The Federal Circuit recently issued a decision in Antares Pharma, Inc. v. Medac Pharma, Inc. (Fed. Cir. 2014) that examined the issue of whether claims have been properly broadened in a reissue application. A patent holder can seek broadened reissue claims within a two year period from the grant of the original patent, as set forth in 35 U.S.C. § 251. However, there are restrictions on how a patentee can broaden claims during the reissue proceeding. Those restrictions include 1) the recapture rule and 2) the original patent requirement. The Court in Antares found reissue claims to be invalid for failing the original patent requirement. Under the original patent requirement, the invention claimed in the reissue application must be directed to the same invention disclosed in the original patent. The Court found that the original patent requirement mandates that newly claimed subject matter be disclosed in an explicit and unequivocal manner in the specification. In other words, the newly added claims cannot be merely suggested or indicated in the specification. In contrast, the Court noted that continuation and divisional applications are avenues for applicants to shift the scope of the claims from one invention to another without the original patent requirement of § 251.
In the instant case, the Court found that the claims of the original patent were directed to a jet injector, whereas the claims added in the reissue were directed to previously unclaimed safety features in combination with a generic injector. Looking to the specification, the Court found that:
Although safety features were mentioned in the specification, they were never described separately from the jet injector, nor were the particular combinations of safety features claimed on reissue ever disclosed in the specification.
The Court effectively states that, while there may be a suggestion that the claimed safety features could be used with any type of injector, the specification fails to “explicitly and unequivocally” disclose the particular claimed combination. Of note, the Court mentions a number of times that the appellants themselves state in their brief that the reissue claims cover a different invention than the original claims. Therefore, the Court found that the newly added claims do not satisfy the original patent requirement of § 251 and thus held the claims to be invalid.
The takeaway from Antares is twofold. First, when pursuing a broadening reissue, it is important to make certain that any broadening amendments meet the original patent requirement by ensuring that the specification explicitly and unequivocally discloses the invention sought in the reissue application. Second, it would seem prudent to avoid any statements that newly added or amended claims cover a different invention than the originally granted claims. Antares filed a petition for rehearing en banc on December 18, 2014. Therefore, the Federal Circuit may have more to say on this issue.
This update was prepared by John J. Penny, V and Joshua I. Rudawitz, members of the Intellectual Property practice of Nutter McClennen & Fish LLP. For more information, please contact Jack, Josh, or your Nutter attorney at 617.439.2000.
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John (Jack) J. Penny, V is the chair of Nutter's Intellectual Property Department. He counsels clients in the development of strategic patent portfolios; prepares opinions concerning infringement, validity ...
Joshua I. Rudawitz is an associate in Nutter’s Intellectual Property Department. He focuses his practice on all aspects of patent law, drawing on his mechanical engineering background and love of technology. Josh is a regular ...
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