This is unlike Federal Circuit case law, which is considered binding precedent on patent matters throughout the USA.
2.
During the 45-day period, the generic company is not permitted to bring a declaratory judgment lawsuit against the brand company.
3.
A DJ plaintiff must also be able to show present activity that could constitute infringement, or concrete steps taken with the intent to conduct such activity. This requirement was clearly met and not at issue in this case.
4.
35 USC §371 (e)(5).
5.
21 USC §§355, 360, and 35 USC §§156, 271 (the Hatch–Waxman Amendments to the Federal Food, Drug and Cosmetic Act).
6.
§355(j)(5)(B)(iv).
7.
‘New drug application’. In this case, Pfizer is the holder of the approved NDA for Neurontin.
8.
Certification by ANDA applicant that the applicable patent(s) is (are) invalid/unenforceable and/or not infringed.
9.
Generic Pharmaceutical Association (GPhA) website, accessed 18th January, 2006.
