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.


LES Event on Copyright for Software

January 17, 2017
Inline image
INVITATION TO A LES ISRAEL EVENT
LES Israel is hosting an event on Monday,January 30th, 2017, at IBM Israel Ltd., 94 Derech Em-Hamoshavot Petach-Tikva, at 09:00am.
 
The event will be dedicated to the topic “Rights in Software”
 
The topic will be presented, as follows:
 
Part A: Lectures
  • Ziv Glazberg, Patent Attorney and Advocate (Ziv Glazberg), a Partner atG&A Glazberg, Applebaum & Co., a law and patent firm, will speak on “Patent Protection for Software”;
  • Eran Bareket, Advocate (Eran Bareket), a Senior Partner at Gilat, Bareket & Co. of the Reinhold Cohn Group, a law and patent firm, will speak on “Copyright for Software – Protection and Exceptions”; 
  • Haim Ravia, Advocate (Haim Ravia), a Senior Partner, Chair of the Internet, Cyber & Copyright Group at Pearl Cohen Zedek Latzer Baratz, a law and patent firm, will speak on “Alternative Use of Copyrights in Software and Digital Content”
Part B: Panel
 
Moderator: Suzanne Erez, Patent Attorney and Advocate(Suzanne Erez), IPLaw Counsel, EMEA IPLaw – Israel, Research, IBM;
 
o   Einav Zilber, Patent Attorney and Advocate (Einav Zilber), Director, Global Law Department, Intellectual Property Counsel, Applied Materials Israel and Applied Materials India;
o   Yoav Alkalay, Patent Attorney and Advocate (Yoav Alkalay), Head of IP, Amdocs;
o   Ben Haklai, Advocate (Ben Haklai), Commercial (Legal) Lead, Microsoft Israel;
o   Hananel Kvatinsky, Patent Attorney (Hananel Kvatinsky), Director of Intellectual Property, Orbotech Ltd.;
o   Ori Buberman, Advocate (Ori Buberman), Head of Intellectual Property, Mobileye Ltd.;
 
The event is free to LES Israel members.
Non-members: NIS 50 charge.
 
Registration is by email to les_israel@yahoo.com.
 

Novartis Patent Application Struck Down In Israel Opposition

January 11, 2017

glivec

Israel Patent Application No. 174082 to Novartis is titled “METHANESULFONATE SALT OF N – PHENYL – 2 – PYRIMIDINEAMINE DERIVATIVE, PROCESS FOR ITS PREPARATION AND USE THEREOF FOR THE PREPARATION OF A TABLET CONTAINING THE SAME”.

On allowance, Teva Opposed the patent. This decision relates to the utility requirements and to double patenting.

Background

The Israel Application is a divisional application of IL 133906 which is a national phase entry of PCT/EP1998/004427, claims priority from a Swiss application filed back in 2007. The case published as allowed at the end of May 2010, and an Opposition was filed by Teva on 28 August 2010.

Following Statements of Case from the parties, Novartis submitted a request to correct the claims, and narrowed the scope of claim 1, adding a dependent claim 2. This somewhat delayed the proceedings. In May 2012, the Applicant requested a further amendment to narrow the scope of claim 1. (During Opposition, and indeed after grant, claims may be narrowed, so long as doing so is clearly a narrowing in all cases).

Teva did not object to either amendments and submitted an amended statement of case in June 2013. Novartis responded in September 2013 and by November 2014 both sides had submitted their evidence.

Teva submitted an expert opinion by Dr. Mark Zakrzewski and Novartis filed expert opinions from Dr. Simon Bates and from Patent Attorney Dr. Gail Volman. However, in lieu of a hearing, the parties agreed that the Commissioner would rule on the case based on the submissions, and, following his agreement to so doing, the parties filed their summary statements and counter statements.

The subject matter of the patent is Imatinib (N-phenyl-2- pyrimidine-amine) which was developed in Ciba Geigy, later Novartis, and is marketed as Gleevec® in the U.S. or Glivec® in some other countries. It is a competitive tyrosine-kinase inhibitor used in the treatment of some types of cancers, most notably Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).

