Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-00270-SLR, Judge Sue L. Robinson.
IMRON T. ALY, Schiff Hardin LLP, of Chicago, Illinois, argued for plaintiff-appellant. With him on the brief were RICHARD J. HOSKINS and SAILESH K. PATEL. Of counsel was JOEL M. WALLACE.
CHRISTOPHER J. HARNETT, Ropes & Gray LLP, of New York, New York, argued for defendants-appellees. With him on the brief were JAMES F. HALEY, JR., CHING-LEE FUKUDA and HASSEN A. SAYEED.
Before DYK, REYNA, and TARANTO, Circuit Judges.
Dyk, Circuit Judge.
Plaintiff-Appellant Antares Pharma, Inc. (" Antares" ) appeals from a decision of the United States District Court for the District of Delaware denying Antares' motion for preliminary injunction. Antares seeks to enjoin alleged infringement of claims 31, 34, 35, and 37 of a reissue patent, RE44,846 (" the '846 patent" ). Because we hold that these reissue claims are invalid for failure to comply with the " original patent" requirement of 35 U.S.C. § 251, we affirm.
Antares is a developer of automatic injection devices used to self-administer
pharmaceuticals. It is the assignee of U.S. Patent No. 7,776,015 (" the '015 patent" ), which issued on August 17, 2010. That patent, entitled " NEEDLE ASSISTED JET INJECTOR," discloses a system for injecting medicant in which a needle punctures the skin before forcefully expelling the medicant, thereby minimizing some of the downsides of typical jet injectors (in which the medicant itself ruptures the outer layers of skin), while still maintaining some of the advantages of typical jet injectors. During prosecution, the applicants repeatedly distinguished their invention from the prior art by focusing on the " jet injector" limitation present in their claims but not the prior art. The originally issued claims all contained the " jet injection" limitation.
On June 22, 2012, roughly 22 months after the '015 patent issued, Antares sought a reissue for the patent pursuant to 35 U.S.C. § 251, stating that there was an error in the original '015 patent insofar as the patentee claimed " more or less than he had a right to claim in the patent." See 35 U.S.C. § 251. Section 251 allows a patent holder to correct an existing, issued patent by broadening or narrowing the originally issued claims. If the claims sought on reissue are broader than the original claims, the patentee must apply for the reissue within two years of the patent issuing. Id. Here, the applicants complied with the two-year requirement.
The '846 reissue patent was granted on April 15, 2014. The specification and claims 1-22 were left unaltered; claims 23-37 were added. The originally allowed claims recite various embodiments of a jet injection device and specify, for example, the exact depth the needle assist plunges to, the force at which the medicant is expelled, and the gauge of the needle. The reissue claims (claims 23-37) cover embodiments of injection devices (not restricted to jet-injection devices) with particular combinations of safety features. Claim 31, for example, covers certain injectors containing at least a latch, pushbutton, and needle guard. By Antares' own admission, the reissue claims recite a different invention from what was originally claimed. See Appellant Br. 14-15 (" These are two different inventions . . . . [Original c]laim 1 is directed to 'jet injection device' performance. . . . [Reissue c]laim 31, on the other hand, is directed to safety features for any 'injection device.'" ) (emphasis in original).
Defendants medac Pharma, Inc. and medac GmbH (collectively, " Medac" ) manufacture and sell pre-filled, hand-powered methotrexate syringes. On September 10, 2013, Medac submitted a 505(b)(2) new drug application (" NDA" ) with the FDA for their pre-filled methotrexate syringes, which they intend to sell under the trade name RASUVO. Antares does not accuse the methotrexate medication itself of infringing any patents; rather, Antares accuses the injection device housing the methotrexate of infringing various claims. Because the product prospectively sold under the application would allegedly infringe claims of the '846 patent, the filing of the application constitutes an act of artificial infringement under 35 U.S.C. § 271(e)(2)(A) (assuming infringement is established).
Antares filed suit against Medac in the District of Delaware on February 28, 2014, initially alleging infringement of certain patents not involved in the present appeal based on Medac's filing of the 505(b)(2) NDA. On March 14, 2014, Antares filed a motion for preliminary injunction. On April 18, 2014, Antares filed an amended complaint, adding the '846 patent to the list of patents it was asserting against Medac, and amended the motion for preliminary injunction accordingly, asserting
claims 31, 34, 35, and 37 of the '846 patent. Since only the asserted claims in the '846 patent are at issue on appeal, we ...