Janssen Biotech, Inc. v. Celltrion Healthcare Co.

239 F. Supp. 3d 328, 2017 U.S. Dist. LEXIS 30507, 2017 WL 981396
CourtDistrict Court, D. Massachusetts
DecidedMarch 3, 2017
DocketC.A. No. 15-10698-MLW, 16-11117-MLW
StatusPublished

This text of 239 F. Supp. 3d 328 (Janssen Biotech, Inc. v. Celltrion Healthcare Co.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Janssen Biotech, Inc. v. Celltrion Healthcare Co., 239 F. Supp. 3d 328, 2017 U.S. Dist. LEXIS 30507, 2017 WL 981396 (D. Mass. 2017).

Opinion

MEMORANDUM AND ORDER

WOLF, D.J.

At the January 18 and February 14, 2016 scheduling conferences, the parties requested the court’s guidance on the appropriate measure of damages to which plaintiff Janssen Biotech, Inc. (“Janssen”) would be entitled if defendants Celltrion Healthcare, Co. and Celltrion, Inc. (together, “Celltrion”) and Hospira, Inc. (“Hospi-ra”) are found to have infringed U.S. Patent No. 7,598,083 (the “’083 Patent”). The parties represented that such guidance would facilitate informed settlement discussions. A hearing on issues concerning the standards for determining damages was held on February 23 and 24, 2017. For the reasons explained in detail at those hearings, the court provided the following guidance to the parties.

1. A plaintiff is entitled to compensation for reasonably foreseeable lost profits that it would not have suffered “but for” the defendant’s infringement. See Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538, 1545 (Fed. Cir. 1995). “A fair and accurate reconstruction of the ‘but for’ market.. .must take into account, where relevant, alternative actions the infringer foreseeably would have undertaken had he not infringed” and, therefore, “takes into account any [adequate] alternatives available to the infringer.” Grain Processing Corp. v. American Maize, 185 F.3d 1341, 1350-51 (Fed. Cir. 1999). Accordingly, if Celltrion could, as a practical matter, have made the Remicade biosimilar, Inflectra, that it began marketing in the United States on about January 1, 2017—at a competitive price and on a comparable schedule—without infringing the ’083 Patent, Janssen would not be entitled to recover any profits on Remicade that it lost to Inflectra. It would, instead, be limited to a reasonable royalty.

2. The fact that Celltrion produces Inflectra abroad would not prevent Janssen from recovering lost profits relating to sales of Inflectra in the United States if those sales could not have been made without the production and sale of the infringing media powders in the United States.

In Power Integrations v. Fairchild Semiconductor, the Federal Circuit held that the presumption against the extraterritorial application of the United States Patent laws prevented a patentee from recovering damages measured by its foreign sales. 711 F.3d 1348, 1371-72 (Fed. Cir. 2013). It held that “where the direct measure of damages was foreign activity, i.e., making, using, selling outside the United States, it was not enough, given the required strength of the presumption against extraterritoriality, that the damages measuring foreign activity have been factually caused, in the ordinary sense, by domestic activity constituting infringement under [35 U.S.C.] Section 271(a).” Carnegie Mellon Univ. v. Marvell Tech. Group, 807 F.3d 1283, 1307 (Fed. Cir. 2015).

In the instant case, it is alleged that Celltrion’s agent, HyClone Laboratories, Inc. (“HyClone”), infringed the ’083 Patent [331]*331by making and selling its powder in the United States. In contrast to Power Integrations, however, the resulting sale of the damages-measuring product, Inflectra, also occurred in the United States. In these circumstances, the presumption against extraterritoriality would not overcome the principle of full compensation, and the usual “but-for” causation test would apply.

The fact that Remicade is not now itself patented because this court has found the patent on which it is based invalid, see August 19, 2016 Memorandum and Order (Docket No. 226), does not affect plaintiffs entitlement to damages, including lost profits, for any proven infringement of the ’083 Patent. A patentee may recover damages in the form of lost profits to compensate for sales of an un-patented product (i.e., Remicade) lost to an infringer’s non-infringing product (i.e., In-flectra), if the infringer could only have captured the patentee’s sales by infringing the patent by, in this case, using an infringing powder. See Micro-Chem. Inc. v. Lextron, Inc., 318 F.3d 1119, 1125-26 (Fed. Cir. 2003). More specifically, a paten-tee is entitled to lost profits, even on un-patented products, if a competitor makes the sales-eapturing end-product using an infringing method or product, where the competitor could have only captured the sales by infringing the patent. See Minco Inc. v. Combustion Eng’g, 95 F.3d 1109, 1119 (Fed. Cir. 1996).

3. To decide whether it was feasible for Celltrion to have used a non-infringing media powder to produce Inflec-tra, it must be determined whether, starting on the date of first infringement, Cell-trion could have switched to using a non-infringing alternative. The fact-finder must consider how the market would have developed “absent the infringing product,” if the infringement had not occurred. Grain Processing, 185 F.3d at 1350-51. “A proper reconstruction of the ‘but for’ world that would have existed absent infringement must consider actions the infringer would have taken to avoid infringement—including designing around the patented intellectual property—starting on the date of-first infringement and not on some later date, such as the date of first notice” or the date the infringement began generating lost profits. Apple Inc. v. Samsung Electronics Co. Ltd., 2013 WL 5958172, *2-3 (N.D. Cal. 2013). Before the date of sales that cause the patentee to lose profits, any infringement would justify damages in the amount of a reasonable royalty.

4. If the pending cases are dismissed without prejudice for lack of standing because all owners if the ’083 Patent are not joined as plaintiffs and a new case is brought, 35 U.S.C. § 271(e) (6) will not limit Janssen’s damages to a reasonable royalty for any proven infringement of the ’083 Patent. Celltrion initiated the process prescribed by the Biologies Price Competition and Innovation Act (the “BPCIA”), 42 U.S.C. § 262(1), but did not properly complete it as required to obtain the limitation of damages to a reasonable royalty provided by § 271(e)(6).

“The Biologies Act lays out a step-by-step process for exchanging information and channeling litigation about patents relevant to the application.” Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 1054 (Fed. Cir. 2016). Section 271 (e) (6) limits a patentee’s damages to a reasonable royalty if it proves infringement of a patent identified under 42 U.S.C. §§ 262(1)(4) and (5)(B) in a suit filed more than 30 days after the end of the process prescribed by the BPCIA. As one step in that process, § 262(1)(4).requires that each party negotiate in good faith in an attempt to agree on a list of patents that will be subject to an immediate infringement action. Section [332]

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Amgen Inc. v. Sandoz Inc.
794 F.3d 1347 (Federal Circuit, 2015)
Amgen Inc. v. Apotex Inc.
827 F.3d 1052 (Federal Circuit, 2016)
Rite-Hite Corp. v. Kelley Co.
56 F.3d 1538 (Federal Circuit, 1995)

Cite This Page — Counsel Stack

Bluebook (online)
239 F. Supp. 3d 328, 2017 U.S. Dist. LEXIS 30507, 2017 WL 981396, Counsel Stack Legal Research, https://law.counselstack.com/opinion/janssen-biotech-inc-v-celltrion-healthcare-co-mad-2017.