Was the 7th Amendment to the Israel Patent Law, Concerning Drug Term Extensions Unconstitutional?

November 24, 2015




Back in 2004, following corresponding legislation in the US (Hatch Waxman Act) Israel amended their Patent Law to Provide for patent term extensions with what is known as the third amendment the Israel Patent Law. This creates a regime wherein during the period of patent protection genetic players may develop synthesis routes and seek regulatory approval for genetic versions of patented drugs, and, to ensure at least 14 years of post regulatory approval sales under a monopolistic patent regime, the basic patent may be extended by up to 5 years.

The third amendment was ambiguous and in an ex-partes ruling affecting three patents in what is now known as the Novartis ruling, 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 is now the Seventh Amendment of the Israel Patent Law, to tidy up this and other ambiguities of the original amendment.

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.

The Seventh Amendment has retroactive effect.  The Patent Term Extension laws have, meanwhile, been amended again (Eleventh amendment to the Law). However, this ruling relates to the 7th amendment.

The Original Ruling of the Commissioner of Patents


Since the 7th amendment provides a shorter period of protection and since it is retroactive, the Association of Israel Industrialists appealed the original patent term extension concerning Israel Patent Number 110956 for Ezetrol, a drug that is used to lower cholesterol levels in blood. In consequence, the Current Commissioner of Patents, Asa Kling, shortened the previously granted patent term extension for of 1014 days to 496 days.

Merck appealed the Commissioner’s decision to the District Court on constitutional and other grounds and argued that the seventh amendment should either be interpreted narrowly so that property rights already granted by law cannot be rescinded, or that the Seventh amendment should be struck as unconstitutional.

Ezetrol is a drug that is used to lower cholesterol levels in blood. Israel Patent Number 110956 to Merck Sharp & Dohme Corp. (formally called Schering Corporation) is exclusively licensed to Merck & Co. Inc., whose daughter company in Israel has the rights to distribute the drug in Israel.

The Commissioner of Patents first ruled that the basic patent which was due to expire on 13 September 2014 would be extended and would expire on 23 June 2017. However, this period of 1014 days was subsequently shortened to 496 days and the drug will therefore expire on 22 January 2016. See here.

The extension itself issued under the then version of the Law (third amendment) on 22 September 2005. The commissioner’s revised ruling was based on a submission of 7 January 2013 from the Association of Israel Industrialists requesting  to shorten the extension period based on the seventh amendment of Section 64K from 2006.

64K states that the Commissioner may, on application by a person who is not the holder of the basic patent or of an exclusive license, cancel an extension order, if he concludes that there are grounds on which the grant of the extension order can be opposed; the Laws of prescription shall not apply to an application for cancellation under this section.

According to the Association of Israel Industrialists this shortening of the period of protection was legitimate since Section 22 of the amendment explicitly makes the amendment retroactively applicable.

Section 22(a) states that the instructions of the original Law, as phrased, will apply to extension requests and to extensions given before the amendment enters into effect, as long as the basic patent that was the basis of the patent term extension request is still in force. Section 22(b) notes that the above is true, however extension orders issued prior to the amendment would not lapse merely for failing to fulfill the requirements of Sections 5 or 6 of 64D of the main law, as detailed is Section 3 of this Law.

According to the Association of Israel Industrialists, since the basic patent had not lapsed when they petitioned the Commission on 7 January 2013, the Commissioner should apply the amended Law. The Commissioner accepted this argument and therefore shortened the patent term.

The patentee disagrees. They consider that since an extension was given on 22 September 2005, they had a property right for the extension period as ruled, and despite the seventh amendment, this right was inviolate for two reasons:

  1. Property is a basic constitutional right under the Basic Laws of 1980 and so it is appropriate to interpret new laws in a way that prevents retroactive cancellation of property. Applying the 7th Amendment retroactively would be unjust and would certainly destroy property, certainty, stability and fair expectations, where the patentee has relied in good faith on an extension that has already issued. Relying on the issued patent, Merck claims has resulted in their planning, development, pricing and marketing of the patent protected drug. Applying the transition rules in a way that provides retroactive protection should therefore only be allowed in other cases, where doing so does not adversely affect rights already granted.
  2. If the amendment cannot be interpreted in such a manner that it excludes retroactive application of the law to issued patents, then it should be cancelled as it is unreasonable and thus contrary to Section 8 of the Basic Law, Human Rights and Freedoms 1980, under which one does not abrogate property rights unless doing so is in accordance with the basic values of the State of Israel, has a correct purpose and is proportionate, or covered by a specific law. According to the patentee, there is no fitting purpose that would justify applying the Law retroactively, and such retroactive application is not proportionate.

The patentee further claimed that the the Seventh amendment to the Patent Law should be canceled due to inherent flaws in the legislative procedure. Specifically the patentee alleged that the Knesset members were presented with a false picture of what the current Law was and the effects of the amendment, such that the amendment was based on a flawed understanding. This allegation was thrown out, as it was not proved, and there is a working assumption that the Knesset committees are open to hear all views of relevant parties and thus there is a working assumption that final amendments are based on a proper intelligent understanding.

The patentee also claimed that under Section 17c(i) of the Knesset Law סעיף 17(ג1) לחוק הכנסת the Commissioner of Patents should have made the Knesset a party to the opposition proceedings. This claim was also thrown out based on the precedent 4550/13 Bahat vs. Ministry of Health.

During the original hearing regarding shortening the patent term, the patentee argued that since there were no special regulations for calculating patent term extensions, the Amendment should be thrown out as inapplicable. The Commissioner rejected this position claiming that the calculation does not require special regulations since the Law itself explains the method of calculation making regulations for this unnecessary and superfluous.

In addition, Merck argued that even if the Commissioner considers his hand tied and that he has to apply the seventh amendment retroactively as per Section 22, he still should not understand this to mean that the patent would lapse on 22 January 2016 instead of 23 June 2017. Merck requested application of Section 64(9)a of the Law that states that “a patent term extension will remain in force, as per 64(10) for a period equal to the shortest patent term extension granted by a country offering patent term extensions (excluding temporary extensions) from a known country” [Bolar Country – MF]. The shortest term was the 497 day extension granted by the USPTO and should be the maximum extension.However, this was granted only on 23 August 2006 and didn’t exist on 22 September 2005 when the patent term extension issued.  Nevertheless, the patentee is entitled to 14 years post regulatory approval marketing under patent conditions from the earliest approval, which was Germany on 17 October 2016 and not 22 January 2016, so even if an extension to 23 June 2017 is no longer applicable, Merck was still entitled to a patent term extension until 17 October 2016.

All the above arguments were raised in the the original hearing regarding shortening the patent term before the Commissioner of Patents who threw them all out, ruling that the patent should lapse on 22 January 2016. Citing the patent term extension in IL 83148 to Roche (13 June 2007), The Commissioner considered that any interpretation of the transitional period to cases where the patentee’s rights were not damaged would empty the legislation of meaning. Furthermore, the Commissioner cited a Supreme Court precedent relating to retroactive taxation of the findings of oil exploration, that made it clear that retroactive legislation that canceled property rights though problematic, were, nevertheless possible.

