Opposition to IL 201320 to Pfizer & limits to amending the Statement of Case

July 2, 2018

Patent Application IL 201320 to Pfizer is titled “CRYSTALLINE FORMS OF 6-[2- (METHYLCARBAMOYL) PHENYLSULFANYL]-3- E -[2- (PYRIDIN2- YL] ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS”.

On allowance, it published for Opposition purposes, and Unipharm submitted an Opposition.

Prior to publication following allowance, Applicants have very wide discretionary powers to amend claims or submit new claims, provided the claimed mater is supported from the specification. After publication, in response to Oppositions, or even after grant, the Applicant/Patentee is only allowed to correct obvious typographical errors or to narrow the scope of protection by cancelling claims or by amendments that clearly narrow the scope of protection. Nothing that protects matter previously not within the ambit of the claims can be allowed.

In this instance, during the Opposition proceeding, Pfizer requested a narrowing amendment to the specification to clearly define the term ‘substantially pure’ that appears in claim 2. Commissioner Alon allowed the amendment in a ruling of 5 March 2018, and gave the parties a window to amend their Statements of Case to take the amendment into account.

Unipharm, who had already submitted their evidence, decided not to amend the statement of claims, but Pfizer submitted an amended Statement of Claims that was wide ranging.  This included background to the development of the invention and eleven appendices.

Unipharm then requested that Pfizer’s amendment be struck from the record, arguing that amendments to the claims following amendments to the specification should be based on those amendments to the specification. Pfizer disagrees. They note that the Law does NOT require that amendments to the counter-statement of claims be related to the earlier amendments to the statement of claims at the start of the Opposition proceedings, or that they be based on the amendments to the specification. Furthermore, the interim ruling allowing amendments to the statement of case did not include such limitations.

The Applicant drew a parallel to civil court proceedings, however the Commissioner does not accept this since in civil court proceedings, when the plaintiff amends his Statement of Case, he can expect the defendant to be allowed to amend their Statement of Case, whether in direct response, or to broaden their position, and this is the risk taken when amending the Statement of Case once the proceeding is underway.

In contrast, in Patent Opposition proceedings, it is the Applicant that has a right to amend the specification, not the Opposer. In this instance, it is the Applicant that causes the Statement of Case to need to be amended, and he can therefore expect that the Opposer will also amend his Statement of Case , and will not restrict himself to amendments resulting from the Applicant’s amendment. If the Opposer does amend their Statement of Claims, the Applicant can make their amendments.

So what is the appropriate Law if the Opposer does NOT amend their Statement of Case? The Commissioner reasons that the Applicant can certainly correct their Statement of Case with respect to anything that needs correcting. Whenever the specification is amended, the main points of disagreement often shift. The Opposer deciding not to amend the Statement of Claims does not prevent the Applicant from relating to new issues raised by the amendment to the Specification, and to redirect his allegations to these issues. This serves the procedure and focuses the Statement of Case on the real issues. The Commissioner considers that the term “issues arising from the amendment” should be interpreted broadly, in light of the relevant case-law.

Nevertheless, where the amendment to the Statement of Case is totally disconnected to the amendment to the specification, it becomes a regular amendment to the Statement of Case which should be subject to the regular criteria. The submission should be accompanied with a statement justifying the amendments and explaining why they could not have been included originally, and why they should be allowable. This is necessary to prevent the amendment to the Specification becoming a technical tool for allowing unlimited amendments to the Statement of Case whenever the Specification is amended.

In this instance, the amendment to the Statement of Case was the addition of background relating to the development of the XLI formulation. From Examination of the amended Statement of Claims, the Applicant did not indicate any connection, even minimal, between the amendments to the specification and the amendments to the Statement of Case. Furthermore, the Applicant did not justify why the amendment was required now, and was not part of the original Statement of Case, or why the Statement of Case was not amended earlier.

In these circumstances, the Commissioner considers that the Opposer is correct, and the amendments as submitted should not be allowed. The Applicant is given 15 days to refile an amended Statement of Case whose claims are related to the amendment to the Specification, or to state that they do not wish to file an amended Statement of Case. Alternatively, the Applicant may submit a request to amend the Statement of Claims justifying the amendments submitted.

The deadlines for submitting evidence that were given in the interim ruling of 5 March 2018 are canceled. New deadlines will be given once the Applicant files his Statement of Case.

Costs for this will be considered when ruling costs for the main ruling.

Interim ruling by Commissioner Ophir Alon Concerning Unipharm’s Opposition to IL 201320 to Pfizer


Can Non-Israelis be Subpoenaed to testify in Opposition Proceedings?

