The Medicines Co. v. Hospira, Inc.

The Federal Circuit affirmed the lower court’s finding of non-infringement, but remanded the case to determine if patents are covered by a distribution agreement, which would render them invalid based on the on-sale bar.

February 06, 2018

GENERICally Speaking

Case Name: The Medicines Co. v. Hospira, Inc., 2014-1469, 2014-1504 (Fed. Cir. Feb. 6, 2018) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Andrews, J.)

Drug Product and Patents-in-Suit: Angiomax® (bivalirudin); U.S. Patents Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ’343 patent”)

Nature of the Case and Issue(s) Presented: The Medicines Company manufactures and sells bivalirudin, an anti-coagulant, as Angiomax. Sales of Angiomax represent over 90% of Medicines’ revenue. Medicines’ original method of manufacturing Angiomax occasionally produced batches containing unacceptable levels of impurities. To solve this problem, Medicines developed an improved manufacturing process that it patented in the patents-in-suit, whose patent applications were filed on July 27, 2008. Medicines’ manufacturer began using this improved process to make Angiomax in October 2006. On February 27, 2007, Medicines entered into a Distribution Agreement with Integrated Commercialization Solutions, Inc. (“ICS”). Per the agreement, Medicines could not use any other distributor for the duration of the contract, but could reject purchase orders submitted by ICS. Medicines, however, was required to use commercially reasonable efforts to fill ICS’ purchase orders.

Hospira submitted an ANDA seeking to market generic bivalirudin. Medicines sued Hospira for patent infringement. After a bench trial, the district court determined that Medicines’ patents were not infringed and that the patents were not invalid under the on-sale bar provision of the patent act. Medicines’ appealed the finding of non-infringement while Hospira appealed the on-sale bar determination. The Federal Circuit upheld the lower court’s finding of non-infringement, but remanded the case to determine whether the ICS distribution agreement covered the patented method.

Why Hospira Prevailed: Regarding non-infringement, the Federal Circuit concluded that Hospira’s method of manufacturing its generic Angiomax was different from the patented method, and thus did not infringe either patent-in-suit. The patents-in-suit required the addition of pH-adjusting solution at a controlled, steady rate, while Hospira added the solution in three distinct portions. Further, Hospira did not use a homogenizer, which was required in the patented method. For those reasons, Hospira’s method did not infringe either the ’727 or ’343 patents.

Regarding the on-sale bar, the court determined that the ICS distribution agreement amounted to an offer for sale to trigger the on-sale bar, but did not have a factual record to determine whether or not the agreement encompassed the patented method. The distribution agreement was clear on this point, stating that Medicines “now desired to sell” Angiomax to ICS. While Medicines could reject ICS purchase orders, Medicines was required to use commercially reasonable efforts to fulfill those purchase orders. Thus, Medicines could not reject the purchase orders for just any reason. Further, practically speaking, because Angiomax represented over 90% of Medicines’ revenue and the distribution agreement forbade Medicines from using other distributors for Angiomax, Medicines could not reject all ICS purchase orders. For these reasons, the distribution agreement was an offer for sale. The court then remanded the case for the lower court to determine whether or not the distribution agreement covered the patented product.

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