Unipharm Requests Accelerated Examination of Pending Novartis Patent Application

novartisIsrael Patent Application No. 249922 is a divisional application of 205208 that was filed on 3 January 2017, and which claims priority from USSN 60/985,668 filed on 6 November 2007. Under Section 16, the filing of the divisional application was published on 29 February 2017.

The ‘922 application relates to “DUAL-ACTING PHARMACEUTICAL COMPOSITIONS BASED ON SUPERSTRUCTURES OF ANGIOTENSIN RECEPTOR ANTAGONIST/BLOCKER (ARB) AND NEUTRAL ENDOPEPTIDASE (NEP) INHIBITOR”.

On 4 January 2017, the Applicant received a Notice Prior to Examination under Section 18 and regulation 36. Examination has not started.

UnipharmUnipharm requested that the examination of the Application be accelerated under Section 19a of the Israel Patent Law. The request was supported by an Affidavit from Mr Zevulun Tomer, Unipharm’s CEO:

I affirm that if IL 249922 to Novartis AG is examined in due course, it will cause a delay in Unipharm’s development of a product that is a high priority. … Making the Examination special will prevent delays and costs and serves the public interest by making drugs more available at lower cost and by opening the market to competition.

EntrestoOn 2 April 2017, Novartis AG opposed the request. Their position was that the request was vague and did not fulfill the conditions of Section 19a(c). Novartis notes that Unipharm did not provide details regarding which drug they intended developing, and if their intent was to develop a generic version of ENTRESTO, Novartis noted that that product was protected by other patents, some of which were pending patent extensions, and so accelerating the examination of ‘922 would not have the allegedly desired consequences.

Novartis also noted that if an Opposition is eventually submitted against IL 205208 under Section 26 of the Israel Patent Law which published for opposition purposes on 31 January 2017, anyway under Commissioner Circulars 035/2017 and 020/2012, no extensions in the Examination of the ‘922 application would be allowed.  The Commissioner noted that on 23 April 2017, the period for submitting an Opposition was still open, so there was no need for him to address this theoretical issue. In response to Novartis’s counter-statement, Unpiharm reiterated their claims.

Section 19a(c) provides the situations where a third-party can request acceleration of a pending application to another:

(c) A person other than the applicant, and who is not associated with the applicant or works on his behalf, may submit to the Commissioner a detailed request along with an affidavit supporting the facts, for an accelerated examination of an application that was published under section 16A, if one of the following occurs: (1) There is an established concern that the examination of the application of the patent according to the set order may cause the applicant of an accelerated examination application, who works in the field of the invention, a delay in the development or in the production of a product or a process claimed in the patent application under this subsection. (2) Time elapsed since the submission of the request is unreasonably long under section 15 or from the day the request entered the national stage under section 48D, and taking into consideration any significantly lengthy time since the lapsed date up to the beginning of the examination of other application of the same type. (3) Public interest; (4) Extenuating circumstances which provide justification.

As established re Israel Patent Application 221842 J. L. Glatt Lift ltd, 14 June 2016: 

 The possibility of accelerating examination under Section 19a is an exception to the general rule regarding examination that is given in Section 9 and regulation 34:

Applying the exception is likely to damage the principle of the first to file is to be awarded the patent and is likely to damage the general quality of patent examinations. For example, prior art that is not yet examined could be overlooked.

It is clear that accelerating examination under Section 19a is reserved for extreme cases where it is justified to deviate from the normal order. The burden of proof is on the Applicant for  Accelerated Examination who is to detail his request and support it with evidence.

Unipharm’s request and Mr Tomer’s affidavit relate in general to Section 19a(c) but it appears that they intend part (1) which relates to ‘delays in developing or manufacturing a product’ that Unipharm intends to manufacture, and to part (3) that relates to the ‘public good’ that is served by greater accessibility to drugs, reduced costs and competition in the market.

Unipharm claims that under their work program, if a patent issues for the ‘922 application, this will prevent them developing and then manufacturing their product.  Unipharm’s affidavit details the managerial program and preferences. The Commissioner Asa Kling does not see any reason not to accept an Affidavit from a CEO who may be presumed to know the company’s plans. There is no need to cross-examine under Section 163a of the Israel Patent Law 1967, and if it should transpire that Unipharm have lied, this Affidavit could be used against them. Therefore, it seems that Unipharm have provided the appropriate support for their request as required by Section 19a(c)(1) of the Law for accelerated examination.

This is not the case with respect to ‘public interest’ under Section 19a(c)(3) of the Law. As explained in the Glat Lift case, accelerated examination under Section 10 is reserved for extraordinary cases that are important to the State of Israel in general. The Application and Affidavit do not point to such a specific condition. It does not explain how accelerated examination will result in competition that will bring about a drop in prices. As Novartis noted, it doesn’t even explain which market sector will have enhanced access. The Section 19a(c)(3) justification is rejected.

However, due to the Section 19a(c)(1) justification, examination of pending application 249922 will be expedited on payment of the relevant fee. Suspension or extensions will be permitted only in accordance with Section 19(a)(1) of the Law. No costs are awarded.

COMMENT

In this instance, as we are dealing with a divisional application, there is no danger of earlier filed not published art being missed due to the patent being examined out of turn. The Commissioner Circulars 035/2017 and 020/2012 explain Patent Office policy to examine divisional applications of opposed applications as fast as possible. There is a real danger that applicants for pharmaceuticals that are opposed will file continuations and divisionals to keep the patent application alive in an attempt to evergreen. So on balance, it seems that the request is reasonable and the Commissioner was right to grant it. If Novartis are acting in good faith, they should be interested in having their patent application examined as fast as possible. They have not provided a justification for delaying, such as wanting to wait for examination of a corresponding application to be concluded so that they can request allowance under Section 17c or similar.

With a justification under Section 19a(c)(1) it does not matter that the Section 19a(c)(3) request was denied. However, I don’t fully understand the Commissioner’s reasoning. If he considers that one has to be facing a drug shortage within an epidemic, that is one thing. However, I don’t think that one should have to explain how allowing generic competition lowers drug prices for the common good. This is self-evident and true for all drugs, and the underlying logic of free markets and really dates back to Adam Smith’s Wealth of Nations. Still, the Law does seem to require something extraordinary.

We note that Unipharm successfully handled this request themselves, without professional representation. This is not the first time that Unipharm have successfully fought inter-partes proceedings at the Israel Patent Office without using an attorney. Nevertheless, others are strongly advised not to follow their example.

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