PIV Notice Need Not Address All Claims to Preserve Rights

April 3, 2023

In Bausch Health Ireland v. Mylan Pharms. N.D. WV., 1:22CV20 Bausch moved for judgment of infringement on the pleadings under Rule 12(c) to prevent Mylan’s launch of its generic equivalent to Bausch’s drug Trulance® for treating chronic idiopathic constipation and irritable bowel syndrome with constipation.  Bausch’s motion was predicated on the failure of Mylan to assert in its Paragraph IV notice (PIV) non-infringement of two claims of the asserted patents. Bausch also moved to strike Mylan’s affirmative defenses under Rule 12(f). In its answer Mylan denied infringement of all asserted claims.

Bausch motion for judgment of infringement on the pleadings asserted that Mylan’s denial of infringement was precluded by its failure to raise non-infringement of the two claims in its PIV notice. Mylan, while denying that it did not raise the non-infringement in the PIV notice, even if it had failed to raise the defense it was not precluded from doing so in the infringement action. Under the Hatch-Waxman act a generic manufacturer must certify that all patents in the Orange Book are “invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.” 21 U.S.C. § 355(j)(2)(A)(vii).” The generic company must also provide to the patent holder and the NDA owner a PIV notice letter that includes “a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.” Id. at § 355(j)(2)(B)(iv)(II).

The district court denied Bausch’s motion because the Federal Circuit has previously held that the notice provision “cannot be enforced by a private party in a patent infringement action.” Minnesota Mining & Mfg. Co v. Barr Labs., Inc., 289 F.3d 775, 777 (Fed. Cir. 2002). This decision has been followed by several district courts in the intervening years. The district court denied Bausch’s motion “[B]ecause it possesses no authority to penalize any perceived deficiencies in Mylan’s Paragraph IV notice letter under the Hatch-Waxman Act, it will not limit Mylan to the theories raised in the PIV notice. Mylan may develop its non-infringement contentions in the ordinary course of this litigation and the Court denies the Plaintiffs’ motion for judgment on the pleadings as to its infringement claims.”

While failing to provide a noninfringement opinion in a PIV notice may not preclude presenting such a defense, it may expose the generic company to the assertion of willfulness and a grant of attorney’s fees. At a minimum, it will require the generic to prove he had an opinion of counsel that he did not infringe when the infringement began which, in an ANDA case, is when the ANDA is filed with FDA.