As detailed in Calne , the Commissioner considered that the 7th Amendment was carefully crafted to strike a balance between the different interests and was in accordance with the limitations of the Basic Laws, and, citing 4550/13 Bahat vs. Ministry of Health  stated that the Courts would only intervene in Knesset legislation in extreme cases, and not where the Knesset merely regulates the market and economy, and that the courts should act with restraint. Furthermore, the transitional legislation makes clear what the Knesset chose from the various available options.

The Commissioner considered that there was a lack of evidence supporting assertions of the patenteee that Knesset were unaware of the patentee’s interests when amending the Law. Furthermore, the protocols of the Knesset committee meetings from 11 October 2005, 7 November 2005 and 12 and 13 December 2005 indicate to the contrary.

Finally, arguments to use the German patent as the basis of the extension were rejected by the commissioner as this would imply applying the eleventh amendment before it was legislated.

The Appeal

the appeal

In their Statement of Appeal, Merck reiterated their arguments as previously submitted to and rejected by the Commissioner.

Judge Greenberg considers that these arguments may be variously categorized as (i) interpretation of the Law, (ii) Constitutional arguments, and (iii) technical arguments.

The Association of Israel Industrialists requested that the Commissioner’s ruling be upheld, and accused Merck of submitting a creative interpretation that did not sit with the wording of the Law, and the retroactive nature of the Law clearly applied to both procedural and substantive issues. The Seventh amendment was not a new judicial regime but merely a clarification of the Knesset’s intent regarding the third amendment. Although the eleventh amendment was not retroactive, it is clear that the seventh amendment was.

As to basing the extension of the US, it was Merck who decided to use the US as the country of record, selecting this as per the third amendment as interpreted by Axelrod, and the Commissioner was right to consider the US extension only, and not to relate to the German case.

The Ruling

After considering the submissions of the parties, Judge Greenberg concluded that the Appeal should be partially accepted. As far as the patentee’s assertion that the transition clauses of Section 22 should only be applied procedurally but that the retroactive application of the Law damaged a granted property right and should not be applied, this was unacceptable. Laws are generally expected to apply henceforward. However, this generalization can be challenged when explaining the Law. In this instance, Section 22 does not allow a from now onwards explanation since it states explicitly that the guidelines of the main law, as legislated, shall apply to pending patent term extensions and to patent term extensions that have been issued as long as the the basic patent is still in effect.

Thus it is clear that the amendment to the Law may be applied retroactively to already issued extensions. The Amendment is clear and is not open to creative interpretation.

Furthermore, Section 22b states that new considerations for granting a patent term extension could not be applied retroactively. Thus it is clear that the legislators were aware of the difference between legitimate challenges to property rights and those that were illegitimate.

This raises the issue of the legislator’s intention in the amendment. The Association of Israel Industrialists argued that the purpose of the retroactive nature was to repair the damages from the third amendment to prevent the Commissioner’s interpretation in Novartis, which the legislators considered was contract to the intention of the Law, and resulted in the 7th amendment.  The patentee disagrees and claims that the amendment had nothing to do with Novartis which was not appealed and the Association of Israel Industrialists never tool any steps to change this ruling. Rather, the Association of Israel Industrialists ran to the legislative to amend the Law, shifting the balance away from the drug developers and in favour of the generic companies it represents.

The Association of Israel Industrialists’s position in this regard is persuasive to the judge. The Appellant (patentee) has not given any alternative explanation for the retroactive effect of the amendment and so has to claim that the legislative committee was mislead. These claims of of flaws in the legislative process require some evidence which is not there. Rather, as the Association of Israel Industrialists has demonstrated, the Committee considered a wide range of perspectives from the relevant players and this leads to an assumption that the they did their job properly and the amendment is based on a full consideration of the conflicting concerns.  Consequently, the Law is exceptional in that it consciously and intentionally retroactively changes the duration of patents from their duration prior to the rule without the Appellant being able to explain this. Alternatively, one can conclude that the amendment was designed to correct a lacuna in the original amendment and the Appellant is wrong to consider this separate and independent from the Novaris case.

Thus contrary to the Appellant’s reading, the Judge refers to the words of explanation for the amendment (Proposal 187 from 5 July 2005, page 1002 which states that “The proposed legislation is designed primarily to to clarify issues that were raised in applying the Law concerning patent term extensions and the conditions for applying for them, and for the way of calculating the extension and when it terminates”.

Thus it is clear that the Extension was designed to clarify the way extensions were calculated and not to create a new calculation that contradicted that of Section 3. The Section 7 amendment was  did not relate to Novartis, it was only related to in the decision, only in the poorly worded Law itself, which led to the explanation given in the Novartis ruling.

Had the legislators had the skill to word the third amendment correctly to reflect their intention, as they did in the 7th amendment), the Novartis ruling would never have issued, and the law would have remained as it was.

This leads to two conclusions. Firstly, as far as explaining the Law is concerned, it is clear that the law should be interpreted such that the transition clauses are as stated and that the Legislators intended the calculation as stated in the 7th amendment, for previously extended cases as well because the purpose of the amendment was to correct them. Secondly, in the constitutional area, one can conclude that the amendment is in accordance with the limitations of Section 8 of the Basic Law Human Dignity and Freedom, since the retroactive application is proportional. This is also clear from the three tests that the courts use to review the proportionality of laws, and are appropriate in the case in question that relates to the transition period. See Supreme Court Appeal 1715/97 The Investment Agency of Israel vs. the Minister of Finance, P.d. 51 (4) 367 (1997), page 407.

The relevant law is Section 64(xi)a which states that  the extension will remain in effect as per section 10(x) for at least the shortest of the extension periods given for the basic patent, apart from temporary rulings where necessary.

The judge noted that according to the commissioner and to the respondent, once it is clear that the extension given in the US is the shortest extension,despite it issuing a year after the patent term extension, it is, nevertheless, the shortest extension. Whilst this interpretation is in accordance with the terminology of the Law which specifies the shortest extension without relating to when it issues, this interpretation means that a later decision can shorten an extension that has already issued.  Judge Ben-Zion Greenberger considered this interpretation untenable since it would make all patent terms unknown and would leave things open making it impossible for companies to plan.

Judge Greenberger also considers the extension granted in the US under the third amendment should not be applicable to the Seventh amendment in Israel since the proceeding is different, the rules for calculation are different. The Opposer of the extension does not need to search for the shortest period issued, as per the Commissioner’s ruling in the Novartis case.

On the basis of the above, the Commissioner’s reliance on the US patent to retroactively amend the Extension period was wrong since at the time of the application, it did not exist. Once the US extension is not considered, then there is consensus that the next shortest period was that issued in Germany. Judge Greenberger therefore restored the extension period to 17 October 2016 and ruled 25000 Shekels costs to the patentee.

Appeal against Commissioner of Patents Decision Concerning the Patent Term Extension for IL 110956  for Ezetrol, 10 November 2015.


Although retroactive legislation is problematic and uncommon. It does happen. The change in the Patent Law to allow internet publication of the journal is an example of retroactive legislation.

Interestingly, the Talmud recognizes this legal creation as הפקר בית דין הפקר, that a court can cancel property rights. It may be used to retroactively annul a wedding by making retroactively removing the ring given by the groom to the bride from the groom’s property.

