typical timelines under the five-year, new chemical entity, exclusivity regulatory structure, on
September 22 and 23, 2016, Amarin Corporation plc (Amarin), through its subsidiary Amarin Pharmaceuticals Ireland Limited, received paragraph IV certifications from Roxane Laboratories, Inc. and Dr. Reddys Laboratories,
Inc., respectively, advising Amarin that such companies have filed abbreviated new drug applications (each, an ANDA) with the U.S. Food and Drug Administration (FDA) that seek regulatory approval for generic versions of
Vascepa
®
(icosapent ethyl) capsules.
The pharmaceutical composition and
current FDA approved use of Vascepa are covered by the following patents, each of which is listed in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book:
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Patent number
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Patent Coverage Type
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Expiration Date
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8188146
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Pharmaceutical composition
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Jan 27, 2020
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8293727
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Method of use
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Feb 9, 2030
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8293728
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Method of use
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Feb 9, 2030
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8298554
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Pharmaceutical composition
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Apr 29, 2030
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8314086
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Method of use
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Feb 9, 2030
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8318715
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Method of use
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Feb 9, 2030
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8357677
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Method of use
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Feb 9, 2030
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8367652
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Method of use
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Feb 9, 2030
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8377920
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Method of use
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Feb 9, 2030
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8399446
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Method of use
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Feb 9, 2030
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8415335
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Method of use
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Feb 9, 2030
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8426399
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Method of use
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Feb 9, 2030
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8431560
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Method of use
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Feb 9, 2030
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8440650
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Method of use
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Feb 9, 2030
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8445003
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Method of use
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Apr 29, 2030
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8445013
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Method of use
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Apr 29, 2030
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8501225
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Method of use
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Apr 29, 2030
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8518929
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Method of use
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Apr 29, 2030
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8524698
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Method of use
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Apr 29, 2030
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8546372
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Method of use
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Apr 29, 2030
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8551521
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Method of use
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Apr 29, 2030
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8563608
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Method of use
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Apr 29, 2030
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8617593
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Method of use
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Apr 29, 2030
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8617594
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Method of use
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Apr 29, 2030
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8623406
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Method of use
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Apr 29, 2030
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The paragraph IV certifications allege to varying degrees that the above-listed patents are invalid,
unenforceable and/or will not be infringed by the respective parties manufacture, use or sale of the proposed generic products for which the ANDAs were submitted.
Under the Food Drug and Cosmetic Act, or FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended,
or the Hatch-Waxman Amendments, after receipt of a valid paragraph IV notice, Amarin may, and plans to, bring patent infringement suits in federal district court against such generic companies seeking approval for their respective products within 45
days from the date of receipt of each respective notice. If such a suit is commenced within this 45-day period, the Hatch-Waxman Amendments provide for a 30-month stay on FDAs ability to grant final approval to any of the proposed generic
products that reference Vascepa. Such 30-month stay would expire on January 26, 2020, seven-and-a-half years from FDA approval of Vascepa on July 26, 2012. The stay may be shortened or lengthened if either party fails to cooperate in the
litigation and it may be terminated if the court decides the case before the end of the 30-month stay. If the litigation is resolved in favor of a generic applicant before the expiration of the 30-month period, the stay would be lifted and
FDAs
determination on the application may be completed. Such litigation is often time-consuming and costly, and may result in generic competition if such patents are not upheld or if the generic
competitor is found not to infringe such patents.
Amarin intends to vigorously enforce its intellectual property rights. Paragraph IV
litigation typically results in the consolidation of pending cases into one case. Because, as previously disclosed, July 26, 2016 marked the four year anniversary of FDAs approval of Vascepa and the opening of the regulatory window for
ANDA filings, Amarin expects that it may receive additional paragraph IV certifications in the near future. Amarin plans to update investors on any such additional certifications and Amarins planned patent litigation against such ANDA filers
in its quarterly and annual reports, including its planned quarterly report on Form 10-Q for the quarter ended September 30, 2016.
The information contained herein is intended to be considered in the context of more complete information included in Amarins filings
with the Securities and Exchange Commission (SEC) and other public announcements that Amarin has made and may make from time to time by press release or otherwise. Amarin undertakes no duty or obligation to update or revise the
information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through
other public disclosures. For more information on the risks associated with Amarins efforts to secure and maintain intellectual property protection for Vascepa, please see the Risk Factors section of Amarins quarterly report on Form 10-Q
filed with the SEC on August 4, 2016.
Forward-looking statements
This Current Report on Form 8-K contains forward-looking statements, including statements about additional paragraph IV certifications Amarin
may receive in the future from ANDA filers, Amarins intention to file patent infringement suits against generic companies from which it has received and may receive valid paragraph IV notices and to otherwise vigorously enforce its
intellectual property rights, Amarins expectations regarding the timing and outcome of the planned litigation and the expected timing of any updates to investors regarding any of the foregoing matters. These forward-looking statements are not
promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include Amarins ability to successfully enforce its
regulatory exclusivity and intellectual property rights, and to defend its patents; the possible introduction of generic competition of Vascepa; and the scope, validity and duration of patent protection to provide exclusivity for Vascepa. A further
list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarins filings with the SEC, including its most recent Quarterly Report on Form 10-Q, filed on August 4, 2016.
Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
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