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The Medicines Co. v. Hospira, Inc.

United States Court of Appeals, Federal Circuit

July 11, 2016

THE MEDICINES COMPANY, Plaintiff-Appellant
v.
HOSPIRA, INC., Defendant-Cross-Appellant

         Appeals from the United States District Court for the District of Delaware in No. 1:09-cv-00750-RGA, Judge Richard G. Andrews.

          Edgar Haug, Frommer Lawrence & Haug LLP, New York, NY, argued for plaintiff-appellant. Also represented by Porter F. Fleming, Angus Chen, Jason Ari Kanter, Laura Krawczyk, Catalin Sebastian Zonte; Damon Marcus Lewis, Washington, DC.

          Bradford Peter Lyerla, Jenner & Block LLP, Chicago, IL, argued for defendant-cross-appellant. Also represented by Sara Tonnies Horton, Aaron A. Barlow; Joshua Segal, Washington, DC.

          Megan Barbero, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for amicus curiae United States. Also represented by Mark R. Freeman, Benjamin C. Mizer; Thomas W. Krause, Robert McBride, Joseph Gerard Piccolo, Kristi L. R. Sawert, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

          Doris Hines, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, for amicus curiae American Intellectual Property Law Association. Also represented by David Mroz, Erin McGeehan Sommers; Denise Whelton DeFranco, American Intellectual Property Law Association, Arlington, VA.

          Emily Curtis Johnson, Akin, Gump, Strauss, Hauer & Feld, LLP, Washington, DC, for amicus curiae Intellectual Property Owners Association. Also represented by James Edward Tysse; Michael P. Kahn, New York, NY; Mark W. Lauroesch, Intellectual Property Owners Association, Washington, DC; Steven W. Miller, Procter & Gamble Company, Cincinnati, OH; Kevin H. Rhodes, 3M Innovative Properties Company, St. Paul, MN.

          Anthony Miller, Miller, Patti, Pershern PLLC, Dallas, TX, for amicus curiae Miller, Patti, Pershern PLLC. Also represented by John Jeffery Patti, Steven Scott Pershern.

          Tamsen Valoir, Boulware & Valoir, Houston, TX, for amicus curiae Houston Intellectual Property Law Association. Also represented by Mark John Gatschet, Mark John Gatschet, PLLC, Austin, TX.

          Eric J. Marandett, Choate, Hall & Stewart, LLP, Boston, MA, for amicus curiae Biotechnology Innovation Organization. Also represented by Irene Oberman Khagi.

          Craig E. Countryman, Fish & Richardson, P.C., San Diego, CA, for amicus curiae Gilead Sciences, Inc. Also represented by Jared Alexander Smith; Jonathan Elliot Singer, Minneapolis, MN.

          Roberta Jean Morris, Menlo Park, CA, for amicus curiae Roberta Jean Morris.

          Bruce M. Wexler, Paul Hastings LLP, New York, NY, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by Eric William Dittmann, Joseph M. O'Malley, Jr., Young Jin Park; Stephen Blake Kinnaird, Anand Bipin Patel, Washington, DC; David Even Korn, James Milton Spears, Pharmaceutical Research and Manufacturers Association of America, Washington, DC.

          Before Prost, Chief Judge, Newman, Lourie, Dyk, Moore, O'Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll, Circuit Judges.

          O'Malley, Circuit Judge.

         Today, we consider the circumstances under which a product produced pursuant to the claims of a product-by-process patent is "on sale" under 35 U.S.C. § 102(b). This is important because, if "on sale" more than one year before the filing of an application for a patent on the governing claims, any issued patent is invalid and the right to exclude others from making, using, and selling the resulting product is lost. We conclude that, to be "on sale" under § 102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. We conclude, moreover, that no such invalidating commercial sale occurred in this case. We, therefore, affirm the district court's judgment that the transactions at issue did not render the asserted claims of U.S. Patent Nos. 7, 582, 727 ("the '727 patent") and 7, 598, 343 ("the '343 patent"), owned by Plaintiff-Appellant The Medicines Company ("MedCo"), invalid under § 102(b).