The patentee’s argument is based on the assumption that a patent is a property right and that patent term extensions are therefore somehow inviolate. I disagree. I think that patents are, by their nature, intrinsically uncertain. They can be voided due to prior art at any time after they issue. When patent term extensions came into effect, they were applied to pending patents and to issued patents that were already in force. They granted an additional period of protection to companies that had priced their drugs without knowing that this would happen. Patent term extensions are already exceptions. It was clear to all parties that the Law was flexible and depended on the international agreements. Patent term extensions are thus exceptions to a rule that tries to find a fair balance between competing rights. Since the amendment was supposed to ensure that Israel manufacturers were not disadvantaged when compared to their foreign counterparts, the amendment was knowingly and willingly legislated so as not to disadvantage Israel manufacturers. There is nothing final about patent term extensions.

Achieving a partial success and using the German patent instead of the US one as the basis for the patent term extension was an achievement. Nevertheless, we suspect that this ruling will be appealed to the Supreme Court.

When Different Applicants Request Patent Term Extensions (PTEs) For Different Patents Based on a Common Patent and Regulatory Approval

October 26, 2015


A semi-official version of the Israel Patent Law 1967 as currently amended is found on WIPO’s website. There have been three amendments of the Section of the Law that relates to Patent Term Extensions which is found in Sections 64a-64q, some of the letters relating to sections that have been repealed.  The last amendment was in 2014 and so there are some clauses that have not been explained by a court. Due to the enormous value of even very short extensions, there have been a number of applications for Patent Term Extensions which have raised interesting questions.

This Ruling concerns patent term extensions for four separate patents having different applicants. The patents are IL 159512, IL 127115 and IL 130492 and pending application number IL 132304 to Immunex, Daiichi Sankyo, Amgen and Amgen Freemont, and Amgen respectively.

All the requests are based on a patent term extension for Prolia which has the active ingredient Denosumab. The drug is designed to strengthen bones and is prescribed for women with postmenopausal osteoporosis.

The four separate applications for patent term extensions were all filed on 1 September 2011 by Reinhold Cohen representing the different applicants.  The patent term extension requests for IL 127115 and IL 130492 fall under the regime of Section 16b1 of the Eleventh amendment which sets out the transition period and requires the Commissioner to complete examining pending patent term extensions within two years of the patent issuing or within two years of the amendment coming into effect, whichever is later.

The time-frame of IL 15912 is in accordance with Section 64O as will IL 132304 should it issue.

On 22 January 2015 the applicants challenged the Examiner’s ruling under Section 161. In brief, the Applicants rejected suspending considering the patent term extension requests for IL 127115 and IL 130492 until after IL 15912 issues or until 27 January 2016.

The commissioner issued an interim ruling in accordance with Regulation 151 that states that: where different applicants request a patent term extension based on the first patent to issue for a specific active ingredient, each request will be examined on its merits until the Commissioner publishes one of these rulings after examination on the merits. Based on a comparison to Section 9 of the Patent Law, where two or more applicants request a patent extension based on the same earlier regulatory approval, the first to file takes precedence where there are no other extraneous circumstances to cause a different application to be preferred. The commissioner does not consider that in a case where different applicants come to an understanding and co-file requests for patent term extensions, he should in any way be bound to go along with them. That said, as the Applicants noted, since one or more patent applications may be rejected, it is reasonable to suspend requests for a patent term extension of later filed applications until one case is granted an extension. Essentially therefore, applications will be examined in turn according to their filing date.

The Applicants of 127115 and 130492 requested a hearing to discuss the above ruling which was held at the end of June 2015, and as a result of this, the examination of these patent term extension requests were suspended. In June 2015 the applicants filed their summaries and a hearing was scheduled. Due to this procedural delay, the requests for Patent Term Extensions of 127115 and 130492 are still pending. In the meantime, Application 159512 has issued and IL132304 has been allowed and published for opposition purposes.

In April 2015 the Applicants noted that a patent term extension was granted in the United states for US 6,740,522 to Immunex titled “Antibodies against ligand for receptoractivator of NF-kB” which relates to Prolia. Amgen and Amgen Freemont were then informed by the patent office that since the US patent as extended still lapses before the Israel issued patent for IL 15912 even without an extension, their application is moot. The applicants requested further suspending ruling on the patent term extension until IL 132304 is allowed. The Commissioner would rather examine the first case until allowance, making examining the other cases moot.

The Applicants’ supported their request with the following argument:

Until a patent term extension issues, none of the applicants should be restricted in any way. The only reason given in Section 64D for not granting a patent term extension is that one has already been given based on the basic patent and regulatory approval for the active ingredient. If this has not yet happened, all applications for patent term extensions are legitimate.
Thus a number of statements of intent to grant patent term extensions all based on the same regulatory approval of the same basic patent can issue.
The Applicants cited the patent term extension granted in 83148 to Roche Diagnostics GmbH and to IL 120701 to Wyeth to the effect that the rights to a patent term extension come into effect with it issuing.
According to the Applicants, Section 64D(4) relates to granting an Extension and should not be applied to intentions to grant.  A statement of intent to issue a patent term extension is not the same as a patent term extension order. It is not inconceivable that several statements of intent for different patents could issue. Textual support that a ‘patent term extension order’ and ‘intent to issue a patent term extension’ are not the same thing is found in Section 64L which relates to the lapsing of a ‘patent term extension order’ or an ‘intent to issue a patent term extension’ thereby making clear that these are not the same thing.
As Section 64L and Section 64K(3) teach, an ‘intent to issue a patent term extension’ can lapse, thereby indicating that this may happen prior to an actual order issuing. This indicates that the legislation should certainly have related to any intention to issue other patent term extensions than the one pending publication of the intent to issue. As detailed below, this need does not occur in Section 64D(4) of the law which relates to conditions for not granting an earlier order.
The Commissioner does not consider that the publication of several Intents to Grant Patent Term Extensions can help the Commissioner apply Section 64D(4) of the law, which does not allow granting an Extension for a drug based on an active ingredient that has been previously used as a basis of a patent term extension. The Commissioner understands Section 64D(4) as requiring publication of a single intention, thereby being clear to the public.
The Applicant’s understanding that the patent office should publishing several intentions for several drugs does not address the fact that eventually only one will be allowed. Consequently this will simply sow seeds of doubt. The term intent means real intent for a single application for a single patent term extension.
Section 64E relates to additional publications concerning the progress of a particular application. The applicants don’t believe that the final publication is indeed a final publication as future patent term extensions from other countries could change this.

The Commissioner does not consider such readings reasonable. According to the Commissioner, the Eleventh amendment which included Section 64E creates a split opposition proceeding such that the Section 64EE(1) publication demonstrates that the Application fulfils the basic requirements for which it was granted, and separates the calculation of the term for separate opposition. In this regard, section 64G(2) relates to the later opposition that only relates to the duration of the Extension and cannot be used to challenge the Extension on grounds appropriate to Section 64EE(1). Thus without a prior opposition under Section 64EE(1) the register remains clearer.