June 10, 2018

novartis

Israel 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”. It is the national phase entry of PCT/EP2005/000400.

Unipharm

On allowance, Unipharm filed an Opposition to the patent application being granted.  Within the Opposition proceeding, Unipharm, who for this case, have dispensed with the services of Adv. Adi Levit, their legal counsel and have been handling the Opposition unaided by attorneys, have requested that the Israel Patent Office subpoena  John Hutchinson and Mr Kowalski, workers at Novartis to give testimony.

This request follows an earlier request to reveal documentation regarding testing that was appended to the Expert Witness testimony of Professor Davies, Novartis’ expert witness, which was ordered in an earlier interim ruling of 3 January 2018.

Discovery

In response to the discovery request, Novartis submitted an Affidavit with various appended papers. In light of this, Unipharm now alleges that the Affidavit implies that Novartis has not revealed all documents it should have. Unipharm further indicates that the explanation proffered by Hutchinson, who is signed on the Affidavit, “appears to be odd”. Therefore, Unipharm wish to Subpoena him to cross-examine him on this.

lab bookUnipharm further claims that a document titled “Certificate of Authenticity” was included with respect to the laboratory notebook, parts of which were included in the appendices attached to the affidavit. According to Unipharm, Mr Kowalski, who was one of the named inventors, is signed on this document. Consequently, Unipharm requested to cross-examine him as well.

Novartis requests that Unipharm’s request be rejected. They claim that the Commissioner does not have the authority to subpoena witnesses not within the judicial territory of the State of Israel, who are not direct parties in a proceeding. Novartis also notes that Mr Hutchinson’s signature on the Affidavit accompanying the discovery documents was done in the framework of his employment as a patent attorney in the Legal Department of Novartis. Novartis claims that ALL information regarding the management of the proceeding is subject to legal confidentiality and may also be considered as being a trade-secret.

As to Mr Kowalski, he never signed an Affidavit of Evidence in the process and is not a party to it. Similarly Novartis claims that Unipharm has not stated why they need to cross-examine that inventor who was one of three named inventors.

Discussion

The witnesses that the Opposer wished to interrogate are beyond the territorial jurisdiction of Israel and are not parties in the case. Thus the Applicant is correct that Section 163b of the Patent Law 1967 that Unipharm referred to is not a legal basis for their being subpoenaed. The references that Unipharm related to in their request, dealt with witnesses that gave Affidavits or expert witness testimony, and thus could be subpoenaed for cross-examination purposes.

A party that wishes to subpoena a citizen or foreign resident to testify must do so under the International Inter-State Legal Assistance Law 1998. See Appeal 3810/06 Dori and Zacovsky Building and Investments Ltd vs. Shamai Goldstein, paragraph 17, 24 September 2007.

Section 47 of the Legal Assistance Law states:

The Authority is allowed to request from another country, that testimony be collected, including that physical evidence be transferred for display in Israel, if the court allows that the evidence is required to hold the trial in Israel; regarding this law, and where the case is pending, the term court refers to the tribunal that is hearing the case.

From the wording of this Section, it transpires that the court will open a proceeding to summon foreign witnesses to a hearing only if it is convinced that their testimony is necessary to conduct the proceeding. In this instance, the Commissioner considers that there is significant doubt as to whether the presence of the witnesses for cross-examination purposes is really required.

Unipharm has requested to cross-examination Mr Kowalski regarding an Affidavit for discovery that he is signed on. The purpose of the discovery process is to enable the main proceeding to be handled efficiently; legal proceedings with face-up cards where each party knows what documents the other parties hold to prevent surprises at the hearing. By this means, unexpected delays are prevented, allowing the court to reveal the truth. Appeal 4235/05 Bank Mizrachi United vs. Ronit Peletz, 14 August 2015.

Opposite the principle of discovery, there are other interests such as efficiency of the court proceeding, defense of the legitimate interests of the party revealing documents, and preventing damage to the interests of third parties – See Appeal 2534/02 Yehuda Shimshon vs. Bank HaPoalim ltd. p.d. 56(5) 193. So the case-law has ruled more than once that it will not allow cross-examination of affidavits of this kind, if they are properly presented (see Appeal 2376/13 Rami Levy Shikma Marketing Ltd vs. Moshe Dagan 8 July 2014, and Zusman Civil Procedures 7th Edition, page 436.

