Can Non-Israelis be Subpoenaed to testify in Opposition Proceedings?

June 10, 2018

novartis

Israel Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION”. It is the national phase entry of PCT/EP2005/000400.

Unipharm

On allowance, Unipharm filed an Opposition to the patent application being granted.  Within the Opposition proceeding, Unipharm, who for this case, have dispensed with the services of Adv. Adi Levit, their legal counsel and have been handling the Opposition unaided by attorneys, have requested that the Israel Patent Office subpoena  John Hutchinson and Mr Kowalski, workers at Novartis to give testimony.

This request follows an earlier request to reveal documentation regarding testing that was appended to the Expert Witness testimony of Professor Davies, Novartis’ expert witness, which was ordered in an earlier interim ruling of 3 January 2018.

Discovery

In response to the discovery request, Novartis submitted an Affidavit with various appended papers. In light of this, Unipharm now alleges that the Affidavit implies that Novartis has not revealed all documents it should have. Unipharm further indicates that the explanation proffered by Hutchinson, who is signed on the Affidavit, “appears to be odd”. Therefore, Unipharm wish to Subpoena him to cross-examine him on this.

lab bookUnipharm further claims that a document titled “Certificate of Authenticity” was included with respect to the laboratory notebook, parts of which were included in the appendices attached to the affidavit. According to Unipharm, Mr Kowalski, who was one of the named inventors, is signed on this document. Consequently, Unipharm requested to cross-examine him as well.

Novartis requests that Unipharm’s request be rejected. They claim that the Commissioner does not have the authority to subpoena witnesses not within the judicial territory of the State of Israel, who are not direct parties in a proceeding. Novartis also notes that Mr Hutchinson’s signature on the Affidavit accompanying the discovery documents was done in the framework of his employment as a patent attorney in the Legal Department of Novartis. Novartis claims that ALL information regarding the management of the proceeding is subject to legal confidentiality and may also be considered as being a trade-secret.

As to Mr Kowalski, he never signed an Affidavit of Evidence in the process and is not a party to it. Similarly Novartis claims that Unipharm has not stated why they need to cross-examine that inventor who was one of three named inventors.

Discussion

The witnesses that the Opposer wished to interrogate are beyond the territorial jurisdiction of Israel and are not parties in the case. Thus the Applicant is correct that Section 163b of the Patent Law 1967 that Unipharm referred to is not a legal basis for their being subpoenaed. The references that Unipharm related to in their request, dealt with witnesses that gave Affidavits or expert witness testimony, and thus could be subpoenaed for cross-examination purposes.

A party that wishes to subpoena a citizen or foreign resident to testify must do so under the International Inter-State Legal Assistance Law 1998. See Appeal 3810/06 Dori and Zacovsky Building and Investments Ltd vs. Shamai Goldstein, paragraph 17, 24 September 2007.

Section 47 of the Legal Assistance Law states:

The Authority is allowed to request from another country, that testimony be collected, including that physical evidence be transferred for display in Israel, if the court allows that the evidence is required to hold the trial in Israel; regarding this law, and where the case is pending, the term court refers to the tribunal that is hearing the case.

From the wording of this Section, it transpires that the court will open a proceeding to summon foreign witnesses to a hearing only if it is convinced that their testimony is necessary to conduct the proceeding. In this instance, the Commissioner considers that there is significant doubt as to whether the presence of the witnesses for cross-examination purposes is really required.

Unipharm has requested to cross-examination Mr Kowalski regarding an Affidavit for discovery that he is signed on. The purpose of the discovery process is to enable the main proceeding to be handled efficiently; legal proceedings with face-up cards where each party knows what documents the other parties hold to prevent surprises at the hearing. By this means, unexpected delays are prevented, allowing the court to reveal the truth. Appeal 4235/05 Bank Mizrachi United vs. Ronit Peletz, 14 August 2015.

Opposite the principle of discovery, there are other interests such as efficiency of the court proceeding, defense of the legitimate interests of the party revealing documents, and preventing damage to the interests of third parties – See Appeal 2534/02 Yehuda Shimshon vs. Bank HaPoalim ltd. p.d. 56(5) 193. So the case-law has ruled more than once that it will not allow cross-examination of affidavits of this kind, if they are properly presented (see Appeal 2376/13 Rami Levy Shikma Marketing Ltd vs. Moshe Dagan 8 July 2014, and Zusman Civil Procedures 7th Edition, page 436.

This general rule has two exceptions: The first is that where reading of the Affidavit alone or with reference to its citations, that the Affidavit is defective, the court can order the party revealing documents to file a further Affidavit. Second, where the issue of confidentiality is used, the court can examine the document and decide if this claim is reasonable (see for example, Appeal 240/73 Baruch Vilker vs. Dov Tishler, 205, 2 December 1971 and Appeal 6823/05 Abraham Roimi vs. Bank Leumi of Israel, 12 January 2016.

In this instance, Unipharm did not append an Affidavit, detail or justify why they considered that the current case is one of these exceptions. Thus the Commissioner cannot rule that this is the case, and so the request is rejected.

As to the evidence of Mr Kowalski, Unipharm did not claim that there was any connection between the documents appended to the Affidavit of the Discovery and to the experiments that were appended to Novartis’ evidence, which was the basis of the original discovery request. Note, Mr Kowalski’s signature is only on the Certificate of Authenticity taken from the lab-book that was appended to some pages therefrom that were submitted in the discovery documents. In these circumstances, it is not clear what value Mr Kowalski’s testimony has, even were he to be subpoenaed.

In light of this, the Commissioner does not consider that the requirements of Section 47 of the Law of Legal Assistance are fulfilled with regard to Mr Hutchinson or Mr Kowalski.

The Request is refused. Unipharm will cover Novartis’ costs and their legal expenses to the tune of 2000 Shekels + VAT. These costs will be paid within 30 days.

