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Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd.

United States District Court, D. Massachusetts

September 28, 2016

JANSSEN BIOTECH, INC. ET AL, Plaintiffs,
v.
CELLTRION HEALTHCARE CO. LTD., ET AL., Defendants.

          MEMORANDUM AND ORDER

          WOLF, D.J.

         This Memorandum is based on the transcript of the decision rendered orally on August 17, 2016, allowing defendants Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira, Inc.'s (collectively "Celltrion") Motion for Summary Judgment of Invalidity of U.S. Patent No. 6, 284, 471 for Obviousness-Type Double Patenting (the "Gilead Motion"). This Memorandum adds citations, and clarifies and amplifies some language.

         I. SUMMARY

         Plaintiffs Janssen Biotech, Inc. and New York University, (collectively "Janssen"), are the holders of patents related to a biologic medication called Remicade, which is based on an antibody called infliximab. Plaintiffs allege that Celltrion has infringed these patents by filing an abbreviated Biologic License Application for a product that is "biosimilar" to Remicade.

         Two patents are at issue in this motion for summary judgment based on obviousness-type double patenting. They are U.S. Patent Number 6, 284, 471 (the "'471 patent" or '"471"), and U.S. Patent Number 6, 790, 444 (the "'444 patent" or "'444"). The '471 patent covers a genus, or group, of compounds that includes infliximab. The '444 patent is for the infliximab antibody specifically.

         Plaintiffs concede that the M44 claims are not patentably distinct from the '471 claims. Both patents are based on an application filed in 1991, which is sometimes called the "priority application." The priority date for each patent is 1991.

         The '471 patent was filed in 1994, and issued on September 4, 2001. If it stood alone, it would expire on September 4, 2018 because it was filed before the 1995 effective date of the law altering patent terms, the Uruguay Round Agreements Act (the "URAA"). The URAA is codified at 35 U.S.C. §154, most pertinently at §154(c)(1). The URAA provides protection for 20 years from the date of the original, priority application or 17 years after issuance, whichever is longer, for applications filed before 1995. Therefore, if the '471 patent stood alone, it would expire in 2018. However, for applications filed after 1995, patent protection extends for 20 years after the date the original, priority application was filed. The application for the '444 patent was filed in 2001, after the 1995 effective date of the URAA, and was issued in 2004. As it was based on a 1991 priority application, it expired 20 years later, in 2011.

         In Celltrion's Gilead motion, the defendants seek summary judgment of invalidity on Claims 1, 3, 5, 6 and 7 of the '471 patent for obviousness-type double patenting based on the '444 patent. The only question presented by the motion is whether, in view of the Federal Circuit's decision in Gilead Sciences, Inc. v. Mateo Pharma Limited, 753 F.3d 1208 (Fed. Cir. 2014), the earlier-expiring '444 patent should be held to be a double patenting reference that invalidates the '471 Patent. I find that it is such a reference and, therefore, the '471 patent is invalid.

         Gilead involved two patents based on applications filed after 1995. Therefore, it did not implicate the provision of the URAA that provides patent protection for at least 17 years after issuance if the application for a patent in dispute was filed before 1995. As this case is factually different than Gilead, Gilead is not binding precedent. I find, however, that in enacting the URAA, Congress and the President did not intend to alter the judicially-created doctrine of obviousness-type double patenting or restrict the power of the courts to apply it to patents resulting from applications filed before 1995.

         I also find that the Federal Circuit would apply the Gilead ruling to the circumstances of this case and again find that a later-issued but earlier-expiring patent can serve as a reference that renders an earlier-issued but later-expiring patent invalid for obviousness-type double patenting.

         II. PROCEDURAL HISTORY

         On August 16, 2016, the court heard oral argument on the Gilead Motion. On August 17, 2016, the court issued an oral decision, allowing the Gilead Motion. On August 19, 2016, the court issued an order summarizing the reasons for its oral decision. This Memorandum, like the August 17, 2016 transcript, more fully explains those reasons.

         III. DISCUSSION

         In Gilead, 753 F.3d at 1214, the Federal Circuit wrote that "[i]t is a bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention." The court explained that "[t]he public should ... be able to act on the assumption that upon the expiration of [a] patent it will be free to use not only the invention claimed in the patent but also [any] modifications or variants [of it] which would have been obvious to those of ordinary skill in the art at the time the invention was made." Id. (citing In re ...


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