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.


Cost Ruling in Moshe Lavi vs. Zach Oz – A failed attempt to get a poorly written patent canceled.

December 20, 2017

Figs for ACMoshe Lavi owns Israel Patent No. 157035 titled “MODULAR SUPPORT BRACKET” which describes  a support bracket for an air-conditioner unit. He’s tried to enforce it in the past against Zach Oz Airconditioners LTD, and the parties came to an out-of-court settlement.

Lavi then sued again, and Zach Oz countered by applying to have the patent cancelled. This attempt was unsuccessful and a ruling upholding the patent issued on 5 March 2017.

Lavi then applied for costs under Circular MN 80. According to Lavi and his attorneys, Pearl Cohen Zedek Latzer Brats, the costs incurred in fighting the Opposition were a fairly massive 526,750.058 Shekels!? We assume that there is a typo here, and the costs requested were just over half a million Shekels and not just over half a billion shekels, as that would be ridiculous even for Pearl Cohen. It seems that they charge in dollars and not Shekels, and are unaware of the need to round up to the nearest 5 agarot.

Lavi claims that he is entitled to the real costs incurred, which are reasonable, necessarily incurred and proportional in the circumstances. He accuses Zach Oz of acting in bad faith by challenging the validity of the patent. His counsel appended a list of legal counsel’s hours, invoices, and an affidavit by Moshe Lavi.

The Respondents Zach Oz, confusingly represented by an Adv. Pearl (not Zeev, even he is aware that fighting both sides of an opposition proceeding is not acceptable) claimed that the costs were unreasonable and some were unnecessary or disproportional. They also claimed that it was Moshe Lavi who acted inequitably. They note that the case-law states that costs are not meant to be a punishment, and the costs in this case were unreasonable and were incurred due to unnecessary wariness by the patentee. Furthermore, the adjudicator is supposed to take into account the public interest and importance in maintaining the integrity of the patent register. Awarding inflated costs in cases that they lose, would discourage people from challenging the validity of patents and would prevent access to legal recourse.

Ruling

The winning party is entitled to costs incurred in legal proceedings. However, the arbitrator is not obliged to rule actual costs, and is required to consider the specifics of the case and judicial policy. See paragraph 19 of Appeal 6793/08 Loar LTD vs Meshulam Levinsten Engineering and Subcontracting Ltd. 28 June 2009.

In the case-law it was ruled that for the Applicant for actual costs to prove that they are reasonable, proportional and necessary in the specific circumstances. See Bagatz 891/05 Tnuva Cooperative for Marketing Agricultural Produce in Israel Ltd. et al. vs. The Authority for granting Import licenses et al. p.d. 70(1) 600, 615 from 30 June 2005. The limitation of costs to being necessary and proportional is:

To prevent a situation wherein the costs awarded are too great, and will discourage parties from seeking justice, will create inequalities and make court proceedings unnecessarily costly, limiting access to the courts. (Appeal 2617/00 Kinneret Quarries ltd. cs. The Nazareth Ilit, Planning and Building Committee, p.d. 70(1) 600, (2005) paragraph 20.

The amount of work invested in preparing submissions, their legal and technical complexity, the stage reached in the proceedings, the behavior of the parties before the court of the patent office and with regard to opposing party, inequitable behavior of the parties, etc. All these are considerations that should be taken into account when considering “the  specifics of the case”.

In this instance, the patentee did win his case and is entitled to recoup costs, and the losing party does not dispute this. However, in this instance, the patentee is not entitled to the requested costs for reasons detailed below.

Firstly, after consideration of the case and the submissions, none of the parties appear to have acted inequitably. It is not irrelevant that neither party has related to the decisions made in this instance, including the main ruling. This is because there is no evidence of inequitable behavior by the parties. Similarly the affidavits are acceptable. In this regard, it is not reasonable to accept the patentee’s allegation that the challenge to their patent was baseless. The file wrapper shows that the challenger made a reasonable and fair attempt to show that the patent was void, based, inter alia, on prior art.

Furthermore, as to the costs requested, the adjudicator, Ms Shoshani Caspi did not think that they were reasonable, essential or proportional, as required by the Tnuva ruling.

