When can a sufficient disclosure for patentability purposes nevertheless fail to adequately "describe" the claims of a patent? According to the Federal Circuit in a case issued this week, when the claims are added in a broadening reissue application. In Antares Pharma Inc. v. Medac Pharma Inc., the Court had the opportunity to expound on the "original patent" requirement of 35 U.S.C. § 251 for reissue claims. Writing for the 3-judge panel, Judge Dyk explained that prior Federal Circuit case law defined this requirement as "analogous to the written description requirement . . . ." Of course, this is distinct from a "new matter"-type "written description" requirement, because § 251 has one of those requirements also. Instead, the Antares case can be understood in the context of the line of written description cases like Gentry Gallery v. Berkline Corp. and Tronzo v. Biomet, where patent specifications that only include one embodiment, or tout a particular embodiment, can only support claims drawn to that embodiment. Similarly, as in this case, a patent specification that only appears to envision "jet"-type automatic injection devices for the self-administration of pharmaceuticals cannot support reissue claims that cover non-jet-type injectors.
The problem in this case stems from the Court's reliance on a 1942 Supreme Court case, U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942). The strict adherence to the language in this case forced the Federal Circuit to contort reissue jurisprudence to such a degree that it appeared to demand a heightened disclosure requirement. This stems, in part, from the Court elevating a line from Industrial Chemicals that suggested that to satisfy the "same invention" requirement "it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification." Id. at 676. As such, the Federal Circuit was forced to conclude that the "original patent" requirement was somehow more exacting than the original requirements for patentability, necessitating the conclusion that "the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention." (emphasis added).
The patent at issue in this case was U.S. Reissue Patent No. RE44,846, entitled "Needle Assisted Jet Injector." When it had previously issued as U.S. Patent No. 7,776,015, it had the same title and all claims were drawn to jet injection devices. The specification explained that that the disclosed system for injecting pharmaceuticals utilized a needle to puncture the skin, instead of the typical jet injectors in which the medicant itself ruptured the skin. In fact, the entire specification was drawn to only jet injectors, and during prosecution, the applicants focused on the "jet injectors" limitations to distinguish the prior art. Nevertheless, within two years of issuance, the applicants filed reissue claims drawn to particular combinations of safety features for injectors, although without being limited to jet injectors. Each particular limitation may have found support in the specification, but it was only with respect to jet injectors (and not injector devices more generally).
The case posture before the Federal Circuit was an appeal of the denial of a preliminary injunction. Medac Pharma had filed a 505(b)(2) NDA application for pre-filled methotrexate syringes. Because Medac was seeking approval to sell a product that would allegedly infringe the '846 patent, Antares filed suit pursuant to the Hatch-Waxman cause of action -- 35 U.S.C § 271(e)(2)(A). Antares soon moved for a preliminary injunction, which was denied because the District Court believed that the reissued claims were vulnerable under the "recapture rule." When appealing such a denial, generally the case turns on whether the lower court had abused its discretion. This often results in just an affirmance. However, this Court took the additional step of determining that the claims were "invalid for failure to satisfy the original patent requirement of 35 U.S.C. § 251." Because it was unnecessary to reach the recapture conclusion, the Court did not address it.
The relevant statute, section 251, reads:
Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue
(emphasis added). The original patent requirement stems from a different requirement that existed before the current statute -- the "same-invention" requirement. Prior 35 U.S.C. § 64 read in pertinent part: "Whenever any patent is wholly or partly inoperative or invalid . . . the commissioner shall . . . cause a patent for the same invention . . . to be reissued to the patentee . . . ." (emphasis added). On its face, these requirements appear distinct. However, the Federal Circuit pointed out that P.J. Federico (co-architect of the 1952 statute) believed there was no indication that the requirement had been changed. The Court also cited several cases in supporting the proposition that the two standards were the same. This exercise in tracing the history of the statute was done in order to make the 1942 Industrial Chemicals case mentioned above relevant for the present discussion.
As suggested above, the Industrial Chemicals case matches nicely with the Tronzo v. Biomet written description case. The applicants had developed a process for the production of a chemical compound (ethylene oxide), which the applicants believed required the presence of water. Even though the specification did not provide any disclosure of the process without water, the patentees obtained a reissue patent because the specification read in one place: "Water can be admitted in the reaction vessel . . . ." (emphasis added). Despite this suggestion, the Industrial Chemicals Court invalidated the reissue claims because they did not cover the same invention. In doing so, the Court rejected the use of experts that said the invention could work without water, because it was clear on its face that the original patent required the presence of water.
This analysis would probably have been sufficient for the present case. However, because the Federal Circuit was reading Supreme Court case law from before the 1952 statute, the language was not going to sync up nicely. Moreover, patent drafting in the 1930s differed significantly from the practices employed today. For example, reissue application No. 20,370, at issue in Industrial Chemicals, had a specification that stretched only one and a half columns. Most introductions today are longer. Therefore, it is understandable that not all of the idiosyncrasies found in this 1942 case will translate well to today's practice. Nevertheless, this is what the present Court did. In an effort to make all of the square pegs fit into the round holes, Judge Dyk was required to contort the language and reasoning of intervening case law. The resulting conclusion was that the "original patent" requirement for reissue patents was somehow more exacting than the written description requirement for original applications (despite an earlier acknowledgement that they were basically the same). This is unfortunate because the case appears to fit squarely within current written-description jurisprudence. Nevertheless, moving forward, reissue applicants, accused infringers, and district courts are all going to need to figure out what it means to satisfy the "clear and unequivocal" disclosure test when it comes to reissue patents.
Antares Pharma, Inc. v. Medac Pharma Inc. (Fed. Cir. 2014)
Panel: Circuit Judges Dyk, Reyna, and Taranto
Opinion by Circuit Judge Dyk
