United States: After District Court Invalidates Pharmaceutical Product Patent Based On Clinical Trials, Federal Circuit Reverses Because Clinical Trial Was Not Public

Last Updated: July 22 2013
Article by Stanley M. Gibson

Sunovion Pharmaceuticals, Inc. ("Sunovion") and Dey L.P., Dey, Inc., and Mylan, Inc. (collectively, "Dey") develop pharmaceutical products to treat lung disease. Sunovion filed a patent application, followed by an application to test its products in human subjects. After it received a patent, it held a series of clinical trials before it finally released a commercial product, known as Brovana, in 2007.

Dey also filed a series of patent applications, for which it received several patents. It also ran clinical trials and ultimately released a commercial product. Dey's patent applications were filed after Sunovion's, and its patents were issued after Sunovion's patent was considered.

As explained by the Federal Circuit, "[b]oth parties own patents and sell products concerning the treatment of chronic obstructive pulmonary disease ("COPD") by storing the compound formoterol in an aqueous solution and administering it through a nebulizer. Sunovion owns U.S. Patent No. 6,040,344 (the "Gao patent"), which issued in March 2000 from an application filed in 1998. Dey owns two families of patents, the second of which includes U.S. Patent Nos. 7,348,362; 7,462,645; 7,465,756; 7,473,710; and 7,541,385. The patents in the second Dey family all issued in 2008 or 2009 but claim the benefit of an application filed on July 10, 2003. According to Dey, the significant difference between the two companies' patents relates to the stability of the formulations during long-term storage."

During the case, the parties stipulated that the formulation of a particular batch of the product, Batch 3501A, is identical to the formulation that Sunovion ultimately marketed as Brovana. As part of the clinical trials, a total of 587 subjects participated in the study. Of those, 124 received Batch 3501A. At least some of those individuals received Batch 3501A prior to July 10, 2002, which was more than one year before Dey filed the patent application that led to its second family of patents.

In March 2007, before Brovana launched, Dey filed a patent infringement action asserting that Sunovion infringed its first and second families of patents. Sunovion moved for partial summary judgment, and the district court granted the motion. As explained by the Federal Circuit, as part of that motion, Sunovion conceded that "the Batch 3501A composition [fell] within the asserted claims stemming from Dey's second family of patents," which meant that the composition would anticipate Dey's asserted claims if it was in "public use," under 35 U.S.C. § 102(b). The district court concluded that Sunovion's clinical trial of Batch 3501A did constitute a "public use" of Dey's inventions, and, accordingly, held the asserted claims of Dey's second family of patents invalid. Dey appealed from the district court's ruling on summary judgment.

On appeal, the Federal Circuit analyzed whether the prior use of the formulation in clinical trials constituted an invalidating public use. "To decide whether a prior use constitutes an invalidating 'public use,' we ask 'whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.'" Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).

The Federal Circuit analyzed the facts as follows: "[t]he district court focused its analysis on two fact-bound issues. On both, we view the record differently than did the district court. First, we do not share the court's belief that the use of Batch 3501A by Study 50 participants was indisputably open and free. The district court observed that participants were given the drugs, took them home, and, 'whether or not they would have been able to reverse engineer batch 3501A . . . used the invention as intended.' The court also highlighted the fact that a few participants failed to return unused medication, as they were required to do, but nonetheless were given more of the medication. Based on those facts, the court concluded that the participants 'were not prevented from using their personal supply of that substance however they saw fit' and that 'the participants' unfettered use of the composition for weeks at a time itself constituted a public use.'"

The Federal Circuit was not persuaded that confidentiality was broken: "The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public."

As result, the Federal Circuit concluded that the case did not involve undisputed evidence of a complete lack of confidentiality protections, "as there was in prior cases basing invalidity on third-party public use. See Eolas, 399 F.3d at 1335; Baxter, 88 F.3fd at 1058-59; Beachcombers, 31 F.3d at 110. And the fact no formal obligation of secrecy was imposed on the study subjects does not automatically transform Sunovion's clinical trial into a public use. We have never required a formal confidentiality agreement to show non-public use, e.g., Bernhardt, 386 F.3d at 1379-81; in the absence of such an agreement, we simply ask whether there were 'circumstances creating a similar expectation of secrecy,' Invitrogen, 424 F.3d at 1382. The 'public use' inquiry is replete with factual considerations, such as the (disputed) extent to which study participants were informed of and able to disclose the pertinent details of the claimed prior art. See, e.g., W.L. Gore, 721 F.2d at 1549. Because a finder of fact could conclude that the study was conducted with a reasonable expectation of confidentiality as to the nature of the formulations being tested, summary judgment on the public use issue was inappropriate."

The Federal Circuit also found that the district court's decision was premised on misconceptions regarding Section 102(b). As the Federal Circuit explained, "[f]irst, the court found it significant that the patent holder, Dey, did not control Sunovion's clinical studies and that study participants did not owe any obligation of confidential to Dey." The Federal Circuit explained that this analysis was not correct because "we measure the adequacy of the confidentiality guarantees by looking to the party in control of the allegedly invalidating prior use. In third-party use cases, that is the third party." As a result, the Federal Circuit found that "[b]ecause a secret third-party use is not invalidating, our task is to assess whether the third party's use was sufficiently 'public' to impose the section 102 bar. That Sunovion's trial subject owed no duty of confidentiality to Dey is, of course, true, but it does not bear on that question."

Finally, the Federal Circuit concluded that "[b]y allowing publicly accessible prior uses to block a later-filed patent, the public use bar seeks to prevent assigning a monopoly to "inventions that the public reasonably has come to believe are freely available." Tone Bros., 28 F.3d at 1198. Study 50, with all of its restrictions on the use of the drugs and information concerning the formulations, does not indisputable fall within that description. Accordingly, we decline to hold, on summary judgment, that Sunovion"s clinical trials of its own product represent clear and convincing evidence that Deys inventions were accessible to the public more than a year before Dey sought to patent them."

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