The expert opinion of the expert who attended the hearing, costs of 29,685 Shekels including VAT were incurred. This was considered reasonable. It also appears to have been necessarily incurred. However, the Applicants did not need to use lawyers to prepare the expert opinion’s opinion for him, whilst claiming costs for him preparing his opinion as well. This is a double request for costs and should be eradicated.

In his Affidavit, Mr Lavi claimed that the challenge to his patent caused him to spend $137,901.37 including VAT. This is the 499,065.058 Shekels requested by the Applicant, excluding the expert opinion. The Affidavit explains that this sum includes his legal counsel’s work, couriers, printing, etc., however, no evidence of couriers and printing costs were given, and it appears that these incidentals were included in the invoices from his legal representative. To provide evidence for the legal costs incurred, invoices from PCZL were appended which included the hours spent by attorneys working on the case.

One cannot ignore the fact that the list of work done included demanding extensions, attempts to negotiate an out-of-court settlement, interim proceedings that the opposing party won, an appeal of the refusal to throw the case out, https://blog.ipfactor.co.il/2015/03/08/il-157035-if-one-accused-of-infringing-a-patent-does-not-challenge-its-validity-is-the-accused-estoppeled/

and other costs that are not essential and thus not reasonably chargeable to the other side.

double dipThe attempt to roll these unnecessary costs to the losing side and the double charging for the expert witness are inappropriate to use an understatement, and one assumes that these requests were made inadvertently as they were signed by educated attorneys that are well versed in the relevant legal processes.

Furthermore, after a detailed review of the file, Ms Yaara Shashani Caspi concluded that the case was relatively simple and there were neither particularly complicated legal or factual questions. Consequently, it is difficult to accept that the request for costs of 499,065.058 Shekels [sic] including VAT is reasonable, essential or proportional in the circumstances. It will be noted that as ruled in the Tnuva case (paragraph 19). The real costs that the patentee incurred is only the starting point and not the end point of the costs ruling.

It transpires that the time spent in each round was very large. For example, 65 hours was spent on a request to cancel an expert opinion, and 44 hours on the request for costs, etc. The Applicant did not provide an acceptable justification for these figures.

In light of the above, legal costs will be awarded by estimation, and in addition to the 27,685 Shekels (including VAT) to the expert witness, a further 150,000 Shekels (including VAT) are awarded in legal fees.

The deadline for paying the costs is 30 days, then interest will be incurred.

Legal Costs Ruling by Ms Shoshani Caspi in cancellation proceedings of IL 157035 Moshe Lavie vs. Zach Oz, 25 October 2017.

Comment

The whole case was mishandled by Zach Oz, who could and should have won the original infringement case in court, but decided to accept a poorly worded out-of-court settlement. By any reasonable attempt to construe the claims so that the patent was not anticipated by support brackets for shelves, Zach Oz’ supports were not infringing. In other words, they could have used the Gillette defense.

Ms Shoshani Caspi’s criticism of PCZL overcharging and double dipping is appropriate in this instance. The attempt to have the case thrown out on a creative estoppel based on not having challenged the validity of the patent when sued for infringement was ridiculous. Ironically, this patent is not worth the costs spent on litigating it. This is a clear instance of lose-lose by all concerned except the lawyers.


November 8, 2017


LES Israel and IPAA invite you to an event on Wednesday, November 15, 2017, 09:00-
12:30 at ZOA House (אמריקה ציוני בית ,(26 Ibn Gabirol St. (corner of Daniel Frisch St.), Tel
Aviv (The presentations will start at 9:30).
The event will be dedicated to the topic:
Patent Term Extension Peculiarities
Israel and Europe
The topic will be presented by distinguished speakers, as follows:
 Mr. Liad Whatstein (Liad Whatstein, Adv.), Founding Partner of the Israeli law firm Liad
Whatstein & Co.:
Patent Term Extensions under Israeli law – The Eccentricities of The Local System
 Mr. Tjibbe Douma (Tjibbe Douma, Adv.), Senior Associate at the law firm of De Brauw
Blackstone Westbroek NV, The Netherlands; and
Ms. Tessa Malamud-Cohen (Tessa Malamud-Cohen, European and Israeli Patent Attorney),
Director, Patents, Global Intellectual Property of Ferring Pharmaceuticals/Bio-Technology
General (Israel) Ltd.:

SPC Squatting: SPCs Based on Third Party Marketing Authorization
 Mr. Tal Band (Tal Band, Adv.), Head of the IP Practice Group in the Israeli law
firm S. Horowitz & Co.:
Patent Term Extensions in Israel – When is it “Game Over”?

