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Nov. 13 — The Federal Circuit agreed Nov. 13 to hear as a full court what qualifies as a “commercial offer for sale” that kicks off the one-year patent application filing requirement.
In this case, The Medicines Co. owns patents covering “pharmaceutical batches” for making Angiomax (bivalirudin), known as a product-by-process patent.
A three-judge panel held that the company's request to supplier Ben Venue Laboratories to prepare three batches according to the new process was a commercial offer. The request occurred more than one year before Medicines applied for the patent, rendering the patent invalid under the panel's decision.
The panel held that “The Medicines Company paid Ben Venue for performing services that resulted in the patented product-by-process, and thus a ‘sale' of services occurred.”
Those services were not for experimental purposes—which don't count in the on-sale bar consideration—the court said, because Medicines realized “a commercial benefit” from the supply: Medicines used the result to prove to the Food and Drug Administration that the process would produce “already-approved specifications for finished bivalirudin product.”
The court is asking Medicines, the generic drug maker and alleged infringer Hospira Inc., which became part of Pfizer Inc. in September, the U.S. Department of Justice, and any interested third parties to weigh in on these questions:
(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[, 60 U.S.P.Q.2d 1537] (Fed. Cir. 2001), that there is no “supplier exception” to the on-sale bar of 35 U.S.C. §102(b)?
Mylan Inc. will undoubtedly be an additional interested party, as both it and Hospira are seeking to market generic bivalirudin as an injectable that is given to patients undergoing angioplasty, a procedure used to clear clogged coronary arteries.
Mylan is separately appealing a district court's October 2014 infringement finding based on its abbreviated new drug application (ANDA).
By contrast, a different district court determined that Hospira's proposed generic would not infringe Medicines' patents. Medicines appealed that judgment, but the Federal Circuit panel didn't rule on it. Meds. Co. v. Hospira, Inc., 791 F.3d 1368, 115 U.S.P.Q.2d 1587 (Fed. Cir. 2015).
The panel would have to consider Hospira's noninfringement if the en banc court reverses the panel's on-sale bar decision.
“We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan, and other generics,” Medicines' CEO Clive Meanwell said in a statement after the en banc court's announcement.
The on-sale bar is a feature of the Patent Act prior to the 2011 enactment of the America Invents Act. Pre-AIA Section 102(b) bars patenting an invention that was “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 AIA changed the U.S. system from first-to-invent to first-inventor-to-file. The changeover, which applies to patent applications with an effective filing date of March 16, 2013, or later, eliminates the need for an on-sale bar but in essence replaces it with a rough equivalent: Anything the patent applicant does more than one year before filing may be a “disclosure” that can be used by the Patent and Trademark Office to reject a proposed patent claim as anticipated or obvious.
No case has yet delved into the definition of “disclosure” to assess whether the “commercial sale” or “experimental use” distinction remains relevant under the AIA.
Hospira’s response is due Dec. 28. Medicines’ response brief is due 30 days after Hospira files.
Edgar Haug of Frommer Lawrence & Haug LLP, New York, represented Medicines. Hospira was represented by Bradford P. Lyerla of Jenner & Block LLP, Chicago.
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