Can a Request for a Patent Term Extension be suspended?

As a general rule, issued patents may be enforced for up to 20 years from their effective filing date so long as renewals are paid. Pharmaceutical Patents are an exception. Because of the time-consuming and expensive testing procedures required before a new drug can be sold, it is possible to obtain a patent term extension, providing up to five years’ additional protection for a new drug in certain jurisdictions to give up to 14 years of effective monopoly after obtaining regulatory approval in at least one market granting patent extensions.

Potentially the sales of a successful patented pharmaceutical may be billions of dollars a year. Israel is one of the countries that does grant such patent term extensions. The relevant section of the law is complicated and has been amended more on several occasions to remove misunderstandings. This ruling concerns what happens when there is both an issued and several pending applications. Can requests for patent term extensions be applied for the issued and all pending applications, and then suspended until the patents issue? Doing so would enable the Applicant to make sure that a patent is extended for as long as possible, and there has been a ruling where the request for a Patent Term Extension was suspended pending examination of a divisional application.

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The Case

Millennium

In August 2008 Millennium Pharmaceuticals submitted Israel Patent Application No. 203641 titled ”PROTEASOME INHIBITORS”. This was allowed in 2015, but Teva filed an Opposition. The patentee requested suspension of a request for a patent term extension until pending applications IL 210056, IL 234285, IL 242291 and Il 242282 were examined.

ninlaro

On 9 August 2016, the drug Ninlaro which includes the active ingredient Ixazomib as the citrate salt was registered. On the basis of this registration, the patentee requested patent term extensions to IL 210056, IL 234285,    IL 242291 and Il 242282 and to IL 203641.

At the time that the patent term extension was requested, none of the patents had issued. The Applicant requested an extension period under Section 94(e)(ii) of the Israel Patent Law 1967, and the requests for patent term extensions were not considered at the time of their submission. However, on 9 November 2017 after an Opposition against IL 203641 was withdrawn, the patent issued.

On 20 November 2017, the patentee requested that the patent term extension for
IL 203641, which was the first allowed patent, remain suspended pending the allowance of the divisional patent application Nos. IL 242291 and 242292. The Applicant was invited to explain himself orally, particularly since the filing and prosecution of divisional applications was something over which the Applicant has some control.

After the hearing was scheduled, the Applicant made a further submission stating that there was a mistake in the original suspension request and that it should be requested to further relate to IL 210056 and its continuation – IL 234285.

The divisional patent application Nos. IL 242291 and 242292 were allowed and published for opposition purposes on 31 December 2017 but IL 210056 and IL 234285 are still pending. However, in a hearing on 2 January 2018 the Applicant alleged that the remaining objections against these are of a formal nature and the completion of their examination is expected shortly.

The Applicant’s Claims

The Applicant argues that if he does not suspend the patent term extension request for IL 203641, it is likely that the patent term extension will be granted before the other patents issue and before it is possible to consider patent term extensions based on them. In such a scenario, the Applicant will have to request a Patent Term Extension on the first patent to be allowed, and not necessarily on the patent for which they want the extension.

The Applicant bases his position on the ruling by then Commissioner Asa Kling concerning IL 184027 to Novartis AG from 10 October 2016 where the request for patent term extension for an issued patent was suspended pending allowance of a further patent for which a patent term extension was requested. The main argument used was that the progress of the patent examination was not in the hands of the Applicant.

The Applicant explained that the filing of the patent application or a divisional application of an existing patent does not put the Applicant in ‘control’. The Applicant cannot determine when a patent is examined, when the allowed patent is published and if oppositions will be filed, and the case is thus similar to IL 184027 to Novartis AG.

The Applicant notes that even if allowed, the pending patents will lapse in 10 or 12 years. This long period until the patents lapse tips the scales in favour of the Applicant, since suspension of the patent term extension procedure will not adversely affect the interest of third parties. Furthermore, even if the Examination is not suspended, the patent term extension for IL 203461 which has already issued cannot be completed since there is no corresponding patent term extension in the US or Europe.

Ruling

The Israel Patent Law does not relate to the order in which a number of Patent Applications for the same formulation are to be considered for the purpose of Patent Term Extensions under Section 64a of the Law. However, Section 64d(3) states that one cannot obtain more than one patent term extension for any material or for a number of patents that relate to one pharmaceutical formulation. For the sake of brevity, these will be referred to hereunder, as parallel applications.