(An opposition was lodged against the application in India by several Indian generic drug manufacturers including NATCO Pharma Ltd., CIPLA Ltd. Ranbaxy Laboratories Ltd., Hetro Drugs Ltd. and also by the Cancer Patients Aid Association. On April 1st, 2013 the Supreme Court of India dismissed Novartis’ patent application, so there are generic versions of the drug on the market. in India and the majority of the patients – 300,000 patients – are treated by the generic versions).

In Glivec, the Imatinib Methanesulfonate is found in the Beta polymorph which differs from the needle-like alpha polymorph and this affects various physical properties.

After the amendments described above, the claim set consisted of five claims, the first being independent.  The main claim is directed to non-needle-shaped crystals having certain diffraction peaks as follows:

174082-claimClaim 2 adds additional characteristic XRay diffraction peaks. Claims 3 and 4 respectively relate to capsules and tablets comprising the beta polymorph and claim 5 relates to a method of fabricating the tables of claim 4.

The Opposer’s Statement of Case

90The Opposer notes that the specification provides support for a material comprising at least 90% of a specific (beta) salt defined by a spectrum of peaks. The main claim, by merely specifying two characterising peaks, effectively claims other polymorphs not necessarily yet discovered and so the claims ‘greedily’ encompass more than the specification teaches.

beta.jpgThe justification for the patent is related to enhanced flow properties of the polymorph. However since the claims cover traces of the polymorph, the claimed material as a whole does not show enhanced flow properties.

Based on the introduction to the specification, the Opposer believes that the scope of the patent should be limited to at least 90% of the specific polymorph as characterized by all its peaks. In response to the Applicants claim that the introductory paragraph was included by mistake, the Opposer notes that such a ‘mistake’ is a factual error and to substantiate that it occurred requires factual support, not expert opinion, and so this claim of mistaken inclusion should be struck from the record or given negligible evidentiary weight. To support this argument, Teva notes that Dr Voleman was not the representative of Novartis during the patent prosecution when the paragraph was allegedly mistakenly included.

Furthermore, Teva posits that the average person of the art reading the application would conclude that the invention is for formulations including  at least 90% by weight of the (beta) salt of Imatinib Methanesulfonate rendering Dr Voleman’s opinion irrelevant.

Double-dip.gifFinally, the Opposer claims that there is overlap between the claims of this divisional and of the parent application, and thus the Applicant is trying to obtain two patents for the same invention. However, this line of reasoning was not related to in the summary and seems to have been abandoned.

The Applicant’s Position

just-another-exampleThe Applicant considers that the specific Example of 90% beta polymorph given in the specification is simply that. It is a non-limiting specific formulation that is provided by way of example.

The Applicant accuses the Opposer of cherry-picking statements from the specification to provide interpretation to the claims, rather than to interpret the claims in light of the specification taken as a complete document. The introductory paragraph was provided for administrative purposes and is not to be used to interpret the patent. Indeed, this paragraph was never intended to be part of the disclosure and was included in the specification by mistake. The parent application cherry-pickingclaimed the beta polymorph in concentrations exceeding 90% and at the time of filing, the Applicant considered that the practice was to conform the background to the claims, and then to file a divisional with the same specification as the parent, but with different claims. Consequently, the limitations of the introductory paragraph referred to the parent and not the divisional, were inherited from the parent, and are not to be considered as limiting the scope of the claims. Thus according to the Applicant, persons of the art would appreciate that the application in question is a divisional application and the paragraph in question related to the parent patent.

morphThe Applicant claims that the present application claims a new polymorph and is a product claim that is per se patentable. To argue the point they referred to TEVA applications for polymorphs that claim the desired properties of the polymorph, such as flow properties, compaction properties, and the like. These are characteristic of the polymorph but it is the polymorphs itself that is being protected as a new composition of matter.

The properties of the beta polymorph are inherent to the crystalline structure and not to the concentration of the polymorph in the formulation. Since the beta polymorph has inherent advantages, its discovery and manufacture has utility and is thus a patentable invention.