The Applicants understanding could result in the commissioner having to publish a string of notices and this will create a lack of clarity. This is not merely theoretical. US 6,740,522 and two other patents were cited as the basic patent in the patent term extensions applications for IL 15912 and IL 130492. Thus patent will lapse on 17 September 2021 which is after the natural life of IL 15912

The applicants consider that publishing an intention to grant an extension for one patent prejudices other patents behind it in the queue. The Commissioner rejects this assertion as it is the same for all publications. In other words, where two patent applications claim substantially the same invention, the first one filed is examined and the examination of later filed ones are suspended. Should the first one be withdrawn or canceled, the second one is examined on its merits.
Were IL 132304 to be eligible for a patent term extension, or even were it to be opposed, the two year period provided for in the eleventh amendment could not be met.

In summary, the Commissioner is not convinced that there is any reason to suspend the request for a patent term extension for the ‘115 and ‘492 cases until the ‘304 case issues if it ever does, and so his earlier ruling stands. The applicants of IL 15912, IL 127115 and IL 130492 are given 60 days to respond to the office actions listing missing information.


This was an imaginative submission. I think that on balance, the commissioner’s interpretation of the Law is better.
I am not sure how one firm of patent attorneys can represent four different applicants in a race to receive a Patent Term Extension PTE based on the same earlier regulatory approval. To some extent the drugs in question may compete with each other. Even if they don’t compete for treating the same illness, only one patent will be entitled to a patent term extension. It seems, therefore, that Reinhold Cohen has a conflict of interest here. No doubt, they understand conflicts of interest differently from me as well.

Religious Perspectives on Intellectual Property

September 10, 2015

The bishop's gambit

My talk was part of the opening plenum titled Religious Perspectives on Intellectual Property. The chairperson and other speakers were a Bishop, an Archbishop and a Cardinal. We all wore similar charcoal suits, but whereas I wore a white shirt and regular tie, rather like the sort of thing I’d have worn to Synagogue in the UK, the others wore black shirts and dog collars. I felt a little like a bagel at Mass, although everyone was very friendly.

The plenum was chaired by the Rt Rev John Sherrington, Auxiliary Bishop of Westminster, Department of Christian Responsibility, The Catholic Bishops’ Conference of England & Wales’. Right Reverend Sherrington is a delightful chap that I could imagine spending a happy evening with in a pub. He wore the largest Crucifix I’ve seen around someone’s neck outside a vampire movie. Apparently, the cross is worn opposite the heart and a ring, symbolizing marriage to the church, is worn on the finger. I reflected that Judaism has bondage style black strapped phylacteries (Tefillin) that hold the paragraphs of the first and second paragraphs of the Shema (dealing with Unity of God and reward and punishment in the Promised Land) and other texts in a box worn on the triceps opposite the hand, and the strap is wrapped seven times round the forearm and then thrice around the finger, symbolizing past, present and future as a sort of eternity ring, whilst reciting Hosea 2: 21 “And I will betroth thee unto Me forever; yea, I will betroth thee unto Me in righteousness, and in justice, and in lovingkindness, and in compassion.” Although the symbol is different, the symbolism is the same.

His Eminence Archbishop Silvano M. Tomasi, Apostolic Nuncio: Permanent Observer of the Holy See to the UN Office in Geneva & WTO spoke on “The contribution of the Holy See to the Intellectual Property debate at the multilateral level”. This was followed by a talk titled “IP Rights and the Fundamental Right to the Commons in the Light of Catholic Social Teaching” by Monsigneur Osvaldo Neves de Almeida, Holy See Secretariat of State, with responsibility for TRIPs (WTO), UNCTAD and formerly for WIPO.

Archbishop Tomasi spoke very well, but didn’t say anything substantive. There was nothing notably Catholic about it. No scriptural references. There was a lot of pontification about respecting patents and copyright as private property whilst finding a balance with the common good and the importance of feeding the poor. The overall effect was somewhat similar to what might happen if an eminent Rabbi were to be asked to address a mixed faith academic conference. As I pointed out in the subsequent discussion, IP Law attempts to do just that but providing geographical and time limited monopolies and fair use clauses. It seemed to me that either the Catholic Church’s representation at WIPO has no effect, or, the various international treaties governing IP resulted from Catholic teaching.

Monsigneur Osvaldo Neves de Almeida’s talk was more interesting. He gave the impression of having more specific knowledge regarding both ethical issues relating to IP, and the church’ position. However, his English, though far superior to my Latin, was nevertheless not great. I think there is a problem that Catholic Bishops are conformists. One cannot expect two bishops to assume different positions, or a third bishop chairing the event, to ask a challenging question. Also, like most Rabbis, it seems that bishops don’t feel the need to use slides. Unlike many Rabbis, they also don’t seem to use parables or jokes to try to engage the audience.

I was afraid that the audience were quietly phasing out, and when I took the podium I decided to wake them. I asked for a quick show of hands to determine which members of the audience were theologians, which were academics and which were patent practitioners.

Vicars and Tarts  see also BBC REV! Series 1 Episode 6.

I then stated that if, instead of a serious, erudite and formal conference, this was a ‘Vicars and Tarts party’ and, after, about two minutes, when the laughter had died down enough to finish the sentence, I noted that I’d have come along as a tart, since I, like other patent attorneys, was an Intellectual Prostitute in that I used my skills to provide services to anyone willing to pay and that I don’t have any professional morals, or at least very few.
I spoke on “Patents, Life and Social Justice: Musings of a Mosaic Maven”. I started with noting that the classic sources such as the Bible, the Talmud and Responsa literature have a lot to say about life and about social justice. However, since patents have only been around since towards the end of the 18th century, there was nothing about patents, and thus nothing about life, patents and social justice. However, I discussed a fascinating anecdote brought in the Babylonian Talmud (Avoda Zara 28a) that relates to life, trade secrets and social justice:
We have a Tradition:
Rabbi Yohanan* suffered from scurvy#. He went to a Roman matron on Thursday and
again on Friday, and received some medicine for his gums. He asked her what he should do the
following day [Shabbat], and she told him that he was cured. He asked for details of the treatment and swore to the God of Israel that he would keep her secret. She told him the treatment. The following day at the beginning of his Sermon, Rabbi Yohanan announced the treatment.

Question – but he’d promised her. Answer, he’d already told her that it wasn’t a real
Question, but he’d swore on the God of Israel. Answer, not exactly. He’d swore to
the God of Israel, i.e. not to reveal to God [who knows all things anyway, but hadn’t
sworn not to tell people.
Question, but it is a Hillul Hashem – a desecration of the Divine Name. [this is the typical term applied to Jews behaving badly in front of non-Jews]. Answer, he told her that he’d break his promise.
Said R. Nahman b. Isaac: Scurvy is different, because although starting in the mouth it extends to the intestines.

Babylonian Talmud Avoda Zara 28a
*180 – 280 C.E. Tzipori (Galilee, Israel – the cure evidently worked as Rabbi Yoachanan lived 100 years!
# Tsadfina – Greek Sӗpedόn (putrid abscess), related to sӗptikόs (Latin, Septicus → septic

Rabbi Nahman b. Isaac’s explanation is that since scurvy is a fatal disease, the common good reflecting the right to know, outweighed confidentiality and the personal property rights of the Roman matron.

