CAFC to Rehear On-Sale Bar Novelty Case

CAFC to Rehear On-Sale Bar Novelty Case

The Medicines Co v Hospira, [En Banc Order] [Original Opinion]

Does a private sale from a supplier count as a novelty-destroying disclosure?  A series of cases has held that, yes, a simple purchase from a supplier can constitute disclosure that could compromise the patentability of the product being sold (the “on-sale bar”). One of such cases, The Medicines Co v Hospira, is currently being reconsidered by the Court of Appeals of the Federal Circuit (CAFC).

In the original opinion, the CAFC ruled that sale of bivalirudin tablets from Ben Venue Laboratories to The Medicines Company was a disclosure that destroyed the novelty of the patent at issue. [8] The CAFC pointed to 35 U.S. Code § 102 (b):

A person shall be entitled to a patent unless —

…(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States …

The facts begin with The Medicines Company developing a new method of producing bivalirudin. During development, The Medicines Company purchased several batches of bivalirudin made by this new method from Ben Venue Laboratories, but did not file for patents on the new method until more than a year later. [2]

The CAFC rejected the argument that these sales were saved under the experimental use exception. [6-7] The CAFC’s reasoning was that “the intent of [invalidating claims under the on-sale bar] is to preclude attempts by the inventor or his assignee to profit from commercial use of an invention for more than a year before an application for patent is filed.” [4] Here, a sale was made for services that resulted from the patented process. The commercial benefit to The Medicines Company was that it could prove to the FDA that it could make a product that passed specifications. [5]

And even though the invention was not reduced to a written description so as to enable the person skilled in the art to practice the invention, the invention was still “reduced to practice” by the sale. [8]

The CAFC therefore invalidated the patent. [8]

But the CAFC has now granted a petition for a rehearing the case on this issue of whether or not the sale of bivalirudin from the supplier gave rise to an on-sale bar. More specifically, the CAFC set out the issues as follows:

(a) Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. § 102(b)? (i) Was there a sale for the purposes of § 102(b) despite the absence of a transfer of title? (ii) Was the sale commercial in nature for the purposes of § 102(b) or an experimental use?

(b) Should this court overrule or revise the principle in Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001), that there is no “supplier exception” to the on-sale bar of 35 U.S.C. § 102(b)?


An interesting factor at play here is that the novelty provisions under 35 U.S. Code § 102 have changed since the America Invents Act. The “on-sale” language is now under Section 102 (a)(1) and the structure of Section 102 has been reworked to reflect a first-inventor-to-file (FITF) system.

Although there is little change to the “on-sale” language, some argue that, under the new FITF system, novelty destroying sales should only include sales that are made available to the public – not between suppliers. This change would certainly seem to accord better with the fundamental bargain theory behind patent law, which holds that patents are granted in exchange for disclosing an invention to the world. A private sale between suppliers might not necessarily be a disclosure of the invention to the world.