Discussion

The guidelines for patentable subject matter are given in the Supreme Court rule 345/87 Hughes Aircraft vs. State of Israel p.d. 44(4) 45, 65:

“true the interpretation of patents is not substantially different from the interpretation of any other document, and the standard laws of interpreting papers apply to it. However, due to the special nature and power of patents, additional care must be taken in interpreting since they effectively provide a monopoly in the marketplace. The basic principle is that the patent should be read as a document in its entirety to understand the inventor’s intention as it is expressed in the document…since the patent is primarily directed to professionals in the technological field that the patent considers to be the field of relevance, it should be interpreted using professional knowledge (state of the art) at the time of filing. However, since the patent is supposed to indicate the inventor’s intention, there is some flexibility in giving interpretation to phrases and terms that appear in the claims and the rest of the specification, such as the description, may be used as a dictionary for these phrases and terms. In other words, as a lexicography of the invention.”

Section 13a of the Law states that:

The specification will conclude with one or more claims that define the invention, however these claims must be fairly based on the specification.

Regulation (20)a(3) of the patent regulations 1968 expounds section 13 and requires that the claims are ‘succinct and clear’.

It will be appreciated that the claims define the scope of protection claimed. The claim interpretation should be based on the specification in its entirety – including the description and the figures (Hughes, page 65). However, one cannot import limitations from the specification into the claims:

“The starting point for the appropriate approach is that patent documentation is a one-sided document that the inventor himself writes and he has freedom to write it as he likes. (Catnic Components Ltd. [22] at 242).  A lack of clarity regarding the explanation of a phrase or term in the claims can be made by reference to the specification so long as this is done with reference to the specification as a whole and not selectively in a way to favour the applicant whilst disregarding other phrases in the specification that lead to a different interpretation (Electric & Musical Industries Ld. And Boonton Research Co. Ld. [21], at 41).”

Section 13(a) deals with the question of whether the claims of the application are fairly based on the specification and whether or not they are sufficiently enabled for persons of the art to practice. The Court of Appeals of the EPO has nicely summed this up as follows:

“Undue breadth is not a reason for refusing a claim under the EPC as long as its subject-matter is novel and inventive, and sufficiently disclosed in and supported by the description.” T 0593/96 INDIGO N.V. (18.11.1996). 

See also  T 0456/91 Syntex (USA) Inc. v. Debiopharm S.A., (3.11.1993).

In this instance, the Opposer alleges that the claims are not supported by the specification to the extent required by Section 13(a) of the Law since the claims are wider than that supported. The Opposer calls the claims ‘Greedy’. The extent that this term can be used with reference to the requirements of Section 13(a) is given in Appeal 1008/58 Alerican Cyanamid vs. Lepitit et al. page 261 from 4 April 1960. See also Opposition by Teva to IL 142809 to Pharmacia AB from 26 February 2015.

In his Opinion from 1 December 2013, Dr. Mark Zakrzewski (Teva’s expert witness) notes that the invention clearly specifies a 90% concentration of the beta phase.

“34. The alleged invention is explicitly described in the Patent Application as a methansulfonate salt of Imatinib Mesylate comprising “at least 90% by weight of crystals of the β-modification…” or “in essentially pure form”.

Based on this, the Opposer considers that claim 1 which lacks this limitation is wider than that supportable under Section 13(a).

Consideration of the Application itself shows that there is no certain preference to limit the concentration of the beta phase. For example, page 3 states:

“The invention relates to an acid addition salt of a compound of formula I comprising non-needle-shaped crystals, especially the β-crystal form of the methanesulfonic acid addition salt of the compound of formula I.

The invention relates especially to a particular, form of the monomethanesulfonic acid addition salt of a compound of formula I,

formula

comprising at least 90% by weight of crystals of the β-modification, said crystals of the β-modification showing on X-ray diffraction a peak at an angle of refraction 2theta of 20°, said peak having a relative line intensity of 65 as compared to the most intense line in the diagram”.

Further on, on page 4 of the specification, the following is stated:

“The term “essentially pure” is understood in the context of the present invention to mean especially that at least 90, preferably at least 95, and most preferably at least 99 per cent by weight of the crystals of an acid addition salt of formula I are present in the crystal form according to the invention, especially the β-crystal form.

…                                                  

The invention expressly relates also to those forms of the methanesulfonic acid addition salt of a compound of formula I in which crystals of the crystal form according to the invention, especially the β-crystal form, are present in essentially pure form…”.

From the above it is clear that the specification does relate to the beta phase in a manner that does not necessitate limiting it to a preferred concentration. Apart from the opening paragraph which will be discussed separately, the specification uses terms such as ‘particularly’ and ‘especially’ with regards to concentrations and does not limit to these desirada.

