The competition for generics' 180-day marketing exclusivity is fierce, and Dr. Reddy's Laboratories filed the first court
case calling into question FDA's methods for determining exclusivity on a patent-by-patent basis. The generics manufacturer
recently filed suit against FDA challenging the agency's determination that Dr. Reddy's was not eligible for 180 days of marketing
exclusivity for a generic version of AstraZeneca's brand-name proton pump inhibitor Prilosec (omeprazole). Specifically, Dr.
Reddy's is challenging the FDA policy that grants eligibility to the first manufacturer that files an abbreviated new drug
application (ANDA) certifying against any patent listed for the approved product.
Dr. Reddy's argues that a patent-by-patent approach is contrary to the exclusivity statute established by Hatch-Waxman and
that exclusivity must go to the first ANDA file that certifies against all the patents listed for the brand-name drug. If
the court finds that a patent-by-patent basis is valid, however, Dr. Reddy's argues that it also should be awarded "co-exclusivity"
under the theory that 180-day exclusivity should be awarded to each ANDA applicant that is the first to certify against any
listed patent.
This article contends that if FDA's position is upheld, because of the trend of innovator pharma companies to list multiple
patents as covering their brand-name drug, the result could be an increase in ANDA filers certifying against a single patent
listed for the approved drug and more "co- exclusivity" among generics manufacturers. Under those circumstances, innovative
pharmaceutical companies must either prepare for multiple legal battles against different ANDA applicants or consider listing
fewer patents for the approved drug.
The Set Up The process by which a generic version is approved and brought to market was established as part of the Drug Price Competition
and Patent Term Restoration Act of 1984 -- also known as Hatch-Waxman -- which amended the Federal Food Drug and Cosmetic
Act. The Hatch-Waxman amendments created the section [505(j) 21 U.S.C. 355(j)] that sets forth the ANDA process used to seek
FDA approval of a generic version of a pioneer drug. In their new drug application (NDA), pioneer applicants must include
information about patents covering the pioneer product. FDA then publishes that patent information as part of the Approved
Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book").
An ANDA must have a patent certification, described in section 505(j)(2)(A) (vii) of the Act. The certification must make
one of the following statements:
- I. no patent information on the drug that is the subject of the ANDA has been submitted to FDA
- II. that such patent has expired
- III. the date on which such patent expires
- IV. that such patent is invalid or will not be infringed by the manufacture, use, or sale of the product for which the ANDA
is submitted.
Section 505(j)(5)(B)(iv) of the act provides an incentive for applicants to file Paragraph IV certifications challenging patents
that may be invalid, unenforceable, or not infringed. In certain circumstances, the first ANDA applicant with a Paragraph
IV certification is granted 180 days of exclusivity. The exclusivity period provides the eligible ANDA applicant with protection
against market competition from similar generic versions of the same drug for a 180-day period from either the date on which
the first ANDA applicant begins commercially marketing its product or from the date of a court decision.
Changing Rules As originally enacted, provision 21 CFR 314.107(c)(1) required that the "applicant submitting the first application [must
have] successfully defended against a suit for patent infringement brought within 45 days of the patent owner's receipt of
notice [of the Paragraph IV certification]." Thus, the regulation required that the ANDA applicant filing the Paragraph IV
certification must have been sued by the NDA holder and have successfully defended its case. FDA established the "successful
defense" requirement to eliminate "an incentive for frivolous claims of patent invalidity or non-infringement" (59 Federal
Register 50338, 50353).
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