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.


Extension of Israel Patent Extended

June 8, 2017

BSSIsrael Patent No. 164987 to Bristol-Myers  Squibb is titled ” PROLINE DERIVATIVES AND  PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME”. On 9 January 2017, the relevant Examiner calculated that the patent was entitled to a 479 day extension. The patentee has appealed this calculation.

The patentee’s representative submitted his calculation and a hearing was held on 28 May 2017. Following the hearing, the Deputy Commissioner accepted the arguments and ruled that the extension should be 679 days.

SunvepraThe patent term extension is for the active ingredient of Sunvepra which is asunaprevir. The Application for a patent term extension was under section 64(o) of the Israel Patent Law. The Applicant notes that the drug is not marketed in any of the relevant States as per section 64(a) and so the period of protection should be calculated on the basis of Section 64(i)(b) as follows:

If the registration is only requested in Israel, the patent term extension will be in force for a period equivalent to that from when the request for registration was submitted to when approval occurred, so long as the Applicant acted equitably and with appropriate efficiency.

The disagreement between the Examiner and the Applicant concerns the proper interpretation of the term approval as used to indicate the period of the extension. There is consensus that this period starts with the submission for regulatory approval, but the end of this period is disputed. The Examiner considered that this period terminates with the registration of the medication in the register of medical formulations as per section 47a of the Pharmaceutical Ordinance 1981. The patentee contends that the date should be the date on which approval for sale of the drug occurs.

In accordance with Section 64a of the Law, the term approval is defined in section (b)1 of the Law in the same manner as in section 54a as follows:

In this Section, ‘approval’ is authorization or permission or other document needed to sell the product.

The Legislative was aware of the difference between the term רישוי meaning approval and רישום meaning registration. The term רישום (registration) is used in sections 64(d)2 and 64(d)3. The meaning of the term רישום (registration) is registration in the Register of Medical Formulations under section 47a of the the Pharmaceutical Ordinance.

The term רישוי (approval) used by the legislative for calculating patent term extensions is wider and includes all approvals needed to market the product. Where the product is a medical device there is no disagreement that after registration in the register there are other approvals necessary before a product can be marketed to the public. These approvals are listed in regulations 14-18 of the Regulations or Pharmacists (formulations) 1986 and we are concerned with the first of these in regulation 14:

No one may market a formulation for the first time in Israel unless it is from a batch that receives marketing approval from the manager.

The Examiner himself was aware that to marketing approval was required in addition to registration as is clear from his letter of 6 September 2016. There is no doubt that this marketing approval was only signed on 4 September 2016 as is clear from the appendix to the Affidavit of Ms Talya Ben-David, Brostol-Myer Squibb’s regulatory manager in Israel. So although the formulation was registered from 18 February 2016, it was only approved for marketing some 200 days later.

The Applicant’s understanding of the Law is ‘technical’. As is clear from the Appeal to the Jerusalem District Court 223/09 Lundbeck vs. Unipharm (25 May 2009) regarding understanding terminology of the Law:

One can therefore say that the substantive scope of considerations that the Commissioner may use when determining the period of protection is different from that when considering a patent application. Deciding whether an invention is patentable is by nature discretionary in that it requires ascertaining novelty, inventiveness, utility, etc. In contradistinction, when determining the appropriate patent term extension, the Commissioner is limited to considering the formal requirements of the Law, without consideration of the way the invention works or the Applicant’s investment in inventing, developing and registering. This is what the legislative body decided was the appropriate way to balance the conflicting interests when providing patent term extensions. The burden on the Commissioner is technical and is designed to be objective.

It so happens that this technical calculation also corresponds to the purpose of the Law which is to compensate the Applicant for regulatory delays whilst enabling competitors to test and develop their generic equivalents without infringing the patent.

Section 54a of the Law, legislated as an amendment to the 1967 Law, cancels the de facto extension of products requiring approval (particularly drugs), by enabling generic competitors to prepare for and obtain regulatory approval whilst the patent is in force and to launch their products immediately on the patent lapsing. In compensation for this change, the patentees were allowed to obtain patent term extensions. The extension is not for the whole patent but only prevents manufacturing and sale of the medical formulation that includes the material covered by the patent (Section 64(h)d of the Law). Just as the de facto extension for regulatory approval is needed to market the drugs, so the compensation for the drug developers, by enabling patent term extensions, is tied to approvals. The patent term extension is needed to compensate the patentees for “the period that has passed until the patentee receives approval from the Israel Office”. See also the words of explanation for the fourth amendment to the Patent Law (use and patent term extension) 1997, Draft Law 2664 page 146 onwards.

Although the Israel Law is not identical to the arrangements reached in the US and in Europe, it seems that there also, the patent term extension is calculated from the time that all approvals are received. See for example Section 14 of the Medical REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL   concerning the supplementary protection certificate for medicinal products of 6 May 2009:

“The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.”

See also 35 USC 156 which deals with determining the “regulatory review period for the approved product” and also the words of explanation for the 13th amendment of the Patent Law 2012:

“The approval of the extension period for patents for medical formulations and medical devices of the type given in the US (Patent Term Extensions PTE) under Section 156 of Volume 35 of the US Code. This approval extends the US patent for delays in obtaining regulatory approval for marketing medical formulations and medical devices that occur after the patent issues, and half of the period for clinical trials for the same medical formulations and medical devices, with deductions from this period for tardiness by the patentee in obtaining such regulatory approval. The period of the Approval given in the US under the US Law cannot exceed five years and cannot extend beyond fourteen years from the first marketing approval of that medical formulation or medical device.