I then discussed the political, historical and theological ramifications of the Weizmann patent, a fairly insignificant 135 line document that described using bacteria to make acetone and butanol. Acetone helped the British synthesize explosives and was very significant in the British War Effort in World War I and butanol enabled the US to make butadiene for artificial rubber in the World War II. Amongst other ramifications, Weizmann’s influence, resulting from the patent, was instrumental in securing the Balfour Declaration and US recognition of the State of Israel, an event that I suggested had theological ramifications for Christians. Having run out of time, I skipped to recent cases and concluded that most controversial issues concerning life science patents, such as BRAC gene patenting, patent term extensions for medicines and the like, were really issues concerning whether or not one believed in capitalism. The main exception is stem cell research which is not patentable subject matter in Europe following Catholic pressure, since Catholics see life as starting with conception. Judaism sees life as starting at 40 days, when membranes form, which, a bio-ethicist explained to me actually comes from Aristotle. That as may be, in Israel, there is no opposition to stem cell research from Rabbis or from religious parties. One hopes that if any treatments result, that Catholics and other Christian groups with similar beliefs will be prepared to use the treatments and won’t see them as being the fruit from the poisoned tree. The full 11,000 word paper will be published shortly.

Over coffee (accompanied by Walkers biscuits with have a (U)D Kosher Certification) a Catholic professor quoted Milton Friedman to the effect that companies’ only purpose is to make money, and disagreed with bishops seeing companies as having a responsibility towards the third world. I am aware that there are dissenters to Friedman’s position, but don’t think that companies have moral or religious duties, only people do.

It occurred to me that none of the senior Catholic clergymen could have made the Vicars and Tarts joke. Furthermore, due to Papal infallibility, the Auxiliary Bishop chairing the plenum could not challenge the Archbishop or the Cardinal.
Afterwards, I had some other realizations that were more disturbing. It seems that due to a combination of factors such as recent pedophilia scandals, the secular mainstream and the fact that Catholicism is a minority faith in the UK, even bishops are unable to preach. All three steered clear of concepts such as God, faith or religious duty.

To put it another way, the previous evening I’d seen the ABBA juke-box musical Mama Mia in the West End. The story line is about 20-year-old Sophie who is preparing to marry her fiancé. She wants her father to walk her down the aisle but does not know who he is since her Mother Donna had had intimate relations with three men. As a pregnant single woman, she’d been thrown out of the house. Sophie wanted to get married so that her children would know who their father was. One of the candidates was homosexual. One had stayed faithfully married to a women he didn’t love. Donna’s girlfriend was twice divorced. In other words, the musical had more to say about personal life choices than either of the bishops’ lectures.

Disturbingly, Monsigneur Osvaldo Neves de Almeida mentioned the three transcendental religions, Catholicism, Islam and Judaism. I realized that as a Jew, I was acceptable to be on a panel with them, however, the Presbyterians, Anglicans, Evangelicals and others in the audience were not. I had had similar issues at the event I arranged in 2011. I was blocked from having non-Orthodox professors presenting.

Novartis – Double Patenting in Israel

July 1, 2015


The present ruling relates to the issue of identical of overlapping patents and patent applications, and examines the ramifications of double patenting in Israel.

IL 2039732 is a Divisional Application of IL 176831 titled “Compressed Pharmaceutical Tablets or Direct Compression Pharmaceutical Tablets Comprising DRR-IV Inhibitor Containing Particles and Processes for their Preparation”.  During prosecution it received a final rejection and the Applicant, Novartis, appealed this final Examiner’s rejection.

The Examiner considered that the claims of the parent and the divisional application are directed to the same invention. After this issue was first raised, the Applicant amended the claims, but the Examiner considered that the amended claim set (claims 1-23) covered the same invention as claims 23-26 of the parent application. Based on 5293/93 Welcome Foundation vs. Patent Commissioner (1993), the Examiner rejected the claims of the divisional application. A telephone conversation was to no avail. The Examiner issued a final rejection noting that there were substantive issues not addressed, and the Applicant appealed this decision to the Commissioner of Patents claiming that the issue is one of interpretation of the Law.

The Commissioner held a hearing and allowed the Applicant to present a short summary of the comparative law in US, Europe, Australia, Japan, China and India. In this instance, the Examiner did not claim that the divisional had identical claims to the parent application, but that there was some overlap. According to the Commissioner, the issue is one of interpretation of Sections 2, 8 and 9 of the law. These state that an inventor is entitled to a patent, that a patent can only cover one invention and that where two or more applicants file for the same invention, the first to file is awarded the patent. The purpose of divisional applications is to prosecute additional inventions claimed within the same parent application.

In the Welcome case, claims 1-10 related to uses of a pharmaceutical preparation in the treatment of various diseases and claim 15 related to a method of preparation of the active ingredient.  Then Commissioner, the late Michael Ophir ruled a claim for use in preparing a medicament’ and ‘use in the treatment of’ were identical. He did not see that the application related to more than one invention. On appeal, Judge Winograd ruled that one can file and prosecution an application for a material, a second one for the method of fabrication and a third one for uses, provided each application is directed to patentable subject matter and there is no overlap between the cases. There Judge Winograd went on to rule that one application cannot include more than one patentable invention, i.e. one should not award more than one patent for one invention, and this is a corollary of Section 8 that a patent should cover one invention. One can file a plurality of applications for a plurality of related patents provided that each one is directed to a patentable invention and the claims are not identical or overlapping.

In the present case, both the parent IL 176831 and the divisional application IL 203972 have the same title. In IL 203972 there is one independent claim. Claims 23 and 24 of the parent IL 176831 each depend on claim 1, and claims 25 and 26 are dependent on claims 24 and 23 respectively.

The independent claim of IL 203972 is directed to using a powder to form a pill for treating a wide range of ailments. Claims 23-26 of the parent IL 176831 are directed to forming tablets and a corresponding process. The divisional relates to various states that are not in the parent application, but both applications have the same specification. According to the Applicant, the parameters are identical but the parent claims the process whereas the divisional application claims use of the active ingredient to prepare a pharmaceutical.

According to the Examiner, the divisional application claims the use of a formulation for treating a disease, where the formulation is given in claims 23-26 and the diseases treated are listed in claims 1-22. In both cases, the formulation is the same, the particle size is the same and the active ingredients and additives are the same as those given in claims 23-26 of the parent.

Novatis found the Welcome decision poorly claimed and poorly reasoned and could not see why two applications could not claim identical or overlapping inventions. They argued that where applicants are the same, there is no need to relate to identical or significantly overlapping claims, holding that the Israel Patent Law does not prevent multiple patenting. Novartis argued that Section 2 is merely a declarative statement that the applicant may file a patent. It does not have legal ramifications, and certainly does not limit the number of patents that the applicant may file. Section 2 does include the word “one” and it should not be read into the claim such that one patent may be requested for one invention. Support for this interpretation is found by contrast to Section 9 which relates to different applicants with patent applications for the same invention.

The parties are in agreement that different applicants cannot be awarded separate patents for the same invention. Novartis holds that the same applicant can be awarded two or more patents for the same invention. The Examiner disagrees. Novartis accepts that there is no economical justification or logic in an applicant having more than one patent, and even sees this behavior as unacceptable. However, so long as there is some difference between the two patents, it is legitimate to award the protection of both patents.

The Commissioner upheld the Examiner’s conclusion and ruled that so long as there is nothing in claim 1 of the divisional that exceeds the scope of the claims of the parent, there is no reason to allow the divisional.


