ABRAXIS BIOSCIENCE, LLC v. ACTAVIS LLC, 2:16-cv-01925

Background

Actavis filed an ANDA seeking FDA approval to market a generic version of Celgene’s Abraxane; Celgene sued for infringement of four patents (ʼ260, ʼ788, ʼ536, ʼ229).
Actavis served initial invalidity contentions (Aug 2016); Celgene served extensive responses (Oct 2016).
After reviewing Celgene’s responses and the post-service decision in Janssen, Actavis prepared proposed amended invalidity contentions (Feb 2017) seeking to add: (1) responses to additional secondary considerations, (2) expanded technical detail for 35 U.S.C. §§ 102, 103, 112 defenses, and (3) an obviousness-type double patenting (OTDP) defense based on Janssen.
Celgene opposed as untimely, lacking good cause, and prejudicial; Actavis declined to narrow its proposed amendments.
The court evaluated the request under Local Patent Rule 3.7 (timeliness, diligence/good cause, and undue prejudice) and granted leave to amend, finding Actavis diligent, the amendments timely, and no undue prejudice to Celgene.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Actavis may amend invalidity contentions to address additional secondary considerations	Amendments untimely; Celgene argues secondary considerations are routinely foreseeable and should have been included originally	Celgene’s responses raised new secondary considerations that Actavis could not reasonably have anticipated; amendment is responsive	Granted — court finds diligence and good cause; amendments track Celgene’s responses and are timely
Whether Actavis may add further technical detail to existing §§102/103/112 defenses	Reintroduction of abandoned claim construction issues; no good cause for new detail	Additional factual/technical detail was needed after reviewing Celgene’s full articulation of nonobviousness	Granted — court accepts that Actavis reasonably supplemented defenses after receiving Celgene’s detailed contentions
Whether Actavis may add an OTDP defense based on Janssen decision	Janssen does not change relevant law; defense is untimely and potentially inconsistent with positions in related litigation	Janssen (issued after service) provided a reasonable basis to investigate and assert OTDP; area unsettled and Janssen supports amendment	Granted — court finds Janssen (post-service) gives sufficient good cause to add the OTDP theory
Whether granting amendments would unduly prejudice Celgene	Amendments would require substantial additional resources, delay discovery, and undermine Patent Rules	Discovery is in early stages; any additional work is not disproportionate; Actavis consents to Celgene amending its contentions; minimal additional factual discovery needed	Granted — court concludes no undue prejudice and likely discovery extensions were already necessary

Key Cases Cited

Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., 210 F. Supp. 3d 278 (D. Mass.) (post-service decision relied on by defendant to add OTDP defense)
TFH Publications v. Doskocil Mfg. Co., Inc., 705 F. Supp. 2d 361 (D.N.J.) (factors for undue prejudice in amendment disputes)