The question that arises in such cases is when does the Applicant have to decide which patent, of those pending, does he wish to extend, and he has to abandon the possibility of obtaining a patent term extension for the other cases.

Examining a number of parallel patent applications for patent term extensions was examined in the case of IL 130492, IL 127115, IL 176921, IL 142282 and IL 216249 to IMMUNEX CORPORATION from 29 June 2016. In that instance, the possibility of suspending an application for suspending examination of a patent extension request was also considered.

In that instance, the Applicants alleged that under Section 64d(4) of the Law, the right to a patent term application only crystallizes once it is actually granted, so in cases where the Applicant files several applications for patent term extensions in one go, they should all be left pending, including those issued, until at least one receives a patent term extension, and only then should the Applicant have to abandon the other cases.  An alternative claim that arose is that where the examination of other corresponding patents cannot be suspended until an extension is granted, the Patent Office should publish a number of notices concerning the intention to grant parallel patent term extensions, thereby not obliging the Applicant to abandon the Applications before a patent term extension is granted following publication for opposition purposes.

In re Immunex, the Applicant’s claims were rejected by the then Commissioner Asa Kling who ruled that where several parallel applications for Patent Term Extensions are examined, after examination, the intention to allow an extension for one of the cases should be published and the other applications should be abandoned, despite the fact that no final decision to grant a patent term extension had occurred, merely the intention. In the ruling it was stated:

An arrangement of this type under Section 19 of the Law was not set out in Section 1b of Chapter D of the Law. Were it to have been the intention of the legislators to have established a similar arrangement for all the applications for patent term extensions, it would have stated this explicitly. Without such a mechanism, the lacuna cannot be rectified by judicial commentary, unless there is no alternative.

In this regard, it is noted that the legislative did give guidance on the order of examination for patent term extensions that relate to a patent that has not yet issued. In Section 64v(b) of the Law it was stated that a patent term extension request would not be considered until the basic patent  issues. From that stated, one can learn what is not stated. Since the legislative did not rule something similar regarding examining different patent term extension requests, it can be deduced that there is no suspension arrangement where this does not serve the legislator’s intention in Section 64v(b) or other purpose that arises.

In this regard, one should consider the two Immunex rulings from 2 April 2015 and from 7 September 2015. Then Commissioner Kling then gave some guidance of how to consider examination of several patent applications. In such cases, one does not expect the Applicant to abandon an application for a patent term extension before it is examined and the Applicant is entitled to exploit the examination through to conclusion, i.e. until an intention of granting a patent term extension is published. These proceedings can sometimes take years, particularly where oppositions are submitted.

The issue of suspending the examination of parallel applications also comes up in cases where the patentee has both an issued patent and a pending application where, for one of these, there is a patent term extension for the same medical device.

From the Law in Section 64v(1), the patent term extension must be examined within 60 days from filing. As to the request for a patent term extension, Section 64v(2) of the Law sets out an exception that states that the request for the patent term extension will not be considered until the patent issues. This may take years, particularly if an opposition is submitted.

Consequently, the Applicant can choose that a patent term extension that relates to the issued patent may be examined within 60 days of the filing date and, if found eligible, can obtain the Extension. However, if the Applicant wants to elect the pending application for the patent term extension, he should abandon the other cases before they publish, as per the Immunex decision. Thus, he should wait for a patent to issue before the request for a Patent Term Extension be considered. During the period, the Applicant does not know how long the patent will last, and whether it will survive oppositions proceedings should any be submitted.

The requirement for the Applicant to abandon requests for patent term extensions for other patents prior to being awarded a patent term extension for the desired patent may leave him bald on both sides. For example, if for some reason the patent chosen is not extended due to an opposition being submitted.

This issue was addressed by then Commissioner Kling in re Novartis AG, where he ruled that the examination of a patent term extension for a registered patent will be suspended until any oppositions of parallel applications are finished, so that the Applicant can have both parallel applications examined. Thus the then Commissioner ruled:

As stated, in this instance, the consideration of the request for a patent term extension will be suspended for one of the applications. As per the Applicant’s request, Application IL 184027 to Novartis AG has not issued since an opposition was submitted which is proceeding first, since the opposition proceeding is not entirely within the control of the Applicant.

