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

May 29, 2018

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.


IL 221116 – Extending the Period for Reconsideration of a Refused Patent

November 2, 2016

mouth-cleanerIsrael Patent Application No. IL 22116 titled “Mouth Cleaner” was applied for by Yaakov Dichtenberg and Danny Unger who is also a patent attorney.

The Application was rejected. Under Section 21a and 164a of the Israel Patent Law 1967,  within 12 months of a final rejection, the Applicant may request reconsideration by the Commissioner. After that time it is possible to have a closed application reopened, but it is difficult and it is generally necessary to show extreme circumstances resulted in the application becoming abandoned.

weve-movedThis Application was filed on 25 July 2012 and, in accordance with Section 16a of the Law, a Notice of Imminent Publication was sent to the Applicants on 5 January 2014. This notice was sent to the address given on the application form which was the address of the first Applicant, Mr Danny Unger, a patent attorney who represented himself and the his c0-applicant. The Application published on 30 January 2014.

On 2 February 2014 the Applicants received a Notice of Imminent Examination in accordance with Section 18 of the Law and regulation 36 of the patent regulations 1968. Since the Applicants did not respond to this Notice within the period ordained in regulation 36, a reminder was sent on 5 November 2014 to the effect that in absence of a response within 30 days, the Application would be deemed abandoned. Subsequently, on 21 December 2014 a Notice of Rejection issued that also informed the Applicants that they could request reinstatement within 12 months.

On 21 December 2015 a request for reinstatement was received together with a response to the Notice Prior to Examination. The Notice of Reinstatement did not include a signed affidavit as required by Commissioner Circular  026/2014, however the Applicants alleged that they never received the correspondence due to a change of address.

On 15 March 2016 the Deputy Commissioner Ms Jacqueline Bracha requested that the Applicants provide a detailed signed statement of the events leading to the Application becoming abandoned and set a date of 20 April 2016 for a hearing.

On 19 April 2016, one day before the hearing, the Applicants requested a postponement for personal reasons. Despite the lateness of the request and the lack of a doctor’s letter, Ms Bracha agreed to the postponement. Nevertheless, the detailed statement was not submitted.

Applicant and Patent Attorney Unger arrived very late to the rescheduled hearing and claimed that he thought that updating the Ministry of the Interior regarding his change of address was sufficient to automatically update the patent office records. The Applicant was informed that Regulation 16a makes it clear that he should have proactively informed the Israel Patent Office of his change of address and that he still needed to provide an affidavit.

On 25 May 2016 an Affidavit was received in which the Applicant informed the Israel Patent Office that he neglected to inform them of his change of address and consequently never received the correspondence from 2014 to 2016 which was sent to his previous address. He went on to affirm that he never intended to abandon the Application and wanted to continue prosecuting the Application in parallel with the US application.

RULING

Section 21a sets the timetable for requesting reconsideration of a rejected Application as follows:

21A. If the Registrar refused to accept an application under section 21, then he may— on the applicant’s application—reconsider the refusal, on condition that the application be submitted within 12 months after the day on which the Registrar refused to accept it as aforesaid.

Section 164a of the Law enables the Commissioner to extend Section 21a due to reasonable causes:

Where the 12 month period stated in Section 21 has passed, the Commissioner may, nevertheless, reinstate a patent application in exceptional circumstances under Section 164a which states:

164.—(a) The Registrar may, if he sees reasonable cause for doing so, extend any time prescribed by this Law or by regulations under it for the performance of anything at the Office or before the Registrar, except for the times prescribed in sections 30, 56, 57, 61, 64F, 64M…

As the Deputy Commissioner, Ms Bracha sees it, Section 21a gives the timeline for an Applicant to restore an Application. Section 164a gives the Commissioner sweeping powers to reinstate but has to be applied with consideration of the fine balance between the Applicant’s interest and that of the public; see 2806/04 Commissioner of Patents vs. Recodati Ireland LTD:

The policy regarding different requests to extend deadlines will vary depending on context and the type of proceeding that the extension is requested for.

If the Commissioner agrees to an extension, he is entitled to make the decision dependent on appropriate conditions in the circumstances as detailed in Section 164b:

The Commissioner may make the extension dependent on any conditions as seen fit.

