Case Name: Dey, Inc. v. Sepracor, Inc., Civ. No. 07-2353-JGK, 2012 U.S. Dist. LEXIS 28112 (S.D.N.Y. March 1, 2012) (Koeltl, J.). (Public use under § 102(b) and intervening rights - Participation by someone who is not the patentee in a clinical trial before the patent's priority is public use; because claim scope changed after reexamination, plaintiff barred from recovering pre-reexamination damages).
Drug Product and Patent(s)-in-Suit: Brovana® (formoterol); U.S. Pat. Nos. 6,667,344 ("the '344 patent"); 6,814,953 ("the '953 patent"); and 7,348,362 ("the '362 patent")
Nature of the Case and Issue(s) Presented: One of the issues here concerned whether defendant Sepracor's participation in a clinical trial constituted a § 102(b) public use that invalidated the claims of the '362 patent and a related family of patents assigned to Dey. The second issue was whether Dey could recover damages for infringing acts that occurred before reexamination certificates issued for the '344 and '953 patents, where the claims had been amended during reexamination to overcome substantial new questions of patentability. Dey filed suit in March 2007, alleging patent infringement based on Sepracor's imminent launch of Brovana. In response, Sepracor filed counterclaims alleging patent invalidity. Sepracor initially moved for summary judgment seeking dismissal of all claims asserted against it, but that motion was dismissed without prejudice in February 2011 in light of reexamination proceedings that had been initiated in relation to the '344 and '953 patents. When the reexamination ended, Sepracor filed its motion for partial summary judgment. The Court granted Sepracor's motion, finding the '362 patent invalid under § 102(b), and barring Dey from recovering damages related to the '344 and '953 patents arising before the October 2011 completion date of the reexamination proceedings.
Why Sepracor Prevailed: In 1998, Sepracor filed an Investigational New Drug Application so that it could begin human clinical trials in relation to a formoterol-based inhalation solution. One of the studies tested three batches of formoterol formulations; the composition for one of the formulations eventually would become Sepracor's Brovana product. To support its conclusion that the clinical trial constituted a public use of the compound claimed in the '362 patent, the Court noted that the participants in the trial were under no obligation of confidentiality to Sepracor or Dey, and in fact, the consent forms the participants signed encouraged them to "discuss this study and your participation in it with your regular doctor." Nor was there any indication that the participants' personal doctors were bound by any type of confidentiality agreement. And although participants were encouraged to return unused doses of the medication, the record indicated some participants failed to do so, and were provided with replacement doses. The Court also distinguished a line of cases that Dey cited, holding that clinical trials are experimental in nature and do not constitute public uses. The Court noted that those cases were inapplicable because they involved factual scenarios where the patentee carried out the alleged public use. Here, however, because the public use did not involve the patentee, the Court found the experimental use exception not applicable. The Court concluded that the indicia of lack of confidentiality, coupled with the plain lack of any control or obligations to the patent holder demonstrated that the invention claimed in the '362 patent was in public use during the Sepracor trial of its formoterol inhalation solution.
Next, the Court addressed intervening rights and Sepracor's argument that Dey was precluded under 35 U.S.C. §§ 252 and 307 from recovering any damages for alleged acts of infringement occurring before the '344 and '362 patent reexamination certificates issued. Sepracor argued that because the scope of the asserted claims of those patents was substantively amended to overcome rejections during reexamination, Dey could not seek damages in relation to those claims. Dey argued that the amendments made during reexamination were simply done to clarify the text of the claims or to make them more definitive, and should have been considered identical in scope to the original claims. But Sepracor identified five changes to the asserted claims of the '344 and '953 patents that were substantive in nature. The Court noted that it was only necessary for it to find one substantive change to claim scope made during reexamination for it to preclude the recovery of damages. Ultimately, Sepracor convinced the Court that four out of the five amendments were substantive in nature. The Court concluded that the combination of additions and amendments, such as "by nebulization," "aqueous solution," "without propellant" and a general narrowing of concentration ranges reduced the scope of the independent claims from a ready-to-use formoterol composition that might be administered in a number of ways and forms, to a more specific invention that was for administration by nebulization only.