This general rule has two exceptions: The first is that where reading of the Affidavit alone or with reference to its citations, that the Affidavit is defective, the court can order the party revealing documents to file a further Affidavit. Second, where the issue of confidentiality is used, the court can examine the document and decide if this claim is reasonable (see for example, Appeal 240/73 Baruch Vilker vs. Dov Tishler, 205, 2 December 1971 and Appeal 6823/05 Abraham Roimi vs. Bank Leumi of Israel, 12 January 2016.

In this instance, Unipharm did not append an Affidavit, detail or justify why they considered that the current case is one of these exceptions. Thus the Commissioner cannot rule that this is the case, and so the request is rejected.

As to the evidence of Mr Kowalski, Unipharm did not claim that there was any connection between the documents appended to the Affidavit of the Discovery and to the experiments that were appended to Novartis’ evidence, which was the basis of the original discovery request. Note, Mr Kowalski’s signature is only on the Certificate of Authenticity taken from the lab-book that was appended to some pages therefrom that were submitted in the discovery documents. In these circumstances, it is not clear what value Mr Kowalski’s testimony has, even were he to be subpoenaed.

In light of this, the Commissioner does not consider that the requirements of Section 47 of the Law of Legal Assistance are fulfilled with regard to Mr Hutchinson or Mr Kowalski.

The Request is refused. Unipharm will cover Novartis’ costs and their legal expenses to the tune of 2000 Shekels + VAT. These costs will be paid within 30 days.

Interim Ruling in Opposition to IL 175831 Ofer Alon, 30 April 2018.

Comment

It is possible that Mr Tomer has indeed bitten off more than he can chew by handling legal issues procedural issues such as requesting subpoenaing witnesses without legal counsel. However, the costs ruled against him are trivial when considering the issue in question. The Unipharm’s Expert Witness cannot testify to things that he does not know such as what else was in the lab-book, and in Opposition proceedings there is no assumption of validity of the patent. Thus it would be premature to write this request off as a strategic or even a tactical error.


Bayer – Part II – Are Patents for Bio-Similars Elligible for Patent Term Extensions???

June 5, 2018

This is the second part of a ruling concerning Patent Term Extensions (PTEs) for Kovaltry. The first part related to when the ninety day period from registration commences and is discussed here.

This second part of the ruling is a precedential decision that rules whether a patent for a bio-pharmaceutical material such as a protein can be can be considered as being a basic patent if there is a previously registered bio-similar molecule; it being appreciated that the amino acid sequence may be the same, but the spatial structure, activity and efficacy may still be different. In view of its legal and financial significance, the decision is fully translated below. We apologize for any incorrect technology. 

After the request for a patent term extension for Kovaltry was received from Bayer, the Patent Office issued an Office Action as follows:

Paragraph 6 of the Affidavit appended to the letter of 22 August 2017 notes that there is no other formulation that includes Recombination Human Coagulation Factor VIII, fabricated by the defined cell culture and the defined conditions under which KOVATLRY is manufactured. It is possible that the Blood Coagulation factor claimed in the Application is different from the Blood Coagulation Factors that have been registered, but the Active Ingredient of the Recombination Human Coagulation Factor VIII formulation is registered in the registry of pharmaceutical formulations in various formulations mentioned hereinabove.

The other medical formulations mentioned as including Factor VIII were Novoeight, Octanate 1000, Koate and Kogenate.

Kovaltry

On 11 December 2017, the Applicant responded to the Office Action and claimed that the active ingredient, the Recombinant Human Coagulation Factor VIII, is a new material derived from a new genetic engineering process that is protected in the present application, and that Kovaltry is the first formulation that allows its medical usage in Israel, as required for a patent term extension in Section 64D(3) of the Law.

The Applicant explained that Factor VIII is intended for treating Hemophilia A which is characterized by a problem with blood clotting due to a fault in or a lack of Factor VIII. In the new process covered by the Application, the heat shock protein 70 (HSP70) is introduced into the gene of the host cell and additional actions are taken to produce the active ingredient, which creates a new protein Factor VIII, which has a different structure from other proteins that relate to a lack of endogens in the Factor VIII coagulant. The structure of the protein, as applied for in the Application is as follows:

Bayer

The Applicant further explained that the folding structure of the protein is different due to the manufacturing route, and it attracts a lot of sugar groups (glycans), which allow the protein to automatically fold and provides a pharmokinetic advantage to the protein when compared to other formulations. In this regard, the Applicant notes that most properties, such as the glycan group appended, which have been glycosylated, are relevant to the half-life of the protein in the blood.

The Applicant claims that the registration file of the Kovaltry formulation indicates that the Ministry of Health considered the formulation to have a new active ingredient, and so it had to undergo the specific regulatory requirements of the Ministry of Health. The Applicant relies on the Procedure of the Ministry of Health for registering products of this type; Changes and Innovation in Medical Formulations from 1 February 2015, which differentiates between six different categories for registration.

