Composition and device inventions are “strict liability” for “public use” bar and infringement

Recently, I had a businessperson telling me that her competitor has a patent on a composition for treating an inflammatory condition.  The claim of the composition is recited as:

“A composition for treating an inflammatory condition X, wherein the composition comprises A, B and C.”

The businessperson’s conclusion is that she can sell the composition as long as she does not tell people to use it for treating the inflammatory condition.  She is wrong.

In a typical composition claim as recited above, the stated “purpose” does not really matter.  The claimed invention is the composition including A, B and C.  Therefore, the above claim basically exclude others from making, using, selling and offering to sell “a composition including A, B and C” regardless of the purpose.  In another word and borrowing a term from the tort law, this is a “strict liability” claim.

The encounter made me think—what about “a public use” of the above composition for treating a different condition? Would such public use trigger the “public use” bar under 35 U.S.C. § 102(b) (2006) (pre-America Invents Act) (current version at 35 U.S.C. § 102(a)(1)(2012))? 

Here is the text of the 35 U.S.C. § 102(a)(1)(2012):

“A person shall be entitled to a patent unless...the claimed invention was … in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention…”

The Federal Circuit’s answer to the above question is yes.  Here is the case on point: Pronova BioPharma Norge AS v. Teva Pharmaceuticals USA, Inc., which is a pending petition before the Supreme Court.  This issue being petitioned is: whether the statutory bar for “public use” of an invention under 35 U.S.C. § 102(b) (2006) (pre-America Invents Act) (current version at 35 U.S.C. § 102(a)(1)(2012)) broadly bars a patent when an innovator company allows any public access to its invention even if the invention is not actually used in public for its intended purpose.

Pronova v. Teva (Fed. Cir. Sept. 12, 2013) is a non-precedential case by the Federal Circuit.  In this non-precedential opinion, the CAFC invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations because Pronova's predecessor in interest had permitted unrestricted use of formulations falling with the scope of the claims.  In this decision, the CAFC confirmed that a public use requires the disclosure of all aspects of the claimed invention in public and without limitations regarding secrecy or use.  The CAFC ruled that the Pronova's predecessor’s submission of samples of the claimed formulation to a research scientist without restriction, along with a disclosure of the compound’s formulation and the scientist’s subsequent confirmatory analytical testing constituted an invalidating public use.  The CAFC rejected Pronova’s argument that the samples had to actually be used for their intended purpose in order to constitute an invalidating public use.  Specifically, the CAFC stated that "[a]n invalidating public use need not be the intended use of the invention disclosed or claimed in the patent as long as the invention is fully disclosed without restriction." 

In another word, for triggering public use bar to patentability, how the claimed invention is used does not matter.  What matters is that the public has the unrestricted access to the claimed invention—it’s a strict liability.

Thanks for reading.

Connie

connie@patentonomy.com

What is a “public use” bar to patentability?

 “Public use” and “on sale” are often the first bars applied to the patentability of a claimed invention.  According to the America Invents Act (AIA) 35 U.S.C. § 102(a)(1),“A person shall be entitled to a patent unless...the claimed invention was … in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention…”  Therefore, if you sell in public or allow the public access to your invention before you filing for the patent protection, the invention is no longer patentable.

The standard for “public use” is well established by the case law.  The "seminal case" regarding “public use” is Egbert v. Lippmann, 104 U.S. 333, 336 (1881) (the corset case, which has been studied by every patent law student), where the Court posed the essential question:  "[w]as the invention's use public in the sense that it was made available to others with no limitation or restriction?"  In Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351, 1355 (Fed. Cir. 2013), the CAFC reiterated that the standard for public use is where "a completed invention is used in public, without restriction." 

Public use can be negated where there exists disclosure under a confidentiality agreement or "similar expectations of secrecy," Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005).  One measure of the extent to which the disclosure is confidential (as opposed to "public") is "the amount of control which the discloser retains over the invention during the uses in question." See, Lough v. Brunswick Corp., 86 F.3d 1113, 1121 (Fed. Cir. 1996) (insufficient control); Eolas Technologies Inc. v. Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (unrestricted disclosure to employees); Beachcombers, International, Inc. v. Wildewood Creative Products, Inc., 31 F.3d 1154 (Fed. Cir. 1994) (unrestricted disclosure to party-goers); and Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265–67 (Fed. Cir. 1986) (inventor retained control of puzzle and information).   The "sophistication of those to whom disclosure was made" is also a factor in the extent to which a use is a public use.

Public use can also be negated where some but not all aspects of an invention are disclosed. See, W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1549 (Fed. Cir. 1983) and Janssen Pharmaceutica, N.V. v. Eon Labs Mfg., Inc., 134 F. App'x 425, 431 (Fed. Cir. 2005) (all aspects of the invention must be disclosed). 

Therefore, to protect your invention against “public use” and “on sale” bar, you should only disclose your complete invention to a third party under a confidentiality agreement and don’t start selling or offering to sell or license your invention before filing for the patent protection.

Thanks for reading.

Connie

connie@patentonomy.com