As ruled in the decision concerning IL 157563 ICOS Corporation from 21 October 2013:

Citing Opposition IL 110548 Shmuel Sadovski vs. Hogla Kimberly Marketing LTD. regarding Revivals, the relevant considerations are the time passed and the underlying reasons for the delay. In this regard, the time passed not only provides an indication of the reasonableness of the Applicant’s behaviour, but also affects the likelihood of third parties relying on the case being abandoned, since it is evident that the longer an application remains abandoned, the greater the likelihood that third-parties will have relied upon the invention not having been patented.

In this instance, the period beyond the 12 months automatically  granted by Section 21a of the Law is minimal. The Applicant filed a request on the last day but did not file it properly since no Affidavit was included. The Affidavit was only submitted after the hearing.

However, the behaviour of the Applicant does not conform to that expected of a Patent Attorney, who, in this case, represents not just himself, but also a second Applicant. A Patent Attorney is expected to know that he should provide an address to the Israel Patent Office and that this address will be the one that post is sent to. The Patent Office cannot change the address of record without instruction to do so in a formal request to change the address of record. No such request was submitted. Furthermore, the Applicant found it difficult to conform with the revival instructions after being instructed to provide an affidavit explaining the circumstances leading to the application going abandoned. Nevertheless, it does seem that the Applicant followed the case or he would not have known that he should request revival of the Application.

elephant-and-post-boxIn the circumstances, the Deputy Commissioner ruled that the case should be returned to the Examiner as per Section 21a. However, because of the public interest, the Deputy Commissioner makes revival conditional on anyone relying on the patent lapsing from when it lapsed until when it was reinstated being allowed to continue using the invention, even if a patent should eventually issue.

Notice is given to the Applicant that his address has still not been updated.

Decision by Ms Jacqueline Bracha regarding reinstatement of IL 221116 “”Mouth Cleaner” to Yaakov Dichtenberg and Danny Unger”,  7 September 2016

COMMENT

Apart from being rather surprised that a registered Patent Attorney could forget to update the patent office about his change of address and assume that the Ministry of the Interior would do it automatically, I am at a loss as to why he didn’t bother checking up the progress of the application for his own invention on-line.

Since the request for revival was filed within the 12 month time period, at least, since all yearly and monthly deadlines are to the same calendar day, I think the decision is correct.

chewing-gumI couldn’t resist reviewing the Application as claimed, and note that the first few claims attempt to monopolize apples and chewing gum. Go figure.


Extending the Deadline to File Complaint

September 13, 2016

genentechIL 146954 to Genentech is titled “HUMANIZED ANTI-ErbB2 ANTIBODIES AND TREATMENT WITH ANTI-ErbB2 ANTIBODIES”. It is the national phase of PCT/US2000/07366. The active ingredient is Pertezumab.

Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer on June 8, 2012.[3] Pertuzumab was developed at Genentech and is now owned by Roche which acquired Genentech in 2009. The drug received regulatory approval in Israel on 8 July 2012, and on 21 February 2013 a patent term extension was requested and this was granted until 11 May 2021.

patent-extensionThe patentee requested an extension of time for responding to an Examiner’s action under Section 161 of the Israel Patent Law 1967. As explained below, the intended response relates to the intention to publish the grant of a patent term extension until the date awarded. However, the intention published in the July 2016 journal.

On 19 February 2013 the patentee requested a patent term extension for IL 146954. The conditions set out in Section 64e(5) of the Law were in place, but at that stage there was no extension to the basic patent in the US as required by 64d(5).  In the January 2015 journal there was an announcement of the intention to grant an extension under Section 64e(5) 1 of the Law.

Afterwards, when the Section 64d(5) requirement was met, the patentee gave evidence of the patent term extension of the basic patent in the US. In that notice the patentee noted that they expected that the Examination would be completed and a corresponding extension of the patent would be granted.

Consequently, the Deputy Senior Examiner completed her Examination and, on 4 July 2016, informed the patentee that the patent was entitled to a 353 day extension until 10 June 2021, which is the length of the extension in the US, and is the shortest of all the extensions granted by an extension granting state, as per Section 64i(1) of the Law.  The Patentee had until 18 July 2016 to respond to this notification.

calculating-sec-154-patent-term-adjustments-1-728-1On 18 July 2016, the patentee responded to this notification. From the wording of the response it is clear that the patentee does not have any problem with the mathematics used in  calculating the patent term extension. However, the patentee noted their position that the Examiner should take into consideration not just the Patent Term Extension period in the US (PTE), but also the Patent Term Adjustment (PTA) in the US.

