When Different Applicants Request Patent Term Extensions (PTEs) For Different Patents Based on a Common Patent and Regulatory Approval

Prolia

A semi-official version of the Israel Patent Law 1967 as currently amended is found on WIPO’s website. There have been three amendments of the Section of the Law that relates to Patent Term Extensions which is found in Sections 64a-64q, some of the letters relating to sections that have been repealed.  The last amendment was in 2014 and so there are some clauses that have not been explained by a court. Due to the enormous value of even very short extensions, there have been a number of applications for Patent Term Extensions which have raised interesting questions.

This Ruling concerns patent term extensions for four separate patents having different applicants. The patents are IL 159512, IL 127115 and IL 130492 and pending application number IL 132304 to Immunex, Daiichi Sankyo, Amgen and Amgen Freemont, and Amgen respectively.

All the requests are based on a patent term extension for Prolia which has the active ingredient Denosumab. The drug is designed to strengthen bones and is prescribed for women with postmenopausal osteoporosis.

The four separate applications for patent term extensions were all filed on 1 September 2011 by Reinhold Cohen representing the different applicants.  The patent term extension requests for IL 127115 and IL 130492 fall under the regime of Section 16b1 of the Eleventh amendment which sets out the transition period and requires the Commissioner to complete examining pending patent term extensions within two years of the patent issuing or within two years of the amendment coming into effect, whichever is later.

The time-frame of IL 15912 is in accordance with Section 64O as will IL 132304 should it issue.

On 22 January 2015 the applicants challenged the Examiner’s ruling under Section 161. In brief, the Applicants rejected suspending considering the patent term extension requests for IL 127115 and IL 130492 until after IL 15912 issues or until 27 January 2016.

The commissioner issued an interim ruling in accordance with Regulation 151 that states that: where different applicants request a patent term extension based on the first patent to issue for a specific active ingredient, each request will be examined on its merits until the Commissioner publishes one of these rulings after examination on the merits. Based on a comparison to Section 9 of the Patent Law, where two or more applicants request a patent extension based on the same earlier regulatory approval, the first to file takes precedence where there are no other extraneous circumstances to cause a different application to be preferred. The commissioner does not consider that in a case where different applicants come to an understanding and co-file requests for patent term extensions, he should in any way be bound to go along with them. That said, as the Applicants noted, since one or more patent applications may be rejected, it is reasonable to suspend requests for a patent term extension of later filed applications until one case is granted an extension. Essentially therefore, applications will be examined in turn according to their filing date.

The Applicants of 127115 and 130492 requested a hearing to discuss the above ruling which was held at the end of June 2015, and as a result of this, the examination of these patent term extension requests were suspended. In June 2015 the applicants filed their summaries and a hearing was scheduled. Due to this procedural delay, the requests for Patent Term Extensions of 127115 and 130492 are still pending. In the meantime, Application 159512 has issued and IL132304 has been allowed and published for opposition purposes.

In April 2015 the Applicants noted that a patent term extension was granted in the United states for US 6,740,522 to Immunex titled “Antibodies against ligand for receptoractivator of NF-kB” which relates to Prolia. Amgen and Amgen Freemont were then informed by the patent office that since the US patent as extended still lapses before the Israel issued patent for IL 15912 even without an extension, their application is moot. The applicants requested further suspending ruling on the patent term extension until IL 132304 is allowed. The Commissioner would rather examine the first case until allowance, making examining the other cases moot.

The Applicants’ supported their request with the following argument:

Until a patent term extension issues, none of the applicants should be restricted in any way. The only reason given in Section 64D for not granting a patent term extension is that one has already been given based on the basic patent and regulatory approval for the active ingredient. If this has not yet happened, all applications for patent term extensions are legitimate.
Thus a number of statements of intent to grant patent term extensions all based on the same regulatory approval of the same basic patent can issue.
The Applicants cited the patent term extension granted in 83148 to Roche Diagnostics GmbH and to IL 120701 to Wyeth to the effect that the rights to a patent term extension come into effect with it issuing.
According to the Applicants, Section 64D(4) relates to granting an Extension and should not be applied to intentions to grant.  A statement of intent to issue a patent term extension is not the same as a patent term extension order. It is not inconceivable that several statements of intent for different patents could issue. Textual support that a ‘patent term extension order’ and ‘intent to issue a patent term extension’ are not the same thing is found in Section 64L which relates to the lapsing of a ‘patent term extension order’ or an ‘intent to issue a patent term extension’ thereby making clear that these are not the same thing.
As Section 64L and Section 64K(3) teach, an ‘intent to issue a patent term extension’ can lapse, thereby indicating that this may happen prior to an actual order issuing. This indicates that the legislation should certainly have related to any intention to issue other patent term extensions than the one pending publication of the intent to issue. As detailed below, this need does not occur in Section 64D(4) of the law which relates to conditions for not granting an earlier order.
The Commissioner does not consider that the publication of several Intents to Grant Patent Term Extensions can help the Commissioner apply Section 64D(4) of the law, which does not allow granting an Extension for a drug based on an active ingredient that has been previously used as a basis of a patent term extension. The Commissioner understands Section 64D(4) as requiring publication of a single intention, thereby being clear to the public.
The Applicant’s understanding that the patent office should publishing several intentions for several drugs does not address the fact that eventually only one will be allowed. Consequently this will simply sow seeds of doubt. The term intent means real intent for a single application for a single patent term extension.
Section 64E relates to additional publications concerning the progress of a particular application. The applicants don’t believe that the final publication is indeed a final publication as future patent term extensions from other countries could change this.

The Commissioner does not consider such readings reasonable. According to the Commissioner, the Eleventh amendment which included Section 64E creates a split opposition proceeding such that the Section 64EE(1) publication demonstrates that the Application fulfils the basic requirements for which it was granted, and separates the calculation of the term for separate opposition. In this regard, section 64G(2) relates to the later opposition that only relates to the duration of the Extension and cannot be used to challenge the Extension on grounds appropriate to Section 64EE(1). Thus without a prior opposition under Section 64EE(1) the register remains clearer.

The Applicants understanding could result in the commissioner having to publish a string of notices and this will create a lack of clarity. This is not merely theoretical. US 6,740,522 and two other patents were cited as the basic patent in the patent term extensions applications for IL 15912 and IL 130492. Thus patent will lapse on 17 September 2021 which is after the natural life of IL 15912

The applicants consider that publishing an intention to grant an extension for one patent prejudices other patents behind it in the queue. The Commissioner rejects this assertion as it is the same for all publications. In other words, where two patent applications claim substantially the same invention, the first one filed is examined and the examination of later filed ones are suspended. Should the first one be withdrawn or canceled, the second one is examined on its merits.
Were IL 132304 to be eligible for a patent term extension, or even were it to be opposed, the two year period provided for in the eleventh amendment could not be met.

In summary, the Commissioner is not convinced that there is any reason to suspend the request for a patent term extension for the ‘115 and ‘492 cases until the ‘304 case issues if it ever does, and so his earlier ruling stands. The applicants of IL 15912, IL 127115 and IL 130492 are given 60 days to respond to the office actions listing missing information.

COMMENT

This was an imaginative submission. I think that on balance, the commissioner’s interpretation of the Law is better.
I am not sure how one firm of patent attorneys can represent four different applicants in a race to receive a Patent Term Extension PTE based on the same earlier regulatory approval. To some extent the drugs in question may compete with each other. Even if they don’t compete for treating the same illness, only one patent will be entitled to a patent term extension. It seems, therefore, that Reinhold Cohen has a conflict of interest here. No doubt, they understand conflicts of interest differently from me as well.

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