Interim Ruling in Opposition to IL 175831 Ofer Alon, 30 April 2018.

Comment

It is possible that Mr Tomer has indeed bitten off more than he can chew by handling legal issues procedural issues such as requesting subpoenaing witnesses without legal counsel. However, the costs ruled against him are trivial when considering the issue in question. The Unipharm’s Expert Witness cannot testify to things that he does not know such as what else was in the lab-book, and in Opposition proceedings there is no assumption of validity of the patent. Thus it would be premature to write this request off as a strategic or even a tactical error.


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.


Can a Knowingly Abandoned Patent Application be Reinstated?

May 22, 2018

BioMarin

IL 206845 to BioMarin Pharmaceuticals Inc. was refused under Section 21a of the Israel Patent Law 1967. The patent application was the national phase of a PCT application submitted on 6 January 2009. The national phase entry was submitted on 6 July 2010 and claims priority from US applications filed on 7 January 2008 and 22 April 2008.

On 30 January 2013, the Applicant was sent an Office Action to which the Applicant had four months to respond. No response was forthcoming. Following the extensions available under Circular 005/2011 then in force, on 5 March 2014 the Applicant was informed that the file would be closed if no response was submitted within 30 days. This letter went unanswered and the file was closed on 23 June 2014.

3 years

Three years and three months later, on 15 October 2015, the Applicant requested a retroactive extension to respond to the notice of abandonment.

The request was accompanied by an Affidavit that testified to the developments leading to the case becoming abandoned.

  1. In 2005, Merck Serono purchased all rights to the Kuvan medical product, and to the process for manufacturing the active ingredient claimed in the application.
  2. This transfer of rights was not recorded in the patent register and the Application was filed in the name of Biomarin.
  3. In 2012, Merck Serono decided that it was not interested in the patent issuing in Israel and told Biomarin not to respond to the Office Action.
  4. In 2015, Biomarin repurchased their rights to the invention and in 2016-2017 reviewed the usefulness of getting the patent to issue in Israel.
  5. Following the reconsideration, the present request for extension of time to respond was submitted in October 2017.

change-my-mindThe Applicants argued that their repurchasing of their rights and their reconsideration of the portfolio provides sufficient justification for reconsidering the refusal of the patent. Furthermore, unlike in the US and Europe, there is no legal requirement for abandonment so thus, even if the abandonment was following an intentional decision by Applicants or the predecessor thereof, this does not mean that, following a change of circumstances, this cannot be reconsidered and they are entitled to a further opportunity

mistake EinsteinThe Applicants presented their arguments at a hearing on 14 February 2018, during which they claimed that the Applicants can be considered as having made a mistake that they now wish to rectify. They also claimed that returning the application to examination will not cause damage to third parties. Finally, they argued that in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), certainly is no more important than other considerations.

Sections 21 and 21a of the Law set out the normative arrangement for these matters as follows:

21.  If the Applicant did not remove the grounds for the Application not being approved within the timetable set out in the regulations or did not correct the lacunae under Section 20, the Commissioner will refuse to allow the patent.
21a. If the Commissioner refuses the patent under Section 21, he can, at the request of the Applicant, reconsider the refusal provided that the request to do so was submitted within 12 months of the refusal.

reasonable

The period laid out in Section 21a of the law is extendable under Section 164 of the Law at the Commissioner’s discretion. The Commissioner’s discretion is summed up in the phrase “if he sees a reasonable basis for so-doing” which is found in Section 164a. The Commissioner’s considerations will change with circumstances, and as Judge Naor stated in Appeal 826/04 Commissioner of Patents vs. Recordati Ireland Ltd (26 June 2004):

The policy regarding different requests for extending deadlines that are brought before the Commissioner, will change with circumstances and with the nature of the proceedings for which an extension is requested.  

 Similarly, the Commissioner has the authority to make the extension dependent on “conditions that he considers to be correct” as stated in Section 164b of the Law.

In cases such as this, there are two main interests. Firstly, that of the Applicant who wishes to protect his invention and, secondly, that of the public which can benefit from inventions that are not patent-protected and are thus in the public domain. It is noted that this case is the national phase of a PCT application and the application and its status is published under section 16a of the Law.

limited

The Deputy Commissioner Ms Jacqueline Bracha considers that the period given in Section 21a, though long, is limited. This protects the public and brings matters to a close. The period given in the Law is a balance between the competing interests.

To extend the 12 month period after the file closes under Section 164 requires ‘reasonable grounds’, as defined in Opposition to IL 110548 Shmuel Sadovsky vs. Huglat Kimberly Marketing ltd, 12 August 2010. The relevant considerations for ‘reasonable grounds’ are the duration of the extension requested and the existence of a real cause for the delay.

Ms Bracha does not consider that the Applicants’ request can be considered reasonable with respect to the delay incurred or the justification to reopen the file. The request to reopen the file was received 39 months after the case was closed. This is 27 months after the usual deadline which is a long time.

As to the submission that the client changing their mind is grounds for opening an intentionally abandoned application, the Deputy Commissioner does not find this convincing. She finds support in Appeal 83/86 Sokol vs. Yismach, p.d. 40(1) 577 cited in the Sadovsky case, where it is stated that:

The discretionary authority to extent deadlines is intended to overcome mishaps and externalities that are beyond the litigant’s control.

One cannot consider a decision not to continue prosecuting as being an external cause, a mishap or an error. Ms Bracha notes that the circumstances described in the Affidavit show that the error we are dealing with is imported from Contract Law and is at best “a mistake in the equity of the deal” which is not grounds for cancelling a contract.