Without substantive reference to the relevancy or otherwise of the Patent Term Adjustment, it is noted that until the patentee requested that the extension NOT be published, Genentech (Roche) had not raised Patent Term Adjustment (PTA) related issues and even now, did not provide details of the Patent Term Adjustment granted by the USPTO. So the Examiner was under no obligation to relate to this additional time period.

Once the period for responding had passed, and on receipt of the Patentee’s response, the Examiner informed the Patentee on 18 July 2016 that she intended extending the patent protection period in  Israel by the Patent Term Extension (PTE) awarded in the US as per Section 65(e)(5)(3) and that this decision would publish for opposition purposes in the July Journal, and this happened. The request to extend the period for filing a critique was submitted on 11 August 2016, after the publication of the extension order. The contents of the critique, which has not been submitted, is unknown.

The reason put forwards by the patentee for the patent extension is based on the allegation that the current law damages their property rights and they are considering the possibility of changing the current legislation. Thus it follows that the patentee does not contend that the Examiner’s actions were in accordance with current legislation. The requested Extension is until the basic patent lapses, which is until 23 June 2020, or a further year if the Patent Term Extension is also considered.

Thus the patentee does not argue that the Examiner was acting in contravention of the law and admits that the Examiner’s actions were in accordance with current legislation. The Commissioner, Asa Kling, does not believe that a patentee’s intention to try to change the legislation is sufficient reason for the Israel Patent Office to delay publishing its actions; particularly when the action has already happened and happened in accordance with the Law.

So the Commissioner does not see fit to extend the period prior to publication.

In a footnote, the Commissioner does not think that his refusal in any way adversely affects the patentee, since he can always submit a detailed request for recalculation under Section 164(c) of the Law.

COMMENT

In a recent decision the Supreme Court weighed in on a challenge to the patent term extension rules as being unconstitutional, and found that the legislative body can write the rules as it sees fit, to find  a balance between the competing need of the drug developers to be able to profit from their investment and have an incentive to conduct research and development and to file applications, with the public good provided by competition, non-monopolistic markets with generic competition.

The specific issue of the differences in Patent Perm Extensions and Patent Term Adjustments was discussed in a February decision.

I can understand the drug manufacturers considering the current law unfair, but, in light of the amendment to the amendment, it does seem to reflect what the Knesset wants and has been upheld by the courts. I don’t think that Genentech – Roche will be able to  have the Law changed.


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

In an odd development, but not one that without precedent – see here and here – Dr Shlomo Cohen Law Offices has asked the Israel Patent Office to reconsider a judicial ruling.

In this instance, the original ruling relates to the Patent Term Extension (PTE) of IL 169693 to “Bristol Myers Squibb” and Pfizer that issued under section 64(v)5 of the Israel Patent Law. The original ruling issued in September 2015, and granted a patent term extension of 974 days until 18 May 2025. That ruling followed a challenge by the patentees to Examiner’s decision of 5 March 2015.

The way that Patent Term Extensions (PTEs) are calculated in Israel is detailed in Read the rest of this entry »


Glaxo Receive Patent Term Extension but Warned to be Polite

May 16, 2016

patent term extension

The Glaxo Group LTD requested a patent term extension for IL 178152 titled “4-[HYDROXY(DIPHENYL)METHYL]-1-{2- [PHENYLMETHYL)OXY]ETHYL}-1- AZONIABICYCLO[2.2.2] OCTANE BROMIDE USEFUL FOR TREATING MUSCARINIC ACETYLCHOLINE RECEPTOR MEDIATED DISEASES, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT “.

The Application was filed on 27 April 2005 and was granted on 1 September 2011 and registered in the name of the Applicant. On 21 April 2015 the Applicant requested a Patent Term Extension based on the medication called ANORO ELLIPTA. According to the Ministry of Health, this medication includes two active ingredients: Vilanterol and Incruse Ellipta which includes the active ingredient Umeclidinium which was registered for sale on 8 February 2015.

