The “Medicare Amendments” Do Not Alter
the Traditional Two-Part Test for Evaluating
Declaratory Judgment Jurisdiction in Hatch-
Waxman Patent Litigation
On January 21, 2005, the Federal Circuit issued its decision in Teva Pharmaceuticals
. v. Pﬁzer Inc.
, Appeal No. 04-1186, slip op., a closely-watched case that
provides important guidance on the prerequisites for a declaratory judgment action
in the context of Hatch-Waxman litigation. This decision can be found at:
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) altered the incentive structure of the Hatch-Waxman Amendments with
respect to patent enforcement in a way that made declaratory judgment actions particularly important to abbreviated new drug application (“ANDA”) applicants.
Prior to the MMA, in al cases in which a patent holder sued an ANDA applicant for patent infringement within 45 days of receipt of a “paragraph IV” notice1, there would be a statutory 30-month stay of the date of approval of the ANDA. Thus, there was a signiﬁcant incentive for the patent holder to sue.
The MMA changed the rules so that the 30-month stay would be available only if the patent had issued and information had been submitted to FDA concerning that patent before the ANDA was submitted. Now, in the case of patents issued after the ANDA is submitted, there is no particular incentive for the patent holder to sue at the time that it receives a paragraph IV notice. Instead, it may chose to wait until the generic product is actual y marketed. Recognizing this fact, generic drug interests pushed for inclusion in the MMA of a provision that would al ow ANDA applicants to sue for declaratory judgment when the patent holder had not itself sued within the 45-day period. That provision was ultimately qualiﬁed, however,
This summary is intended to be a general
summary of various laws and regulations,
and does not constitute legal advice. You
An applicant submitting a new drug application (“NDA”) is required to submit to FDA information
about each patent that applies to the drug, or an approved use of the drug, covered by that NDA.
should consult with competent counsel to
If the sponsor of an ANDA takes the position that one or more such patents is invalid or would
determine applicable legal requirements
not be infringed by its product, it must submit a “paragraph IV” certiﬁcation as part of its ANDA
and send notice of that certiﬁcation to the patent holder and NDA holder. The submission of an
ANDA seeking approval prior to patent expiration is an act of patent infringement.
by permitting such actions only “to the
extent consistent with the Constitution,”
infringing activity”—was met. Teva
, slip op., page 13.
For further information about this decision,
Pﬁzer after Pﬁzer declined to initiate
or to discuss its implications, please
a “reasonable apprehension of suit.”
apprehension prong” of the traditional
dramatical y alter that test. Teva
, slip op., page 16.
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