In a similar manner, it has been determined that not paying a renewal of a patent due to a determination that it is not worthwhile to do so is NOT considered as a reasonable ground for reinstatement, and that is where we are dealing with an actual right that the patentee was awarded and not with a pending application as in this case. See Request for Reinstatement of IL 177522 of “Yad Conena Ltd from 9 June 2014:

The circumstances of the case before me do not fulfill the above requirements. A decision was taken not to pay the Renewal fee. The patentee knew that the there was a need to pay the renewal fee as this was not the first time that he had needed to pay it. One can assume that after the case lapsed and was reinstated in 2011, the patentee made inquiries regarding the next renewal. From the Affidavit it transpires that the patentee made an informed decision NOT to pay the fee. In these circumstances one cannot conclude that the fee was not paid in reasonable circumstances that justify reinstatement.  The economic difficulties that the Applicant noted are not considered reasonable grounds for not paying the renewal, particularly where no evidence of the debit was submitted.

As a footnote, Ms Bracha relates to the claim that the request finds support in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), that in patent law, fidelity and consistency is no more important than other considerations. Ms Bracha considers that certainty is not all-seeing and that sometimes certainty will be sacrificed for other interests. In  re Association of Israel Industrialists, it was stated:

True, there is validity to the suspicion that certainty may be damaged when a court comes to interpret the Law (Aharon Barak Legal Interpretation, Interpreting Legislation Volume 2 583 (1993). Nevertheless, this is one consideration amongst many that can be used where there is nothing in the wording of the Law or elsewhere to directly contradict this. In this instance, it appears that the legislators did not put the question of certainly regarding when a patent lapses as the main consideration.

In other words, the consideration of certainty is an important consideration but where the wording of the Law or its purpose indicate that the legislators preferred some other consideration, the Court will interpret the Law accordingly.

Ms Bracha does not consider that in this instance the Law or the case-law expounding the Law indicate that the legislators preferred the interest of the Applicant over that of public certainty, She considers that to the extent that there is a legal tradition for interpreting Sections 21a and 164 of the Law, it is one that requires the Applicants to provide a real and reasonable cause for incurring a delay, and this is necessary since there is public reliance on the patent lapsing.

revival-2

The Applicants also requested to learn from what is stated in foreign legislation, that what is not stated in our Law is not a requirement. That is, that whereas other laws explicitly state “unintentional” this implies that there is no such requirement in Israel Law. Whilst it is true that Section 21 does not require abandonment to be unintentional, it does provide a normative timeframe for reinstatement, whereas the US and European law do not.  Any deviation from this period is considered in the mirror of Section 164 which is interpreted in light of the nature of the deadline to be extended and the type of proceeding before the Commissioner. This was detailed above, and will not be repeated. It is sufficient to note that one cannot rely on the inclusion or omission of a word in the Israel Law as the basis for its interpretation whilst ignoring the case-law.

It seems that the circumstances are such that the case was abandoned intentionally and can only be rectified if this was not legal. The request is refused.

IL 206845 to Biomarin: refusal to reinstate application, Deputy Commissioner Ms  Jacqueline Bracha, 17 April 2018.     

COMMENT

In extraordinary circumstances, long-dead applications have been reinstated. See for example IL 194015 to Natapov, Perstnev, Perstnev and Vilacer titled “the Insulating Material”. Here the patent had lapsed three years earlier, but had not published. The record is probably Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri  which was revived seven years after it lapsed.

I am frankly surprised by the audacity of the Applicants’ representative for trying to  argue that this knowingly abandoned patent application could be revived more than 12 months after going abandoned and am pleased that the Deputy Commissioner came to the decision that it could not be.


A cost ruling and a tax question

April 17, 2018

This cost ruling highlights a tax issue where it seems to be unclear whether charges for legal work performed on behalf of a foreign entity concerning an issued patent (or trademark) in Israel incur VAT. It also highlights the problems that can occur where firms split and one professional leaves taking clients and on-going issues with him. What is required is professionalism and good between the management of the original firm and the new representatives to deal with costs incurred by the original constellation. Unfortunately, sometimes this good will is lacking.

alkermesAlkermes Pharma Ireland LTD has an exclusive license from Novartis to manufacture a drug in accordance with IL 142896 and its divisional patent no. IL 179379 entitled “Multiparticulate Modified Release Composition”. The active ingredient is Methylphenidate and is commonly known as Retalin. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

MediceMedice Arneimittel GmbH filed a request to cancel the relevant patents and the claim scope was narrowed in a preliminary action by Alkermes, but the cancellation actions were unsuccessful. Now Alkerermes has requested costs of $1,029,561.95 which comes to 3,626,118.18 Shekels costs.

History and Timeline

IL 179379 is a Divisional Application of IL 142896. The allowed patents published for opposition purposes on 8 March 2007 and 31 March 2011 respectively. Since no oppositions were filed, they issued on 9 June 2007 and on 1 July 2011. On 6 August 2012, an exclusive license for manufacturing was issued in the name of Alkermes.

On 14 November 2012, Medice Arneimittel GmbH applied to cancel the patent. The application was supported by a technical opinion provided by Professor Golomb.

On 7th February 2014, before a counter-claim and evidence were submitted, the patentee requested to amend the specification under Sections 65 and 66 of the Israel Patent Law 1967 which allows the scope of a challenged patent to be restricted by the patentee within the scope of the monopoly originally allowed.

On 6 March 2013, the Medice Arneimittel responded and on 14 March 2013 Notartis answered and on 17 March 2013 Medice Arneimittel GmbH requested permission to respond to the answer. On 5 May 2013, then Commissioner Kling scheduled a date for a hearing to discuss the amendment. In the hearing which was held on 4 June 2013, the Commissioner ruled that he case be conducted under Section 102(vi) as if the amendment was accepted, and after the cancellation proceedings be ruled, on the amendment would publish for opposition purposes.

In light of this ruling, Medice Arneimittel submitted an amended cancellation proceeding together with a further affidavit from Professor Golomb.

On 4 March 2014, Novartis/ Alkerermes submitted their counter claims submitted with an expert opinion from Professor Mark A Stein and Professor Joseph Cost.

