Orange Book Blog

ACI "Paragraph IV Disputes Master Symposium," Chicago, October 3-4

American Conference Institute will be holding its first-ever "Paragraph IV Disputes Master Symposium" next week, October 3-4, in Chicago.  McAndrews, Held & Malloy Partner Scott McBride will be speaking at the conference on claim construction strategies.  The rest of the agenda is as follows:

• Identifying patents which may be ripe for challenges of invalidity and noninfringement: offensive and defensive strategies for brand and generic companies
• Use of IPR and other PTO proceedings in a paragraph IV challenge: strategies for brand names and generics in navigating new proceedings in alternate and parallel forums which may change the rules of the Hatch-Waxman endgame
• The start of the paragraph IV litigation countdown: the paragraph IV certification and notice letter
• Obviousness in review: formulating assertions and defenses in view of new substantive and procedural developments in the federal courts and PTO
• Advanced strategies for drafting and perfecting pleadings and effectively using dispositive motions in paragraph IV disputes
• Of customs and courts: the importance of mastering the requirements of local patent rules in paragraph IV disputes
• A view from the bench (featuring Judge Davis of the E.D. Tex.; Judge Holderman of the N.D. Ill.; and judges Brown, Pisano, and Bongiovanni of the D.N.J.)
• The end of Roche v. Bolar? Understanding how new 271(e)(1) controversies may alter the course of brand name and generic strategies in paragraph IV litigation relative to safe harbor research exceptions
• Mastering regulatory maneuvers in paragraph IV disputes: seeking relief from the FDA in the course of Hatch-Waxman litigation
• New exclusivity challenges for brand names and generics
• Pay-for-delay and settlement drafting update
• Continuing claim construction conundrums impacting Markman strategies
• Evolving theories of inducement and divided infringement in paragraph IV litigation concerning method of treatment patents
• Protonix--case study of an at-risk launch: pros and cons of launching at risk and survey of new developments in seeking injunctive relief and damages
• Inequitable conduct: ethical considerations for paragraph IV matters before the PTO and district court

In addition, ACI is offering two pre-conference workshops on October 2: "Hatch-Waxman and BPCIA Master Class--Perfecting Your IP and Regulatory IQ of Small and Large Molecules"; and "Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios."

Orange Book Blog readers receive discounted registration with code OBB 200.  For more information or to register, please visit the conference website.

Invalidity Due to Public Use in ANDA Cases

Pronova Biopharma Norge v. Teva Pharms., No. 2012-1498 (Fed. Cir.)

    by Aaron F. Barkoff

It is not unusual for a defendant in an ANDA case to assert invalidity due to prior public use, but it is rare that such a defense succeeds.  In a unanimous decision last week, the Federal Circuit held the asserted claims of Pronova's U.S. Patent No. 5,656,667 invalid as anticipated by prior public use, reversing a District of Delaware trial decision in the process.

Pronova's '667 patent protects Lovaza capsules, a drug product derived from fish oil and indicated to reduce triglyceride levels.  The asserted claims of the '667 patent were directed to pharmaceutical compositions comprising specific concentrations of different omega fatty acids.

The parties agreed that more than one year before the priority date of the '667 patent, Pronova's predecessor shipped two vials of a composition that met all of the limitations of the asserted claims to a third-party researcher, Dr. Skrinska.  Evidence at trial showed that Skrinska "tested the two samples to confirm (and did confirm) their content."  There was no evidence, however, that Skrinska used the samples to reduce triglyceride levels in a person.

The primary issue on appeal was whether Pronova's shipment of the samples and Skrinka's testing amounted to an invalidating public use.  Pronova argued that to be invalidating under § 102(b), an invention must be used by someone other than the inventor for its intended purpose—here, to reduce triglyceride levels.  The ANDA filers, on the other hand, contended that an invalidating public use need not be the intended use of the invention, as long as the invention is fully disclosed without restriction.

The Federal Circuit explained the test for "public use" in Invitrogen v. Biocrest:

The proper test for the public use prong of the § 102(b) statutory bar is whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.  Commercial exploitation is a clear indication of public use, but it likely requires more than, for example, a secret offer for sale.  Thus, the test for the public use prong includes the consideration of evidence relevant to experimentation, as well as, inter alia, the nature of the activity that occurred in public; public access to the use; confidentiality obligations imposed on members of the public who observed the use; and commercial exploitation.

The Federal Circuit held that the "use" in Pronova met this test, stating:

Because we find that [Pronova] sent samples of the invention claimed in the '667 patent Skrinska . . . without restriction and Skrinska thereafter tested the samples, we hold that [Pronova] put its invention to an invalidating public use.

The court contrasted this case to Dey v. Sunovion, another recent case in which an ANDA filer asserted prior public use as an invalidity defense.  There, the purported public use was a clinical trial of the claimed pharmaceutical composition.  But there, as the court explained:

Because only the clinical trial administrator, not the subjects taking the medication, was made aware of the invention's claimed formulation and stability characteristics, and the administrator had signed a pledge of confidentiality, we held that "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, [such that] summary judgment on the public use issue was inappropriate."  A fact finder could so conclude even though the subjects did not likewise sign a confidentiality pledge because "they were given incomplete descriptions of the treatment formulation."

Finally, the court addressed Pronova's argument that only the "intended use" of a pharmaceutical can qualify as a "public use":

We are not persuaded by Pronova's argument that "use" of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract, or at least physically ingested.  Certainly, where . . . unsophisticated users are provided a compound with no detail regarding its formulation—as in Dey—there will be no public use.  Where, as here, however, a compound is provided without restriction to one highly skilled in the art, that compound's formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one.  Once the formulation was disclosed in full to Skrinska, without any restriction on its use, it had been released into the "public domain" for purposes of 102(b).