However, reference to foreign laws is not required since the term ‘approval’ in Section 64(i)2 is clear and unambiguous:.

The proceeding for considering the request for a patent term extension

extension

Section 64(o)b provides a very short period for examining requests for patent term extensions. This short period obligates fast examination and does not allow back and forth exchanges between the Examiner and the Applicant.

The examination of the patent term extension request commenced on 6 September 2016. In an Office Action the Examiner explained that the Application did not accord with Section 64(d)(3) of the Law since at the time of the Application, there was no regulatory approval in Israel, so he considered that the registration did not allow the formulation to be legally marketed.

The Applicant challenged this ruling before the Commissioner but this before this was substantively considered, an Affidavit was submitted that showed that marketing approval was given on 4 September 2016 and so the Commissioner ordered the request to be examined.

On 8 January 2017 the Examiner informed the Applicant that the Commissioner was willing to give a 783 day extension, and gave him a month to relate to this. The method of calculation was not detailed.

calculationThe following day, on 9 January 2017, the Applicant requested details of this calculation and established telephone contact with the Examiner. The contents of the conversation were not documented but the Applicant’s representative explained the main points discussed. [why the Examiner wasn’t interviewed is not discussed]. In the discussion, it was noted that an error had occurred in calculating the extension period which did not conform with either the Applicant’s or the Examiner’s interpretation of the Law. The Examiner considered that the extension period should be from when regulatory approval was requested until registration of the product. Consequently, that day, 9 January 2017, the Examiner issued a letter correcting the 783 days to 479 days, commencing on 27 October 2014, when regulatory approval was sought, and ending on 18 February 2016 when registration occurred. Due to an error, the Applicant was not given a month to appeal this decision. Instead, it was published in the January 2017 patent journal. Thus on 31 January 2017, a notice that an extension would be given under Section 64(e)c of the Law, despite the Applicant appealing the decision on 22 January 2017. It is emphasized that Section 64(e)c of the Law allows the Commissioner to publish the announcement within 60 days, thereby allowing the Applicant to appeal the examiner’s decision prior to it publishing, which is his right under section 161 of the Law.

There is no doubt that the publication is an error that should be corrected under Section 170 of the Law. The error is twofold: Firstly, it should not have published before the Applicants appeal was heard. Secondly, the publication did not accord with Section 64(i)b of the Law, as clarified in this ruling.

Therefore, a new announcement will publish in the June 2017 journal to the effect that the patent term extension is 679 days. Under section 170(c) the public may oppose this correction.

Ruling by Deputy Commissioner Bracha regarding Patent Term Extension to IL 164987.

COMMENT

I found this ruling convincing and concur that it seems to fit with the intent of the Law and not just with its literal wording. However, the corrected calculation may be opposed both substantively based on alternative interpretations and also due to third parties relying on the shortened term. We await further developments.

 

  

 

 


Extending the Deadline to File Complaint

September 13, 2016

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

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

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

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

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

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

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

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

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

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

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

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

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

COMMENT

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

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

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


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

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

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

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


Amending the Specification of an Opposed Patent Application

July 7, 2016

abbvie.png

Under Israel Law, allowed patent applications publish for opposition purposes for three months prior to issuing. If an opposition is filed, the issuance may be delayed for rather longer, if the patent issues at all.

As a general rule, the Applicant may amend ‘scribal errors’ i.e., typos in the specification and may narrow the scope of coverage of the claims, but cannot add material or widen the claims to cover something not previously within their ambit. In practice, applicants often request amendments that are allegedly permissible but which the opposer considers as somehow adding material or widening the monopoly sought. Sometimes amendments are opposed as a delaying tactic as until a patent issues, it cannot be enforced.

In the present instance, the application in question is IL 122546 to Abbvie Inc. titled “COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME”, which was filed two decades ago on 28 June 1996 by Abbot Laboratories as the national phase of PCT/US1996/0011015 which itself claims priority from a US provisional application (no 60/000654) filed on 29 June 1995. The case was transferred to Abbvie in June 2013.

The case was allowed and published for opposition purposes on 31 January 2012, and on 29 April 2012 oppositions were filed by Vertex Pharmaceuticals and by Teva Pharmaceutical Industries LTD.

Abbvie petitioned to amend the claims and this interim ruling relates to the proposed amendment and examines whether it is supported and whether it is indeed a narrowing of the scope of the claims.

last minuteIn his ruling of 2 May 2016, the Commissioner Asa Kling allowed the amendments to the claims but this is an interim ruling anyway and the patent, if eventually granted, will lapse anyway 20 years from filing on 29th June 2016. This begs the question as to the point of continuing with the opposition?!

The ruling has been carefully translated and is reproduced below but I have added a break as it may not be of interest to everyone…

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Glaxo Receive Patent Term Extension but Warned to be Polite

May 16, 2016

patent term extension

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

COMMENT

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


Request to Revive Patent Refused

May 10, 2016

mistakes

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

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

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

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

COMMENT

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

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

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

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

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

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

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

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

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