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January 31, 2007



After Medimmune v. Genentech, Apotex has a better chance at convincing the CAFC to change its "reasonable apprehension" test. But I doubt Apotex will succeed... I cannot see how they overcome the Art. III "case or controversy". It is clear from the complaint that Glaxo decided not to sue Apotex within 45 days, because Apotex successfully designed a work-around.

Robert Dailey

The issues here differ substantially from those raised in Medimmune. It seems to me that Medimmune answers a rather narrow question: If a contracting party has not bargained away its right to contest the validity of the patent, must that party breach the contract to have standing under the DJ Act? Of course, contracts generally emerge as a product of intense negotiations between the parties (including threats, counter-threats, etc.) Therefore, an accused infringer would typically have already met the DJ standing requirements before the parties entered the contract. So how does an accused infringer act on its right to sue under the DJ Act if it did not bargain that right away in the contract? Medimmune tells us how.

Nowhere does Medimmune grant DJ standing to diffuse defendants. At most, an NDA filing stands as a diffuse threat to a broad class of unidentified plaintiffs. Placing the general public on notice of one's IP rights has never been sufficient to grant a potential infringer DJ standing.

Furthermore, no reasonsble method of statutory construction would seem to yield the result that Apotex wants. Congress has provided a detailed protocol for dispute resolution within the H-W Act itself, especially in regards to standing. The text of H-W gives no indication that Congress intended to import provisions of the DJ Act into H-W. In fact, H-W appears to contemplate the opposite: ANDA filers would not have standing during the 45-day window.

If Medimmune gives Apotex anything, it is probably the ability to avoid being sanctioned for filing this DJ complaint.

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