We will allocate some time at the end of the event for discussion and welcome comments
from the audience.
The event is free to LES Israel and IPAA members.
Non-members: NIS 70 charge.

Kindly confirm your participation by return email to les_israel@yahoo.com.

COMMENTS

The speakers are considered distinguished by IPAA and LES. I’ve cut and pasted their notification verbatim. I do not disagree, but merely wish to note, that the adjective is not one I chose. The speaker list is balanced in that Tal represents TEVA who usually are generics opposing patent term extensions (although recently trying to reinvent Copaxone to keep it evergreen). Liad works for the patent developers who try to obtain patent term extensions, and Tessa works in-house in the industry. I do not remember meeting Mr. Tjibbe Douma and suspect with a name like that, I would.

counting-sheepMy extensive practice has not involved patent term extensions since I split with Jeremy Ben-David, whose father, Dr Stanley Davis, drafted the Neurim patents for Circadin, whose UK Patent Term Extension went to the European Court of Justice, see here, here, here, etc, so the event has little interest to me personally, although is clearly important for the pharma crowd. Perhaps we should let sleeping sheep lie.


Retroactive Extension Granted for Reporting a Lecture Disclosing a Patent Application Prior to Filing

October 10, 2017

Background

retroactivePatentability requires that a patent is novel, inventive and useful at the priority date, which is the effective filing date.

The Novelty requirement is absolute, but there are three exceptions given in Section 6 of the Israel Patent Law 1967:

  1. A publication of the invention without consent of the patentee is not novelty destroying, provided that patentee files an patent application promptly on learning about the publication;
  2. Display at a exhibition is not novelty destroying, provided a patent application is filed within six months;
  3. A scientific lecture is not novelty destroying, , provided the registrar was given advanced warning and a patent application is filed within six months.

Section 164 gives the Registrar (Commissioner) wide discretionary powers to extend missed deadlines.

In this ruling, the Deputy Commissioner considers whether the advanced warning of Section 6(3) can be extended retroactively under the discretionary powers given by Section 164, i.e. if the Applicant can inform the Commissioner of a scientific lecture post facto and pay extension fees, so that the lecture by the inventor is not considered as novelty destroying prior art.

The Case

Japan flagOn 6 March 2012, Otsuka Pharmaceutical Co. Ltd. filed Israel Patent Application Number 218495 as a National Phase Entry of PCT/JP2010/053032 titled “Therapeutic Agent for Chronic Pain” that was itself filed on 26 February 2010. The PCT application claimed priority from JP 2009-211021 filed on 11 September 2009.

On 27 August 2009, i.e. before the priority date, the “Conference Proceedings of the 69th Tohoku District Meeting of the Japanese Society of Psychosomatic Medicine” were published. One of these was titled  “An example of complete response of ariprazole against refractory head and neck pain associated with depression”.

A significant amount of the scientific work that was the basis of the patent application and of the conference paper was disclosed in a lecture on 12 September 2009. The Patentee claims that the PCT application was filed within six months of the abstract, and claims priority from the priority application and so the PCT application benefits from the grace period under Section 30 of the Japanese Patent Law.

On 22 July 2010, prior to entering the national stage in Israel, the Agent for Applicant requested an extension to the deadline of Section 6(3). The Head of the PCT Department refused this, since the notification of the publication was not provided in advance, and he considered that only time limits given in the Law can be extended.

On 15 August 2010, the Applicant responded that they would file a second request on entering the national stage into Israel and would provide written and verbal arguments justifying an exception, and, on 16 May 2011, a further notice refusing the extension was issued by the patent office.