On 2 June 2014, Medice Arneimittel submitted their counter-evidence including a further affidavit from Professor Golomb together with a request to submit a further three prior art publications. On 18 June 2014, the Commissioner allowed this extra prior art to be submitted, and allowed Novartis/Alkerermes to relate Read the rest of this entry »


Adding Evidence After Filing Statement of Case in Patent Opposition Proceeding

March 22, 2018

Plasto Vak ltd (1990) ltd filed Israel Patent No. 220639 titled “Disposable One Piece Container with a Removable Tear Strip Configured for Separation of the Lid and as a Tampering Alert.” On allowance, Vacotec Packaging ltd filed an Opposition.

lateBoth sides filed their statement of case, and then, at the evidence stage, Vacotec applied to reference two additional pieces of prior art. The Opposer justified the need to add these citations by arguing that the Applicant had taken an unexpected position in their Statement of Case and had post-dated the filing date due to amendments during the prosecution.  This resulted in them doing a further search and discovering the two additional references.

The Applicant , Plasto-Vak ltd denies that there was a change between the position they took during the prosecution and that taken during the Opposition in how the claimed invention overcomes the prior art. They further deny that they agreed to the application being post-dated due to significant amendments and argue that it is too late for Vacotec to file amend their Statement of Case.  They noted that they had submitted their statement of case 5 months earlier, and this request by Vacotec was tardy. Finally, Plasto-Vak ltd denies that the new citations are relevant enough to challenge the patentability of the claimed invention.

The invention in question is a disposable one-piece container. It is claimed as follows:

A disposable one-piece container [100] comprising first and second opposing sections [110 and 120], respectively, interconnected by a folding joint [130], said first and second sections [110 and 120] are separable by pulling said second sections [110 and 120] in opposite directions; wherein said folding joint [130] comprises an axis-segment [230] formed by a folding-line [210] adjacent to the second section [120] of said container [100] and a frangible folding-line [220] adjacent to first section [110] of said container [100]; said axis-segment [230] configured as a rotation axis between said two opposing sections [110,120] enabling the closure of said container [100]; further wherein said container [100] comprises a hold-tab [150] located at the first section [110] adjacently to frangible folding-line [220] and a hold-tab [160] located at said axis-segment [230] adjacently to frangible folding-line [220] and spaced apart from said second section [120]; said hold-tabs [150 and 160] are perpendicular to each other and grippable by a user for pulling in opposite directions.

The Application was submitted on 25 june 2012 and the examination was expedited. It published for opposition purposes on 30 November 2016 and the opposition was filed on 27 February 2017.

Discussion

The Applicant is correct that in general in opposition proceedings, the Opposer cannot rely on additional citations beyond those brought in the statement of case. Consequently, submission of additional references requires correcting the statement of case. See Appeal 47387-01-11 Bromium Compounds vs. Alvemarle Corporation USA 8 August 2011 and the IL 155919 Teva vs. AstraZeneca opposition from 5 December 2011.

Amendments to the statement-of-case are allowed where they help focus the discussion on points of disagreement between the parties, where there is no justification to prohibit the correction. See Opposition to IL 187923 Pimi Aggro Cleantech ltd vs Xena international 19 May 2013:

This forum has the authority to allow corrections to the Statement of Case in instances where the amendment focuses on the issues in question and where there are no reasons not to allow the amendment. Such reasons for refusing to allow the amendment include inequitable behaviour, denying the opposing party their rights in a way that may not be compensated for with monetary award in a costs ruling for the interim action, and tardiness in requesting the amendment (see interim request to amend the statement of case in cancellation proceedings against IL 154398 in Logo Engineering Development vs. State of Israel, Ministry of Agriculture, Volcani Institute 29 April 2004. Furthermore, exercising the authority to allow such amendments depends on the stage of the proceedings reached, since patent oppositions delay and prevent the Applicant from receiving the patent.

In this instance, there does not seem to be any real reason not to allow the amendment to the statement of case and the addition of these references since the Applicant can respond to the amended statement of case. The Opposer claims that their evidence is ready and can be submitted within a week so that no real delay will result from allowing the additional material to be submitted.

Two issues that the Applicant raises deserve responding to:

  1. The delay in filing the request
  2. The relevance of the new citations

It is preferable to conduct a proper search before filing the Statement of Case, and not have to subsequently amend it at the evidence stage. The Opposer claims that the search was based on the Applicant’s position as stated in the meeting with the Examiner and this resulted in the need to conduct a further search after receiving the Applicant’s statement of case.

In the prosecution, the Applicant claimed that the main difference between the applied for invention and the prior art in that the tabs are very close to the fold line.

“In response to the office action issued on 17.02.16, the applicant respectfully submits the following:

In item 1a of the office action, the examiner states that D1 discloses the present invention. The applicant interprets that the present invention is rejected as not novel. Meanwhile, the tabs functionally directed to separating upper and lower parts of the container are located in the positions absolutely different in comparison with the prior art document. Specifically, they are adjacent to the fragile folding line while, in D1, are located distantly. This limitation is the main discriminating constructive feature regardless of a material of the container.

…”

The Opposer submits that the Applicant is now claiming that there are additional differences that claim patentability due to other features as raised in the meeting.

To show that a claimed invention is anticipated, one has to find a piece of prior art that relates to all the features of claimed.  The claims are interpreted in light of the specification, and one cannot import features not described in the specification:

The correct interpretation is that terms in the claims should be interpreted in light of the specification to give them the meaning intended by the inventor. This can be narrow or broad, so long as the interpretation is anchored in the specification and is clear to persons of the art.

However one should differentiate between the ways that one can widen and clarify the monopoly and how one understands the invention. One can refer to the specification to understand the monopoly but that not claimed is not part of the monopoly. See Appeal  345/87 Hughes Aircraft Co. vs state of Israel et al. p.d. 44(4) 45, 70.