The active ingredient Umeclidinium is the subject of claim 1 of the patent and the medication itself is claimed in claim 3.

An Affidavit from Mr Fowler, a Glaxo representative, was appended to the Extension request. This affirmed that Anoro Ellipta was the first medication registered for usage in Israel which included the active ingredient Umeclidinium.

The earliest approval for Anoro Ellipta was from the FDA in the United States and issued on 18 December 2013. Even now, the drug has not received a Patent Term Extension in the US, and the request for a Patent Term Extension in Israel is under Section 64 e(5) of the Israel Patent Law 1967 as currently amended.

The Patent Term Extension abroad that is the basis of the request in Israel is the Patent Term Extension Italy, which until the filing of the request for a Patent Term Extension was the only extension given by a recognized (Bolar) country. Since then, France and Spain have issued similar extensions.

In a letter from the Deputy Chief Examiner dated 19 May 2015, the Applicants were asked whether the combination of  Vilanterol and Umeclidinium in Anoro Ellipta creates a new active ingredient, since claim 1 claimed one active ingredient and claim 3 claimed the combination. In the same letter, the Deputy Chief Examiner noted that Vilanterol was already the subject of a patent term extension request and therefore the Application was not the first application as per Section 64(d)4.

In response and with a further Affidavit from Mr Fowler, the Applicant countered that on the basis of this being the first medical usage of Umeclidinium, the medication Umeclidinium deserved a patent term extension and this was the first time this active ingredient was registered. That Vilanterol had previously been registered was immaterial.

The Deputy Chief Examiner disagreed. and on 28 July 2015 ruled that this could not be considered the first usage under the Law, since the Applicant failed to show that the combination created a new medication. Furthermore, if a new medication is indeed created then the basic patent does not support this combination. She went on to affirm that in her opinion, the previous registration of Vilanterol rendered the combination of Vilanterol and Umeclidinium impossible to be considered as a first use and thus entitled to a Patent Term Extension.

The request was rejected and the Applicant appealed to the Commissioner, submitting a further affidavit, this time signed by Helen Quillin, the Deputy President of Glaxo and an employee thereof since 1993. the Affidavit affirmed that Anoro Ellipta is a ground breaking drug for the treatment of chronic lung blockage. The Applicant contends that the application for a patent term extension is legitimate. As far as the request relates to Umeclidinium as claimed in claim 1 of the ‘152 patent; the registration of this drug on 28 January 2015 was the first registration in Israel. Even if Umeclidinium combined with Vilanterol creates a new medication, it still fulfils the requirements of Section 64d(1) of the Law since bot the combination and Umeclidinium alone cannot be considered to have been registered earlier. It is noted that this is the first time that Applicant related to the question raided by the Deputy Chief Examiner.

The Question of the first registration of a drug combination has been related to a number of times by the patent office. What is required is that the registration in question is the first registration of the active ingredient.

Thus, for example, concerning Novartis AG 97219 (decision from 26/12/2005), the then Commissioner ruled that the term composition in section 64a is in the singular, and intends a single active ingredient. The then Commissioner stated that where a patent term extension is applied for on the basis of a patent for a combination of active ingredients and at least one of these had not benefited from prior Ministry of Health Approval, a patent term extension was possible. Furthermore, the District Court related to this in an appeal of the above case to the Tel Aviv District Court (1062/06 Novartis vs. Commissioner of Patents 26/2/2007) where it is stated that the term  חומר – material or matter implies the active ingredient and not the specific formulation, so long as the formulation is not more than the sum of its parts. Furthermore, in the Lundbeck decision concerning Cipralex, the isolated right hand molecule was not considered a new substance when compared to the  racemic mixture.  the court explained that the active ingredient may assume different forms, such as salts, and even if a drug is the first use of a particular form of the active ingredient, if the active ingredient has previously been registered in a different form, the second registration cannot be considered as the first registration of the active ingredient.

Based on the above, one can conclude that Anoro Ellipta is the first permitted usage of Umeclidinium and may be entitled to a drug term extension under Section 64d(3).

Vilanterol has been previously registered. As explained in 117459 Merck vs. Sharp and Dohme Corp. the previous registration of one active ingredient that is found in a new mediation that includes several active ingredients need not necessarily prevent the new medication from benefitting from a Patent Term Extension.