The reader will appreciate that the patent relates to the non-needle-like beta phase but not to specific concentration ranges. See Section 22 of Dr Bates’ opinion on behalf of the Applicant:

“22. Contrary to Dr. Zakrzewski’s assertions, the specification teaches and enables form β per se, without any purity limitations. An “essentially pure” form β is one of the preferred embodiments of the invention, but by no means reflects the entire scope of the invention. Dr. Zakrzewski apparently selects a couple of paragraphs which highlight a preferred embodiment, disregards the teaching of the specification as a whole will readily understand that the invention is the discovery and development of the novel form β and that the invention is not limited to form β only when it is “essentially pure”.”

As to the practice of claiming new polymorphs, Dr Bates opines:

“Indeed, just like new chemical entities, novel polymorphs are claimed per se without quantitative purity limitations. At the most, quantitative limitations are a preferred embodiment, as in the instant case. For the sake of demonstration, I instructed applicant’s counsel to search polymorph patents issued to Teva by the USPTO. Overall, 78 patents claiming polymorph forms were found. 77 patents out of 78 patents claim the polymorph forms per se, without “quantitative” or “purity” limitations…”

The Applicant explained that the introductory paragraph was the result of the Examiner requiring the specification of the parent to be conformed to the claimed invention, and then was inherited in the divisional application. This claim, related to in Dr Voleman’s opinion, relates to factual matters. Commissioner Kling concurs with the Opposer that Dr Voleman is not the ‘correct’ witness to testify that this was a mistake and does not have first-hand knowledge regarding that which she is about. Such a claim requires support by an affidavit and is a matter for first-hand testimony and not for an expert witness to hypothesize about.

That said, the state of affairs is not sufficient to warrant deviating from the general principle stated in the Hughes Aircraft Decision, that the specification should be considered ain its entirety. From this perspective, the Commissioner is willing to accept the Applicant’s claim that the introduction is not indicative of the scope of the invention and cannot be relied upon to the exclusion of the rest of the specification to explain that scope of the application. A person of the art who reads the document as a whole would not rely on the introductory paragraph alone, but would read the patent application in its entirety.

Utility

The Opposer alleges that the claimed invention does not have utility since it does not demonstrate the advantages of the beta polymorph when present in minor proportions.

It is true that amongst other requirements, in accordance with Section 3 of the Law, a patentable invention has to have utility. The utility is a requirement that the patent application as a whole must satisfy as stated by Judge Hendel in Appeal 5041/13 Anat Gabai et al vs. Aminach Mattresses, 21 January 2014:

Reading the main paragraph that gives the requirements for patentability teaches that “utility” is the second criterion of the four criteria for patentability. This is not by chance. All patent applications are expected to have utility.

The nature of the utility requirement is discussed by Judge Netanyahu in Appeal 665/84 Sanofi vs. Unipharm p.d. 41(4) 729:

At the time of filing the Application, it has to include a promise of utility. If this is the case, generally the requirements of Section 3 are met. Proof of this promise will be required at the Opposition stage, if this is submitted as grounds for Opposition, or in a cancellation proceedings or infringement action. In Oppositions, the burden of proof is on the Applicant since the patent has not yet issued; in cancellation or infringement proceedings the burden is on the challenger / infringer.

See also the Opposition to 179840 Aminach Furniture Industries Ltd vs. Anat and Moshe Gabai, 20 November 2012.

In this instance, it appears that the promise that is the basis of the Application is the advantage of the Beta phase regardless of concentration. (There is no dispute that the beta phase is novel and inventive). The advantages that Novartis’ witness Dr Bates has alleged are the improved flowability and compactability of the beta phase when compared with the alpha phase, and the parties concur that these properties are desirable in pharmaceutical formulations.

To the extent that the claimed properties are substantiated, they are substantiated for formulations with a greater than 90% concentration of the beta phase. The Applicant did not demonstrate or provide evidence of these properties in lower concentrations.

As stressed above, in the Sanofi ruling, the court emphasized that the claimed advantages have to be proven at the opposition stage if the utility is challenged. Some evidence is required to show that the promise is attained, although not necessarily the quantity of experimental evidence that would be required were the opposers to actively provide counter-evidence.

