Dey v. Sunovion: Shielding Clinical Studies From §102(b) 'Public Use' Scrutiny

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By Nicholas Giove, Frommer Lawrence & Haug LLP

I. Introduction

Dey L.P., Dey Inc., and Mylan Inc. (“Dey”) sued Sunovion Pharmaceuticals Inc. (“Sunovion”) for infringement of a series of patents that cover long-term stable, ready-to-use nebulizer formulations containing the drug formoterol to treat chronic obstructive pulmonary disease (“COPD”).

Sunovion moved for summary judgment of invalidity under 35 U.S.C. §102(b), alleging that the clinical trials of Sunovion's own accused product constituted an invalidating prior “public use” of Dey's asserted claims.

Judge John G. Koeltl of the U.S. District Court for the Southern District of New York granted Sunovion's motion,1 characterizing Sunovion's clinical trial—which by all accounts followed typical clinical trial confidentiality protocols—as “indisputably open and free.”2 Dey appealed.

The Federal Circuit (Judges William C. Bryson, Pauline Newman, and Kathleen M. O'Malley) reversed and remanded Judge Koeltl's grant of summary judgment of invalidity, and in doing so confirmed that “[t]he ‘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.”3

II. Sunovion's Clinical Study (‘Study 50')

Dey and Sunovion independently developed ready-to-use nebulizer formulations containing the drug formoterol and marketed those formulations under the brand names Perforomist®(Dey) and Brovana®(Sunovion).4 Both companies sought and received patent protection for their respective products.5 Before Dey filed its patent applications, Sunovion conducted a clinical trial—Study 50—which tested in human patients the same allegedly infringing formulation that Sunovion ultimately would market as Brovana®.6

The parties did not dispute the essential facts underlying Sunovion's conduct of Study 50: (i) trial investigators and administrators were subject to strict confidentiality obligations that prohibited them from publicly disclosing study information; (ii) subjects self-administered the study medication at home and were expressly permitted to discuss the medication with their personal doctors; (iii) subjects were not bound by a formal confidentiality agreement, but did sign consent forms stating that the medications “must be taken only by the person for whom it was intended”; (iv) subjects were required to carefully track their use of the study medication and return unused medication vials; (v) although subjects knew the active ingredient and the dosage strength of the medication they might be taking—the study was double blind7—they had no information regarding the novel/claimed features of the formulation covered by Dey's patents, e.g., stability characteristics and specific formulation details; and (vi) although thousands of vials of study medication were distributed during the trial, records indicate that only a fraction of 1 percent were lost and not returned.8

III. Majority Opinion (Bryson)
A. The ‘Public Use' Analysis Is ‘Replete with Factual Considerations' to Determine the Degree of Public Accessibility

Under the pre-America Invents Act (“AIA”) version of 35 U.S.C. §102(b), an applicant may not receive a patent for an invention that was “in public use … in this country, more than one year prior to the date of the application for patent in the United States.” 35 U.S.C. §102(b) (2006).9

The Federal Circuit confirmed that a prior use constitutes an invalidating “public use” only if “the purported use: (1) was accessible to the public; or (2) was commercially exploited.”10 The Federal Circuit further confirmed that determining “public accessibility” is a fact-intensive inquiry11 that considers, among other things, “the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use.”12

The same standard for “public accessibility” applies regardless of whether the patentee or—as was the case inDey v. Sunovion—an unaffiliated third party was responsible for the alleged use. The Federal Circuit observed that “[a]lthough prior uses are often carried out by or at the direction of the inventor-patentee, we have held that ‘third party prior use accessible to the public is a section 102(b) bar.’”13 The panel emphasized that:

[e]ven in the case of third-party uses, being “accessible to the public” still requires public availability; secret or confidential third-party uses do not invalidate later-filed patents.14

The Federal Circuit also took the opportunity to reiterate that the lack of a formal confidentiality agreement between Sunovion and the study subjects “does not automatically transform Sunovion's clinical trial into a public use.”15 Indeed, the Federal Circuit has “never required a formal confidentiality agreement to show non-public use.”16 And in the absence of such an agreement, a court must “simply ask whether there were circumstances creating a similar expectation of secrecy.”17

