by Dennis Crouch
More to come on this case, but I wanted to provide readers with the filed briefs below.
The Medicines Co. v. Hospira (Fed. Cir. 2016) (en banc)
Briefing is now complete in the en banc challenge to the ‘no-supplier-exception’ to the on-sale bar. The en banc question here focuses on when a manufacturing supply contract crosses-the-threshold into impermissible “on sale” activity and raises the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA). Although the patents at issue in this case involve pre-AIA law, the same “on sale” language is found in the revised statute. If the post-AIA statute is interpreted so that sales still include ‘secret sales’ then the decision here will continue to be of substantial importance. (Note that the U.S. Government argues that pre-AIA precedent is wrong and that secret sales should not trigger the on sale bar even pre-AIA).
The following questions are presented for the en banc panel:
1. Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. § 102(b)?
(a) Was there a sale for the purposes of § 102(b) despite the absence of a transfer of title?
(b) Was the sale commercial in nature for the purposes of § 102(b) or an experimental use?
2. 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)?
The parties here include MedCo (the Patentee) who (prior to filing the patent application) hired Ben Venue Mfg. to actually produce ‘validation batches’ of its bivalirudin drug. Hospira is challenging the patent and is seeking approval to market a generic version.
The original panel found that the sale constituted an invalidating on-sale bar. Of interest here, the “sale” was Ben Venue’s “sale of services” to manufacture the patented product-by-process rather than sales of the product themselves. The original panel found no principled distinction between these concepts – thus applying the on sale bar. Because the ‘sales’ at issue were associated with MedCo’s ‘validation batches,’ the patentee has also now argued experimental use.
Friend of the Court Briefs:
- US Amicus Brief (secret sales and secret offers should not be seen to trigger the on sale bar).
- AIPLA Amicus Brief (transfer of title is not required for an on sale bar trigger)
- BIO Amicus Brief (the original panel’s interpretation is bad policy)
- Gilead Amicus Brief (only “arm’s length sales between two entities” qualify for the on sale bar; here that does not apply when an inventor controls (through contract) the activities of the manufacturer).
- HIPLA Amicus Brief (experimental use continues to be an exception to the patent negating effect of on sale activity)
- IPO Amicus Brief (Contract manufacturing is not a ‘sale’)
- Miller Patti Pershern Amicus Brief (for AIA patents, this ‘flaw’ in the system has been corrected because only prefiling public sales activity triggers the patent prohibition)
- Prof Morris Amicus Brief (focus should be on whether the inventor made a sale, here the inventor was the buyer and there is no “on buy” bar; on sale activity should not be termed ‘prior art.’)
- PRMA Amicus Brief (Parties should be permitted to outsource manufacturing prior to filing for patent protection).