On subsequently entering the National Phase into Israel, and with reference to Section 48D(a) of the Law, the Applicant noted that, prior to entering the national phase into Israel, they had requested an extension to Section 6(3), and appended the decision of 16 May 2011.

During the Examination, the abstract from 27 August 2009 was cited against the claimed invention as being novelty destroying. Consequently, the Applicant requested a hearing to discuss whether the Section 6(3) deadline is extendible and, if so, whether the circumstances in question justify the Commissioner retroactively extending the deadline under section 164.

Discussion

Sections 6 and 164 are reproduced below:

  1. The right of the owner of an invention to be granted a patent shall not be affected by publication said in section 4—

(1) if it is proved that the matter published was obtained from him the owner of the invention or his predecessor in title and was published without his consent, and if the patent application was filed within a reasonable time after the publication became known to the applicant; or

(2)(a) the publication was by the owner of the invention or his predecessor in title in one of the following ways:

(i) display at an industrial or agricultural exhibition in Israel or at a recognized exhibition in one of the Convention States, of which official notice was given to the Registrar before its opening;

(ii) publication of a description of the invention at the time of a said exhibition;

(iii) use of the invention for the purposes of the exhibition and at the place of the exhibition;

(b) the publication was by use of the invention, even without its owners’ consent, at the time of the exhibition, at the place of the exhibition or outside it, on condition that the patent application was submitted within six months after the exhibition opened;

(3) publication was by way of a lecture by the inventor before a scientific society or by publication of the lecture in official transactions of the society, on condition that the Registrar was given notice of the lecture before it was delivered and that the patent application is filed within six months after the aforesaid publication.

Section 6(3) lists three conditions, that if fulfilled, render the prior publication as not damaging to the patentability of the patent. The first condition relates to the nature of the publication and to the reasons for it happening. In this instance, it relates to a lecture by the inventor before a scientific society or the publication of the lecture in the formal society conference proceedings. There is no doubt that the publication in question fulfills these conditions.

The third condition relates to the period from which the publication occurs and the date of filing of the patent. The proceedings were published on 27 August 2009, and the international publication was on the 26 February 2010. The Applicant claims that one should see the date of filing of the PCT Application designating Israel, as being the date as far as Section 6(3) is concerned. The Deputy Commissioner, Ms Jacqueline Bracha considers that the Applicant is correct in this regard.

Section 48(c) of the Law is an exception to Section 15 that states that a PCT Application designating Israel, receives a date as per the PCT Convention:

48C. The provisions of this Law shall apply to applications addressed to Israel, with the changes specified in this Chapter and with the changes specified below:

(1) the provisions of sections 11, 14, 15, 17(a) and 20 shall not apply;

(2) the provisions of section 16 shall apply to an application, in respect of which the applicant met the conditions prescribed in section 48D;

(3) the date of the application shall be determined in accordance with the provisions of the Convention;

(4) the provisions of section 165(a) shall not apply to information published under the Convention in respect of applications;

(5) notwithstanding the provisions of section 168(a), documents published according to the Convention in respect of applications shall be open for public inspection.

In accordance with Section 11(3) of the PCT Conventions, the filing date of the PCT application is considered as the National Entry Date in all designated states:

(3)  Subject to Article 64(4), any international application fulfilling the requirements listed in items (i) to (iii) of paragraph (1) and accorded an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.”

In light of this, the effective filing date in Israel is the filing date of the PCT Application designating Israel, and so the Applicant has fulfilled Section 6(3) of the Law.

The Applicant does not dispute that he did not fulfill the second condition requiring informing the Commissioner of the lecture before it happened. However, he alleges that it is within the Commissioner’s Authority to extend this deadline using the powers granted to him under Section 164 of the Law.

