When does the ninety day period for requesting a patent term extension commence?

Extension for IL 124123 to Bayer. When does the ninety day period for requesting a patent term extension commence?

In this ruling, the Commissioner accepts that the 90 day period for requesting a patent term extension should be calculated from the date at which the Ministry of Health informs the Applicant of the issuance of the decision to grant a patent term extension, and NOT from the date on the certificate. We now wait for someone to request that all sorts of cases be reopened, and extension fees refunded.

There is a second part to this ruling, in which the Commissioner rules on whether this is indeed the first registration of the drug. For blogging purposes, I am relating to the issues separately.

Kovaltry

The Application for the Extension for IL 124123 to Bayer was filed on 7 August 2016 and relates to the KOVALTRY formulation in the medical products registry from 8 May 2016, and which contains Recombinant Human Coagulation Factor VIII (no relation).

The Deputy Chief Examiner sent an Office Action on 13 September 2017 in which she raised the following objections:

  • The Application does not fulfill Section 64xv(a) of the Patent Law 1967 since it was received 9 days after the formulation was registered in the pharmaceutical registry.
  • The Application does not fulfill section 64d(3) of the Patent Law 1967, since it is not the first registration of Recombinant Human Coagulation Factor VIII in the pharmaceutical register.

The Applicant was also required to provide additional details regarding extension orders in the US and in recognized European countries.

On 11 December 2017, the Applicant responded to the Office Action. Following the Request for Patent term extension being rejected on 3 December 2017, the Applicant challenged the grounds for rejection. In their response, they submitted a detailed list of allegations on 7 February 2018 and a summary on 20 February 2018. The Applicant also attended a hearing on 25 February 2018. After the hearing on 1 March 2018 the Applicant submitted a completion of their case.

Bayer raised two main claims. The first was the way of calculating the timing of the request for the extension conducted by the Deputy Senior Examiner in accordance with Section 64xv(a) of the Law. The second related to the previous registration of bioactive ingredients for medical purposes in accordance with Section 64iv(3) of the Law.

Timeline for Submitting the Request for Patent Term Extension

When the Application was submitted on 7 August 2017, the Application wrote that “This Application based on the Kovaltry formulation that was registered on 8 May 2016, and so the Application is submitted within 90 days of registration.”

Ms Assem Mehta Deputy President, Head of the Department of Patents and Licenses, and Assistant to the Secretary, affirmed in an Affidavit supporting the request for patent term extension, dated 22 August 2016, noted in Section 4 of the Affidavit, that the medical device was registered on 8 May 2017.

However, from the Office Action, the Registration Date that appears on the Certificate of Registration is indeed 8 May 2017, but the request for the Patent Term Extension was only filed on 7 August 2017 which is 91 days from the registration date. Based on this data, the Deputy Chief Examiner ruled that the request does not conform to Section 64xv(a) of the Law which requires that:

Section 64xv(a)A request for a patent term extension should be submitted in the appropriate manner, after paying the fee, and not more than 90 days from registration in the Pharmaceutical Registry.

In the response to the Office Action from 11 December 2017, the Applicant claimed that although 8 May 2017 is the date at which the registration for marketing Kovaltry appears in the register, the Authorization only issued on 10 May 2017, and this was the date at which the Manager of the Register for Pharmaceutical Formulations informed the Patentees of the Approval. The Applicant appended a further Affidavit dated 14 January 2017, from Mr Gal Friedman, the Head of Regulation of Bayer Israel, which markets the Applicant’s products in Israel. In the Affidavit, Gal Friedman asserted that regulatory approval was only received on 10 May 2017. An email notification from the Head of Registration of Pharmaceutical Formulations, Dr Einbinder was appended. The email address was given as the formal electronic mailing address of Bayer Israel.

The Applicant claims that from their attempts to clarify the matter, that in the past, the date on the certificate was the only date available for calculating the 91 day period. However, nowadays, one can use the date of informing the Applicant as the starting period of the 90 days.

The Applicant claims that neither the Patent Law nor the Pharmacists Ordinance 1981 define the registration date that appears on the registration certificate. They thus allege that there is no basis to explaining that the 90 day period stated with this date is the correct date for calculating the 90 day period for requesting a patent term extension from a the Deputy Commissioner ruled, rather than the date at which the Applicant was informed (i.e. 10 May 2017).

The Applicant went on to claim that time periods for calculating things that depend on the Authority are generally to be calculated from when the citizen is made aware of the action of the Authority or when the notice is sent.

The Applicant wishes to draw a parallel to the C-471/14 Seattle Genetics from 6 October 2015, where it was ruled that the period for giving marketing approval under the European regulations, is from the day that the Applicant is informed, i.e. the date of notification. The Applicant claims that the basis for this determination is that the marketing approval does NOT enter into effect from the day that the decision is taken, but rather from the date that the Applicant is informed of the decision. Consequently, certificates of registration have two dates and the Applicant believes that one should prefer the later of the two, which fulfills the intention of the legislation, which is to provide a sufficient window for Applicants who have a basic patent, to request a patent term extension – something that they cannot do before knowing that a marketing approval has issued.

