Antares Pharma, Inc. v. Medac Pharma Inc.

Citation112 U.S.P.Q.2d 1865,771 F.3d 1354
Decision Date17 November 2014
Docket NumberNo. 2014–1648.,2014–1648.
PartiesANTARES PHARMA, INC., Plaintiff–Appellant, v. MEDAC PHARMA INC. and Medac GmbH, Defendants–Appellees.
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

771 F.3d 1354
112 U.S.P.Q.2d 1865

ANTARES PHARMA, INC., Plaintiff–Appellant
v.
MEDAC PHARMA INC. and Medac GmbH, Defendants–Appellees.

No. 2014–1648.

United States Court of Appeals, Federal Circuit.

Nov. 17, 2014.


771 F.3d 1355

Imron T. Aly, Schiff Hardin LLP, of Chicago, IL, 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, NY, 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.

Opinion

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.

Background

I

Antares is a developer of automatic injection devices used to self-administer

771 F.3d 1356

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).

II

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

771 F.3d 1357

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 limit our discussion to those claims.

On May 5, 2014, Medac counterclaimed for invalidity and non-infringement of the patents-in-suit. On May 28, 2014, Medac filed its opposition to the motion for preliminary injunction, arguing that the asserted reissue claims of the '846 patent were invalid for violating the recapture rule and failing the original patent requirement of § 251. The recapture rule generally prohibits applicants from claiming, on reissue, claim scope surrendered during the course of the original prosecution. See In re Mostafazadeh, 643 F.3d 1353, 1358 (Fed.Cir.2011). As discussed below, the original patent requirement requires that the original specification expressly disclose the particular invention claimed on reissue.

On July 10, 2014, the district court denied the motion for preliminary injunction, finding that Antares failed to carry its burden of showing a likelihood of success on the merits with respect to the '846 patent because claims 31, 34, 35, and 37, added during reissue, are likely invalid for violating the recapture rule. The court found that, during the original prosecution, the applicants repeatedly distinguished the prior art by focusing on the fact that the claims were limited to jet injectors. During reissue, when the applicants sought to claim safety features not limited to jet injectors, they were broadening their claims to cover non-jet injectors. Because the court held that the recapture rule was violated, it did not consider the question of whether the original patent requirement was satisfied. The court held that Antares would likely suffer irreparable harm and that the balance of interests was in equipoise.

Antares appealed the denial of the preliminary injunction with respect to the asserted claims of the '846 patent. We have jurisdiction pursuant to 28 U.S.C. §§ 1292 & 1295. We review the district court's denial of the preliminary injunction for abuse of discretion, but we review errors of law relating to that denial de novo. Globetrotter Software, Inc. v. Elan Computer Grp., Inc., 236 F.3d 1363, 1367 (Fed.Cir.2001). We review the applicability of the recapture rule and the original patent requirement of 35 U.S.C. § 251 de novo. Medtronic, Inc. v. Guidant Corp., 465 F.3d 1360, 1373 (Fed.Cir.2006).

Discussion

I

Antares argues that the district court incorrectly applied the recapture rule and that, under the “overlooked aspects” cases, the recapture rule is inapplicable. In this respect, Antares relies on Mostafazadeh, 643 F.3d at 1360. Antares argues that, while the recapture rule generally prohibits a patentee from “regain[ing] through reissue the subject matter that he surrendered in an effort to obtain allowance of the original claims,” the recapture rule is entirely inapplicable if the reissue claims recite “overlooked aspects” of the invention. Mostafazadeh, 643 F.3d at 1358 (quoting In re Clement, 131 F.3d 1464, 1468 (Fed.Cir.1997) ); see also In re Youman, 679 F.3d 1335, 1347 (Fed.Cir.2012). Antares argues that overlooked aspects are “patentably distinct (1) inventions; (2) embodiments; or (3) species not originally claimed[,] not mere incidental features of the originally-claimed invention.” Mostafazadeh, 643 F.3d at 1360 (citation omitted).1 Because we hold that the asserted claims of the '846 patent fail the original patent requirement of 35 U.S.C. § 251, we

771 F.3d 1358

do not reach the question of whether the recapture rule applies and, if it does, whether it was violated here.

II

Typically, if an applicant files a patent application disclosing and claiming one invention and later realizes that the specification discloses a second or broader invention, he may seek coverage of those additional claims pursuant to 35 U.S.C. § 120, which allows for continuing applications to claim the priority date of earlier applications. One type of continuing application is a continuation application. A continuation application is “a second application for the same invention claimed in a prior nonprovisional application and filed before the original prior application...

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1 books & journal articles
  • Chapter §21.03 Reissue
    • United States
    • Full Court Press Mueller on Patent Law Volume II: Patent Enforcement Title CHAPTER 21 Correcting Patents in the USPTO (Reissue and Reexamination)
    • Invalid date
    ...of another application for a patent." Powder Co. v. Powder Works, 98 U.S. 126, 138 (1878).[45] Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1358 n.3 (Fed. Cir. 2014) (citing 35 U.S.C. §251 (1952); 35 U.S.C. §64 (1870); Gill v. Wells, 89 U.S. 1, 19 (1874); United States Patent a......

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