So even where the Applicant stresses one or other element in the claims or in the rest of the application during the examination or in the statement of claims, since the claims themselves were not amended in the opposition, the Opposer knew what the claimed elements to be searched were.  (this is not to be understood as license to ignore that claimed during the patent examination).

Nevertheless, the resulting delay is not serious enough to warrant forbidding the correction of the statement of case and the addition of the two new references and allowing it will not drag out the opposition. To the extent that the Opposer could have found these new citations 10 months ago, the damage to the Applicant by the resulting tardiness may be compensated for by awarding costs to the Applicant.

As to the alleged lack of relevancy of the new citations, there is no clear a priori basis to exclude the possibility that these publications are relevant to the patentability. The Applicant submitted a 23 paragraph statement to try to show why these citations are not relevant and so it seems reasonable to accept the possibility that the citations are relevant and to relate to them substantively in the Opposition proceedings instead of to prevent their being submitted.

In light of the above, Ms Jacqueline Bracha allows the statement of case to be amended to relate to the two additional citations as follows:

  1. The corrected statement of case and additional evidence must be filed within 7 days
  2. The applicant will file their statement of case and evidence within the following three months as per section 59(b) of the Regulations
  3. The Opposer will pay 5000 Shekels including VAT costs to the Applicant

 Re IL 220639 to Plasto Vak ltd (1990) ltd; Interim ruling by Ms Bracha on addition of Evidence not referenced in Statement of Case, 21 February 2018


Unipharm without legal representation, wins Interim Proceeding Against Novartis

February 22, 2018

galvusIsrael  Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION ” the patent application is a national phase of PCT/EP/2005/000400. It relates to a pharmaceutical used in the treatment for diabetes known as Vildagliptin (previously LAF237, trade names Galvus, Zomelis,) which is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1[2][3] and GIP[3] by DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.

Unipharm has opposed the patent issuing and, in an intermediate proceeding, Unipharm (not represented) submitted a disclosure request for:

  1. The specific testing referred to Appendix E of a the Applicant’s expert witness.
  2. All other tests relating to all the formulations that were performed where the particle size distribution was examined.

Unipharm

Alternatively, Unipharm requests that the part of the evidence that relates to the evidence submitted in the European Opposition proceeding from Dr Davis’ statement, including Appendix E, be struck.

The patent relates to tablets that are made by direct compaction and which include DPP-IV, (s)-1-[(3-hydroxy-1-adamantyl)amino]acetyl-2-cyanopyrrolidin (Vildagliptin) in free radical form or as a salt, wherein at least 80% of the particles compressed into the tablet are in size range of 10 microns to 250 microns.

novartis

In their Statement of Case, Novartis explains that use of direct compression was not obvious to persons of the art wishing to produce vildagliptin formulations, and the distribution and size of the particles affects the character of the tablet in a manner that determines the efficacy of the formulation. The chosen distribution enables tablets to be produced by direct compaction which have high quality, acceptable stability and good physical properties.

With respect to this, Novartis’ expert witness, Dr Davis, explains in his expert opinion as follows:

“There is no prior art suggesting that tablets of vildagliptin can be made using direct compression with this size range or any size range. This particle size range and percentage of the active agent is not disclosed in the prior art. It should be noted that the particle size distribution is important to achieving good physical properties in the tablet (e.g. good hardness). Evidence filed in a technical annex for the corresponding European Patent Application No.15199440.7 (available on-line from the EPO at https://register.epo.org/application?documentId=EZQR8ZQ06757DSU&number=EP15199440&lng=en&npl=false),  comparing 88% PSD of 10-250 micron (within the claim) versus 79% PSD of 10-250 micron (outside the claim) shows that the use of a particle size distribution as claimed is important in providing directly compressed tablets with good hardness (Appendix E).”

The Expert witness related to the technical appendixes that were submitted by the Applicant to the European Patent Office which compares tablets that fall within the ambit of claim 1 to those that do not, and this is the basis of the discovery request that Unipharm submitted.

Claims of the Parties

disclosureUnipharm’s opposition to this evidence is that Professor Davis relied on test results from tests that he himself did not conduct, and they express wonderment that Novartis did not produce the drug developers to be cross-examined. In response, the Applicants claim that the disclosure process should be allowed in cases where it is proven that the documents in question are relative to the proceeding in general and to the point of contention between the parties, and in this instance the Opposer did not justify his request for disclosure of documents and did not explain how the disclosure would help clarify the question under debate.

grain size

Novartis further allege that the request for disclosure is wide and general, in that it relates to all testing and formulations made, where particle size was examined. The Applicant further asserts that Dr Davis referred to Appendix E merely to show that it was published and not as evidence that the data therein is true (!?).

As to Unipharm’s alternative request, Novartis claims that the Opposer did not base this allegation, and that we are referring to an expert opinion based on data provided to him and his relying on the publication is equivalent to any expert relying on a professional publication such as a paper in a scientific journal or a patent application in a relevant field.

file-wrapperIn response, Unipharm claims that the Applicant’s expert, Professor Davis, did not merely testify that the document was included in the file wrapper of the European Patent Application, but also reached conclusions in his expert opinion that were based thereon. As far as anything connected to the scope of the disclosure, Unipharm focuses their request and asks to receive the documents relating to the experimentation with the particle distributions and efficacy of formulations made with the specific distributions.

Unipharm claims that the documents will reveal that the tests conducted, if indeed conducted, do not provide sufficient instruction to persons of the art to produce the invention successfully without additional experimentation and thus the patent application should be rejected as not enabled under Section 12 of the Israel Patent Law 1967.

Discussion and Ruling

legal fishing expedition

There is no doubt that the Commissioner of Patents can request disclosure and access to documents in opposition proceedings. The disclosure is efficient in that it provides documents to the Patent Office that are not covered by Section 18 of the Law (Duty of Disclosure) and which can help clarify if an application is patent worthy. However, disclosure is performed in a manner to prevent the Applicant going on an illegal fishing expedition in the Applicant’s filing cabinets.

