By Dennis Crouch
Gilead Sciences v. Natco Pharma (Fed. Cir. 2014)
Gilead’s two virus inhibition patents at issue in this case are quite similar to one another, although there is no priority claim creating an official family relationship between the patents. Patent Nos. 5,763,483 and 5,952,375. In a not-uncommon fashion, the application resulting in the ’375 patent was filed first, but, because of a variety of prosecution delays, was the last to issue. The ’375 patent is also set to be the first-to-expire. Note, after the ’483 patent issued, Gilead filed a one-way terminal disclaimer for the ’375 patent – limiting that patent’s term so that it cannot extend beyond the term of the ’483 patent. Of course, that limitation is meaningless since the ’375 patent naturally expires first anyway. The following timeline may help illustrate the relevant dates:
Double Patenting: This setup raises the prospect of obvious-type double-patenting. That doctrine is not based upon any statute, but has been applied by courts as a mechanism to prevent patentees from prolonging their patent term by obtaining a second-patent with claims that are not patentably distinguishable from the claims in the first patent. The general rule is that a terminal disclaimer cures the obviousness-type double patenting. However, here, one of the patents (the ’483) patent does not have a terminal disclaimer.
Later Issued but Earlier Expiring Patent: The district court ruled in favor of Gilead – holding that, as a matter of doctrine, a later-issued but earlier-expiring patent cannot serve as a double-patenting reference against an earlier issued but later-expiring patent. That rule cited here by Judge Wigenton (D.N.J.) follows two Delaware district court cases stating the same proposition. Abbott Labs. v. Lupin Ltd., 2011 WL 1897322 (D. Del. May 19, 2011) and Brigham & Women’s Hosp. Inc. v. Teva Pharm. USA, Inc., 761 F. Supp. 2d 210 (D. Del. 2011). Those cases are in conflict with a PTAB decision on the same topic: Ex Parte Pfizer, Inc., 2010 WL 532133 (Bd. Pat. App. & Interf. Feb. 12, 2010).
On appeal, the Federal Circuit focused on the particular legal question: “Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?” The answer: Yes it can. With the result here being that the district court’s decision is in error. The majority’s reasoning makes sense – the primary purpose of the double-patenting doctrine is to prevent a patentee from unduly extending its patent term and here, Gilead is attempting to do so by an additional 22-months.
The majority opinion was filed by Judge Chen and joined by Judge Prost. Chief Judge Rader filed a dissenting opinion arguing that the court should have acted more cautiously in extending the judge-made rule. Judge Rader writes:
Under the AIA’s new “first-inventor-to-file” framework, prospective patentees are under tremendous pressure to file their applications early. I am concerned that today’s opinion will have unforeseen consequences in this new race to the Patent Office.
I would suggest that – most likely – the doctrine of obviousness-type double patenting would have never been created if the current regime had been in place way back when. Most notably, calculating patent term as 20-years from filing eliminates most potential game playing and the publication rules would typically result in an earlier filed patent being seen as prior art – even if jointly owned.
Extension and Adjustment: Although this issue has been addressed somewhat in other cases, this decision does not offer any insight as to how double-patenting applies to cases where the difference in patent term is due to a patent term adjustment or extension.
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The currently proposed legislative patent reforms would codify the double patenting exception in a somewhat narrower fashion. This would potentially limit any further judicially motivated alterations in its scope.