In this instance, the Applicant continues to allege that they deserve a patent for formulations with even minimal beta content. The Opposers have noted that there is no evidence that such low concentration formulations have advantages over the alpha phase and the Applicant has not provided evidence to support their claims or a reasonably convincing counter-argument in response to the Opposer’s reasoning. This is not to say that had the Applicant’s expert witness related to this, his arguments would have been found convincing – See Opposition ruling concerning IL 143977 Unipharm vs. AstraZenica AB paragraph 44.

In this instance, at the joint request of the parties, no witness is being cross-examined. From this it is clear that the Applicant has not substantiated their claim that formulations with low concentrations of the beta phase have sufficient utility  to be patentable.

The overlap between the claims of the Divisional Application and those of the Parent

In addition to the above, the present application is not patentable due to the significant overlap between the claims and those of the parent patent.

Whilst it is true that in their summation, the Opposer abandoned this line of reasoning, the Commissioner does not consider that this fact alone is sufficient for the matter to be dropped since oppositions are a continuation of the examination process and the patentability question is once again opened. The purpose of oppositions is to ensure the purity of the register and is a continuation of the administrative process (See Opposition to 136482 Bromium Compositions vs. Albermarle Corporation USA, 7 November 2010.

Section 2 prohibits granting a patent for an already patented invention. See also the IL 203972 Novartis decision. To address the issue of double patenting it is necessary to consider the scope of the invention. The scope of the invention may be learned from the total breadth of protection that the patentee receives (see 2626/11 Hassin Fire Industries vs. Koniel Antonio (Israel) Ltd. 14 November 2013 paragraphs 35-38.)

Independent Claim 1 of the parent application claims the beta phase of the Imatinib Methanesulfonate salt at concentrations of at least 90% with a strong 2theta XRay defraction peak at 20° as follows:

formula-parent

Thus the parent claims the same beta Imatinib Methanesulfonate salt concentrations of at least 90% whereas claim 1 of child patent does not include a minimum concentration. The specifications are the same apart from minor differences that are insignificant, and so the claim construction considerations used to define the terms are the same in both the parent patent and in the divisional application. Despite different phraseology the scope of the claims overlap.

The differences are in the non-needle like form of the crystal, the characteristic XRay diffraction peaks and the concentration limitation of the parent.  Careful examination indicates that the same polymorph is covered by both cases, although defined differently, with the sole difference being the concentration limitation in the parent is not in the divisional application and this removal of the concentration limitation is the feature that the Applicant points to as being the patentable feature. However no advantage is given for the low concentrations covered by the divisional application. The Applicant claims that the parent patent and divisional application cover different aspects of the invention. However, the concentration is not an aspect warranting separate registration.

The IL 174082 Application is refused. Costs are applicable as per Commissioner Circular M.N. 80.

Comments

It seems to me that the person of the art considering a patent publication to understand the scope of the claims is a patent attorney with pharmacological background, or a team including technical people and patent counsel. I don’t believe that any industrialist (except possibly Dr Zebulun Tomer of Unipharm who has been challenging blockbuster patents for years and has been known to file oppositions by himself) would construe the claims of a pharmaceutical patent without seeking legal advice so Dr Volman can be considered as an expert.

The Commissioner is correct that there is no obvious or demonstrated utility for the lower concentrations.


Requesting a patent allowance to be cancelled

January 8, 2017

reconsideration

Israel Patent Number 219586 to Fritz Collischan & Co. KG was allowed. The patent is titled “DEVICE FOR COUNTING OBJECTS FED AS BULK MATERIAL”and is the national phase entry into Israel of PCT/EP2010/067146 which published as WO2011/054974.

In a rather surprising move, Data Detection Technologies Inc, represented by Pearl Cohen Tzedek Latzer Brats requested that the allowance of the patent be cancelled. Actually this is not the first request of this type, for the present patent.  Back on 9 March 2015, following a request to have the allowance withdrawn on grounds that the applicant did not provide a list of prior art as required to under Section 18 of the Law, the same third party requested that the patent be disallowed, and on that occasion, the Applicant agreed for it to be returned to a state of pending allowance. Following that episode, the now pending patent application was returned to the Examiner and eventually was allowed on 29 September 2016 and published for Opposition purposes under Section 26 of the Law. Data Detection Technologies Inc have again requested that the case be returned to the Examiner as they have found additional citations and video clips that they claim reveal the invention and which were sent by themselves to the Applicant some month before allowance.

