Last week, the Federal Circuit heard oral argument in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., a patent case. In it, the Federal Circuit is reviewing a district court’s determination that, when calculating a patent term extension for a reissued patent, the U.S. Patent and Trademark Office is statutorily required to base its calculation on the original patent’s issue date and not its reissue date. Judges Dyk, Mayer, and Reyna heard the oral argument. This is our argument recap.
Eric T. Werlinger argued for Aurobindo Pharma USA. Judge Dyk asked “why is it that Congress conceivably would want to treat the extension question differently, depending on whether the same claim appears in the original application, or a situation in which the same claim is continued as a result of a reissue?” Werlinger responded by arguing that “what Congress was looking to do with [35 U.S.C.] § 156(c) is to set a single bright line regimen that is applicable to all patents.” He explained that Congress “was looking for something that was very easy for folks to understand, for the PTO to administer, and it didn’t want to get into claim by claim distinctions.” He argued that it accomplished that with “§ 156(c), by pegging it to the issue date of the patent.”
Judge Dyk later asked why the court would look at 35 U.S.C. § 251 and § 252 rather than 35 U.S.C. § 156, given that § 251 and § 252 “were enacted long before § 156.” Werlinger responded by arguing that “you do look at those provisions.” He explained that, if Congress “wanted to create a special PTE regime for reissued patents, it would have done so explicitly.” He further argued that Congress “has not promulgated an alternative interpretation of the word ‘issued’ as applied to reissued patents,” and, he argued, “we have to view that silence as purposeful.”
Werlinger indicated his “problem with [Merck Sharp’s] reading of § 252” is that it would violate at least three canons of construction. First, he argued, Merck Sharp is “asking you to infer an alternative meaning of the word ‘issue,’ which is the operative word in § 156(c). ” He explained that, if you “were to read § 252 to do that,” then you are violating the canon of construction “that words are supposed to have a single meaning throughout the statute.” Second, he argued, Merck Sharp “is creating an idiosyncratic interpretation of a word that’s already appearing in the statute.” “When Congress intends to do that,” he continued, “they do so explicitly,” and “that has not been done here.” The third canon, he argued, is that “Congress is presumed to write the law with full knowledge of pre-existing law.” He explained that “reissue patents have been around for a long time,” and § 251 and § 252 existed when “§ 156 was written.” He emphasized that, “if Congress wanted to alter the operation of § 156 as applied to reissued patents,” it “would have passed an explicit regime.”
A judge asked for Werlinger’s “response to the argument that” his position “could lead to absurd results.” Werlinger replied that this argument is based on “hypotheticals, where a matter of days might make the difference between getting five years of PTE or no PTE at all.” He argued that this “might be the way that the bright line of this statute works,” but “that does not mean that it’s absurd.”
David M. Krinsky argued for Merck Sharp & Dohme. Krinsky argued that “the language of [§] 156 is very helpful to us here.” He said the “‘patent’ ought to be construed to be the ‘original patent.'” He argued that, “if there’s any doubt about that,” the court should “look to § 251,” which “doesn’t refer to two different patents” but “to ‘reissuing a patent.'” Krinsky maintained Congress, “when it referred to ‘the patent’ in § 156, was referring to, in the case of reissues, one and the same patent with one and the same term.” According to Krinsky, “the best” and “the only reading of § 156(a) and (c) is that ‘the patent’ refers to the one patent that’s been here all along, and the date the patent issued is the original issue date.” He explained, moreover, that this is “the only reading that gives a sensible result under the Hatch-Waxman Act,” where “a patentee gets credit for the period of time where they had a patent in effect, but they effectively couldn’t make use of that patent because the FDA was still reviewing their drug.”
Krisnky went on to argue that § 252 “explains how reissued patents should be treated in litigation.” A judge, however, suggested “this isn’t the kind of litigation they were referring to; they were talking about infringement litigation.” Krisnky responded by indicated that “this is an important point, because this is an infringement litigation.” He said “§ 252 provides for intervening rights when an act of infringement occurs prior to the reissuance of a patent.” And he explained that the act of infringement, “here–the abbreviated new drug applications that give rise to this cause of action and the filing of this complaint–all occurred after the reissue.”
Krinsky later addressed the argument that the court should “treat a reissued patent as a separate patent” and that, accordingly, “§ 156 needs to refer to the reissue–to a different patent–because the [original] patent is dead.” Krinsky argued that, according to precedent, “the statute permits the claims of the reissue patent to reach back to the date the original patent issued, but only if those claims are identical with claims of the original patent.” Here, he explained, “the reissue shouldn’t affect the calculation of patent term, and it should reach back.” In addition, he argued, the consistent practice of the PTO supports “how the statute should be read,” and that is that “the date the patent is issued is the original issue date.”
Maureen D. Queler argued for the USPTO. She began by arguing “the phrase ‘the issue date’ in § 156, for PTE, is best interpreted in view of the Patent Act as a whole.” She argued, “for a reissue date, in view of §§ 251 and 252,” that “means the date the original patent was issued.” She maintained this “interpretation aligns the language of § 156 with the statutory provisions governing the very patent that we’re talking about, which is a reissue.”
On the issue of absurd results, Queler argued, “the absurd result that the PTO finds most persuasive, is the fact that more FDA delay here leads to less PTE.” She said “that simply does not align with the policy behind PTE, which is to compensate for agency delay.” She argued “the statutory context, the policy,” and “USPTO practice . . . all go towards the best reading, which is using the original issue date, not the reissue [date].”
A judge asked her if there would be “a greater opportunity to game the system if we find the date to be the reissue date, and not the original” issue date. Queler responded by arguing that gamesmanship would likely occur using the reissue date by “either not filing the reissue or, at the Patent Office, taking certain steps to delay your reissue application, until you get PTE on the original patent.” By contrast, she explained, “there is no gamesmanship” under the interpretation using the original patent’s issue date because “there’s no reason that you would want to file a reissue if you knew it would cut off PTE.”
In his rebuttal, Werlinger argued that “issue” is an “undefined term term in the statute, and under the law undefined terms presumptively carry their ordinary meaning.” Additionally, he argued, “reissued patents must have a distinct issue date, otherwise” the statutory sections don’t “make sense.” Regarding the PTO’s practice, he explained that “Merck is saying ‘issue’ refers to the issue date of the original patent” with “no limiting principle.” Meanwhile, he explained, what the “PTO is proposing” is that it only does this “if the original and the reissue both cover the product.” Werlinger argued that Skidmore deference is not appropriate here because the case can be resolved “with the application of canons of construction.” Moreover, he said, “the PTO has not articulated a coherent interpretation of § 156.”
We will continue monitoring this case and report on developments.