The considerations to be weighed up prior to giving a disclosure order are detailed in Opposition to 60312 Biotechnology General Corp vs. Genentech Inc and in Opposition to 143977 AstraZeneca AB vs. Unipharm ltd, and these are the stage of the opposition reached; the amount of documents and their content; the weight of the claim that the Applicants are attempting to prove with the documents asked disclosure of, their evidential weight, the possibility of the Applicant to obtain the documents themselves, and the burden it will cause the opposing party.

In these rulings it was also determined that disclosure could damage the property rights of the opposing party by forcing revelation of trade-secrets. However, the possibility of such damage being caused does not remove the authority of the Patent Office to demand such a disclosure, but obliges consideration of the legitimate property rights of the party when applying that authority.

In the opinion of Commissioner Alon Ofir, Novartis is correct that the experimental results will have no effect on the average person of the art’s ability to implement the invention. The answer to this question is found in what is revealed and not in what is not revealed in the patent application.

Nevertheless, Unipharm is correct with regard to everything related to the tests described in Appendix E, since the Applicant himself relied upon this in his statement. In this regard the Commissioner does not accept that this evidence can be considered as external evidence that their Expert Witness relied on. The document was prepared by Novartis themselves, with data they control, and their expert witness relied on it in his Opinion.

tablet-compression-machine

The particle size distribution is claimed by Novartis themselves as being a central element of their invention, and the claims of the Application itself limits the requested patent to one wherein 80% of the particles are in the 10 micron to 250 micron range. The Applicants themselves state in their Statement of Case, that the choice of particle size and distribution is what enables the fabrication of tablets of an acceptable quality by direct compression. Their Expert Witness finds support for this claim in Appendix E which compares tablets having this particle distribution with tablets that do not.

In these circumstances, one should consider the documents as relating to the central question being debated by the parties. Thus the documents relating to Appendix E are ruled relevant and Novartis are required to provide not just those relied upon but other documents summarizing experiments done with the intention of producing Appendix E, even if not included therein.

Novartis is given 30 days to produce an Affidavit of Disclosure with the relevant documents describing test results obtained in the experimentation leading to Appendix E, whether or not included in the Appendix, but relating to the hardness of tablets made from different particle distribution.

As an after-note, the Opposer is chastised for using language that does not show respect for the proceedings which was inappropriate.

No costs are awarded.

Ruling on Interim Proceeding regarding disclosure, by Commissioner Ofir Alon, 3 January 2018.

COMMENT

trawlingIn court proceedings in the United States there is wide discovery and the parties effectively go on fishing expeditions with trawlers and haul up everything and then have to wade through the bycatch.  This is not the case in Israel. One can ask for specific documents, but have to justify the request. Thus I have used the term disclosure and not discovery.

self representation

In this instance, Unipharm is not-represented, or to be more accurate Dr Zebulun Tomer is representing himself. No doubt if he runs into trouble he will call on his attorney Adi Levit to represent them. It is unlikely that the inappropriate language lost Unipharm a costs award as, since they have not used legal counsel, they are not entitled to costs anyway.

We strongly discourage industrialists to represent themselves in Opposition proceedings. The Tomers, however, have so much experience of killing pharma patent applications that there are very few lawyers that have handled so many cases.


New Israel Patent Commissioner Makes Purpose Driven Interpretation of Patent Term Extension Legislation to Transfer Protection from One Drug to Another

December 21, 2017

Wyeth submitted a request for a patent term extension for Israel Patent Number 120701 titled “2 – PHENYL – 1 – [4 – (2 – AMINOETHOXY OR PROPOXY) ) – BENZYL] – INDOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ” The patent issued on 26 December 2005 and the basic 20 year protection period will run out on 18 April 2019.

CONBRIZAOn 17 June 2012 Conbriza was registered in the Israel register of drugs. Conbriza contains bazedoxifene acetate. This was the first Israeli registration of Bazedoxifene for medicinal purposes and so, on 19 October 2015, a patent term extension order issued for Conbriza, until 14 April 2022.

DuaviveOn 16 November 2016, the drug Duavive which contains bazedoxifene acetate together with conjugated estrogens was registered in the Israeli register. The Applicant explained that Duavive is a more modern version of Conbriza which Pfizer (which owns Wyeth) had developed and is marketing in Israel.

The treatments are both for treating the symptoms suffered during menopause, such as the so-called hot flushes.

calculation

On 22 May 2017, the Wyeth informed the patent office that Conbriza was taken off the drug register and Duavive was registered. Wyeth claimed that the change should not affect the patent term extension since both drugs contained bazedoxifene, and that the patent term extension should be calculated from the first of the registrations.

Following this notification, the Applicant was invited to attend a hearing under section 149 before a ruling issued. The Applicant did want to attend such a hearing and on 5 July 2017 the Commissioner Ophir Alon indicated that in the hearing, which was held on 31 July 2017, the Applicant would explain why they felt that the provisions of Section 64(vii)(3) should not apply in this case.

Ruling

Section ii(1) of Chapter D of the Law deals with patent term extensions. Inter alia, Section 64D of the Law states that:

64D. The Registrar shall not grant an extension order, unless the following conditions have been met:

(1) The material, the process for its production or its use, or the medical preparation that incorporates it or the medical equipment was claimed in the basic patent and the basic patent remains in effect;

(2) In respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);

(3) The registration said in paragraph (2) is the first registration that allows the material to be used in Israel for medical purposes;

(4) No extension order was granted previously in respect of the basic patent or in respect of the material.

From here, it is clear that the condition for giving a patent term extension is that there is a registration of a drug that includes the active ingredient and it is the first registration that allows the active ingredient to be prescribed in Israel, which was not previously subject to a patent term extension.