         I. Background

         A. The Patents and Transactions at Issue

         This suit arises from the submission of two Abbreviated New Drug Applications ("ANDAs"), ANDA Nos. 90-811 and 90-816, by Defendant-Cross-Appellant Hospira, Inc. ("Hospira"). In these ANDAs, Hospira sought Food and Drug Administration ("FDA") approval to sell generic bivalirudin drug products before the expiration of the patents-in-suit: the '727 patent and the '343 patent. The two patents-in-suit are listed in the FDA's Orange Book as covering Angiomax, the trade name of a form of bivalirudin that MedCo markets in the United States.

         The patents-at-suit have nearly identical specifications. They claim pH-adjusted pharmaceutical batches of a drug product comprising bivalirudin, a synthetic peptide comprised of twenty amino acid residues that is used as an anticoagulant, and a pharmaceutically acceptable carrier. Bivalirudin drug products are used to prevent blood from clotting and are regarded as highly effective anticoagulants for use during coronary surgery.

         The bivalirudin active pharmaceutical ingredient ("API"), without further processing, is too acidic for human injection. MedCo thus prepares Angiomax using a compounding process in which it creates a bivalirudin solution, adjusts the solution's pH with a base, and then freeze-dries the solution. A potential adverse consequence of the compounding process used to make the product, however, is the degradation of bivalirudin, which may form impurities such as Asp9-bivalirudin ("Asp9"). The bivalirudin may become unusable if high levels of Asp9 form. The manufacture of batches with unacceptably high Asp9 levels led to the creation of the patented solution.

         MedCo is a specialty pharmaceutical company that does not have its own manufacturing facilities and is not capable of making its products in-house. Instead, since 1997, MedCo has contracted with Ben Venue Laboratories ("Ben Venue"), a third-party provider, for Ben Venue to manufacture commercial quantities of an original formula of Angiomax, which is not covered under the patents-in-suit. In June 2005, Ben Venue manufactured a batch of bivalirudin drug product with an Asp9 level of 3.6%, which exceeded the FDA's approved maximum level of 1.5%. MedCo discarded that batch and shut down production of Angiomax for six months to investigate the problem and revise its process. In 2006, another batch had an unacceptable Asp9 level, so MedCo again shut down production of Angiomax and hired a peptide specialist to investigate and resolve the issue.

         The investigation led to the development of the new compounding process claimed in the patents-in-suit. MedCo incorporated the new process into a revised Master Batch Record, and Ben Venue has made all batches since October 2006 using the new process. According to MedCo, the new compounding process produces an improved Angiomax product that does not have randomly high Asp9 levels, but instead has a maximum Asp9 level of 0.6%. The '727 and '343 patents contain product and product-by-process claims, respectively, for pharmaceutical batches of the improved drug product with a maximum impurity level of Asp9 of 0.6%.

         The patents, respectively, claim:

Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

         Claim 1 of the '727 patent.

Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and a pharmaceutically acceptable carrier, for use as an anticoagulant in a subject in need thereof, said batches prepared by a compounding process comprising:
(i) dissolving bivalirudin in a solvent to form a first solution;
(ii) efficiently mixing a pH-adjusting solution with the first solution to form a second solution, wherein the pH adjusting solution comprises a pH-adjusting solution solvent; and
(iii) removing the solvent and pH-adjusting solution solvent from the second solution; wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6% as measured by HPLC.

         Claim 1 of the '343 patent.

         The applications for the '727 and '343 patents were filed on July 27, 2008. The critical date from which the on-sale bar of § 102(b) must be measured is, therefore, July 27, 2007.

         In late 2006, MedCo paid Ben Venue $347, 500 to manufacture three batches of bivalirudin according to the patents-at-issue. Ben Venue completed the first such batch on October 31, 2006 for $67, 500. That batch contained 5, 746 vials of commercially saleable bivalirudin. On November 21 and December 14, 2006, Ben Venue completed two more batches of bivalirudin containing 27, 594 and 26, 918 vials, respectively, for $140, 000 each. Each full commercial-sized batch of 28, 000 vials of Angiomax has a market value of approximately $10 million when sold on the open market as anticoagulants. Thus, collectively, the three batches had a market value ...


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