by Dennis Crouch
In Antares Pharma v. Medac Phama (Fed. Cir. 2014), the court has invalidated Antares’ reissue patent no. RE44,846 — finding that the reissued claims fail to comply with the “original patent” requirement of 35 U.S.C. 251. This “original patent” requirement is roughly equivalent to both the written description requirement and the prohibition on new matter — all three basically require that the original patent specification disclose the particular invention now being claimed. Here, however, the court takes the requirement a major step further — indicating that the requirement is only satisfied if the newly claimed invention was described as the invention in the original disclosure. The leading Supreme Court case on the topic is US Industrial Chem v. Carbide & Carbon Chem, 315 U.S. 668 (1942). In that case, the Supreme Court held the asserted reissue invalid because claimed solution no longer required water even though the original specification had at least hinted that water was optional. There, the court held that reissued claims must be “the same invention described and claimed and intended to be secured by the original patent.” Under the Federal Circuit’s interpretation here, the requirement is that new or amended claims are only valid if the original specification “clearly and unequivocally disclose[s] the newly claimed invention as a separate invention.” Going forward the biggest question is whether this requirement will also be extended to the written description requirement and new matter limitations.
Section 251 of the Patent Act creates the reissue process that allows a patentee to seek correction of errors in an original patent. In the process, the patentee can broaden its patent scope, but only if the reissue application is filed within two-years of the original patent issuance. Further, a reissue application may not “recapture” scope that was surrendered during the original prosecution in order to obtain allowance nor may the reissue claim an invention that was not fully and expressly disclosed in the original written description.
Here, the patent covers the seeming torture device of a needle-assisted jet injector. Soon after patent issuance, however, the patentee sought a reissue that removed the “jet injector” limitation and focused on novel safety features that were not originally claimed. The court writes:
The original specification here does not adequately disclose the later-claimed safety features to meet the Industrial Chemicals standard. The specification discussed only one invention: a particular class of jet injectors. . . . 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. Rather, the safety features were serially mentioned as part of the broader conversation: how to build the patented jet injection device. . . . Nowhere does the specification disclose, in an explicit and unequivocal manner, the particular combinations of safety features claimed on reissue, separate from the jet injection invention. This does not meet the original patent requirement under § 251.
Based upon this failure, the patented claims are invalid for violating the original patent requirement of Section 251.
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This is an interesting and important case with regard to reissue applications and it may have important implications for the written description requirement as well.
A few limited remarks:
I should note first that the Federal Circuit here failed to explain how failure of the original patent requirement is a proper validity defense under 35 U.S.C. 282. [Update – I apologize, but I failed to express the point was thinking. My basic point was that validity challenges for improper reissue are expressly stated in the statute while subject-matter challenges are not there.]
Second, the posture of this case is interesting – the patentee was appealing a denial of preliminary injunction. However, rather than simply affirming the denial (based upon likely invalidity), the Federal Circuit here ruled conclusively that the claims are invalid as a matter of law.
Finally, as alluded-to, this case appears poised to reach well beyond its reissue context and impact the entire population of patents under the context of the written description requirement. Here, the court indicated that the standard from Industrial chemicals is “analogous to the written description requirement.” Going forward, the USPTO may well begin limiting applications that shift claim focus under this newly revived doctrine.
Opinion by Judge Dyk, joined by Judges Reyna and Taranto.