B. Dispelling ‘Misconceptions About the Reach of Section 102(b)'

In addition to confirming the fact-intensive nature of §102(b)’s “accessibility” inquiry, the Federal Circuit also put to rest certain “misconceptions” relied on by Sunovion and the district court regarding the scope of the public-use defense.18

1. Prior Use by an Unaffiliated Third Party Is Not a Per Se ‘Public Use'

Patentee Dey exercised no control over Sunovion's clinical study. And study participants owed no obligation of confidentiality to Dey. The district court seized on those undisputed facts—and Federal Circuit opinions stating that a “[p]ublic use includes ‘any use of [the claimed] invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor’”19—to invalidate Dey's patents.

The Federal Circuit clarified that those statements were “not meant to apply to third-party use cases,” because “[i]f they did, any unaffiliated third-party use, no matter how secret, would necessarily invalidate a patent because such uses are, by definition, made by persons not owing a duty of secrecy “to the inventor.”20 Instead, the “adequacy of the confidentiality guarantees” requires looking at the actions of the party in control of the allegedly invalidating prior use.21

2. Prior User's ‘Knowledge' of Claimed Invention Relevant to Public Accessibility Determination

Relying on opinions stating that “the core issue is not public knowledge of the invention, but the public use of it,” the district court disregarded the fact that—other than the active ingredient and dosage strength—study participants knew nothing about the novel/claimed features of Dey's invention.22 Noting that such arguments take the cited precedent out of context, the Federal Circuit reiterated that although “we do not ask for an ‘enablement-type inquiry’23 under section 102(b), a court still must decide whether the ‘claimed features of the patents [were placed] in the public's possession.’”24 None of the cases cited by Sunovion “permitted the district court to discount the relevance of the study participants' limited knowledge of Batch 3501A's formulation or to sidestep disputed factual questions about the nature of the allegedly public use.”25

IV. Structuring Clinical Trials to Avoid ‘Public Use' Allegations

The Federal Circuit reversed the district court's grant of summary judgment because “[i]mportant issues of fact remain in dispute, principally whether sufficient precautions were taken to exclude members of the public from obtaining information about the potentially invalidating” use of the study medication.26

The Federal Circuit adamantly disagreed with the district court's conclusion “that the use of [study medication] by Study 50 participants was indisputably open and free.”27 In reaching its conclusion the panel noted that: (i) only “a tiny fraction of the thousands of vials [of study medication] were lost”; (ii) “the practicalities of the study required self-administration at home”; (iii) “the particulars” of Dey's invention “embodied in the formulation and stability characteristics of [the study medication] were kept sufficiently confidential”; and (iv) “[i]nvestigators were the most knowledgeable persons involved in the study, and they were required to sign a pledge of confidentiality.28

In dicta that will be of particular interest to innovator pharmaceutical companies, the panel expressly noted that “the confidentiality controls in Study 50 were far from unique” and “[i]n fact, Sunovion appears to have conducted its clinical trial like many others, at least with respect to formal confidentiality obligations and restrictions on information regarding the drugs being studied.”29

Innovator companies may rest easier knowing that so long as they implement typical confidentiality protocols, clinical trials—whether conducted by themselves or an unaffiliated third party—likely should not result in an invalidating public disclosure. Such typical protocols include:

  1. requiring all investigators and administrators to sign formal confidentiality agreements; 30
  2. requiring investigators to maintain records that carefully track the use of study medication distributed to participants;31
  3. requiring participants to maintain daily drug usage logs to track their use of the study medication and to identify any lost doses;32
  4. if the study requires participants to self-administer the study medication at home, requiring participants to acknowledge that only they may take the medication;33 and
  5. avoiding, if ethics permit, disclosing to participants the novel/claimed elements of the patented invention.34