Section 64L states the cases where a patent term extension lapses. In 64L(3) it is stated that:

64L. An extension order shall laps in each of the following instances:

(3) If registration of the medical preparation that incorporates the material was cancelled—on the day on which the registration was cancelled;

Thus the wording of the black letter law seems to be that if the registration including the active ingredient is cancelled, the Patent Term Extension is cancelled as well.

The Applicant’s claim is that in cases where the company that registered the first drug has a number of registrations for different drugs containing the active ingredient, the Legislators did not intend that the protection period would lapse simply because one of these was cancelled. Rather, the legislators intended that only in cases where at some time after the issuance of the extension period, there are no registrations of drugs including the active ingredient in Israel, the extension period would lapse. In such an instance, where there are no drugs on sale in Israel there is no legitimacy in keeping the patent term extension active and so Section 64L(3) applies.

The Applicant claims that since Duavive contains the active ingredient and was registered before the registration of Condiza was cancelled, one or other preparation containing the active ingredient was continuously registered in Israel and so the patent term extension remains in force.

The Purpose of the Patent Term Extension Regime

As known, the term of a patent is 20 years from filing in Israel [or from the PCT filing date – MF] subject to paying extension fees. This period is the accepted balance between the desire to encourage inventors on one hand, and to enable the population to benefit from technological advances on the other.

balance

This balance has a special regime for pharmaceuticals and medical devices that is given by Section B1 of Chapter 4 of the Law. This regime compensates patentees for delays in registration but allows the generic drug industry to prepare for market entry to the benefit of the population as a whole. Where the conditions of the Law are met, it is possible to extend patents for pharmaceuticals and medical devices by up to five years.

This is how things were presented on page 18 of Appeal 8127/15 Israel Association of Industrialists vs. Mercke Sharpe and Dohme Corp, 15 June 2016:

The purpose of the extension period is to compensate the patentee for the period of patent protection that is de facto lost due to the amendment of the patent law. The period of protection in Israel and other countries having patent term extensions takes into account the period that the patentee takes to register the drug which is longer than the period lost by the patentee. However, in the Draft Amendment by the Committee for Constitution, Law and Justice it is stated that the extension is for the period that the patent for the drug is registered but regulatory approval by the Ministry of Health has not yet occurred, and so the extension is identical to this period. Either way, the main purpose is to provide fair compensation to the patentee.

Explaining section 64L(3)

As stated previously, there are two possible interpretations to Section 64L(3) of the Law. In the first explanation the words “registration of the medical preparation that incorporates the material was cancelled” relates only to the first registration, as defined in Section 64D(2), so that when the first registration is cancelled, the patent term extension ends.

The second explanation, proposed by the Applicant, is that one should understand the words “registration of the medical preparation that incorporates the material was cancelled “ as relating to all drugs that include the active ingredient and not merely the first one to be registered, so that there are no drugs including the active ingredient on the register.

Ofir Alon

The New Commissioner Ophir Alon considers that the interpretation is in line with the rationale of the Law proposed by the Applicant. As stated previously, the intention of the legislator was to compensate the patentee for the period required to register the drug. Section 64D of the law refers to the conditions for granting a patent term extension. The purpose of 64D(2) of the Law is to ensure that the active ingredient has undergone registration, and that of 64D(3) to ensure that that this was the first instance of the active ingredient being registered.

Since these conditions are fulfilled, it does not seem that there is much significance in the first registration specifically, that its cancellation requires cancellation of the patent term extension and cancelling the compensation that the law provides the patentee, whilst the active material remains registered, albeit with other active ingredients.

Registration of more advanced or better drugs that include these active ingredients is desirable.  Such registration is likely to require additional registration by the Ministry of Health. Adopting an interpretation under which the cancellation of the first registration for which the patent term extension period was calculated automatically results in the cancellation of the patent term extension will lead to a situation in which the patentee who has several registrations will have to keep the registration of a drug not being sold in force merely to keep the patent extension in force. This is artificial and not desirable.

However, accepting the second interpretation allows the patentee to cancel or not renew the first registration whilst keeping the patent term extension in place to protect additional drugs subsequently registered. This prevents circumstances where a patent term extension is in place but no drugs are registered for sale in Israel.

In summary, it appears that the correct interpretation of the Law is to compensate the patentee for the period he could not exploit his patent whilst waiting for regulatory approval, which includes protecting the public interest by promoting development of new treatments, and these aims are achieved by the interpretation allowing the extension to stay in force as long as there are drugs that include the active ingredient.

This interpretation serves the purpose of the Law and the public interest as it provides an incentive for the patentee to develop new versions of its drugs, that are more advanced or more efficacious than the original treatment, and allows the cancellation of registrations that are n longer marketed.

The Commissioner is aware that linguistically, the objective pronoun “the medical preparation” apparently relates to the medical preparation mentioned previously. Nevertheless he does not think that a literal reading helps to clarify things in this instance. For example, if we were to take a literalist approach to understanding section 65L(3) we would wonder what the legislator intended by “including the ingredient” at the end of the section, since it is clear that the medical preparation whose registration was the basis of the patent term extension includes the active ingredient, as stated in Section 64D(2):

(2) in respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);

FROM THE GENERAL TO THE SPECIFIC

The cancellation of the Conbriza registration occurred after Duavive was registered, and so in one form or another the active ingredient was continuously registered from when Conbriza was registered until today.

So, by applying a purpose-driven interpretation to Section 64L(3), the registration was never cancelled and from when the patent term extension was issued until today, the medical preparation was under continuous protection.

The medical preparation Duavive includes the bazedoxifene ingredient together with conjugated estrogens. In other words, to create continuity in the registration, the active ingredient has to be identical to the one for which registration was granted. The Patent Term Extension for Israel Patent No. IL 120701 will remain in force subject to the Applicant submitting an Affidavit that the combination of the bazedoxifene ingredient together with the conjugated estrogens does not create a new material. This affidavit must be submitted within 30 days of this ruling.

