Etonogestrel – USA

Etonogestrel – USA


Case No. 17-3984

Judge: Chief Mag. Judge Mark Falk

Date: 06/28/2021

Court: District of New Jersey – MEMORANDUM OPINION


This is a patent infringement case. Defendants (“Merck”) market and sell an implantable progestin contraceptive under the trade name Nexplanon®. Plaintiff, Microspherix, contends Nexplanon infringes three patents: US 9,636,401; US 9,636,402; and US 8,821,835. The initial complaint was filed on June 5, 2017. On August 7, 2018, the case was stayed pending inter partes review instituted against the asserted patents. The IPR proceedings concluded in August 2020, and the stay was lifted by Order entered on August 10, 2020. On August 17, 2020, Merck sent Plaintiff proposed amended invalidity contentions. After many back and forth, Plaintiff declined to consent on February 19, 2021. On March 5, 2021, Merck filed the present motion to amend contentions in view of new prior art discovered during IPR and § 112 arguments.


Court said that the Local Patent Rule 3.7 governs requests to amend contentions. The Rule allows for amendments “only by order of the Court upon a timely application and showing of good cause.” Merck raised the issue of amendment very quickly after the IPR proceedings concluded – within a calendar week. Also, late discovery of prior art can be good cause to amend contentions and that there was a fulsome IPR review that could reasonably be construed to provide a basis for additional Section 112 positions.


With respect to “Undue Prejudice” to Microspherix, Court said that the case is nowhere near motion practice or a trial. The case was stayed for two years while IPR proceeded. It is not clear that much, if any, discovery has occurred. There are no dispositive motions pending. Claim construction has not occurred. The only impact of the amendments would be perhaps a revising of certain claim construction submissions and a small amount of discovery. This does not rise to the level of prejudice or a “significant delay” that would materially alter when this case is reached.


Therefore, Merck’s motion to amend its invalidity contentions was GRANTED.

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