Patent Deadlines are generally extendible, apart from the deadline for filing an opposition, the deadline at which a patent lapses (but can be restored), the grace period for renewals, and deadlines relating to patent term extensions. Other than these, the Registrar (Commissioner) has wide discretion to grant extensions. This is clear from Section 164 of the Law, repeated below:

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; however, for purposes of section 10—

(1) the Registrar shall not extend the time prescribed by subsection (a)(1), 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;

(2) the Registrar shall extend the time prescribed by subsection (a)(2) only as long as the application has not yet been accepted and if he is satisfied that a mistake was made innocently.

(3)The Registrar may make the extension of times conditional on conditions as he deems fit.

(c) An application for extension of a time may be submitted within the time or after it.

(d)Notwithstanding the provisions of subsections (a) and (b) and the provisions of any other Law, if the last day of the period prescribed in section 10(a)(1) falls on a .day that is not a work day, then the period shall end on the first work day thereafter; this provisions does not derogate from the power to extend beyond the time prescribed in section 10(a)(1).

The Examiner considered that this condition is not a deadline that can be extended and so the Commissioner does not have jurisdiction under Section 164.

The Deputy Commissioner notes that as far as the publication in question is concerned, the Applicant acted in good faith opposite the Patent Office. Firstly, even before entering the national phase the Applicant requested an extension to inform the patent office, when filing, he noted the request on the Application form and listed the reference in the list of disclosed prior art in accordance with the duty of disclosure under Section 18 of the Law. When discussing the requirement in the hearing, the question arose as to whether the Applicant should have appealed Dr Bart’s ruling. Perhaps the Applicant should have Appealed under Section 161 but the Deputy Commissioner does not consider it too late to discuss the issue substantively, nor does she consider the failure to appeal as being inequitable behavior.

The main issue under discussion, is whether the requirement to provide advanced knowledge of a publication is a deadline that can be retroactively extended under section 161, i.e. whether this is an exception to the rule.

To answer this question, it appears appropriate to consider the underlying purpose of the condition and its source. Section 11 of the Paris Convention for the Protection of Intellectual Property 1883 states that the signatory states should provide temporary protection for a period not exceeding that defined in section 4 of the Convention (grace period) for displaying an invention or design at an official exhibition. Indeed, allowing exhibited goods to be protected was one of the aims of the convention:

“(a) Since lack or inadequacy of protection of industrial property at international exhibitions was one of the reasons which promoted the conclusion of the Convention, it is natural that the principle of such protection should already have been included in the original text of the Convention of 1883. It was then the intention to oblige the member States to take necessary legislative measures to that effect but to leave them free in determining the ways and means of achieving this end.”

GHC Bodenhausen Guide to the Application of the Paris Convention for the Protection of Industrial Property, as Revised at Stockholm in 1967 (1968) page 149.

Since the individual states had wide discretion regarding their national legislation and the administrative requirements for obtaining this protection, the basis for the pre-exhibition notice, which is largely unique to Israel, is not part of the convention itself. Additionally, examination of the pre legislative proposed law does not provide an explanation.

The Law in many jurisdictions does not require a pre Exhibition notice of intent to exhibit to be submitted to the patent office. The Japanese Patent Office requires sub mission of the patent application together with a notice within six months of the exhibition. (See Hiroya Kawaguchi “The Essentials of Japanese Patent Law” (2007) p. 31.

A similar requirement for submitting a the notice of an exhibition together with the application is found in Section 55 of the European Patent Convention:

“(1) For the application of Article 54, a disclosure of the invention shall not be taken into consideration if it occurred no earlier than six months preceding the filing of the European patent application and if it was due to, or in consequence of:

(a) an evident abuse in relation to the applicant or his legal predecessor, or

(b) the fact that the applicant or his legal predecessor has displayed the invention at an official, or officially recognized, international exhibition falling within the terms of the Convention on international exhibitions signed at Paris on 22 November 1928 and last revised on 30 November 1972.

(2) In the case of paragraph 1(b), paragraph 1 shall apply only if the applicant states, when filing the European patent application, that the invention has been so displayed and files a supporting certificate within the time limit and under the conditions laid down in the Implementing Regulations.”

In the US, the exhibition of the invention is part of the one year general grace period for inventor disclosures – See §35 US Section 102b of the US Patent Law and Daniel J. Gervais International Intellectual Property: A Handbook of Contemporary Research (2015) p.45.