Ruling concerning the Patent Term Extension for Israel Patent No. IL 120701 for bazedoxifene (Conbriza and Duavive), Ophir Alon, 15 October 2017

COMMENT

This ruling could be a baptism of fire for the new Commissioner.

The main question that the appointment of a new commissioner generates is whether he will favour the drug development industry or the genetic drug industry. The sums of money generated every day of a patent term extension and in supplementary patent protection for variants such as changes in dosage regimes is enormous. In this regard, Israeli companies are involved as both generic players and as drug developers. Despite TEVA being the world’s most successful generic drug provider, It was Teva’s Copaxone falling over the so-called patent cliff that caused the massive drop in share prices and layoffs, rather than lost sales of generics.

Here the Commissioner has taken an analytical approach to the law, trying to understand the rationale rather than the most literal interpretation. This is in line with guidelines penned by Former Chief Justice Aharon Barak who was known for such interpretations, which perhaps less charitably and more formalistically could be described as subverting the Law as legislated to further lofty aims as he saw them. Such creative interpretations coupled with him declaring that Basic Laws were constitutional and reading into them powers that the Knesset never intended, has led to judicial activism that those on the right see as undermining the Knesset as legislator, and those on the left see as saving democracy from the people’s elected representatives.

I remember litigators that represent the drug developing companies saying during Dr Meir Noam’s term as Commissioner, that, until he was replaced, their clients could not get justice. I do not know if this was fair. Dr Noam was a chemist, and generally where he accepted Unipharm’s arguments that an opposed patent application lacked novelty or inventive step, their arguments were persuasive, or at least seemed so to me. Nevertheless, in practice, he did rule in favour of the generic companies, but his rulings held up on Appeal.

At the start of his term in office, the previous Commissioner, Adv. Asa Kling, could not rule on cases where one side was represented by Reinhold Cohn or Gilat Bareket because of a perceived conflict of interest. Centocor Ortho Biotech Inc. received regulatory approval for a pharmaceutical preparation described in IL 154325.

From the affidavits submitted by employees of the agents for applicant (Reinhold Cohn Patent Attorneys) it is clear that, despite the firm being organized and having procedures in place to cover patent term extensions, there was human error. The deadline was missed and this was discovered seven months later.

Section 164 A1 of the patent law states that:

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…section 64… …unless he is satisfied that the application in Israel was not submitted on time because of circumstances over which the applicant and his representative had no control and which could not be prevented;

The Deputy Commissioner Jacqueline Bracha threw Reinhold Cohn a life-line by ruling that mistakes were unavoidable, thereby allowing a missed deadline for requesting patent term extensions to be retroactively extended despite the Law being unequivocal that the deadline was not extendible. For more details, see here.

The patent term extension legislation has been amended several times, in the third, seventh and eleventh amendments to the Israel Patent Law.

The third amendment was ambiguous and in an ex-partes ruling affecting three patents in what is now known as the Novartis ruling, Then Acting Commissioner Israel Axelrod understood that the amendment was designed to give a real advantage to the drug development companies and they could choose the country to base their patent term extension on.  This was not what the Knesset intended and the amendment was again amended in what was the Seventh Amendment of the Israel Patent Law, to tidy up this and other ambiguities of the original amendment. Israel Axelrod, who was widely expected to be appointed as Commissioner but instead, was side-ways promoted to the Beer Sheva District Court.

In 2006, under intense pressure from the US who put Israel on their special 301 Watch List of countries not properly protecting Intellectual Property, the State of Israel amended their Patent Law again.

Arguably the Commissioner is correct that the purpose of the Law is to strike a balance between the conflicting interests. Arguably, however, as in the Novartis ruling and subsequent amendment, the intention of the legislators remains to provide narrowest possible intention to rules governing patent term extensions, to encourage generic competition, thereby favoring local industry over foreign companies, and providing cheap medicine. We should bear in mind that the legislation was the result of heavy US protectionist pressure, and in the same way that the US government tries to benefit US interests, it is (at least arguably) legitimate that the Israel Law is intended to protect local interests as much as possible.

Teva is not, of course, the only Israel company to bring a drug to market. Neurim managed to patent Circadine which is a treatment for insomnia based on melatonin, and also obtained patent term extensions around the world. In the UK, the patent office refused to grand a patent term extension arguing that the active ingredient was used in a treatment for sheep.  Judge Arnold upheld the patent office’s position, see patent term extensions for Neurim which was appealed to the House of Lords, and Lord Robin Jacobs referred it to the European Court of Justice ECJ in his last ruling on the bench. The ECJ took a similar position to that of the current commissioner, preferring an interpretation that considers the rationale behind the law to a literalist ruling.

The main problem with ex-partes rulings is that arguments of the other side are not heard.  It is not inconceivable that Duavive works and Conbriza didn’t, not because of a new material being developed but because of some symbiotic effect between the bazedoxifene ingredient and the conjugated estrogens. In this instance, Duavive was developed by Wyeth/Pfizer but it is not inconceivable that such a drug could be developed by a third party. If the Conbriza formulation is not on sale and no other drug by the patentee, should Wyeth-Pfizer be entitled to a drug term extension past the main patent lapsing? Another hypothetic question worth considering is that an active ingredient protected by a patent term extension could actually not be so active at all, and could be co-dispensed with a drug that itself is active, but cannot be patented. The combination could be protected by the patent term extension in a scam designed to defraud the public. I am not alleging that this is the case here. I have no ideas what conjugated estrogens do or how they work. I am merely highlighting a slight logical flaw in the Commissioner’s reasoning.

That as may be, this ruling is a brave but reasonable one. Being ex-partes it cannot be challenged directly, but could be challenged by TEVA, Unipharm or some other generic company launching a Bazedoxifene containing formulation during the extension period.  The Knesset could also decide to amend the Patent Extension Law to rule out this interpretation if they deem fit to do so.