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October 12, 2010


Declaratory Judgement jurisprudence presents two contradictory legal precedents that have been set aside by the courts. One is Caraco Vs Forest lab and the other one is Janesson vs Apotex. The Caraco case presents judicially created article III controversy despite Forest labs issues a covenant not sue declaration. The Caraco case precludes the entry of generic companies to make available the low cost generic version to the public and hence presents a potential cognizable injury to the generic company. The Janesson vs Apotex does not present article III controversy as Apotex stipulated to the validity of the product patent. The Eisai vs Teva presents yet another article III controversy as the situation in this somewhat resembles the Caraco case. Despite statutory disclaimers have been issued against two patents and Eisai declared covenant not to sue on the remaining two patents, the listing of patents in the Orange Book proved impending blocking mechanism for the generic entry unless court verdict prevails upon the Orange Book listing patents as non-infringing or invalid. Hence, the situation is bit different from the aforesaid cases.

Thanks, Kevin. I found your summary of the facts a little confusing, as it implied (to me at least) that Ranbaxy received 180-day exclusivity for filing a paragraph III certification. My understand is that Ranbaxy filed a paragraph III certification against the '841 patent - the patent that will expire next month, and with it the PI against Teva - but Ranbaxy filed paragraph IV certifications against the other Orange Book patents, before Teva filed its ANDAs. It is those P-IV certifications that are the cause of the 180-day exclusivity.

"This case illustrates how the complex (perhaps Byzantine) regulations for patent infringement litigation under Hatch-Waxman have effects outside the mere statutory language of 35 U.S.C. §271(e)."


"Byzantine" is a very appropriate way to refer to Hatch-Waxman. I also call it the "multi-headed hydra." A very poorly drafted piece of legislation, in other words has all the earmarks of the compromise that Hatch-Waxman was.

Thanks, Dan, for pointing that out. We will correct the sentence to make that point clear.

Thanks for the comment.

Dear Kumar:

The court here says Caracao controls, based on the imposition of a regulatory obstacle to generic entry (that frankly cannot be resolved other than by litigation). It also raised the distinction that Teva/Gate is being obstructed by the (in)activity of a third party (Ranbaxy), so that a DJ action is (again) the only way for Teva/Gate to overcome the obstacle.

There is also the flavor that there is no estoppel here, as in Janssen, where the generic drug maker stipulated to the validity and enforceability of the Orange Book listed patents, and to its own infringement. Here, Teva/Gate merely stipulated that its generic product would infringe, but contended in its Paragraph IV certification that the Orange Book listed patents were not valid or enforceable.

Also, keep in mind that regardless of the disclaimers and covenants not to sue, Eisai did not delist these patents from the Orange Book; if it had, then the court would likely have affirmed dismissal, since the only obstacle would have been the '841 litigation (which was/is on-going).

Thanks for the comment.

Good call Fed. Circ. Iirc, I spoke out against what this DC did in this case in a previous thread.

Thanks kevin for your reply

I have some very basic questions. May be I'm missing some very basic legal knowledge of Hatch-Waxman law.

1)Why did the FDA approve TEVA's first ANDA in April 2008? The opinion on page 7 states the 30-month stay expaired at that time. But isn't it true that the first ANDA filer's (Ranbaxy's)exclusivity had not started to run at that point? Why isn't that relevant to prevent FDA approval of the first ANDA?

2)Are there separate 30-mo stays for the first and the second (Gate) ANDAs? If so, when does the 30-mo stay expire for the second ANDA?

3)If Teva had started the commercial marketing of a generic donepezil immediately after receiving FDA approval of its first NDA in April, 2008 (despite the preliminary injunction), what effect does that have on Ranbaxy's 180 day exclusivity? Would Teva have to stop marketing the drug when Ranbaxy entered the market?

Thanks for any comments

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