From here it is clear that the Israel Law is somewhat unique in requiring prior notification. In light of the difference between the Laws and the legislative being silent regarding whether or not this period can be extended, the question of the interest that the Israel Law intended to protect by requiring prior notification of exhibition or lecture becomes important.

There are three possible purposes that come to mind.

  1. One possibility is to protect the inventor who, prior to exhibiting or lecturing, must determine that the exhibit or lecture will not damage his future protection. By providing notification, the Commissioner can obtain the disclosure and will be reminded of the Section 6 exception. If the inventor does not receive the authorization to exhibit, he can quickly file an Application before the publication. This paternalistic rationale, even if a positive thing, is somewhat exceptional on the IP horizon.
  2. Another possible purpose is certainty of the public regarding whether a prior disclosure is legally and not merely factually novelty disclosing or not. In other words, the public wishes to know as early as possible, if an invention is to be patent protected or if it is in the public domain. Even if this is an appropriate aim, it is not achieved by the requirement for earlier registration under section 6(3) of the Law, since such notification is not known to the public prior to the patent application becoming available for public inspection 18 months after filing (and until fairly recently, only on allowance). At the time that the patent file wrapper is available for inspection, it makes no difference if the Patent Office was informed of the exhibition or lecture in advance or after the event. Thus the public reliance on publication is different from the reliance on national phase entry which interested parties can and do follow, see for example, 23511-05-12 Mindcake LLC vs. Israel Commissioner of Patents and Trademarks, 17 January 2013:

Thus, the extension of the national phase entry deadline is a matter of significance, since when this date passes, the invention is immediately transferred from the patentee to the public domain, who is allowed to make use of the invention according to their will.

In this instance, we cannot assume that this reliance is relevant since the public learn about the exhibition approval long after it has issued, so long as it is before the patent wrapper itself is open for inspection.

3.A third aim might be to provide the Commissioner with the tools to determine whether a prior art publication is indeed at a scientific or recognized exhibition or not. For such an aim, the Deputy Commissioner does not consider that prior notice makes much difference. The onus is on the patentee to convince the Commissioner, who is not required to make investigations. So in cases where the Applicant is unable to convince the Commissioner that the exhibition should not be novelty destroying, his request will be refused. From here it is clear that any evidentiary problems will work against the Applicant and we therefore return to the first suggestion that the purpose is to protect the Applicant.

This is not the first time that the Court of the Patent Office has considered this issue. In re IL 68447 to Byong Wha Suh (published on 29 February 1984), the Commissioner was petitioned to extend the Section 6 time-frame. After considering the European Patent Law, the Commissioner reasoned that one could indeed extend the deadline for informing the ILPO and reasoned as follows:

“We state immediately that in our Opinion, section 164a of the Israel Patent Law is sufficiently broad to allow the Section 6(2)(a)(1) deadline to be extended.
The Section allows deadlines that are stated in the Patent Law or the Regulations to be extended, and the wording is not limited to procedural deadlines (such as the deadlines for filing and responding in contentious proceedings), but also allows extensions of deadlines that can affect the validity of a patent. This can be learned from the wording of Section 164 which specifically excludes extending deadlines for paying renewal fees for lapsed patents. This teaches that the legislative body did not see fit to prohibit other deadlines being extended at the Commissioner’s discretion.

It is true that there is no positive reference to Section 6(3) in Section 164 of the Law. Section 164 does, however, allow the Commissioner to retroactively allow extensions. The Applicant is correct in his claim that “so long as the Commissioner receives notification of the lecture before it is given” relates to time limits, even if not explicitly. It is also clear that this time passes with the lecture and so any time thereafter misses the stated deadline for the action.

To the extent that the advanced deadline is paternalistic, prohibiting extending the time limit will not enable the intent to be achieved. From here, the Deputy Commissioner deduces that the Commissioner (and by transfer of powers, she herself) has the authorization to extend the time limit.