If the request for a patent term extension was not suspended, the Applicant would be in a situation where he would not be able to complete the examination of the two requests for patent term extension where there is nothing to stop him submitting them and benefitting from them.

In these circumstances, and in the absence of any other temporary step, by suspending the request for a patent term extension for a patent for as long as a patent application cannot be examined, the intention of the legislators of Section 64v(2) is fulfilled.

Consequently, the examination of the patent term extension of Application IL162661 shall be suspended until the earliest of the examination of the patent term extension for IL 184027 to Novartis AG if it issues, and the acceptance of the opposition and the rejection of the Application No IL 184027 in its entirety.

Thus the Commissioner required that in re Immunex, the application for a patent term extension be considered under the 11th amendment of the Law from 2014, in paragraph 2430 page 274, which defined the examination period there.

Since section 1 of Chapter 4 does not relate to these issues, one has to find the correct balance between the interest of the Applicant to utilize his right to a patent term extension, and the competing interests such as certainty, reasonableness and the rights of competitors. This raises the question whether in all circumstances, the optimal way to find a balance between the competing rights as stated above, is by suspending the examination of patent term extensions whilst there are pending applications.

RULING

Commissioner Ofir Alon accepts that the legislation allows the submission of multiple requests for patent term extensions for multiple parallel applications for the same medical formulation. He also accepts that the commissioner can suspend examination of the requests in appropriate cases.

Commissioner Ofir Alon does NOT accept the Applicant’s assertion that in re Novartis that in ALL CASES where there is a pending request for patent term extension based on a pending patent application, that all parallel applications for patent term extension be suspended. However, it is true that the legislation did formulate a suspension for patent term extension requests for pending applications.

64v(a) If a request for a patent term extension is applied for in accordance with the regulations by the appropriate party, the Commissioner should consider the request within sixty days of it being submitted.

(b) in accordance with that said in (a), if a request for a patent term extension is submitted before the basic patent issues, the request for the patent term extension will not be considered until the basis patent issues.

It is true that the law considers patent term extension requests for pending applications should be suspended until the patent issues, even if this is close to when such patents would lapse. In this manner, the Legislators showed that they considered it important to give applicants for patent term extensions the possibility to request these for pending applications, and that these would be considered, putting the Applicant’s interest first DESPITE the resulting lack of certainty.

However, this arrangement relates to the Examination of THAT same patent application. The law is silent with regards to other pending parallel applications, and does not clearly allow them to be suspended. Commissioner Alon does not see anything in the law as written, nor in the intent of the Law that warrants automatically suspending requests for patent term extensions whenever there is an issued patent and pending parallel patent applications.

In the explanatory notes of the 11th amendment (see the proposal for the 13th amendment of 2012, pages 792, 794 of 7 May 2015) it states:

The amendments that are suggested are intended to increase the certainty for both the drug manufacturing companies that are patent protected, and for generic manufacturers, by minimizing the number of countries that can be used as the basis for calculating the patent term extension in Israel, and by ruling as early as possible regarding requests for patent term extensions, thereby enabling the opening of the Israeli market to generic drugs as early as possible. In this manner there will be increased budgeting certainty for the country to plan for purchasing drugs and medical devices.

In the explanation of Section 64v(a) that states that examination should be within 60 days, similar things were considered:

The suggested amendment states that a request for a patent term extension should be examined as soon after filing as possible, and if it is submitted prior to the basic patent issuing, as soon after it issues as possible, to give the decision regarding whether or not to grant an extension as soon as possible, thereby increasing certainly regarding the period of protection for medical formulations and devices that are patent protected.

The legislators’ intention was to have requests for patent term extensions examined as early as possible. So automatically suspending requests indefinitely is, according to Commissioner Alon, NOT the intention of the legislation.

Commissioner Alon also believes that unless one suspends the request for a patent term extension for a patent that has already issued, it will prevent the intention of the Law which is to allow patent term extensions to eventually be considered for pending applications. The Applicant is able to choose that the patent term extension is applied to a pending application without suspending the request, however by so doing, the Applicant will have to give up on the patent term extension for the issued patent before an intention to grant the suspension is given.

certainty

The desire of the patentee to choose the Application when there is a state of certainty is clear and understood, and so the question regarding which patent will be extended from among the various patents for a certain active ingredient may be very important to the Applicant. However, one has to balance this interest of the Applicant with other interests, particularly the interest for clarity that the legislators were interested in obtaining.

