Public use bar inappropriate when participants in clinical trials do not discern specifics of new product

Sung-Hoon Kim | May 22, 2013

Dey, L.P. v. Sunovion Pharmaceuticals, Inc.

May 20, 2013

Panel:  Bryson, O’Malley, and Newman.  Opinion by Bryson.  Dissent by Newman.

Summary:

The Federal Circuit reversed and remanded the holding of the District Court that some of Dey’s patents were invalid because a Sunovion’s clinical trial, where Sunovion tested its own product, constituted an invalidating public use.  The Federal Circuit determined that although some of test samples were lost and clinical trial was not perfectly confidential, Sunovion’s clinical trial is not an invalidating public use as long as participants do not recognize the specifics of a new drug.

연방지방법원 뉴욕 남부지원(U.S. District Court for the Southern District of New York)은 Sunovion의 임상실험 (clinical trial)이 공용 (public use)에 해당된다고 판단하여, Dey의 특허가 무효 (invalid)라도 판결하였다.

이에 불복하여, 원고는 연방항소법원 (U.S. Court of Appeals for the Federal Circuit)에 상고 (appeal)하였다.  연방항소법원은 임상실험 도중 test sample이 분실되었거나 임상실험이 완벽히 비공개로 진행되지 않았더라도 실험참가자가 신약에 대한 자세한 정보를 모른다면Sunovion의 임상실험은 공용에 해당되지 않는다고 판결하였다.

Details:

Patents at issue:

During the late 1990s and 2000s, both Sunovion and Dey developed pharmaceutical products to treat lung disease.  Sunovion filed a patent application, followed by an application to test its product in human subjects, and then received a patent and held clinical trials.  Like Sunovion, Dey filed a series of patent applications, received several patents, ran human subject trials, and released a commercial product.

Dey’s patent applications were filed after Sunovion’s, and Dey received its patents after consideration of Sunovion’s patent.

Sunovion owns U.S. Patent No. 6,040,344, which was issued in March 2000 from an application filed in 1998.  Dey owns two families of patents, the second of which were all issued in 2008 or 2009, but claimed the benefit of an application filed on July 2003.

Clinical trial:

Sunovion produced a commercial product called Brovana in 2007.  In February 1998, Sunovion filed an Investigational New Drug application with the FDA and began clinical trials (“Study 50”) with human subjects.

The participants in Study 50 were given some information about the study and were subject to certain controls.  However, they were not provided with any more specific information about the formulation of formoterol known as Batch 3501A.  They signed a consent form stating that the medications “must be taken only by the person for whom it was intended,” and that subjects would have to keep dosage logs and return unused medications.  They were responsible for securely storing the drug and maintaining records of its disposition and use.  They were allowed to discuss this study with their doctors and were not prohibited from speaking with others about the study.

The test administrators were also subject to detailed restrictions.  They had to sign a formal “Clinical Investigator Confidentiality Agreement.”  They were forbidden from disclosing the study protocols or dispensing the drug to any person who was not a trial subject.  They were instructed to return unused supplies of the drug.

The study records indicate that a fraction of one percent of vials containing Batch 3501A were lost and not returned.

Anticipation and public use bar:

§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 U.S.”

Factors to be considered: 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).

Other factors: “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.” Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371, 1379 (Fed. Cir. 2004).

Unaffiliated third party: the same rule applies when an unaffiliated third party is responsible for the allegedly public use; “third party prior use accessible to the public is a section 102(b) bar.” Eolas Techs. Inc. v. Microsoft Corp. 399 F.3d 1325, 1334 (Fed. Cir. 2005).

District court:

Dey sued Sunovion for patent infringement.  Sunovion moved for partial summary judgment, asserting that its own clinical trial anticipated Dey’s inventions and was accessible to the public, thereby invalidating Dey’s patents.

The District Court held that Sunovion was entitled to summary judgment of invalidity because Sunovion’s own clinical trial constituted clear and convincing evidence of a third-party public use of Dey’s inventions.

The District Court determined that the use of Batch 3501A by Study 50 participants was open and free: participants were given the drugs and took them home; a few participants failed to return unused medications, as they were required to do, but nonetheless were given more of the medication.

The District Court determined that confidentiality obligations imposed in Study 50 were so loose that summary judgment of invalidity was justified: participant “may wish to discuss this study and your participation in it with your regular doctor.”

In sum, the District Court held that the patented invention was in public use when Sunovion used it in its clinical trial in light of “all of the indicia of lack of confidentiality of the clinical trial in this case, coupled with the plain lack of any control or obligations to the patent holder.”

CAFC:

The Federal Circuit held that Sunovion has not shown that it is entitled to summary judgment based on its assertion that its clinical trial constituted a public use of Dey’s invention within the meaning of §102(b), and therefore, reversed the grant of summary judgment for Sunovion.

The Federal Circuit determined that the use of Batch 3501A by Study 50 participants was not open and free: the fact that a tiny fraction of the drug was lost does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted.

The Federal Circuit determined that confidentiality obligations imposed in Study 50 were not so loose that summary judgment of invalidity was justified: participants were not told the identity of the particular drug or formulation they were receiving even if they were permitted to discuss the study with their doctors.

In sum, the Federal Circuit held that a reasonable jury would conclude that the study was conducted with a reasonable expectation of confidentiality as to the nature of the formulations being tested (“closely monitored clinical trial”), and therefore, summary judgment on the public use issue is inappropriate.

Dissenting opinion:

Judge Newman agreed with the majority that the District Court’s holding should be reversed and held that Sunovion’s clinical trial does not constitute an invalidating “public use” of Dey’s invention.

However, Judge Newman found that there no pertinent fact remains at issue: the facts of the clinical trials are well-established in FDA records and are uncontested by the parties; the formulation and quantity of drug distributed are known; the number of trial participants, the terms of participation agreements, the information disclosed to the trial participants, the restrictions on drug use and distribution imposed by Sunovion are all known.

Therefore, since the court failed to identify any material facts in dispute, Judge Newman held the entry of judgment for Dey.

Takeaway:

When performing clinical trials/experiments for new products, Applicants should carefully draft confidentiality agreements for all participants in the trials/experiments so that the specifics of new products are not disclosed to the public.  Also, applicants should closely monitor the status of used/unused sample during the trials/experiments.  However, they do not have to panic if a small number of the samples are lost as long as participants are not informed of and cannot readily identify the claimed features of new products.

Patent At Issue

Full Opinion

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