The Applicant alleges that this position is supported by the District Court ruling in 32321-10-16 Bristol Myers Squibb Holdings Ireland vs. Commissioner of Patents and Trademarks 26 December 2017, where Section 64x(2) of the Law was interpreted to mean that the period of marketing approval commences with the informing of the decision to the Applicant and not with the date that the Approval was made. The Applicant considers that this should apply to Section 64xv(a) of the Law as well.

The Applicant also considers that the explanation of the Law made by the Deputy Chief Examiner could result in many cases where the patent term extension period was determined by the date appearing on the certificate and the number of days would need to be recalculated.

DISCUSSION AND RULING

The issue in question is the correct explanation of the term “Day of Registration of the Medical Formulation” as mentioned in Section 64xv(a) of the Law.

In legislating that the Applicant should submit their request for a patent term extension within 90 days from registration in the Pharmacist’s Register, the legislators attempted to achieve two purposes:

  1. To give the Applicant sufficient time to prepare their application
  2. To allow the public to know with certainty whether a patent term extension was being sought for a particular product, thereby providing market certainty.

Section 64xv(a) has been amended. In the earlier version under the third amendment to the Law, the period for applying for a patent term extension was 60 days from registration of the formulation under the Pharmacist Regulations (formulations) 1986.

In the seventh amendment from 2006, 3 January 2006, Book of Laws 2048, page 195-197, the Section was amended to extend this period to 90 days. The Pharmacist’s Regulations were similarly amended and now state “from the day of recordal under the Pharmacist’s Ordinance. In the 11th amendment the Authority of the Commissioner to extend the period was taken away, so the period is non-extendible (Amendment 11, 2014, Law book 2430, 27 January 2014, pages 274, 278.

From the Applicant’s claims it transpires that there are four periods that could be considered the period of registration from which the 90 days are calculated:

  1. That given as the date of registration
  2. The day that the approval is printed on the certificate
  3. The date when the Pharmaceutical Division informs the owners of the registration – the sending date. and
  4. The date of knowledge – the day on which the owners of the registration receive notification of the registration.

The date of registration is that appearing on the certificate from which the ninety day period has traditionally been calculated when calculating the deadline for requesting a patent term extension (considering the certificate as it stands today).

The date of printing is presumably the date when the Ministry of Health produces the certificate. This is the date on page 3 of the Kovaltry certificate which states printed on 10 May 2017.

The claims and evidence before me do not support the contention that the date of printing of the certificate is necessarily the date on which the Ministry of Health informed the Applicant that their request for registration was successful. Indeed, one can assume that the date of printing will actually change each time that the same document is sent to the printer and so the same certificate could exist with different printing dates. Consequently, the Commissioner does not think that this date can be relied upon as the date for registration with regard to the correct explanation of Section 64xv(a) of the Law.

As to the period of sending or the period of becoming aware, the Commissioner accepts the Applicant’s allegation that calculating the deadline from the Official Date is problematic where the Applicant only becomes aware of the date retroactively, since it is difficult to require someone to take an action within a time period from an event occurring that he does not know about.

The issuance of a marketing authorization is an administrative action as defined in Section 3 of the Law of Interpretation:

An administrative action is an order or an appointment, notice, license, approval and the like, that is given in writing under Law and is not a legislative action.

In his book Administrative Authority, Y Zamir states that (Zamir, Administrative Authority Vol. 2 Second Edition, 201 on page 1320):

Common sense tells us that there are things where not being informed of an administrative decision that adversely affects a person’s rights, should not be in effect at all, or in certain circumstances, if the person was not informed of the decision. For example, let’s consider that an Administrative Authority cancels the work permit of a person but does not inform him of this, is it conceivable that the person will be tried under criminal law for running a business without a license? If an Authority applies a tax and does not tell him, can he be held liable for not paying that tax? Where a Law states that a person is allowed to Appeal or to critique an administrative ruling in some other way within a specific period from that decision issuing, and the person is not informed, should he be prohibited from criticizing the ruling? In summary, it appears that the present situation requires a legislative solution or case-law, that relates to publication of civil rulings. The underlining is by Commissioner.

Logic obliges that giving notification to someone regarding an administrative action relating to him cannot be applied without the person being aware of the administrative action. This is also stated in regulation 4 of the Patent Regulations 1968:

The calculation of the time period for doing an action the Law or regulations require or allow, following actions of the Commissioner or subsequent thereto, should enter into effect from the date when the requirement is given to the postal service and addressed to the client or agent-of-record at the official address, or sent by electronic mail, as per Regulation 16(b). This period starts with the sending of the electronic mail, unless it is established to the Commissioner’s satisfaction, that the message was not delivered.

True, in this instance, we are NOT talking about an action that the Patentee is required to take following an action of the Commissioner of Patents, but due to the action of a different Authority, the Ministry of Health, however the underlying logic is appropriate. It is noted that where the Pharmacists’ Regulations themselves give a time period for an action, the time period is from when the action of the Authority is made known to the person concerned, see, for example, Regulation 9(3) of the Pharmaceutical Ordinance:

 (b) If the director considers that the registration of the formulation in the register should not be renewed, he should inform the registered owner before the registration lapses, the notification should be by registered mail to the official address of the registered owner.  

