United States: Don't Let A Disclosure Or Sale Thwart Your Patent Protection

One of the statutory bars to patentability in the United States prohibits a claimed invention from being described in a printed publication, being in public use or on sale, or being otherwise available to the public before the effective filing date of the claimed invention.¹ The first three restrictions are generally referred to as a bar on public disclosure, public use bar, and on-sale bar, while the last is a catch-all provision. The law does provide for a grace period if the restricted activity occurred one year or less before the effective filing date of a claimed invention (e.g., the filing of a patent application) and was done by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or joint inventor.²

While the text of the relevant section may seem straightforward, many real-world scenarios raise questions as to what constitutes a public disclosure, public use, sale, or public availability. Understanding what has been found to bar patent validity informs the type of dialogue needed with an inventor to assess whether patentability has been or may be affected. That assessment then guides next steps in protecting the inventor's intellectual property.

WHAT MAY BE DEEMED PUBLIC DISCLOSURE

The Manual of Patent Examining Procedure (MPEP), which is published by the United States Patent and Trademark Office (USPTO) as guidance to patent examiners, expands on different aspects of the public disclosure bar and on-sale bar. For example, there is currently no geographic limitation on where prior public use or availability occurs under the September 2011 law established by the America Invents Act (AIA).³ In addition, public use is clarified as referring to use by one who is under no limitation, restriction, or obligation of confidentiality to the inventor.⁴ The on-sale bar is distinct from the bar on public disclosure in that even a sale made without public knowledge to a third party buyer under obligation to keep the invention confidential can disqualify an invention from patentability.⁵ The U.S. Supreme Court set out a two-part test, referred to as the Pfaff test, to determine the applicability of the on-sale bar: whether the invention was ready for patenting, and whether the invention was subject to a commercial offer for sale. Both conditions must be true to apply the on-sale bar.⁶

On the other hand, sale or other use that is commercially exploited is distinguished from permissible experimentation. An inventor may conduct extensive testing without losing the right to subsequently obtain a patent, even if the testing occurs in the public eye.⁷ The U.S. Court of Appeals for the Federal Circuit adapted the Pfaff test in the context of public use, rather than sale, such that the inquiries are: whether the invention was ready for patenting, such that the use was not experimental, and whether the use was public, which is only permitted when the use is experimental.⁸ The answer to both inquiries must be positive for a claimed invention to be barred due to public use.

A 2016 decision from the U.S. District Court for the District of Delaware touched on both aspects of the two-part inquiry regarding public use. Sanofi had undertaken a clinical trial more than a year prior to the effective filing date of its 8,410,167 ('167) patent, and alleged infringer Glenmark used the clinical trial to assert public use by Sanofi that invalidated the '167 patent.⁹ With regard to the second part of the two-part inquiry, Glenmark emphasized the lack of confidentiality restrictions on patients participating in the trial and the fact that the clinical trial protocol itself was not kept confidential.¹⁰ However, the court found the clinical trial to be plainly an experimental use, citing Glenmark's failure to meet the heavy burden of demonstrating, by clear and convincing evidence, that the claimed inventions had been reduced to practice during prior clinical trials and before the critical date of one year prior to the effective filing date of the '167 patent.¹¹

In addition, although concluding that the clinical trial was experimental use was sufficient to preclude the public use bar, the court also addressed whether the use was public.¹² The court noted that lack of confidentiality provisions for patients is not determinative on the public nature of use.¹³ Additionally, in the Sanofi case, the investigators involved in the clinical trial, the physicians to whom a method of treatment would be most significant, were subject to confidentiality obligations, as were others overseeing and observing the trial, such as study managers contracted with oversight.¹⁴ Thus, the court concluded that, even if the use had not been experimental, it was not public use that barred patent validity.¹⁵

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Footnotes

1. 35 U.S.C. § 102(a)(1).

2. 35 U.S.C. § 102(b)(1)(A).

3. MPEP 2152.02(c).

4. Id.

5. MPEP 2152.02(d).

6. Pfaff v. Wells Electronics, Inc., 525 U.S. 55,64, 119 S. Ct. 304, 142 L.Ed.2d 261 (1998).

7. Id.

8. Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005).

9. Sanofi v. Glenmark Pharms. Inc., 204 F.Supp.3d 665,698 (D. Del. Aug. 31, 2016).

10. Id.

11. Id.

12. Id at 699.

13. Id citing Bayer Schering Pharma AG v. Barr Labs. Inc., 2008 WL 628592, at *38 (D.N.J. Mar. 3, 2008).

14. Sanofi at 699.

15. Id.

Originally Published by Intellectual Property & Technology Law Journal

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