It is true that the Commissioner has wide discretionary powers under Section 164, the extent of which changes with circumstances. Application of Section 164(a) to give a retroactive extension will be depend on the nature of the process, the specific circumstances, and the weighing up of the Applicant’s interest and the public’s interest. See Appeal 2826/04 Recordati Ireland Ltd vs. Commissioner of Patents, 28 October 2004.

Section 164 of the Law, cited above, that allows the Commissioner to extend deadlines, does not extend to all of the dictates of the Patent Law (for details of the things that the Commissioner does not have discretion to extend deadlines, see Friedman page 172-178). In this instance, the Court of First Instance correctly noted that the Commissioner can extend deadlines before or after they pass, as stated in section 164(c), so long as he sees a reasonable justification for so doing, but the issue is not one of legal authority, but rather of the correct use of that authority. In Appeal 248/95 Fabio Perini S.P.A v. Industrie Meccaniche Alberto Consani S.P.A., Judge Winograd considered the correct interpretation of Section 164 of the Law (in the original version prior to the third amendment). The Court supported the liberal interpretation granting extensions for filing Oppositions, stating that Opposer serves the public interest and the integrity of the Register, and not merely his own interest by filing Oppositions, and the range of things that the Commissioner is allowed to extend is wide.

As ruled in the IL 110548 Opposition Shmuel Sadovski vs. Hugla Kimberly Marketing Ltd. (12 August 2010), the relevant considerations for deciding that a justification is reasonable is the extent of the delay and the explanation for it. The extent of the delay can affect not just the perceived behavior of the Applicant and whether it is reasonable, but also whether the public can be considered to have relied on that behavior.

In this instance, the Applicant first approached the committee with explanations that do not seem unreasonable. The difference between the Israel Patent Law and that in Japan and many other countries goes a long way to justify the mistake made. Indeed, the Applicant made a submission via their attorneys, prior to entering the national phase so as to address the issue as early as possible. As to third parties relying on the delay, it does not seem that this can be construed as being in any way connected to them not contacting the Patent Office prior to the lecture, as explained hereinabove.

Nevertheless, this ruling is given ex-partes at the request of the Applicant, without the public being represented, and at this stage third parties do not have standing. Third party standing will only occur if and when the patent is allowed. In light of the above, the Deputy Commissioner rules that the application can continue to examination without the prior publication in the form of the lecture acting as novelty destroying prior art, using discretion under Section 164 (b) of the law which states “The Commissioner is authorized to extend deadlines as he sees fit”.

Conclusion

The request is accepted and the deadline for informing the patent office is retroactively extended on condition that a fee be paid from the time of the publication of the Application having been filed on 27 August 2009, until the national phase entry into Israel on 6 March 2012. It is noted that the submitted notice that informed the patent office of the prior disclosure was rejected by the Examiner, and the Applicant could have appealed that decision within 30 days, so extension fees would anyway be due.

The retroactive extension is granted contingent on any Oppositions submitted after allowance being considered on their merit, with the issue of this extension being considered legitimate grounds for inter-partes challenge.

Ruling by Ms Jacqueline Bracha re Section 6 publication of IL 218495, 24 September 2017


An Attempt to Cancel Patent For Breaking GSM Standard Algorithm

September 27, 2017

GSM logoDr Elad Barkan invented or discovered a cryptology method for breaking GSM coded communications and filed a patent application on 30 April 2003 titled “Cryptanalysis Method and System”, which was awarded Israel Patent No. IL 155671 in June 2005. The method was based on the discovery of a fundamental coding flaw in the GSM protocol which caused quite a stir among both telecommunication experts and the cryptology community.

DiscoveryOn 23 June 2015, Rontal Engineering Applications 2001 Ltd applied to have the patent cancelled on various grounds including that it was a discovery and not an invention; that the supplementary tests of inventiveness were met so that there was no inventive step, and that the patent was never implemented. In a long and detailed decision, Deputy Commissioner Ms Jacqueline Bracha considered the various allegations and ruled on the validity of the patent registration.

After the statements of case and the evidence were submitted, a three-day hearing was scheduled in December 2016, and the parties then submitted written summations.