This case demonstrates the complexity of this issue. The Applicant has five parallel patent applications where it is impossible to know when they will issue or be abandoned. The Applicant wishes to suspend the request for a Patent Term Extension for IL 203641 which has issued. It is expected that in a few months the pending divisional applications will issue, and then the Commissioner will have to consider suspending THEM until the final two applications also issue.

If an Opposition is submitted against one of the allowed patents, we can expect five requests for indefinite suspensions of the examination of the request for patent term extensions, until the opposition is concluded. In such circumstances, the public will remain in a state of uncertainty for many years as to which patent will finally be extended.

A main claim of the patentee is that anyway there is a long period of pendency under the 20 year rule before the patent would lapse and so there is no real damage or uncertainty by allowing the suspensions, regardless of which patent is finally extended.

logic

There is some logic to this claim. However, as explained above, the purpose of the 11th amendment was to increase certainty towards having the request considered as early as possible. The 11th amendment did not differentiate between patents that were close to lapsing and those that had a long pendency even without a patent term extension, and it could have done so. Thus in general, the period of when the patent would lapse is not in and of itself, a basis for allowing a suspension of the request or not, as Commissioner Alon ruled in re Farber.

Before concluding, the Commissioner related to the Applicant’s allegation that requests for patent term extensions were anyway uncertain things since the patent term extension had not yet been granted in any of the recognized countries, and so suspending the requests would not cause any damage.

This allegation cannot be accepted. As ruled in Section 64v(5) of the Law, the examination of a patent term extension should occur even before a patent term extension of the basic patent occurs in one of the (Bolar) countries offering a patent term extension, and if the application for a patent term extension fulfils the various conditions, a notice of intention to grant a patent term extension will be published under Section 64(v)(5)(1) of the Law, see the IMMUNEX ruling of 7 September 2015.

 

certainty

This means to say that the Legislators saw fitting to provide certainty to the public regarding patent term extensions, even where there is incomplete information regarding the future of the extension, such that the public would know which patent would be extended, even if the length of the extension was not yet known. See the Opposition to a patent term extension in IL 164147 Mapy Pharma ltd. vs. Celenge Corporation, from 18 January 2017.

uncertain

In light of the above, in the opinion of the Commissioner, the balance suggested above as used in re Novartis, is not unlimited, and should be applied sparingly, considering each case on its merits. Considerations that may be relevant for deciding whether or not to suspend examination of requests for patent extensions include the number of cases that would require being suspended, the time remaining before the patent lapses, the behavior of the Applicant during patent examination and opposition proceedings, the period of suspension requested and other parameters that come up in each specific case. This is necessary to balance between the conflicting interest of the patentee to select the case that he wishes to extend under conditions having as high a degree of certainty as possible, and the conflicting need to provide the public with certainty regarding which patent will be extended as the legislation requires.

Anyway, in the present instance, the Commissioner considers that the request to suspend the examination of the request for patent term extension is premature, since the Applicant has legal means to protect his rights by requesting extensions under Section 64ix(a1) of the Law.

At this stage, there are four co-pending applications that have not yet been allowed. As noted by the Applicant’s attorney in the hearing, the examination of these cases will soon be completed and the Applicant will know the scope of the allowed claims. By the end of the period for filing Oppositions, the Applicant will know if any oppositions are submitted against issued patents.

In light of the above, the Commissioner rules that at this stage, the examination of the request for a Patent Term Extension of IL 203461 should continue on schedule and, if the Applicant sees fit, he may request extensions for responding to any issues raised until he has sufficient data to request the Patent Term Extension on the most preferable application.

Ruling by Commissioner Ofer Alon concerning Patent Term Extension of IL 203541 to Millennium, (suspension of examination) 15 February 2018. 

COMMENT

ofir-alon

This is the second ruling of the new Commissioner Ofir Alon concerning the tricky, controversial, highly litigated area of patent term extensions. In his first ruling, the Commissioner creatively interpreted the Law to express what he considered to be its intent and seemed to favor the patentee. In this second ruling, he has turned down a request from the patentee, but left enough wiggle room to provide no general guidance on how he will rule in other cases where similar issues comes up. In ex-partes decisions, the generic drug development companies such as Teva and Unipharm have no standing, but eventually these issues become inter-partes and it is not likely that patent term extensions that are substantially effected by a ruling will end up in court. We wait to see what happens.

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