Despite bringing the additional material to the Applicant’s attention, the Applicants did not make this art of record and the patent was eventually allowed under Section 17c, on the basis of a corresponding issued patent (which presumably itself issued without the Examiner thereof considering the video clips and publications submitted by Data Detection Technologies Inc. Data Detection Technologies Inc argued that this failure is sufficient to prevent the patent issuing under Section 18c of the Law. Alternatively, since the citations are central to the patentability of the invention, Data Detection Technologies Inc considers that minimally the patent be returned to the Examiner for further Examination.

Data Detection Technologies Inc considers it inappropriate for them to have to fight an expensive opposition proceedings which was caused by the applicant failing in their duty of disclosure.

The Applicant claims that the appropriate way to raise issues relating to the duty of disclosure is via an opposition proceedings, and the arguments submitted by Data Detection Technologies relate to grounds for Opposition under Section 31 of the Law. The Applicant posits that withdrawal of allowance is an appropriate measure only in those rare cases where the decision to allow was flawed, or where a letter of allowance was issued by mistake. The Applicant does not consider this to be such a case.

The Applicant notes that the additional material was collected in an opposition proceeding that Fritz Collischan is fighting against an allowed patent of Data Detection Technologies. In that proceeding, Data Detection Technologies Inc requested an extension to respond to the Opposition and to amend the specification. The Applicant submits that the extension was applied for in bad faith and with factual inaccuracies in the justifications given. The Applicant further submits that the  Affidavit includes hearsay that is not acceptable as evidence.

Ruling

The parties concur that the Commissioner may cancel a notice of allowance and return an application to the Examiner if there is a major flaw in the decision to allow the patent. This authority is derived from Section 15 of the Law of Interpretation 1981 and was adopted by the patent office in the previous ruling concerning Data Detection vs. Collischan from 9 March 2015 and also in the Cellular Dynamics vs. Christopher Reed ruling from 29 April 2014.

The argument is whether the current situation is one where it is appropriate for the Commissioner to exercise their authority and to withdraw the notice of allowance, or whether the appropriate action is for Data Detection Technologies Inc to file an Opposition under Section 31 of the Patent Law 1967?

The Deputy Commissioner, Ms Jacqueline Bracha considers that the choice of appropriate course of action is to be found in the purposes of the two courses, which are also derived from their different ways of being initiated. The authority under Section 15 of the Law of Interpretation is something initiated by the administrative body to correct a mistake that they made in an earlier decision or t as a result of a change of circumstances, as an exceptional course of action where there is no other appropriate recourse authorized by the law (See Y. Zamir, Government Authority (1996) pages 1003-1006. In contradistinction, the purpose of the Opposition proceeding is to critique the Examination and to continue the Examination of a patent application in an inter-partes procedure initiated by the third party (see the Israel Patent Office Ruling re IL 136482 Bromium Compounds Ltd vs Albermarle Corporation of 7 November 2010.

 With all due respect, I consider that the courts approach has changed since then, and nowadays the Supreme Court considers the Opposition procedure as being complimentary to and a completion of the Examination since it is intended to serve the public interest and the accuracy of the register.

In the framework of cancellation of an allowance the amount that the public would have relied on the notice of allowance and the type of mistake that resulted in the allowance are to be considered. However, it should be appreciated that not ALL mistakes justify the cancellation of an administrative decision. A mistaken decision based on consideration of the facts and simply reaching the wrong conclusion, will not, in general, justify changing an administrative decision (see Zamir on page 1006). The Authority will generally reach this result in cases where there is a suspicion that someone has been awarded more than he deserves. Such a suspicion is not sufficient to justify cancelling the benefit by the  government body (see Zamir on Page 1007).

In contradistinction to the civil proceeding to cancel an administrative  decision, the Opposition is an adversarial judicial proceeding or sub-judicial proceeding that allows the parties to bring evidence in accordance with the law of evidence, allows opposing counsel to cross-examine witnesses and enables the patent office to come to a reasoned decision. In such a proceeding, the Patent Authority is not limited by the administrative decision and he can reexamine the patentability of the invention in light of the evidence and claims before it, even apart from the considerations that the Examiner used in reaching the decision of allowance.

