By Melissa L. Kleine and Edward R. Williams
Later this year, the Federal Circuit will issue a decision in In re Cellect, which is on appeal from the Patent Trial and Appeal Board (PTAB). The decision will have potentially wide-ranging effects on patent terms and portfolio strategy; therefore, the implications of the case are worth previewing in advance of the decision.
For all patent applications filed on or after June 8, 1995, the term of patent grant is twenty years from the earliest filing date of any non-provisional U.S. application to which that patent claims priority. Patent applications filed prior to this date were granted a term of seventeen years as calculated from the issue date of the patent. Accordingly, to determine a later-expiring patent in a family of patents, the key dates of interest shifted from the issuance dates of the patents involved to the relevant filing dates of the corresponding patent applications.
Understanding patent term is critical when responding to an obviousness-type double patenting rejection. Obviousness-type double patenting is a judicially-created doctrine (as opposed to a doctrine created by statute) that mitigates two types of harm that could otherwise arise from patent owners having multiple patents that essentially claim the same invention. The two types of harm are 1) unjustified extension of patent term via serial patents, and 2) multiple infringement suits by different parties asserting rights in essentially the same patented invention. Concerns with these harms often arise in continuation or continuation-in-part applications in which a patent owner files broader claims in a child application based on an earlier application that has granted. Obviousness-type double patenting therefore prevents a patent owner from extending patent protection by obtaining a second patent with claims that are an obvious variant, but not identical, to the claims of a first patent.
Obviousness-type double patenting can be overcome by filing a terminal disclaimer that is applied to the second, or later-expiring patent. Terminal disclaimers solve the harms of obviousness-type double patenting by requiring that 1) the later-expiring patent expires with the earlier patent (thus preventing unjustified term extension) and 2) the later-expiring patent remain commonly owned with the earlier patent (thus preventing multiple infringement suits by different parties). A terminal disclaimer may be filed both during prosecution of a patent application and after a patent issues, so long as it is filed before the earlier patent expires.
However, it is important to recognize that the later-expiring patent may not be the later-filed application encountering the obviousness-type double patenting rejection. The term of the respective patents may be complicated by patent term adjustment (PTA) and patent term extension (PTE), both of which were established by statute to prolong the term of a patent under certain circumstances. PTA provides additional patent term when a patent application is subject to delays that are caused by the United Patent and Trademark Office. PTE may extend the term based on certain regulatory delays, for example, FDA review of a new drug. Due to the grant of PTA and/or PTE, two patents may have different term lengths, even if they have the same relevant filing date and would otherwise expire on the same day. For example, an earlier-filed and earlier-issued parent application may receive PTA or PTE that extends the term of the patent beyond the term of a later-filed and later-issued continuation application that claims priority to the parent (i.e., has the same earliest filing date as the parent application).
Given the relationship between obviousness-type double patenting, terminal disclaimers, and patent term length, what happens when PTA and PTE are brought into the mix? At least with respect to PTE, the answer appears to be settled. In Novartis AG v. Ezra Ventures LLC, the Federal Circuit held that obviousness-type double patenting should be considered in terms of a patent’s original expiration date, before the application of PTE. Accordingly, if a patent’s original twenty year expiration date (i.e., before considering any PTE) should have been terminally disclaimed due to obviousness-type double patenting and was not, the patent could be invalidated. By contrast, if a patent eligible for PTE is valid under its pre-PTE expiration date, it is entitled to the full term of its PTE. In other words, a later-filed and later-issued patent (e.g., a continuation application) that, due to PTE, expires before an earlier-filed, earlier-issued patent (e.g., a parent application) cannot function as an obviousness-type double patenting reference to invalidate the earlier-filed patent. In reaching this decision, Federal Circuit reasoned that the judicially-created doctrine of obviousness-type double patenting should not override Congress’s intent in the establishment of PTE.
The question remains as to whether PTA is to be treated similarly to PTE for purposes of an obviousness-type double patenting analysis. At least according to the PTAB’s decision in Cellect, the answer is that PTA should be analyzed differently. Therefore, a later-filed and later-issued patent that, due to PTA, expires before an earlier-filed, earlier-issued patent can function as an obviousness-type double patenting reference to invalidate the earlier-filed patent. To support this conclusion, the PTAB reasoned that the congressional intent underlying PTA was different from the intent relating to PTE, and particularly the establishing statutory language was clear that PTA was not intended to extend the term of a patent past the date of any terminal disclaimer. The PTAB further held that such an application directly addresses the harm the obviousness-type double patenting doctrine sought to prevent, namely unjust time-wise extension of a patent.
The PTAB’s decision in Cellect is now on appeal to the Federal Circuit and a decision is expected this year. Based on the Federal Circuit’s decision, a different strategy to patent portfolio management with respect to filing terminal disclaimers and responding to obviousness-type double patenting rejections during prosecution may be warranted. If you have questions regarding the impact of Cellect on your patent portfolio, please contact your attorney at Andrus Intellectual Property Law.
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