Anoro Ellipta,  like Umeclidinium, is entitled to a patent term extension and claim 3 which states: 

“3. A pharmaceutical composition according to claim 2, which further comprises one or more other therapeutic ingredients.”

does not detract from the fact that the composition contains Umeclidinium and is entitled to protection for that reason.

The Applicant does not consider that  Umeclidinium and Vilanterol form a new compound. This in Ms Quillin’s statement:

“The combination of these two active pharmaceutical ingredients does not create a new compound that differs from each of its components. In fact, each of these active ingredients is stored as a separate dry powder composition within the ELLIPTA™ inhaler of the ANORO™ ELLIPTA™ inhalation product.

The inhaler prevents the two ingredients from coming into contact with each other.

On the basis of the above analysis, the basic patent for ANORO™ ELLIPTA™  is extended by 965 days until 18 December 2027 and this decision will be published for opposition purposes in the forthcoming journal. The calculation is based on the Italian patent term extension and from the first published use in the US.

As an after-note, the Commissioner cautioned the Applicant for making disparaging comments about the Deputy Chief Examiner which should not have been made, and that a certain decorum is required when interacting with examiners.

COMMENT

I think the Deputy Chief Examiner was concerned that allowing a patent term extension for a combination of drugs or a cocktail could enable the unscrupulous to obtain an extension for a drug previously published by combining it with something new or at least not previously published.


Request to Revive Patent Refused

May 10, 2016

mistakes

The Israel Patent Office has ruled that an inadequate payment occurring in a manual docketing system is unreasonable because IP firms should have computerized systems. Despite the client wanting to renew a patent, the attorney of record taking steps to renew, but making a mistake, and attempting to rectify on discovering the error which the Israel Patent Office could have (and in my opinion should have) brought to attorney’s attention, the patent cannot be reinstated!

Asterias Biotherapeutics Inc. owned Israel Patent Number 159324 “A method of differentiating PPS cells into a population of neural cells using TGF-8 super family antagonists”. The patent was filed on 20 June 2002 and issued on 31 July 2o12, so the Applicant’s representative, Colb, should have paid the first, second and third renewals for years 1-6, 6-10 and 10-14. They inadvertently only paid the first and second renewal and the IPO sent a certificate for the second renewal but failed to note that the third renewal should also have been paid. The patent lapsed and this fact published in the August 2013 journal.

Asterias Biotherapeutics, represented by Colb, attempted to reinstate the patent by arguing that there was a mistake by an office worker of the Agent of Record, and only the first and second renewals were paid. The worker docketed the next renewal for 20 June 2016. This date was calculated manually and was docketed in a diary by hand as is clear from an appendix to the submission to reinstate the patent. As the June deadline approached, the status of the patent was checked and it was discovered to have inadvertently lapsed. The Patent Office confirms receipt of the first two renewals and issued a renewal certificate for years 7-10.

The Deputy Commissioner ruled that there is no doubt that the Applicant wanted to renew the patent and that close to realizing that it had lapsed they took steps to revive the patent. However, under Section 60 of the Israel Patent Law 1967, there is a further consideration, namely whether the circumstances leading to the renewal not being paid can be considered reasonable. The Deputy Commissioner, Ms Bracha was not convinced that the Agent of Record had behaved reasonably.  She was unclear as to whether the renewal dates were calculated and recorded manually or whether they used a computerized system as is generally the case. Therefore the request for reinstatement is denied.

COMMENT

I strongly object to this ruling. Any computer system ultimately will require a person to enter data and to correctly act upon it. The Israel Patent Office has successfully computerized itself over recent years but still makes mistakes. I’ve seen papers from other attorneys relating to other applications misfiled by the Israel Patent Office in applications that I am responsible for. Other patent offices around the world still use manual ledgers.Before setting up my own practice, I worked at Seligsohn & Gabrieli which was then run by the late Arnan Gabrieli. He was old-fashioned and didn’t believe in computerization and saw computers as electronic typewriters. Everything was docketed by hand in ledgers by a receptionist. She was diligent as she knew that any mistakes would cost her her job. The system, though primitive, worked.