(b1) If the manager informs that he does not intend renewing the registration, he should extend the registration by no more than six months.

(c) The owner of the registration is allowed to appeal the decision not to renew the registration within six months from receipt of the notification under Regulation (b).

So the patent regulations specifically state that where someone has to respond to an action of the Authority, the period for responding will be calculated from the day of sending or from the day of receipt of the notification if it is proven that the notification did not reach its destination. The pharmaceutical regulations state that the period is calculated from notification.

In the ruling of re Bristol, Judge Magen Altovia related to the “submission approach”.

 It is noted that the serving of papers approach sits well with the administrative law that stresses that the period of serving of papers is more important than the reaching of the administrative decision by the deciding party with respect to setting into practice that allowed.

As Judge Magen Altovia stated in re Bristol, the purpose of the civil law procedures is to fulfill real rights. See Appeal 6708/00 Aharon vs. Aharon p.d. 54(4) 702:

At the end of the day, the civil procedures are there to serve substantive rights, and they are there for a purpose. The wider substantive approach, of which good faith is the wellspring, cannot be accompanied by overly strict civil procedures. The legal culture is not only judged by protected rights, but also sometimes by the ways of approaching situations and the status of those being judged.

Consequently, Commissioner Ofir Alon considers that the 90 day period for requesting a patent term extension be calculated in a similar fashion to other deadlines in the Patent Law, i.e. in accordance with Regulation 4 of the regulations, that the date is to be calculated from when the notification is sent to the applicant / patentee, unless the Applicant can prove that the notice was never received, and in such cases, the period is to be calculated from when the consumer learned about the decision.

The Commissioner does not consider that calculating the period from the day that the Notice was given to the Applicant undermines the second purpose of the legislators; the need for certainty. This interest is not damaged if the date is calculated from the day of sending, since this is usually close to the day that the decision was taken by the Ministry of Health. It should be noted that Section 64 of the Patent Law has to be very carefully interpreted, to reflect the balances intended by the legislators.

In this instance, in the request for registration and in the affidavit, the Applicant noted the date of registration as 8 May 2018, even though Mr Friedman did not note that the notification was first sent to the Applicant on 10 May 2017, which the Commissioner is willing to assume was his intention in light of the Applicant’s claim, and noting the date of the printing appears on the certificate. In light of all of the above, the Commissioner rules that the response was timely filed under Section 64xv(a) of the Law.

COMMENT

This ruling seems to indicate that the Current Commissioner is less formulistic than his predecessors. I was rather taken aback by this ruling since I think that the 90 day period is ample to cover regular postage delays and his deadline should be no different from all the others that are calculated from the date on the certificate.

The Patent Office has very many deadlines triggered by an action they take, including the deadline for responding to Office Actions (typically 3 or 4 months, and extendible), the final deadline for responding to all Office Actions for registering a design (one year from the date of the first office action), the deadline for paying the first renewal (three months from issuance of the patent certificate), the deadline for filing oppositions, the deadline for filing abroad under Paris, etc. ALL of these calculate the deadline from the official date, despite the fact that, in practice, the Applicant will only be aware of the date once he/she receives notification which may be some time later.

The 90 day period is sufficient to cover delays of days in the authority informing the Applicant and the time for the Applicant to inform his client. If it can be shown that there were extraordinary delays involved, then there is due cause to argue that the delays were unavoidable and the Commissioner could reasonably give a discretionary extension. If the Law limits the grounds for discretionary extensions, it does so for good reason. In light of this ruling, ALL the deadlines triggered by Patent Office actions are now suspect.

There is no need for this. The 90 day period is sufficient to cover minor delays and, in this instance, the delay was three days. Sixty days used to be considered enough for filing a request. This period has been extended to ninety days. Ninety days is ample.

The 90 day period should not be extendible. The Law requires unavoidable delays and there was nothing unavoidable in this instance. However, although I think the ruling was horrible, there is a precedent for extending the 90 day period based on errors by agent of record being unavoidable. In XXXX, Reinhold Cohn missed the date due to docketing errors. If Pearl Cohen had claimed that they made a docketing error and calculated the date from receipt of notification, it is difficult to see how the present Commissioner could avoid giving the extension given to Reinhold Cohn. Of course, to do this requires knowledge of the previous decision which requires reading the decisions or following this blog.

Even without this, if the Commissioner simply ruled that the delay was unavoidable, he could simply have granted an extension based on payment of an extension fee. Instead, he has ruled that all deadlines are to be calculated from date of sending, or if not received, from date of notification. We predict that this will open a hornets’ nest.

Actually, there is a second issue here, which is whether this was the first publication. On that ground, discussed in the next blog posting, the extension was rejected. The Commissioner could, therefore, have ruled on that case and left the present issue open.



Categories: Israel IP, Israel Patent, Israel Patent Agency, Israel Patent Office, Israel Patent Office Rulings, patent term extensions, Patents, pharmaceuticals, pharmaceuticals and Biotechnology, Section 64, החלטת רשות הפטנטים, פטנט, פטנטים, קניין רוחני, קנין רוחני

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