In the US, the issue of double patenting is dealt with by filing a terminal disclaimer. Although this procedure prevents extending a term of protection (sometimes called ever-greening), it still has negative ramifications. Third-parties such as an alleged infringer may have to show that he is not infringing a number of overlapping patents. Likewise, a competitor may have to show a number of similar patents are invalid or not infringed. This places an unnecessary burden on third parties.

I think that although Novartis is correct that the Law does not explicitly prohibit multiple patents for the same invention, the Commissioner is correct that not to allow it is a reasonable interpretation of the intention and spirit of the law. Because of the large sums of money involved with pharmaceutical patents, this decision may well end up being appealed to the courts. If that happens, we will see how the Israel courts consider double patenting.

Impotent Appellant Has No Standing

July 1, 2015

class action  no standing

This ruling relates to a Class Action filed in bad faith. The court ruled that when Applicant challenges the validity of claims made for a formulation, failure by the Applicant to take the formulation during the minimal period prescribed by the manufacturer, is sufficient to cancel the standing of the Appellant as representing the class in a Class Action.

The Appellant purchased a formulation intended to strengthen the male libido. Prior to the Appellant finishing the prescribed course of treatment detailed in the accompanying literature and as explained by the Supplier’s Helpline, the Appellant filed suit with the District Court claiming that the product is misleading, and requested that the case be considered as a Class Action. However, the District Court refused to see this as a class action since the Appellant had no standing, and therefore could not represent the class.

Supreme Justice Danziger upheld the decision of the lower court without awarding costs to either party, and added that the need to test that the plaintiff behaves equitably is anchored in Section 8(a)4 of the Class Action Law. The ruling of this court does not indicate a general ruling of what is considered equitable behavior as far as Class Actions are concerned. In one case Inequitable behavior occurs when a case is filed due to false motivation, such as an intent to damage a competitor or to “squeeze a compromise”. In other instances, the mere fact that a plaintiff is acting commercially, looking to profit from the Class Action does not, in and of itself, indicate that he is behaving inequitably, however the plaintiff has to behave equitably during the hearing. This is particularly important in cases where the plaintiff wishes to represent a class of consumers and not merely himself and when a lawyer solicits plaintiffs for a Class Action.

In this instance, the District Court has determined, from the evidence before it, that the Appellant:

  • recorded conversations with the service hotline of the vendor
  • did not read the accompanying literature, tried the formulation for too short a period in direct contradiction of the instructions that he received with the formulation
  • contacted a lawyer prior to finishing the course; filed suite 5 days after stopping the treatment
  • via his attorney, submitted advertisements that were not related to his decision to take the treatment

These facts resulted in the District Court concluding that the plaintiff did not have standing in his own right and could therefore not represent the class of men with impotence issues.

The Court concluded that the circumstances indicate that this is a rare case of someone initiating a Class Action inequitably, and contrary to Section 8(a)(4) of the Law. This conclusion is not based on the motive of the plaintiff, for one may be motivated by material gain, but by the inequitable behavior determined by the District Court. Simply not going the full course indicated by the manufacturer is sufficient to make the Appellant not appropriate to represent the class.

Oddly, and perhaps not inappropriately, this case was heard by three male judges, who agreed unanimously with the verdict.

4534/14 Appeal to Supreme Court, Eli Daniel vs. Direct Nature LTD

The Appellant, Eli Daniel, may not have had to pay compensation or costs, but, due to his actions, has entered the Israel legal text-books as having erectile dysfunction. Not the end of the world.

From discussions with pharmacist clients over the years I understand that the efficiency of all medicines, both classical and alternative (where there are active ingredients, as opposed to homeopathy) work to a greater or lesser extent in different patients due to personal physiology. A class of one is hardly a representative sample to test the efficiency of a treatment. There is a well documented placebo effect and presumably this works in both directions, so a patient lacking belief in a treatment is unlikely to see positive results. I assume that not everyone reacts the same way to aphrodisiacs, and there are large number of foods that are attributed as having both aphrodisiac and libido dampening effects. Apparently, patients taking classical medical treatment for erectile dysfunction still need to feel aroused, and taking the medicine alone has no effect.  I therefore wonder whether the treatment in question works some of the time and for some men. Certainly, there is no indication in this class action that this is not the case.

IL 142809 to Pharmacia Successfully Opposed by Teva Pharmaceuticals

March 18, 2015

R&R          R&R2

IL 142809 to Pharmacia AB was submitted on 25 April 2001 as a national phase entry of PCT/SE/99/02052 “NEW CONTROLLED RELEASE BEAD, A METHOD OF PRODUCING THE SAME AND MULTIPLE UNIT FORMULATION COMPRISING IT”. This published as WO 0027364 on 11 November 1999. The application claims priority from another PCT application filed a year earlier.
On allowance in 2006, the patent published for opposition purposes and on 18 May 2006 Teva filed an Opposition, submitting a detailed statement of case on 18 October 2006. On 12 march 2007 Pharmacia filed a counter-statement. Both sides submitted evidence, held a hearing before then Deputy Commissioner Noah Shalev Shmulovich and then filed their summaries.

As per regulation 202a, the current commissioner, Asa Kling ruled on the opposition based on the material of record.

The application is directed to a bead with controlled release of active ingredients, a method of manufacture and a multi-part formulation that includes the active ingredients. Essentially, the bead comprises a multilayer structure that includes a soluble core covered with non-soluble coatings, and the patent has 23 claims, two of which are independent.

Claim 1 is as follows:

 A controlled release bead comprising:
A core unit of a substantially water-soluble or water-swellable inert material;
A first layer on the core unit of a substantially water-insoluble polymer;
A second layer covering the first layer and containing an active ingredient; and
A third layer of polymer on the second layer effective for controlled release of the active ingredient,
Wherein said first layer is adapted to control water penetration into the core.

Claims 2-7 recite the various lawyers and their formulations and thicknesses. Claim 8 is a Markush claim for various active ingredients. Claims 9and 10 claim different forms of the active ingredient. Claim 10 claims use in vitro. Claims 11-14 claim different materials for the first three coatings. Claim 15 provides dimensions for the core and claims 16 and 17 claim multidose structures.

Claim 18 recites a corresponding method as follows:

 A method of producing a controlled release bead, which method comprises the steps of:
providing a core unit of a substantially water-soluble or water swellable material;
applying a first layer of a substantially water-insoluble polymer to said core;
applying onto said first layer, a second layer comprising an active ingredient and optionally a polymer binder; and
applying onto said second layer, a third polymer layer effective for controlled release of the active ingredient;
Wherein the amount of material in said first is selected to provide a layer thickness that permits control of water penetration into the core.

Claims 19, 21 and 23 claim use of the bead for a treatment for various diseases and claims `19 and 21 claim the active ingredient as tolderene or a salt thereof.

