Paliperidone – USA

Paliperidone – USA


Case No. 19-21590

Judge: Chief Mag. Judge Mark Falk

Date: 06/24/2021

Court: District of New Jersey – MEMORANDUM OPINION & ORDER


This is Hatch-Waxman case arises out of Pharmascience’s filing of ANDA seeking approval to market a generic version of Janssen’s Invega Sustenna® (paliperidone-based) extended release product. Janssen sued Pharmascience’s for infringement of U.S. Patent No. 9,439,906. Pharmascience’s proposed amendments were focused on deficiencies of the claims under 35 U.S.C. § 112. All of these deficiencies allegedly became apparent when Pharmascience reviewed the transcripts from the another trial (Janssen v. Teva, No. 18-734). Pharmascience contends that the trial “revealed new information relating to the patent-in-suit” which gives rise to its request to amend its invalidity contentions.  Janssen opposed the motion.


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.” Pharmascience’s application is timely and good cause has been shown because these new positions were revealed for the first-time during trial. It received the trial transcripts in January 2021, and on February 4, 2021, raised its proposed amendments. Pharmascience contends it did not know of Janssen’s invalidity positions prior to trial because the parties to this case had agreed to defer Janssen’s response to invalidity contentions until the Teva trial was over. Pharmascience raised the issue quickly after reviewing the trial transcripts and stands behind the references to the transcripts provided with their amended contentions as the basis to support them. Court thus concluded that the concept of amending the contentions was raised in a timely fashion and that there is good cause to support the request.


With respect to “Undue Prejudice” to Janssen, Court said that fact discovery does not appear to be complete (and the parties have ongoing disputes), and expert discovery is scheduled through October 2021. The 30-month stay does not expire until May 2022. Allowing the contemplated amendments might result in a small delay of discovery, but it would not cause a “significant delay” that would materially alter when this case is reached. Moreover, no showing that the amendments would cause a dramatic increase in cost or expense has been shown.


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

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