Reasonable enquiries before filing an IP law suit – not in US pharmaceuticals?

For those of you who are unfamiliar with US litigation practice, Rule 11 (of the Federal Rules of Civil Procedure) requires attorneys or parties to make reasonable enquiries before filing a patent infringement suit.

Similar procedural rules exist in many other jurisdictions and should be kept in mind as part of the overall strategy. In many jurisdictions they apply to the plaintiff / applicant. So they can be equally useful for a patentee on the receiving end of a declaratory judgment application as well as a defendant in IP infringement proceedings.

Aaron Barkoff over at the excellent Orange Book Blog recently reported the District court decision in Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008). The judgment concerns a Rule 11 challenge by the defendant to patent proceedings under the Hatch Waxman Act (ie to enable launch of a generic pharmaceutical product).

Here’s a quote from the judgment:

If this Court were to grant KV’s motion, it would put pharmaceutical patent owners in an untenable position. After receipt of notification of an ANDA application for a generic pharmaceutical, the patent owner would need to conduct what is likely to be a highly technical infringement analysis, make the decision to file suit, and then do so, all within 45 days, or face dismissal as a sanction under Rule 11. This would be difficult for patent owners to accomplish and would have the effect of frustrating the purpose of the Hatch-Waxman scheme.

45 days seems more than enough to me. What am I missing?

Remember that Rule 11 only requires that reasonable enquiries are made. So it’s hard to see that pharmaceutical patent owners would ever be at serious risk of breach of Rule 11 in any event.

2 Comments on “Reasonable enquiries before filing an IP law suit – not in US pharmaceuticals?

  1. To determine whether an ANDA would infringe usually requires testing the product. It takes time to get a confidentiality agreement in place, get the product and test it. 45 days is generally too short a time to do that.

  2. Thanks McVooty
    Sure.  So just to clarify – you’re saying that it’s not currently necessary to test the product (though I know that this is often done).  But if Rule 11 applied, then it would be necessary, and 45 days is not enough time.I’m still not convinced that it’s necessary to test the product.  Shouldn’t the PI leaflet be enough?  If this is incorrect, then isn’t there a larger (Regulatory) problem for the generic (one which the innovator is at leisure to identify and point out after the initial 45 days)?

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