Grounds for Opposition
The opposition was based on lack of inventive step (obviousness) under section 5 of the Israel Patent Law 1967. In addition, Teva claimed that some of the claims lack utility contrary to Section 3, that some of the claims lack support from the specification in contravention to Section 13 and the Application is laconic and contravenes Section 12.
Pharmacia argued that claiming that the specification was laconic was an inadmissible widening of the Statement of Case, but the Commissioner, Asa Kling felt that the alleged inadequacy of the specification was inherent in the Statement of Case and that Pharmacia related to the issue so he considered it admissible.
As to inventive step, the Commissioner explained that if at the time of filing, the claimed invention was a simple extrapolation that could be considered as a simple development within the field and allowing a patent for it would prevent progress, it would be incorrect to allow a patent.
The Commissioner noted that both sides accepted that beads allowing controlled release of active ingredients that comprised a miscible or non-miscible core, a sealcoat, layers of active ingredients and additional layers were known at the filing date. The sealcoat serves to protect the active ingredient from reaction with the core and may be water impervious or slightly pervious. In the present invention such water penetration was controlled but in the prior art it was less controlled.

Not that kind of seal coat

Not that kind of seal coat

The present invention differs from the prior art in two ways: (i) the sealcoat is miscible in the prior art but is immiscible in the present invention, and (ii) the seal coat of the present invention is rather thicker than usual, but the thickness is not mentioned in the claim-set.

Teva argued that since the core in this case is impervious the sealcoat is superfluous and non-functional and there is no effective difference from the core of the present invention and that of the prior art.

Teva argued that in the priority document this was stated explicitly:

“Each bead comprises (i) a core unit of a water-soluble, water-swellable or water-insoluble inert material (having a size of about 0.05 to 2 about 2 mm), such as e.g. a sucrose sphere; (ii) a first layer on the core of a substantially water-insoluble (often hydrophilic) polymer (this layer may be omitted in the case of an insoluble core, such as e.g. of silicon dioxide), (iii) a second layer of a water-soluble polymer having an active ingredient dissolved or dispersed therein, and (iv) a third polymer layer effective for controlled release of the active ingredient (e.g. a water-insoluble polymer in combination with a water-soluble polymer)”. (WO0012069 page 6 line 33 to page 7 line 6). This point was also clear from US 6,770,295 to the same applicants.

The Applicant countered that the opposer’s explanation of the phrase “control water penetration into the core” was a misrepresentation and the correct explanation is found on page 2 lines 23-25 of the Application and only rates to beads wherein the water penetration to the core is impeded in a controlled manner and excludes beads where the core is protected by an impervious layer. The Applicant argued that the claim of lack of inventive step was based on this wrong interpretation.  In contradistinction to immiscible cores of the prior art in the present invention the core is miscible and is protected by a partial barrier sealcoat which allows controlled release.
The applicant could not explain the working of the sealcoat and how it inhibited release of the active ingredient but argued that the phenomenon exists and this is sufficient for both enablement and inventive step.
It seems therefore, that the key question is whether an immiscible core or a miscible core protected by an immiscible coating are equivalent or if a miscible core protected by an immiscible coating can be considered inventive over an immiscible core. Citing 345/87 Hughes Aircraft vs. State of Israel, it is accepted that a mere scintilla of invention is sufficient, and the question is whether this exists in the present case.

Teva argued that the utility was not demonstrated in contravention of Section 3 which allows patents for inventions that are new, useful, industrially applicable and non-obvious.
In oppositions, the onus is on the applicant to show utility. Citing 665/84 Sanofi vs, Unipharm the commissioner stated that the application as field has to provide a basis for utility and, if challenged, the Applicant has to prove utility during opposition proceedings. IN enforcement and cancellation proceedings the burden of proof switches and the challenger has to show a lack of utility. Consequently, the Commissioner ruled that without proof of usefulness a patent should not be granted.

According to the Specification, there are three advantages:

  • The claimed bead prevents the soluble core from serving as a reservoir of the active ingredient and extending the controlled release period
  • It reduces the likelihood of the core material releasing active ingredients and reduces the atmospheric pressure (specific vapour pressure?) and prevents the core from swelling
  • It reduces the initial phase during which there is no release of the active ingredient or only minimal release

According to the applicant these advantages transcend specific active ingredients.

The Opposer argued that these advantages are claimed for the specific active ingredient and for other non-specified active ingredients without any rationale or evidence.

The evidence from each side consisted of expert opinions. Teva produced an expert opinion from Professor Golomb, and Pharmacia releid on expert opinions from Professor Wilson and from a Professor Walther who attempted to reproduce the experiments described in the application.
Professor Walther conducted a number of experiments to demonstrate that claimed in the first example for different active biological compounds. These, together with raw data were appended to Professor Walther’s affidavit at the Commissioner’s request.
There were differences between the raw data and the final conclusions with regard to what active species showed the desired effects and whether a heat treatment affected the results. The Commissioner felt that the discrepancies required explanation.
The Applicant claimed that Tolterodine exhibited the desired behavior, as did Reboxetine and cona, theopheylline and Carbamazepine. This was held sufficient to show that the behavior was a general phenomenon.
The tests related to a core with three coatings whereas the specification proposed a fourth optional coating. This, together with other discrepancies were considered to show light on the utility.
The thick initial layer did show slow release of the Tolterodine in a manner that was close to linear.
In the Application, after three hours some 70% of the active ingredient ws released, but in Dr Walther’s corroborative experiments, after this time lapse, only 43% of the active ingredient had been released.
When comparing Professor Walther’s results with the experiments in the specification it appears that the applicant had problems repeating their own experiments. The problem seems to be that Professor Walther simplified the experimental design and still could not achieve meaningful results. He was able to show that a thicker coating impeded release of the active ingredient but not in a qualifiable and repeatable manner.
As far as Tolterodine, the preferred active ingredient was concerned, Professor Walther was unable to show a correlation between thickness and the rate of release and was unable to repeat the examples in the Application. The Commissioner considered the lack of repeatability an reproducibility as undermining the claimed utility and barring the issuance of a patent.
Adequacy of the Specification
Section 12 requires that the specification be adequate to allow persons of the art to implement the invention. The rationale for granting a patent is in exchange for teaching something useful and failure to teach something sufficiently to allow the teaching to be repeated is considered as invalidating the application: “The sufficiency of a specification is a question of fact and necessarily depends upon the nature of the invention and attributes of the skilled person.” ( Hollister [1993] R.P.C. 7 para. 10-14). In this instance, the purpose of the patent as specified in the priority document was to enable the controlled release of the active ingredient at a predetermined rate over the shelf life of the product.
“An important aspect of all controlled release dosage forms relates to the need for consistent drug release between dose units prepared in the same and/or in different production batches, and throughout the shelf-life of the finished product.”

The surelease polymer specified in the specification and used by Professor Walther in his experiments was supposed to provide repeatable and reproducible results:

“In one embodiment, the invention provides a commercial-scale process for manufacture of controlled-release dosage units. The process comprises co-formulating tolterodine or a tolterodine-related compound as an active drug and a pharmaceutically acceptable polymer-based release-controlling component. … more preferably substantially all of the polymer-based release-controlling component used in the process has an age, at time of dosage unit manufacture, which varies by not more than about 180 days, preferably not more than about 120 days, and more preferably not more than about 90 days.”

Professor Walther was unable to show this control. Under cross-examination he stated that:

“So what we know is that Surelease has lot to lot variability. So one batch of Surelease may perform slightly different from another batch of Surelease. That is an effect that the suppliers do know and understand and that is something that, as part of any formulation development, you would establish how robust a product is towards variability and providing sufficient specifications then on it.”

