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

United States District Court, D. Massachusetts

September 29, 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 18, 2016, allowing defendants Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira, Inc.'s, Motion For Summary Judgment Of Invalidity Of Claims 1, 3, 5, 6, 7 of The '471 patent For Obviousness-Type Double Patenting In Light Of The Claims In The '195 And '272 patents (the "Reexam Motion"). The Memorandum adds citations and some text, and clarifies 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 defendants Celltrion Healthcare Co., Ltd., Celltrion, Inc., and Hospira, Inc. (collectively "Celltrion") have infringed these patents by filing an abbreviated Biologic License Application for a product that is "biosimilar" to Remicade, which is named Inflectra.

         Defendants have moved for summary judgment of invalidity on one of the patents at issue in this case, U.S. Patent Number 6, 284, 471 (the "471 patent" or '"471"). They argue that claims 1, 3, 5, 6 and 7 of the '471 patent are invalid under the doctrine of obviousness-type double patenting over the claims in two now-expired patent previously held by plaintiffs, U.S. Patent Nos. 5, 656, 272 (the "'272 patent") and 5, 698, 195 (the "'195 patent").

         For the reasons explained in this Memorandum, the Reexam Motion is being allowed. In summary, the court finds that the '471 patent is not protected by the safe harbor provided by 35 U.S.C. §121. The court also finds that the one-way test for obviousness-type double patenting, rather than the two-way test, applies in this case. As the plaintiffs concede for present purposes, the claims in the '471 are obvious in view of the earlier-issued claims in the '195 and '272. Assuming, without finding, that the two-way obviousness test should be applied, there may be disputed facts concerning whether the United States Patent and Trademark Office (the "PTO") was solely responsible for any delay that caused the '195 patent and '272 patent to issue before the '471 patent. However, any such disputes would not be material because the claims of the '471 patent are also obvious under the two-way test.

         II. PROCEDURAL HISTORY

         On February 19, 2016, defendants filed their initial Motion for Partial Summary Judgment on the '471 patent (Docket No. 127) (the "Gilead Motion"), which plaintiffs opposed. The court subsequently allowed defendants to file a second motion for summary judgment, the Reexam Motion, which plaintiffs also opposed.

         On August 16, 2016, the court heard oral argument on the Reexam Motion. On August 18, 2016, the court issued an oral decision allowing the Reexam Motion. On August 19, 2016, the court issued an order summarizing the reasons for that decision. Like the August 18, 2016 transcript, this Memorandum provides a fuller explanation of those reasons.

         III. APPLICABLE STANDARDS

         A. SUMMARY JUDGMENT

         Federal Rule of Civil Procedure 56(a) provides that the court "shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." A factual dispute, therefore, precludes summary judgment if it is "material" and "genuine." See Anderson v. Liberty Lobby, 477 U.S. 242, 247-48 (1986).

         A fact is "material" if, in light of the relevant substantive law, "it has the potential of determining the outcome of the litigation." Maymi v. Puerto Rico Ports Auth., 515 F.3d 20, 25 (1st Cir. 2008); Martinez-Rodriguez v. Guevara, 597 F.3d 414, 419 (1st Cir. 2010). "Only disputes over facts that might affect the outcome of the suit under the governing law properly preclude the entry of summary judgment." Anderson, 477 U.S. at 248.

         The party moving for summary judgment "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of [the record] which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). However, the moving party's burden "may be discharged by 'showing' . . . that there is an absence of evidence to support the nonmoving party's case." Id. at 325. Summary judgment is, therefore, mandated "after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. at 322; Gorski v. New Hampshire Dep't of Corr., 290 F.3d 466, 475-76 (1st Cir. 2002); Smith v. Stratus Computer, Inc., 40 F.3d 11, 12 (1st Cir. 1994).

         B. OBVIOUSNESS-TYPE DOUBLE PATENTING

         "An issued patent is presumed valid and can only be proven invalid by clear and convincing evidence." Biogen Idec MA Inc. v. Trustees of Columbia Univ. in City of New York, 332 F.Supp.2d 286, 296 (D. Mass. 2004) (citing 35 U.S.C. §282).

[35 U.S.C. §101] precludes more than one patent on the same invention .... Section 101, however, only prohibits a second patent on subject matter identical to an earlier patent. Thus, applicants can evade this statutory requirement by drafting claims that vary slightly from the earlier patent.
(Therefore, courts have] fashioned a doctrine of nonstatutory double patenting (also known as "obviousness-type" double patenting) to prevent issuance of a patent on claims that are nearly identical to claims in an earlier patent. This doctrine prevents an applicant from extending patent protection for an invention beyond the statutory term by claiming a slight variant.

Id. (quoting Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377-78 (Fed. Cir. 2003)).

         "'A later claim that is not patentably distinct from, ' i.e., 'is obvious over[ ] or anticipated by, ' an earlier claim is invalid for obviousness-type double patenting." Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010) (quoting Eli Lilly v. Barr Labs, 251 F.3d 955, 968 (Fed. Cir. 2001)). The doctrine of obviousness-type double patenting is primarily intended "to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about." In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (quoting In re Van Ornum, 686 F.2d 937, 943 (C.C.P.A. 1982)). "The obviousness-type double patenting analysis involves two steps." Abbvie Inc. v. Mathilda and Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 1374 (Fed Cir. 2014).

"First, the court 'construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences.' Second, the court 'determines whether those differences render the claims patentably distinct.'" Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010) (alteration in original) (quoting Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008)). "'A later claim that is not patentably distinct from, ' i.e., 'is obvious over[ ] or anticipated by, 'an earlier claim is invalid for obviousness-type double patenting." Id. at 1385 (alteration in original) (quoting Eli Lilly, 251 F.3d at 968).

Id.

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