In The Medicines Company v. Mylan, Inc., [2015-1113, 2015-1151, 2015-1181] (April 6, 2017), the Federal Circuit affirmed summary judgment of non-infringement of U.S. Patent No. 7,598,343, and reversed a bench trial determination of infringement of U.S. Patent No. 7,582,727.
The district court reasoned that the accused product did not infringe the ‘343 patent because this patent required “efficient mixing,” and then concluded that the accused product did infringe the ‘727 patent because the claims did not include the “efficient mixing” requirement. The Federal Circuit found that the claims of both patents include a “batches” limitation, which, according to the patents, requires efficient mixing — thus both patents require “efficient mixing.”
The Federal Circuit noted that both patents included the “batches” limitation, that set a maximum impurity level for the product. The Federal Circuit said that the claims could not be construed to cover any batch that met the impurity level, because it would cover the prior art, rendering the claim invalid. Rather, properly construed, what the batches limitation requires is the use of a process that achieves batch consistency. The Federal Circuit noted that the patent owner agreed that Medicines agrees that batch consistency is the result of following the patents in suit and is what distinguishes them from the prior art.
The Federal Circuit found a claim construction that covered any process that achieved the impurity standard and was not limited to the disclosed “efficient mixing” was unworkable, because an infringer would not know whether it infringed until all of the batches were completed, and thus would not provide reasonable certainty regarding the claim scope. This reasoning seems faulty because if the infringer used a process which, like the disclosed process, reliably achieved the claimed impurity level, there would be no uncertainty.
The Federal Circuit also noted that during prosecution the applicant characterized the invention as being the process: “[i]n the present invention, various embodiments relate to a less subjective and more consistent process.” The applicant also took care to distinguish its post-critical date sales from its pre-critical date sales because they were “prepared by the new process of the present invention.”
Finally the Federal Circuit noted that the patent owner distinguished the invention to the district court based upon the process disclosed in the specification, telling the court that it was readily apparent that the definition of pharmaceutical batches refers to the compounding processes described in the patents-in-suit.
After a detailed review of the language of the specification, the Federal Circuit found that the specification teaches efficient mixing as a necessary and sufficient condition for achieving batch consistency, and the prosecution history confirms that achieving batch consistency requires efficient mixing. The Federal Circuit concluded that to attribute to the claims a meaning broader than any indicated in the patents and their prosecution history would be to ignore the totality of the facts of the case and exalt slogans over real meaning.
The Federal Circuit went on to find that the required “efficient mixing” was not met by the accused products, and reversed the district court’s finding of infringement.