by Dennis Crouch
In Abbvie Inc. v. Kennedy Institute, the Federal Circuit confirmed that the judicially created doctrine of obviousness-type double patenting (OTDP) continues to be a viable defense following the Uruguay Round Agreements Act (URAA) even though the change to a priority-date-based patent term greatly reduced the potential for abuse. Looking forward, the decision begs the question as to whether the OTDB doctrine has been eliminated as to patents examined under new the America Invents Act of 2011 (AIA). For the first time the rewritten patent statute particularly defines what evidence counts as prior art — now leaving little room for the judiciary to create further categories.
Obviousness-type double patenting (OTDB) has long been an element of patent law that operates to prevent a patent applicant from chaining-together a time-series of multiple patents in order to extend the exclusive rights beyond the expected 20-year term. Historically, the potential term expansion was made possible by filing a second or subsequent patent application (often a continuation application) that issues several years after the original patent. Because the patent term was 17-years from the issue date, later-issued patents would have additional patent term beyond the expiry date of the first-issued patent. The OTDP doctrine operates to block this outcome of extended patent term whenever the invention claimed in the extended-term-patent would be obvious (not patentably distinct) in light of the invention claimed in the first-expiring patent. In that situation, the extended-term patent is held invalid or unenforceable unless the patentee had submitted a “terminal disclaimer” that disclaims the potential extra term and also links the two patents together as if they were one big patent. Writing on this topic in a 1963 CCPA decision, Judge Rich noted:
The public should also be able to act on the assumption that upon expiration of the patent [the public] will be free to use not only the invention claimed in the patent but also any modifications or variants thereof which would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill of the art and prior art other than the invention claimed in the issued patent.
See MPEP 804.
Declining Policy Concerns: Much of the need for the OTDB doctrine evaporated with the 1995 patent term transformation enacted with the URAA. Under the new law, US patent term is now calculated from the application priority date rather than the issue date with the result being that the a divided application no longer necessarily extends the patent term.
Of course, there are some caveats to the notion that OTDB is now an unnecessary relic: First, the term of a patent may be adjusted or extended due to a variety of factors with the result that family member applications may have differing expiry dates. The second source of potential term-separation comes from the statutory definitions of prior art that excludes certain prior applicant disclosures from the scope of prior art. These prior-art exclusions include certain pre-filing disclosures by the applicant as well as prior applications on file with the PTO that are not yet published as of the application latter filing date. The first situation (PTA) was a focus of Gilead Sciences v. Natco Pharma (Fed. Cir. 2014) and the second situation was the focus of AbbVie.
In AbbVie, the patentee held two separate patents both covering aspects of a rheumatoid arthritis treatment. Although both patents were part of the same patent family, only one claimed priority to a certain earlier application. It turns out that the early priority date was not needed because no intervening prior art had been identified. Under the 20-year term rules, the two patents were scheduled to have two different expiry dates. In the appeal, however, the Federal Circuit affirmed that the second patent was invalid for obviousness type double patenting because it was not patentably distinct from the claims of the first patent.
An interesting aspect of the decision involves the court’s attempt to ground the doctrine in statute rather than the judicial creation heritage that Judge Rich had accepted and recognized. Judge Dyk writes:
While often described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act. . . . § 101 forbids an individual from obtaining more than one patent on the same invention, i.e., double patenting. As this court has explained, “a rejection based upon double patenting of the
obviousness type” is “grounded in public policy (a policy reflected in the patent statute).”
Although the policy notion may be grounded in Section 101, the court explains that the practical application of the doctrine “looks to the law of obviousness generally” and is “analogous to an obviousness analysis under 35 U.S.C. § 103.” (quoting Amgen).
While unimportant for the AbbVie decision, the particular grounding of the doctrine may be important going forward because the law of obviousness has been rewritten as part of the America Invents Act of 2011.
The AIA redefines prior art in a number of particular ways. Notably for this discussion, the law spells out the scope of prior art along with certain “exceptions.” These exceptions include disclosures originating from the inventors (Section 102(b)); as well as prior patent applications from the same patent-owned and that were still unpublished by the latter filing date (Section 102(b)(2)(c)). Section 102 has also been rewritten to expressly state that it is defining “prior art” — presumably the entire scope of potential prior art. When the obviousness provision in Section 103 refers to “prior art” it is now clear that we are talking about prior art as defined in Section 102 with the exceptions as noted.
Although a seeming small change in the statute, these alterations repeatedly make clear that certain prior disclosures by an inventor/owner simply don’t count as prior art either for novelty or obviousness purposes. At the margins there continues to be potential for applicants to “play games” with the filing system in order to extend their effective patent term. However, that potential is so reduced from ages past and the statute now defines prior art at such an explicit level of detail that we leave little room for a judicially created doctrine that further eliminates patents.
Creating versus Eliminating Prior Art: At this point, it would be rather odd for the court to create additional forms of prior art that extend beyond the statute. What is unclear is whether the courts will be willing to apply the rewritten statute in a way that eliminates old forms of prior art that are no longer part of the statute. Like OTDP ‘prior art,’ the court will be faced with a similar situation involving prior secret sales or non-public commercial uses by the patentee that previously served as prior art but that do not seem to fit within the re-written definition of Section 102.
One problem with the doctrine is that it is slowly developing. The first challenges may come from a patent applicant who refuses to file a terminal disclaimer in order to get its patent allowed.
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I should say that Congress potentially recognizes that double patenting doctrine is potentially problematic and Rep. Goodlatte has proposed an amendment that would codify double patenting.