The Law does not require computerized docketing. Nor do the regulations.  Computerization enables streamlining and staff reductions which may result in lower operating costs that may be passed onto the clients as lower service charges. It is more efficient. It is not, however, more reliable. Ultimately it relies on humans entering data into a computer and a wrong keystroke can result in an error. Mistakes happen in both manual and automated systems.

I really do not know how many IP firms use manual diaries, how many use spreadsheets and how many have expensive software. I do know that some software has proven unreliable. Some vendors have gone out of business and some firms have not got around to selecting renewal or docketing software. The difference is one of setup costs and operating costs. I am not sure that any one is more reliable. Ultimately a person has to look at the record and typed instructions into the IPO website to pay the renewal on line.

In the USPTO website, one has to enter a patent number and the corresponding application number so that the two numbers have to correspond. This safety feature prevents mistyping causing an error in identifying a particular patent. The USPTO renewal interface not only informs the user that a payment is or is not due, but calculates the amount and whether extension fees are required. In contrast, the IPO system is not, or at least was not automated. Typing the patent number, the fee is not calculated automatically. A person still had to type in that he was paying the first, second (and third) renewal, possibly with extension fees. This stage is prone to mistakes. Even if handled by a patent attorney and not a paramedic paralegal mistakes can and do happen.

Until recently, once one had paid online, one had to print out and forward the ruling to the patent office.  Sometimes the system crashes and one has to start again. One pays by credit card on the Israel Patent Office website but at least until recently, one then had to print out the payment slip, send it physically to the patent office and they had to correctly enter the details and then print out a certificate. I had a case that went abandoned and was revived where I could prove that the payment was made and was received by the Israel Patent Office because I paid renewal fees for two separate cases on the same A4 receipt, and only one was docketed by the Israel Patent Office. Since I had paid and sent them the proof of payment, clearly the data was entered wrongly their end. It happens. It happens at the patent attorney end as well and will happen with both computerized systems or manual ones.

Now, Colb has a large and profitable, established practice. The docketing solution appropriate for him may be beyond the reach of smaller practices. But smaller practices grow. When does a firm need to graduate to a dedicated software practice and when can they rely on a spreadsheet or on a manual solution? If Colb successfully managed for decades with a manual system and built up the practice before computerized systems became available, should the firm be forced to change? The Israel Patent Office is justifiably proud of their ISO certification. Some patent firms have such certification, others do not. ISO requires procedures. It does not require these to be computerized.

As Colb has been found unacceptably negligent in not having a reasonable solution, Asterias Biotherapeutics can sue them for negligence and pharmaceutical patents that are worth renewing 12 years after filing and 13 years from priority may be extremely valuable. I do not believe that any IP firm can afford to insure themselves for claims of tens of millions of Shekels. I predict that Colb appeals this ruling to the courts. I hope that and appeal to the IPAA, the AIPPI, the IPR forum and other representative bodies to file amicus briefs supporting such an appeal. 

In a recent posting, I argued that Einav Zilber wasa more appropriate chairperson of the Israel Patent Attorneys Association (IPAA) than her predecessor, the venerable Dr Meir Noam since he was previously the Commissioner of Patents and is thus conflicted if the Association has to challenge a Patent Office ruling or procedure. I think that this type of case amply demonstrates what I mean.

One more comment. Section 60 allows reinstatement if a mistake is reasonable. In one of her first rulings, Ms Bracha allowed a human error by Reinhold Cohen that resulted in a deadline being missed, to be extended. In that case, relating to patent term extensions, the Law (Section 64) requires the mistake to be unavoidable. It does not allow due care or unintentional mistakes to be rectified. Nevertheless she ruled that human errors are unavoidable. That ruling was in 2012, not long before this mistake occurred. Why didn’t she rule that RCIP should have had a computerized docketing system?


Can a Patent Term be Extended in Israel on the Basis of a Patent Term Adjustment in the US?

February 8, 2016

calendar

Most patents are renewable up to 20 years from filing. The exception is basic pharmaceutical patents which may be renewed until 25 years from filing to ensure at least 14 years of post regulatory approval in Bolar countries.

The Israel Law relating to pharmaceutical extensions is complicated and has been amended several times. It is based on the Hatch Watchman Act in the US, and was legislated in Israel under a great deal of pressure from the United States. The Amendment itself has been amended a couple of times. Because of the large sums of money involved, drug development companies are willing to spend a small fortune to obtain extensions and Unipharm and Teva frequently oppose such extension periods.

