A cost ruling and a tax question

April 17, 2018

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

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

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

History and Timeline

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

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

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

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

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

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

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


Adding Evidence After Filing Statement of Case in Patent Opposition Proceeding

March 22, 2018

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

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

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

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

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

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

Discussion

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

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

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

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

Two issues that the Applicant raises deserve responding to:

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

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

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

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

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

…”

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

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

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

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

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

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

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

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

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

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


Unipharm without legal representation, wins Interim Proceeding Against Novartis

February 22, 2018

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

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

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

Unipharm

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

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

novartis

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

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

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

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

Claims of the Parties

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

grain size

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

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

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

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

Discussion and Ruling

legal fishing expedition

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

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

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

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

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

tablet-compression-machine

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

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

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

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

No costs are awarded.

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

COMMENT

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

self representation

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

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


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

December 21, 2017

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

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

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

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

calculation

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

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

Ruling

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

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

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

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

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

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

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

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

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

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

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

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

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

The Purpose of the Patent Term Extension Regime

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

balance

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

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

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

Explaining section 64L(3)

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

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

Ofir Alon

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

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

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

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

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

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

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

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

FROM THE GENERAL TO THE SPECIFIC

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

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

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

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

COMMENT

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

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

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

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

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

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

Section 164 A1 of the patent law states that:

164.—(a) The Registrar may, if he sees reasonable cause for doing so, extend any time prescribed by this Law or by regulations under it for the performance of anything at the Office or before the Registrar, except for…section 64… …unless he is satisfied that the application in Israel was not submitted on time because of circumstances over which the applicant and his representative had no control and which could not be prevented;

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

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

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

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

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

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

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

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


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.