Complicating matters, during the summation stage, the Opposer, Rontal Engineering Applications 2000 Ltd, filed for bankruptcy. Dr Barkan submitted a request that Rontal Engineering post a bond for 200,000 Shekels, to pay his legal fees should he prevail against them. The Deputy Commissioner agreed with his request and a bond was posted duly on 15 July 2017.

Somewhat unusually, the ruling starts with a list of definitions of various words relating to the GSM protocol. Then the decision goes on to rule if the invention relates to patentable subject matter.  In a 46 page ruling with 165 paragraphs, the Deputy Commissioner found that the invention is patentable per se. Furthermore, the invention described is substantially different to the closest prior art so the patent was upheld.

In my conclusions at the end of this article, I conclude that the Opposers could probably have successfully obtained their real objective by negotiating a claim restriction to exclude brute force attacks which were never intended to be covered by the claims anyway.

A summary of the Decision follows.

Glossary

The patent relates to GSM encryption, and to understand the case, a number of terms need to be defined.

GSM NETWORKGSM is an acronym for Global System for Mobile Communications. It is a standard for cellular phone networks developed in 1987 and available since 1992. The standard was published before the priority date. The standard is a digital telecommunication standard and voice is digitized, transmitted and then converted back into sound. GSM is encrypted to prevent third parties from eavesdropping. The communication takes place via base stations.

Read the rest of this entry »


Exams for Wannabee Israel Patent Attorneys

September 13, 2017

The Israel Patent Office has announced the dates of the qualification exams for Israel Patent Attorneys.

Oral Bagrut PicUnless given a dispensation from one, the other, or both, each candidate has to pass a written exam that tests calligraphy and scribal errors patent drafting skills and langauge skills, and an oral exam that tests dental hygiene knowledge of IP Law, particularly but not exclusively, Israeli law.

exam paperThere are two sessions for the written exams. Those wishing to take an examination relating to computer, mechanical or electronic technologies are invited to come on Monday 27 of November 2017. Those wishing to try their hand at biology or chemistry are invited to come on Tuesday 28 November 2017.

The oral exams will be held on 20th and 21st November and candidates will be assigned specific times on registration.

The deadline for registering is one month in advance.


Employee Inventions

August 14, 2017

termination of employment 2Earlier this month, three decisions were published by the tribunal for establishing compensation for employee inventions. The tribunal consists of a judge, the Commissioner and an academic.

The legal basis for the tribunal providing compensation is Section 134 of the Israel Patent Law which states:

In the absence of an agreement that determines whether the inventor is entitled to compensation and what the compensation should be, appropriate compensation will be determined by the Committee for Compensation established under Section VI.

The three decisions follow a Supreme Court Appeal of a decision of this nature  Supreme Court 4353/14 Barzani vs. Isscar Ltd, from 8 July 2015 which makes clear that the committee’s powers are non-cognitive and the parties can come to alternative contractual arrangements. The rulings provide a good indication of how the committee sees its responsibilities, but are censored of details that could reveal the employee or the company but some general guidelines can still be drawn:

  1. If there is an agreement in place, including one for token compensation or for no compensation at all, the committee has no standing.
  2. Registering the application in the name of the company and the inventor filing assignments of the corresponding patent abroad, including for a nominal sum such as one US dollar, is not considered as an agreement and does not disqualify the inventor from receiving compensation from the committee.
  3. Clauses in the employment contract or an NDA signed by the employee whilst a consultant before starting to work on a salary basis, that state that any invention by the employee will be the property of the company do not mean that the committee has no standing and the employee will not be entitled to compensation ruled by the committee.
  4. A termination agreement signed by the employee in which he states that he does not have and will not have any claims against the company is considered a waiver of compensation.
    Unlike labour law where the labour court assumes powers to delete or amend clauses in a contract that contravene standard labour law, the compensation to inventors is dispositive and can be waived. Furthermore, the committee does not have the power to amend agreements. Once it determines that there is an agreement in place, whatever its terms, the committee no longer has any standing.
  5. Union negotiated general contracts are considered binding on the employee.
  6. Efficiency proposals and valuable discoveries are probably not service inventions

The three rulings may be found here, here  and here.