Novartis applied for an extension for IL 154465 titled IL-1BETA BINDING MOLECULES AND USE THEREOF IN THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS AND MEDICAMENTS.

The active ingredient is known as Canakinub, and this received regulatory approval in October 2010 under the trade name ILARIS.

In this instance, regulatory approval preceded allowance of the patent so Applicant requested an extension of the period for requesting an extension of the patent as defined in Section 61(XV). The patent was granted on 1 March 2011 and following this, the patentee requested an Extension.

It transpired that requests for extensions were filed in the US and in most of the European countries that can be used as the basis for a request for patent term extension as detailed in Appendix B to the amendment.

In the US, there are Patent Term Extensions (PTEs) which may be used as the basis for requesting a corresponding extension in Israel. But there are also Patent Term Adjustments (PTAs) which are not to be confused with Parents and teachers Associations considered different things entirely. The PTA is granted to compensate for delays attributed to patent office tardiness in the USPTO. They do not have anything to do with ensuring a term of enforcement from regulatory approval.

In this instance, the Patent Term Adjustment exceeded the theoretical Patent Term Extension so no Patent Term Extension was granted. In other words, there was regulatory approval in the US which starts the clock for usage. However, the corresponding US Patent never was extended by a PTE. The Israel Examiner therefore rejected the request to grant a PTE in Israel as there was no PTE in the US to consider under Section 64(IV)5.
Novartis were not happy with this decision and requested a hearing before the Commissioner on 17 February 2015. They submitted written arguments on 22 June 2015, a hearing was held on 22 July 2015, and on 11 August 2015 a supplementary affidavit was submitted by a Ms Leslie Fisher (maybe that should be Lesley?).

After the 11 amendment to the Israel Patent Law of 27 April 2014, Novartis requested an extension based on the Notice of Final Determination:

“A determination has been made that U.S. patent No. 7,446,175, claims of which cover the human biologic product Ilaris® (canakinumab), is eligible for patent term extension under U.S.C. § 156. The period of extension has been made determined to be 0 days.

The period of extension, if calculated using the Food and Drug Administration determination of the length of the regulatory review period published in the Federal Register of December 9, 2010 (75 Fed. Reg. 76739), would be 205 days.

Because the patent term adjustment awarded to U.S. Patent No. 7,446,175…of 1,131 days extends the original expiration date to September 24, 2024, which is beyond the 14 year exception of 35 U.S.C. 156(c)(3), the term extension is 0 days…”

(the underlying is by the Commissioner Assa Kling (we suspect that Novartis would have preferred not to draw attention to it).

Essentially what happened was that the US patent was in force for over 14 years due to the Patent Term Adjustment, so no Patent Term Extension was required.

The commissioner noted that the PTE was zero days and that section 64(I) of the Law states explicitly that an Extension of the basic patent relied upon has to be for one day or more and that this is referred to in the US as a Patent Term Extension (PTE) and in Europe a Supplementary Protection Certificate (SPC).

The Applicant has a different understanding of the correct interpretation of the Law based on its purpose and the legislative’s intent and argued that there was a lacuna. However, the differences between PTEs and PTAs was discussed in a ruling concerning a patent term extension for IL 181673 to Genetech.

The law, the previous decision and common sense implies that if the drug has patent protection of 14 years from first regulatory approval it does not deserve a patent term extension in Israel. Furthermore, the Commissioner referenced the understanding reached between Israel and the United States

“A reference PTE which results from marketing authorization delays means any period extending the Basic Patent by one or more days, up to the maximum period allowed under the Patent Act.
“…However, if a reference PTE has not been granted (either as an interim or final PTE Order) in the United States and at least one EU reference country prior to the expiration of the underlying Basic Patent in Israel, then no PTE (interim or final) shall be granted in Israel in respect of that Basic Patent.”

This supports the Law as formulated and the Commissioner’s understanding.
The rejection of the request for a Patent Term Extension in Israel was upheld despite the Applicant having been given an opportunity to present his case before the commissioner as per section 152 of the Law.
COMMENT
I am convinced by the ruling. I suspect it may be appealed though.