Case Cite

Astra Aktiebolag v. Andrx Pharmaceuticals, Inc., No. 1:99-cv-09887-DLC, slip op. (S.D. N.Y. August 5, 2013) (2013 WL 4007575).

IPDQ Commentary

In Astra, the court rejected Defendant’s attempts to avoid damages for batches of a pharmaceutical product it made, even though the drugs were never sold.

Case Summary

Plaintiff originally sued Defendant for infringement based on Defendant’s Abbreviated New Drug Application (ANDA). Id. at 1-2. Shortly before a trial on validity and infringement issues, Plaintiff discovered Defendant had begun manufacturing commercial-size batches of the accused product. Id. at 3. The trial went ahead nonetheless, and a final judgment on infringement and ordering injunctive relief was entered and affirmed on appeal. Id. Later, when Plaintiff sought to file a supplemental complaint, Defendant objected. The District Court rejected Defendant’s arguments and granted the motion. Id. at 4.

Subsequently, Defendant filed a motion for Summary Judgment on the new damages claims, arguing (1) it never sold any of the batches of the accused product and was, therefore, not a “commercial manufacturer” subject to liability for damages under § 217(e)(4)(c); and (2) prior entry of an injunction barred Plaintiff from seeking damages.

The court rejected both arguments:

  • The arguments were made and rejected in connection with Plaintiff’s motion to file a supplemental complaint. Id. at 5. The law of the case doctrine counsels against reopening issues already decided. Id. at 6.
  • Defendant failed to establish the statute was so ambiguous that a resort to legislative history was proper. Id. at 8. Even though the legislative history used the phrase “commercial marketing,” the use of the term “commercial manufacture” in the statute was unambiguous. Thus, manufacture of the batches without any sales was enough to establish Plaintiff’s right to damages for infringement. Id. at 9.
  • The entry of an earlier final judgment on infringement liability did not preclude the possibility of additional remedies for infringement. Id. at 9-10.