Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                            November 2011   

In This Issue

·    District Court Holds That API Manufacturer Cannot Be Sued For Claims Relating To Filing Of ANDA

·    Watson Sued Under Exelon® Patents

·    Impax Settles TriLipix® Patent Litigation

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District Court Holds That API Manufacturer Cannot Be Sued For Claims Relating To Filing Of ANDA

The United States District Court for the District of Delaware recently held, in Leo Pharma A/S v. Tolmar, Inc., that the API manufacturer could not be sued for claims relating to submission of the ANDA.  LEO Pharma, initially, filed suit against Tolmar asserting infringement of U.S. Patent No. 6,753,013 and Reissue Patent No. 39,706, in response to Tolmar’s submission of an ANDA, containing a paragraph IV certification, seeking approval to market a generic version of Dovonex®.  LEO Pharma, thereafter and after the close of fact discovery, attempted to amend the Complaint to, inter alia, join the API manufacturer, Teva Pharmaceutical Industries Ltd., as a defendant.

By way of background, Teva manufactured the API used in Tolmar’s ANDA generic Dovonex ®, and submitted the Drug Master File for the API to the FDA for reference in Tolmar’s ANDA.  Based upon these acts, LEO Pharma alleged, in its motion to amend the pleadings, patent infringement by Teva on the following three grounds:

1.  “35 U.S.C. § 271(e), because Teva participated in, contributed to, aided, abetted and/or induced the submission of Tolmar's ANDAs”;

2.  “35 U.S.C. § 271(a), (b), (c) and/or (g), if Teva 'commercially manufactures, uses, offers for sale or sells,' or 'imports . . . into the United States, or induces or contributes to any such conduct,' the API of the ANDA products”; and/or

3. “35 U.S.C. § 271(b), because Teva has 'engag[ed] in a cooperative venture with Tolmar to submit the ANDA and [has] incorporate[d] by reference Teva's DMF thereto to the FDA to obtain approval to engage in the commercial manufacture, use, sale and/or importation’ of Tolmar's ANDA products…”.

The District Court granted LEO Pharma leave to amend the Complaint on the second ground and denied the remainder of the motion with respect to LEO Pharma’s infringement claims related to submission of Tolmar’s ANDA.  The District Court, in doing so, held that “an API manufacturer like Teva cannot be held liable for ‘inducing’ the submission of the ANDA”, and that, since Teva was not involved in preparing the ANDA, Teva was not subject to infringement claims under 35 U.S.C. § 271(e)(2).  Specifically, the District Court stated that “I decline to extend liability under § 271(e)(2) to third parties for work protected under § 271(e)(1) [and concluded] that the allegation that Teva ‘participated in the work related to the submission’ is distinguishable from actually preparing the ANDA.”

The District Court also noted that the ruling was based upon the following distinction between engaging in protected work under § 271(e)(1) to enable preparation and submission of an ANDA and active involvement in the preparation of the ANDA such as “contributing employees to the various teams responsible for preparing the ANDA, and having employees of each prepare and execute ANDA-related documents…”   

Watson Sued Under Exelon® Patents

Watson Pharmaceuticals, Inc. recently announced that Novartis filed an infringement suit against subsidiary Watson Laboratories, Inc. on November 9, 2011 in the United States District Court for the District of Delaware.  Watson had filed an ANDA, containing a paragraph IV certification, seeking approval to market a generic version of Novartis’ Exelon® in the following dosages – rivastigmine transdermal system patches, 4.6 mg/24 hr and 9.5 mg/24 hr; Exelon® is a prescription medicine used to treat mild to moderate dementia associated with Alzheimer’s or Parkinson’s disease.

Novartis filed suit within the forty-five (45) day Hatch-Waxman window, and is seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 5,602,176; 6,316,023 and 6,335,031; according to the Orange Book, the ‘176 patent expires February 11, 2014, and the ‘023 and ‘031 patents expire January 8, 2019.  Watson, further announced that, based upon available information, it believes that it is the “first applicant” to file an ANDA, containing a paragraph IV certification, for the generic version of Exelon® Patch such that, should the ANDA be approved, Watson may be entitled to 180 days of generic market exclusivity; according to IMS Health Data Exelon(R) enjoys annual sales of approximately $424 million.

Impax Settles TriLipix® Patent Litigation

Impax Laboratories Inc. announced that it recently settled the TriLipix® patent litigation with Abbott Laboratories and its Fournier Laboratories Ireland Ltd. unit.  Abbott filed suit against Impax in the United States District Court for the District of New Jersey asserting infringement of U.S. Patent No. 7,259,186 (“the ‘186 patent”) seeking to prevent Impax from introducing its generic version of the cholesterol drug TriLipix®, which is a delayed-release version of Abbott’s TriCor®.

The ‘186 patent is the only patent listed in the Orange Book for TriLipix® – choline fenofibrate – for reducing cholesterol and fatty acids/triglycerides in the blood.  According to an FTC filing, this settlement, the terms of which are otherwise confidential, provides for Impax to begin marketing TriLipix® delayed-release capsules as early as July 15, 2013, “under certain circumstances in the settlement agreement” that are not identified in the filing; and, in any event, Impax is allowed to offer generic versions in 45-milligram or 135- milligram doses no later than January 1, 2014.  According to the Orange Book, the ‘186 patent is expected to expire January 7, 2025.

This is the second such settlement for Abbott; Teva Pharmaceutical Industries Ltd. currently plans to begin selling a generic version of TriCor in July 2012 under an earlier lawsuit settlement with Abbott. 

The GREENBLUM & BERNSTEIN NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property.  The NEWSLETTER provides monthly updates on recent issues of general interest in this field.  The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  Information regarding the contents of the Newsletter can be obtained by contacting P. Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C. [01300582.DOC