Wyeth’s Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination

Rocking the boat...

Rocking the boat…

There was an amendment to the Israel Patent Law earlier this year. This amendment (11th amendment) relates to patent term extensions. The amendment was announced, but did not go into immediate effect.

Wyeth filed a request to correct a mistake in the Patent Extension Order concerning Israel Patent Number 120701. The extension Order was given on 23 February 2014, and extends the basic patent for Bazedoxifene which, without the extension, would have lapsed on 18 April 2017.  The intention to grant an extension until 26 August 2019 was given in October 2013 and published back then. The calculation was based on the Law prior to the eleventh amendment.

On 18 September 2014, Wyeth submitted a request to correct the Extension Order to provide protection according to the regime after the eleventh amendment.

Section 16 of the Amendment states:

16(a) this Law will apply to Extension Order requests that are pending before the Commissioner of Patents on the day that this Law comes into effect, and for future requests for patent term extension.

Wyeth’s contention is that the amendment to the Law came into effect on 27 January 2014 and due to the publication for opposition purposes, the period for opposition finished on 31 January 2014, so, at the time the Law came into affect no Patent Term Extension had been granted and the request for patent term extension for IL 120701 must, therefore, be considered as pending at the time the amendment came into effect.

The amendment narrowed down the list of countries that could be relied upon for Israel to grant a corresponding extension. Instead of anywhere in Europe that grants an extension, only Italy, UK, Germany, Spain and France could be taken into account. Significantly, Japan was no longer considered a relevant country in regards to patent term extensions. Wyeth’s patent was extended on the basis of the extension of the corresponding Japanese patent. By ignoring Japan, a longer term could be requested.

There is an interesting twist here. In October 2013, the FDA issued approval for Bazedoxifene together with conjugated estrogens as Duavee. This fact was not taken into account in calculating the Patent term Extension and could act against Wyeth. The Commissioner ruled that it would be improper to apply some sections of the amendment and not others, and that the Israel Patent Office should consider the ramifications of this FDA approval as well. In consequence, the Commissioner did not amend the ruling, but rather canceled it as a wrongfully given bureaucratic decision. He ruled that the published patent term extension was null and void and that the Application would be subjected to accelerated re-examination under the amended Law with the ramifications, if any, of the FDA approval of Duavee also considered.

Various legal precedents were given to support this contention and the solution it offered. The Commissioner noted that Patent Term Extensions are not final and could be reconsidered, even previous to the eleventh amendment.  He related to previous rulings concerning Teva vs. Abbott, Neurim, Lundbeck vs. Unipharm and Roche.

In addition to being able to oppose any subsequent patent term extension, the cancellation of the existing patent term extension may also be opposed by third parties.

Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.

One Response to Wyeth’s Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination

  1. Gerald says:

    Thanks for finally writing about >Wyeths Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination | The IP Factor <Loved it!

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