From the above it is clear that where a mistake in a decision is not self-evident and requires substantive clarification, the administrative decision to cancel the allowance is inappropriate.

In this instance, to determine whether the applicant is required to alert the Examiner about the publications that Data Detection mention, one has to see whether the publications “relate directly to the invention” as required by Section 19(a)2 of the Patent Law. To do this, it is necessary to listen to the claims and evidence of the parties regarding the nature of the invention.

Even if a decision is reached that the Applicant should indeed have made these publications of record under the duty of disclosure, it is necessary to consider if a failure to have done so can be dealt with by the alternatives in Section 18 or if the decision to allow the patent [to proceed for opposition purposes] should be cancelled. In this regard, to the extent that a publication allegedly shows the patent being demonstrated or implemented, the Examiner is not duty bound to consider it.  Section 17b of the Law states that:

(a) an Examiner will consider if the Examination answers all the following:
(1) is for an invention considered patentable under Chapter 2;
….
(b) despite section (a)(1), there is no obligation to examine patentability in accordance with Section 4(2). 

In summary, the Deputy Commissioner Ms Bracha does not consider that the present case is a mistake that warrants cancellation of the Notice of Allowance and does not see how the legal and factual issues can be considered in a decision to cancel the allowance and how this advances the case to a final decision on patentability.

The final claim of Data Detection Technologies Inc, that Applicant’s failure to make art of record should not oblige them to enter a lengthy and costly opposition proceeding. It is true that oppositions are lengthy and the regulations provide at least 16 months from initiation of an opposition until a hearing is scheduled. The parties may request extensions and interim decisions, to correct the specification and more. Nevertheless, the Opposer can submit their evidence on filing their statement of case, thereby significantly shortening the procedure. Furthermore, on conclusion of the opposition, the prevailing party is awarded actual costs, if they are essential, reasonable and proportional See Bagatz 891/05 Tnuva Agricultural Cooperative vs. the Authority for Granting Import licenses, p/d/ 60(a) 600. From here it is clear that if Data Detection Technologies Inc are right, they can expense appropriate compensation.

Therefore it is not considered that the decision to allow the patent was clearly erroneous, justifying its cancellation without a factual inquiry, and it is precisely the anticipated costs that are incurred by an opposer for conducting an opposition that tilts the balance towards holding an opposition proceeding.

As an afterword, it is noted that this is not the place to consider the behavior of Data Detection Technologies in a separate opposition before the Patent Office.

Data Detection Technologies are ordered to pay 4000 Shekels + VAT in legal fees to Fritz Collischan.

Comment

This decision is a correct one. Since, nowadays pending applications publish 18 months from priority and the whole file wrapper is available for examination prior to allowance, maybe Israel should formally allow third party prior art submissions.

It seems that Data Detection Technologies Inc is trying to delay issuance without formally filing an opposition. I think that this decision, not allowing this is correct.

Previous opposition rulings that relate to failure to submit art generally did not invalidate the patent on this ground alone, but it is within the authority of the patent office to do so.


Exforge Patent Successfully Opposed in Israel, despite surviving an Opposition based on similar citations in Europe

November 7, 2016

Exforge is a blockbuster drug sold by Novartis for lowering blood pressure that combiexforgenes two medications in a film-coated tablet It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist (ARB or A2RA); typically formulated as the benzenesulfonate salt.

Israel Patent Application No. IL 140665 titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” relates to the drug.

In an Opposition to the Patent Application issuing, the Deputy Commissioner, Ms Jacqueline Bracha, has ruled that the combination of two active ingredients, each individually known for treating high blood pressure, into one pill for ease of dosage is not inherently inventive where the separate efficacy of the active ingredients is known, as are other two component pills for treating hypertension. Though claimed by applicants, there is no evidence of a synergy between the active ingredients.  The Patent Application is therefore ruled not patentable in Israel and significant costs were awarded to Teva and Unipharm. We expect that the decision will be appealed. This decision may have a knock on effect regarding patents for the same drug abroad and may encourage Teva to proceed with at-risk launches of generic competitors in other jurisdictions.

A translation of the ruling follows:

Read the rest of this entry »


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

November 2, 2016

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

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

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

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

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

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

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

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

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

RULING

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

COMMENT

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

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

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