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. |
