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« Ex parte Hakkani-Tur (PTAB 2018) | Main | Webinar on Protecting Software as a Medical Device »

May 24, 2018


They could have used faster and (eventually) cheaper IPRs instead of a DJ action, unless they were hoping their DJ action would obtain a quick cheap license settlement. But if they did not win at the PTAB level they may well not have been able to appeal to the Fed. Cir for lack of Article III standing on similar facts?
Was the DJ complaint even adequate for current practice? i.e, did it specifically identify allegedly invalidating prior art [that others could use]?

Mr. Morgan,

Would an IPR path now be out of the question?

Anon, here is 35 USC 315 (a), and I leave it to you to say if it answers your question or not - I am not speculating if the situation here of a DJ attempt dismissed for lack of jurisdiction is really a perpetual IPR bar under this IPR statute or not:
(a) Infringer’s Civil Action-
(1) INTER PARTES REVIEW BARRED BY CIVIL ACTION- An inter partes review may not be instituted if, before the date on which the petition for such a review is filed, the petitioner or real party in interest filed a civil action challenging the validity of a claim of the patent."

The complaint is here:
and alleges that the claims are invalid under Section 101, and in violation of Sections 1 and 2 of the Sherman Act. While there is a passing reference to Section 103 no art is cited. Which answers the question of why there was no IPR filed.

Mr. Morgan,

Here, I understand your reticence of providing an answer. It certainly appears to require providing a non-trivial legal opinion as to whether or not the failed attempt at DJ would count as "filed a civil action." Certainly, a civil action was filed and certainly that civil action was definitely challenging the validity of a claim of the patent.

The question apparently is that whether the mere act of filing is enough // whether a fatal filing "counts" as a filing or is somehow void ab initio.

Any brave souls out there with an informed opinion?

Dr. Noonan,

Unfortunately, your link is not an open site and carries the following message:

This is a Restricted Web Site for Official Court Business only. Unauthorized entry is prohibited and subject to prosecution under Title 18 of the U.S. Code. All activities and access attempts are logged.

Sorry - thought it was open. You'll have to trust me (or I have to figure out how to link the complaint some other way).

As to the drug -- tenofovir alafenamide fumarate ("TAF")--, note that Truvada with --tenofovir disoproxil fumarate ("TDF") -- made the recent FDA list of Reference Listed Drug (RLD) Access Inquiries (with no REMS issue). The FDA approved generic Truvada in 2017, with Teva and Gilead making a deal. Some of the lawsuits involving Gilead and TAF are over issues other than patents. If, hypothetically, there were an obviousness issue it might be that TAF is obvious over TDF.

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