Does The Experimental Use Exception Survive The AIA?

07 March 2013 PharmaPatents Blog

Now that the March 16, 2013 effective date of the first-to-file provisions of the Leahy-Smith America Invents Act (AIA) is fast-approaching, I have been reviewing the commentary in the USPTO’s February 14, 2013 Federal Register Notices publishing the final First Inventor To File rules and Examination Guidelines. Comment 12 of the Guidelines, which relates to experimental use, caught my attention.

The Examination Guidelines

The discussion of “Comment 12″ of the First Inventor to File Examination Guidelines states:

Comment 12: One comment questioned whether the experimental use exception to public use would continue under the AIA first inventor to file provisions.

Response: Under pre-AIA case law, the experimental use exception negates a use that would otherwise defeat patentability. Neither the AIA nor it legislative history expressly addresses whether the experimental use exception applies to a public use under AIA 35 U.S.C. 102(a)(1), or to a use that makes the invention available to the public under the residual clause of AIA 35 U.S.C. 102(a)(1). Because this doctrine arises infrequently before the Office, and is case-specific when it does arise, the Office will approach this issue when it arises on the facts presented.

I was surprised that the USPTO did not confirm the ongoing viability of the experimental use exception to “public use” prior art.

Experimental Use in the Pharmaceutical Context

Although experimental use may arise “infrequently,” it does arise in the context of pharmaceutical inventions, such as when there was a clinical trial of the invention before a patent application was filed.

Federal Circuit case law holds that a “public use” is

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.

The USPTO First Inventor To File Examination Guidelines are consistent with this principle, stating:

[A]n activity (such as a sale, offer for sale, or other commercial activity) is secret (non-public) if it is among individuals having an obligation of confidentiality to the inventor.

The Federal Circuit applies a “totality of the circumstances” test to assess whether there has been a “public use,” considering factors such as:

  • the nature of the activity that occurred in public
  • public access to and knowledge of the public use
  • whether there was any confidentiality obligation imposed on persons who observed the use
  • whether persons other than the inventor performed the testing
  • the number of tests
  • the length of the test period in relation to tests of similar devices
  • whether the inventor received payment for the testing.

(See Allied Colloids, Inc. v. Am. Cyanamid Co. Fed. Cir. 1995)

In the context of a clinical trial, the court may consider:

  • whether the subjects were bound by confidentiality restrictions
  • whether the subjects knew they were treated with the claimed invention
  • whether the participating physicians were bound by confidentiality restrictions
  • whether the participating physicians knew they were prescribing the claimed invention
  • whether the inventors designed, controlled or monitored the clinical trials
  • whether the results were reported back to the inventors
  • whether any unused product was returned to the inventors
  • whether the clinical trial results were used to improve the tested compositions

(See Janssen Pharm., N.V. v. Eon Labs Mfg., Inc. (Fed. Cir. 2005) (non-precedential)

“Public Use” Still Requires Public Use

As stated elsewhere in the USPTO First Inventor To File Examination Guidelines

[P]ublic use under AIA 35 U.S.C. 102(a)(1) is limited to those uses that are available to the public. The public use provision of AIA 35 U.S.C. 102(a)(1) thus has the same substantive scope, with respect to uses by either the inventor or a third party, as public uses under pre-AIA 35 U.S.C. 102(b) by unrelated third parties or uses by others under pre-AIA 35 U.S.C. 102(a).

Thus, even if the continued viability of a general “experimental use” exception is an open question, exceptions based on a failure to constitute a public use should remain valid under the AIA. Pharmaceutical companies conducting clinical trials before a patent application has been filed should review the factors that a court may consider, and determine whether steps can be taken to increase the likelihood that the clinical trials will not be deemed to constitute a “public” use.

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