Caution Sign on Laptop

In re Janssen Biotech, Inc., Appeal 2017-1257 (Fed. Cir. Jan. 23, 2018), is a cautionary tale concerning patents protecting a blockbuster drug providing patients an important therapy and bringing its owners billions of dollars in annual revenue. It began twenty-five years ago with a then-unremarkable decision to file a patent application. The filed application was of a type that others then also filed—and some may still be filing today. The Patent Office issued that application, without proper examination it turns out, as a patent. Under the circumstances of this case, this type of patent, the courts and Patent Office have since determined, is invalid for obviousness-type double patenting.

The Remicade® Patents

Janssen owns a family of patents that covers its anti-TNFα drug product, Remicade®, and associated therapies. One of those patents issued in 2001 and it includes claims reciting a specific antibody, infliximab, that is the active ingredient in Remicade®. The family includes dozens of other patents. One has claims reciting a method of treating Crohn’s disease with that antibody. Another has claims reciting a method of treating rheumatoid arthritis (RA) with that antibody. The list of patents is seemingly endless, but in this tale only these three patents matter.

Before any of these three patents issued, a single application (the “original” application) filed twenty-five years ago included versions of these claims. The Patent Office examiner issued a restriction requirement, concluding that some of these claims were sufficiently distinct to recite more than one invention, and that examination in that application ought to be limited to just one invention. In such circumstances, Patent Office rules require that if the applicant wanted a patent on the other inventions, it would need to file additional patent applications. The applicant, Janssen’s predecessors in interest, did that—but incorrectly so.

Instead of filing identical versions of its original application, designated as divisionals, the applicant filed two applications, each a continuation-in-part (CIP) of the original application. These CIP applications included all sorts of additional information, none of which was necessary to describe the inventions of the antibody and method claims. One of the CIP applications eventually issued as the antibody patent after ten years of examination comprising years of the applicant’s delays in prosecuting that application. The antibody patent also included two claims reciting an invention not described in the original application. The other application, on the method of treating (MOT) Crohn’s disease, issued more quickly. A yet later CIP of these two applications eventually issued as a patent with claims reciting a method of treating rheumatoid arthritis. These patents do not share a common expiration date. Their relationship is shown below.

ODP and the Safe Harbor

The patent laws permit issuance of separate patents each claiming obvious variants of an invention claimed in another patent within the family. Where this occurs, the judicially-created doctrine of obviousness-type double patenting (ODP) forces the patents’ owner to disclaim the terminal portion of the later-expiring patent and maintain ownership of all patents. These actions, accomplished with a terminal disclaimer, see 35 U.S.C. § 253, prevent the patent owner from potentially receiving a time-wise extension of term and ensure the public fear not the potential of facing multiple lawsuits from different owners of these patents.

But Congress wrote in the 1952 Patent Act a narrow safe harbor preventing application of the doctrine where the Patent Office issues a restriction requirement—as the Patent Office did in the original Janssen application:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

35 U.S.C. § 121. Before this provision, the patentability of the applicant’s inventions recited in divided claims would be assessed against the claims of the invention elected in and issuing from the original application. “The enactment of the safe harbor … brought clarity and fairness to the interaction between restriction and double patenting.” Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1361 (Fed. Cir. 2008).

The Safe Harbor Does Not Protect Patents Issued on CIP Applications

The Federal Circuit has repeatedly said that it “follows ‘a strict application of the plain language of § 121.’” Janssen, Slip Op. at 9 (quoting, citing, and discussing past cases). This safe harbor protects only (i) the original application in which the Patent Office issued the restriction requirement, (ii) divisional applications filed as a result of that requirement, and (iii) patents issuing on these applications. None of Janssen’s three patents issued from any such application; instead each issued from a different CIP application. Nearly fifteen years after those applications were filed, the Federal Circuit held that the safe harbor does not protect patents issuing from CIP applications. Pfizer, 518 F.3d at 1360, 1362 (noting also that nothing in the legislative history of section 121 suggests “the safe-harbor provision was, or needed to be, directed at anything but divisional applications”). Pfizer learned the hard way that it had incorrectly filed as a CIP its application that the Patent Office issued as a patent protecting from competition its Celebrex® product—a product whose sales were then bringing Pfizer billions of dollars annually.

Improperly-Designated CIP Applications Cannot Be Re-designated Via Reissue

Through reissue, a procedure to correct errors in a patent, Pfizer (i) re-designated as a “divisional” the underlying “CIP” application it originally filed in response to a restriction requirement and (ii) deleted all the information and claims that defined the application as a CIP. The Patent Office eventually reissued Pfizer the patent. But in proceedings to enforce the reissued patent, the federal district and circuit courts determined the safe harbor did not protect the reissued patent from double-patenting attacks. For years, the additional information and claims served as a basis on which Pfizer obtained foreign patent protection and otherwise quelled competition. “Fairness to the public,” the Federal Circuit said, “does not permit Pfizer to convert the [CIP] application into a division of the original [] application, and thereby take advantage of the safe harbor provision, simply by designating it as a divisional application years after the fact.” G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1355 (Fed. Cir. 2015). Without the safe-harbor protection, the courts determined the Celebrex® patent was invalid for obviousness-type double patenting.

The Remicade® Antibody Patent, a CIP, Cannot Be Re-designated VIA Reexamination

Where Pfizer foretold Janssen’s fate, Searle eventually sealed it. In 2013, as the treatment method patents were about to expire, a third party anonymously and successfully requested the Patent Office reexamine Janssen’s antibody patent because its claims are invalid over the claims of the treatment method patents. Those method claims, you will recall, recite the same antibody. In response to the Patent Office’s rejection, Janssen unsuccessfully tried to convert its antibody patent from a CIP into a divisional. At stake: four years of exclusivity and the associated billions of dollars Janssen was earning annually. Janssen amended the specification to remove all the additional information and the two claims that defined the application as a CIP. The Patent Office examiner entered that amendment, but did not withdraw the rejection. The Patent Trial and Appeal Board (PTAB) affirmed, in 2017, the examiner’s rejection, concluding there is “‘no reason to permit [Janssen] now, by amendment, to acquire the benefit of the safe harbor where [Janssen] voluntary[il]y and deliberately filed a continuation[-in]-part application with claims directed to subject matter absent from the [original application] and outside the scope of its restriction.’” Janssen, Slip Op. at 7–8 (quoting the PTAB).

Janssen appealed, without success. Janssen sought to correct the designation not through reissue, but during reexamination. But seeing no pertinent difference in these two ways to correct a patent, persuaded by its own reasoning in Searle, and based on the plain language of section 121, the Federal Circuit concluded that Janssen’s antibody patent is not entitled to safe-harbor protection: “For a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest, by the time the challenged patent issues on that application.” Janssen, Slip Op. at 12–13. The court therefore affirmed the PTAB’s rejection of the antibody claims as “unpatentable under the doctrine of obviousness-type double patenting,” id. at 18, ending this cautionary tale, twenty-five years after it began.