The problem is that this variable is not described in the specification, rendering the claimed invention not enabled.
The Commissioner ruled that the claimed invention does not have demonstrable superiority, lacked sufficient disclosure and enablement and that no inventive step was shown. Consequently the application was refused.

Active ingredients are released from the surface of solids. This is true for components that leach out and for components that are released when a carrier dissolves.
As particles shrink, the surface area to volume ratio increases and the rate of dissolution increases. Having a non-functioning core surrounded with a coating containing active ingredients is to ensure that the effective surface area remains more or less constant and thus the active ingredients are released at a constant rate.
The above explanation is obvious to anyone with a background of materials science and chemistry.
Drugs are more effective if the dosage is released slowly at a constant and predictable rate.
The present invention seems to be based on the premise that over time the core will absorb the active ingredient and that a coated absorbent core is better than a non-absorbent one.
The application is based on Tolterodine as an active material, but other pharmaceutical compounds may be expected to behave in the same way.
Of course, using the same binder and beads of constant diameter won’t give reproducible results if there are other significant variables. The problem here is that the Applicant’s own attempts to demonstrate the efficacy of the claimed invention failed. In such circumstances, the Commissioner couldn’t really have come to a different conclusion than that the application was deeply flawed as the person of the art selected by the applicant was unable to reproduce the results.

The previous Deputy Commissioner resigned four years ago. Obviously this was only one case of many that the current commissioner and his deputy or adjudicator had to rule on. Nevertheless, it seems to me intolerable that the parties should have to wait for four years for this ruling and one wonders why the previous deputy commissioner couldn’t have left less abruptly, and finished these pending cases.


A Request for a Patent Term Extension for IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck

February 10, 2015


IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck Sharp & Dohme Corp. was filed on 13 March 1996, and is due to expire on 13 March 2016.

Back in August 2007 a Request for Patent Term Extension was filed based on the commercially available preparation Gardasil. The pharmaceutical preparation contains four active ingredients: Protein L1, types 6, 11, 16 and 18.

The patent claims the Protein L1 type 18 as a product of genetic engineering. The patent relates to the other types of Protein L1 except for HPV 6 L1 for which no patent applications were submitted anywhere. The protein HPV 16 L1 was not claimed in any patent application filed in Israel. HPV 11 L1 was claimed in IL 117591 and expires on 21 March 2016. However, no applications for patent term extensions were filed for this protein.

The legal question that this decision addresses is whether a patent term extension can be requested for a patent that protects only one active ingredient of a pharmaceutical preparation.

The claims of IL 117459 cover a gene sequence of Protein L1 type 18, a vector including the gene sequence, a cell embodying the vector a process of expressing the gene sequence and a preparation that causes a vaccination to the protein including the gene sequence.

The senior examiner considers that Gardasil includes four proteins and any changes in any of them or preparations of three or less will result in a different medicament. Consequently, she considered that there is an inconsistency between the medicine and the claimed invention, in that not all the active ingredients of the claimed invention are in the basic patent.

The Applicant countered that claim 12 of IL 117459  covers a composition that includes (inter alia) HPV 18 L1 and thus the patent does not limit itself to this substance. Consequently, Applicant claims that IL 117459 is a basic patent as defined in Section 64a of the Israel Patent Law 1967 and as referenced in Section 64d. The Law does not require that a basic patent should include all active ingredients of a commercial product, and only one such active ingredient need be listed. Support for this interpretation was argued based on the wording of 64h(d) which relates to an active ingredient included in a preparation and claimed in the basic patent

The Applicant alleged that interpretations that a basic patent should include all active ingredients of the commercially available preparation is contrary to the underlying logic of the legislation and it is unreasonable to include such a limitation by judicial interpretation.

The senior examiner rejected these arguments and the Applicant requested an oral hearing which was held on 28 October 2014 and the Applicant was granted until 10 December 2014 to submit a summary of his arguments.

Section 64d states:

The Commissioner should not grant a patent term extension unless all the following apply:

  • the composition, process for its preparation and usage thereof, medical preparation including the composition, its process for preparation and medical equipment are claimed in a basic latent that is in force.

Section 64a defines the terms ‘composition, ‘medical preparation’ and ‘basic patent’ as follows:

  • Medical preparation – any form of medical drug that has been processed, including preparations for veterinarian applications and those having nutritional value that are injected intravenously.
  • Composition – the active ingredient or salts, esters, hydrates or crystals of the composition.
  • Basic Patent – a patent protecting any composition, production method, use, medical preparation including the composition, or any medical equipment requiring regulatory approval in Israel.

Based on the court ruling concerning the Appeal to patent term extension for IL 97219 to Novartis (26/12/2005) the term composition means a single active ingredient.

In Novartis, then Commissioner Dr Meir Noam (himself a chemist) ruled that the term basic patent in both Section 64a and 64d relates to the first patent that protects an active ingredient and that the term composition is in the singular, implying that one new ingredient is sufficient and that novel combinations of known ingredients cannot be considered as a basic patent.  A preparation that includes one new ingredient that requires regulatory approval may be protected by extending a basic patent. Combinations, aggregations and synergies of known ingredients may be patentable but such patents are not basic patents.

In this instance, the issue is the regulatory approval of a combination of active ingredients, not the basic patent. Gardasil includes four active ingredients. Each one provides a parallel vaccination effect and maintains its pharmaceutical character. The four proteins are separately synthesized by fermentation in recombinant Saccharomyces cerevisiae (a species of yeast) but are combined into one treatment for economical reasons and due to ease of use.

(HPV Type 16 L1 and HPV type 18 L1 are also components of the registered drug Cervarix registered to a third party, and the proteins are each separately active.  However, Cervarix was registered after Gardasil).

Since the drug Gardasil comprises four separately active ingredients that each has an independent effect and do not work as a synergy, the Commissioner accepted that Gardasil could serve as the first regulatory approval of HPV type 18 L1. He found support in the ruling fo Judge Dotan in the Novartis case. He noted that Merck could have requested regulatory approval for the four proteins separately and the discussion would be moot. Finally, citing the Neurim ruling (13281-06-12 based on the ECJ ruling that Melatonin for treating insomnia was not obvious in light of veterinary treatment for causing sheep to rut earlier), it is clear that the purpose of the Law is to provide patent term extensions for new types of treatment, and there was no reason why the Applicant should have had to register each active ingredient separately.

Furthermore, in Appeal 223/07 Lundbeck vs. Unipharm it was ruled that patent term extensions should be analyzed from an IP perspective and not from a pharmaceutical perspective. The Supreme Court upheld this ruling.

Furthermore, in the medical register, Gardasil is listed as including four active ingredients, including HPV 18 L1, and this is, indeed, the first medical registration of this ingredient in Israel.

Consequently, based on the extension awarded in the UK for EP 1359156, the Israel patent was extended 493 days to 19 July 2017.

Ex Partes ruling concerning patent term extensions to IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck Sharp & Dohme Corp. by Commissioner Asa Kling, 11 January 2015.


This is a publication of an ex-partes ruling. It is possible that local generic manufacturers such as Teva or Unipharm may challenge this.


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