V. Judge Newman's Dissent: No ‘Public Use' as a Matter of Law
In her dissent, Judge Newman agreed in principle with the majority, but would have held further that as a matter of law Sunovion's clinical trial does not constitute an invalidating “public use” of Dey's invention because Sunovion adduced no facts that warrant “casting judicial doubt on the standard confidentiality procedures of clinical trials, at this late date of the decades of established practice.”35

Judge Newman emphasized that “[o]n the uncontested facts, Sunovion's clinical trial was not a ‘public use’ within the meaning of 35 U.S.C. §102(b).”36

VI. Deciding Similar Cases Post-AIA
The Leahy-Smith America Invents Act, Pub. L. No. 112-29 (2011), amended 35 U.S.C. §102 to read as follows:

(a) … A person shall be entitled to a patent unless—(1) the claimed invention was … in public use … or otherwise available to the public before the effective filing date of the claimed invention.

35 U.S.C. §102 (2013).

The amended statute: (i) keys “public use” activities to the “effective filing date of the claimed invention” rather than “one year prior to the [filing] date”37; (ii) expands the “public use” bar to cover activities that occur outside of the United States38; and (iii) provides for certain “grace period” exceptions for a “disclosure made 1 year or less before the effective filing date of a claimed invention.”39

Setting aside the timing and location of the alleged public activities, the “in public use” language of the new statute tracks the old statute.40 And the explicit “available to the public”41 language of the new statute codifies the Federal Circuit's declaration in Dey v. Sunovion that the “public use” inquiry must focus on public availability and accessibility.42

The AIA's legislative history confirms that the new “public use” provisions in post-AIA §102(a)(1) require “an overarching requirement for availability to the public” and “will limit paragraph 102(a)(1) prior art to subject matter meeting the public accessibility standard that is well-settled in current law, especially case law of the Federal Circuit”:

[T]he new paragraph 102(a)(1) imposes an overarching requirement for availability to the public, that is a public disclosure, which will limit paragraph 102(a)(1) prior art to subject matter meeting the public accessibility standard that is well-settled in current law, especially case law of the Federal Circuit.43

Legislative history also suggests, however, the potential for a narrower interpretation than the Federal Circuit's current “accessibility” standard. Sen. Orrin Hatch (R–Utah), speaking in the context of an inventor's own pre-filing disclosure—would further limit “patent-defeating” public uses to disclosures that are both “available to the public and enabled”:

But, the important point is that if an inventor's disclosure triggers the 102(a) bar with respect to an invention, which can only be done by a disclosure that is both made available to the public and enabled, then he or she has thereby also triggered the grace period under 102(b). If a disclosure resulting from the inventor's actions is not one that is enabled, or is not made available to the public, then such a disclosure would not constitute patent-defeating prior art under 102(a) in the first place.44

Such a narrow construction of the post-AIA §102(a)(1) “public use” bar directly contradicts the Federal Circuit's pre-AIA §102(b) “public use” standard, as stated in Dey v. Sunovion:

Put another way, although Sunovion is correct that we do not ask for an “enablement-type inquiry” under section 102(b), a court still must decide whether the “claimed features of the patents [were placed] in the public's possession.”45

The post-AIA “public use” inquiry almost certainly will focus on public availability and accessibility. Whether the Federal Circuit will further limit the defense to “enabling” prior uses seems unlikely in view of the text of post-AIA §102(a)(1) and Federal Circuit precedent to the contrary.

VII. Conclusion
Well-controlled clinical trials conducted by the patentee or an unaffiliated third party pursuant to conventional confidentiality protocols should not trigger §102(b)’s public use bar, even if the study participants are not bound by express confidentiality obligations.

Although it may be several years before the Federal Circuit has the opportunity to weigh in on the post-AIA “public use” standard, the plain language of new §102(a)(1) and the AIA's legislative history suggest that the Dey v. Sunovion “public accessibility” standard will persist.

Edgar Haug and Robert Colletti from the New York office of Frommer, Lawrence & Haug, LLP were of counsel on the brief for plaintiff-appellants on this case.

Nicholas Giove is an associate with Frommer Lawrence & Haug LLP in New York.

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