patent infringement : CAFC Alert

The Federal Circuit indirectly imports limitations from the specification into the claims through claim construction

John M. Wang | April 24, 2017

The Medicines Company v. Mylan Inc. Etc.

April 6, 2017

Before Dyk Wallach, and Hughes.  Opinion by Dyk.

Summary

Mylan submitted two Abbreviated New Drug Applications (“ANDA”) to seek approval of Food and Drug Administration (“FDA”) for selling generic bivalirudin drug products before the expiration of patents-in-suit: the ‘727 patent and the ‘343 patent. In its ANDA, Mylan stated that it would limit the Asp9 level of its generic product to less than 2.0 percent. Medicines sued Mylan for infringement of the ‘727 and ‘343 patents. Mylan filed counter-claims seeking declaratory judgments of invalidity. The district court held that Mylan infringed the ‘727 patent, but not the ‘343 patent. The Federal Circuit reverses in part, and held that Mylan does not infringe both patents.


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A guide for the international patent attorney: how to read the recent CAFC en banc decision on laches–a viable defense against patent infringement, for the time being

Le-Nhung McLeland | October 19, 2015

SCA Hygiene Products Aktiebolag v. First Quality Products, LLC

September 18, 2015

Introductory note from the author of this review: When I read this decision, it struck me that the legal analysis is based on concepts and distinctions which may not be clearly appreciated by someone not familiar with the “common law” tradition, the co-existence of remedies “at law” and remedies in “equity”, and the underlying principle of “separation of powers” in the federal government in the U.S. This en banc decision is very important, so there have been already numerous reports on the decision. I hope to contribute, in the form of the interspersed “notes” below, background information which may shed more light on the decision for our international colleagues. Le-Nhung McLeland

En banc decision: Opinion for court by Prost, joined by Newman, Lourie, Dyk, O’Malley, and Reyna. Opinion concurring-in-part, dissenting-in-part by Hughes, joined by Moore, Wallach, Taranto, and Chen. Judge Stoll did not participate in decision.

Note: Twenty three “amicus curiae” briefs were received in this case, which is a measure of its importance. The briefs were submitted on behalf of patent professional associations, as well as a broad range of corporations including Hewlett-Packard, Intel Corporation, Xerox Corporation, Johnson & Johnson, AT&T Mobility II LLC, T-Mobile USA, Roche Molecular Systems, Harley-Davidson Motor Company, and Rockwell Automation, Inc. The en banc majority refers to some of these briefs, in the body of the opinion or in footnotes.


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Laches: a viable defense against patent infringement, but for how long?

Le-Nhung McLeland | October 16, 2014

SCA Hygiene Products Aktiebolag v. First Quality Products, LLC

Summary:

SCA owns U.S. Patent No. 6,375,646 (the ‘646 patent) for adult incontinence products.

October 31, 2003:  SCA sent a warning letter to First Quality, stating that SCA believes First Quality’s pants-type diapers infringe the ‘646 patent, and asking First Quality to either explain why the products do not infringe, or give assurance that First Quality will stop making and selling the products if First Quality believes the products to infringe the patent.

November 21, 2003:  First Quality responded by letter, stating that prior art U.S. Patent No. 5,415,649 (the ‘649 prior art patent) invalidates the ‘646 patent.

July 7, 2004:  SCA filed a request for ex parte reexamination of the ‘646 patent over the ‘649 prior art patent, but did not notify First Quality about the reexamination.

March 27, 2007:  The PTO confirmed the patentability of all the original claims of the ‘646 patent and also granted new claims added during the reexamination.

August 2, 2010:  SCA filed suit against First Quality for infringement of the ‘646 patent (six years and nine month after sending the warning letter, and more than three years after the conclusion of the reexamination.)  First Quality counterclaimed for declaratory judgment of non-infringement and invalidity. After the district court’s claim construction order, First Quality moved for partial summary judgment of non-infringement, and summary judgment for laches and equitable estoppel.  The district court granted summary judgment for laches and equitable estoppel, and dismissed the remaining motion as moot.  SCA appealed.

The conclusion about laches or equitable estoppel is “committed to the sound discretion of the trial judge.”  Therefore, the standard of review of those conclusions by the CAFC is “abuse of discretion” by the trial judge.  Since the underlying elements of laches and equitable estoppel are questions of fact, the CAFC reviews those findings of fact for “clear error.”  However, when summary judgment has been granted, the CAFC reviews the factual elements de novo to determine whether any “genuine issues of material fact remain.”


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