According to the Applicant, when the Israel Ministry of Health relates to the Recombination Human Coagulation Factor VIII as being a new active ingredient as far as registration in the drug register is concerned, one has to apply a similar rationale when considering the drug for a patent term extension in order to fulfill the purpose of the legislation which is the underlining logic of the patent term extension, which is to compensate the patentee for the period when he cannot market the formulation containing the patented product due to regulatory requirements. The Applicant argues that one should differentiate between medical formulations that have active chemical ingredients that are small molecules, and biological formulations that are differentiated by proteins manufactured in different ways. They argue that the different proteins are typically different from each other in both their structure and their physical properties.

From the claims it transpires that the difference results from the way that the protein is manufactured. The applicant explained and supported their explanation with various appendices, the manufacture of a biological pharmaceutical formulation that includes proteins is very difficult due to the size of the protein, the way it folds, the general structure, changes in translating the chain of amino acids to create the protein, the cell culture used to manufacture the proteins, and so on. All changes lead to changes in the protein itself, in its. glycosylation and medical effect.

Due to these differences, the Applicant alleges that Health Ministries around the world have created different regulatory procedures for biological pharmaceutical formulations. They claim that even though there may be several medical formulations for addressing a lack of a particular enogen, such as Factor VIII, due to the issues raised above, they will be different from each other in practice. Furthermore, their active elements which cause blood clotting will be different and have different international classification.

In their response, the Applicant further explained that there are other formulations that treat Hemophilia A, which are fabricated in different ways such as by separating active ingredients from human plasma, formulations obtained by genetic engineering of part or a full gene, formulations that include healed proteins and formulations that include Factor VIII with additional proteins.  The Applicant claims that these formulations are completely different from Kovaltry, despite their purpose being to overcome the endogenic lack of the blood clotting Factor VIII as described above.

The Applicant focused on the differences between the active ingredients of the medical formulations cited by the Examiner and the active ingredient of Kovaltry. As to Kogenate, the Applicant claimed that its active ingredient was different to Factor VIII, even though the sequence of amino acids was the same, since the proteins of the structure are different at the gene level and the protein level. The Applicant appended journal articles that related to the differences between the formulations as an example of improved pharmakinetics.

In light of the above, the Applicant considers that one cannot apply Section 64D(3) of the Law in the same way for biopharmaceuticals when comparing active ingredients with prior art as is done for chemical pharmaceuticals.

In response to these claims, the Deputy Chief Examiner responded in a letter of 31 December 2017, that obtaining the strict regulatory approval required for pharmaceuticals is no indication that a patent term extension is also appropriate. To support this differentiation, the Deputy Chief Examiner referred to 223/09 H. Lundbeck A/S vs. Unipharm ltd et al (22 May 2009).

The letter also notes that the journal papers appended to the response explain that the process for obtaining Factor VIII in the patent in question creates a new protein with a different structure, with glycosylation and different pharmakinetic properties which affect the half-life of the protein in the blood, but do not influence the formulation, and the protein that is the active ingredient of Kovaltry is Factor VIII which exists in Kogenate and other pharmaceutical preparations.

Furthermore, the Deputy Chief Examiner considered that the improved glycosylation or the addition of the HPS70 may affect the folding and could be a new process, but the registration of a medical preparation is given for a formulation and not for the process of manufacture, and differences in the Factor VIII are simply a bi-product of the processing route.

The Deputy Chief Examiner added that though the process of manufacturing the proteins in Kovaltry and Kogenate are different with a difference that expresses itself in yield, better cells and other repeatability differences, the sequence of amino acids is the same, despite the amount of glycans that underwent glycosylation on the proteins So compared to preparations that were registered earlier than Kovaltry, the Deputy Chief Examiner rejected the Applicant’s claims with respect to each of the formulations.

On 7 February 2018, the Applicant submitted a request for a hearing regarding the rejection, and submitted a further statement of claims on 20 February 2018. O 25 February 2018 an ex-partes hearing was held before the Commissioner during which the Applicant reiterated their claims and added the following claims:

Factor VIII is a complex protein and changes in the process result in significant changes to the structure thereof and to the medical affect thereof. Consequently, when comparing twoproteins to ascertain whether or not they are the same material, one has to consider the structure and not merely the sequence of amino acids which is the first stage of characterization, but also the three dimensional form and the intracellular activity.

After the hearing, the Applicant submitted a summary on 1 March 2018 that proposed an appropriate test for considering the novelty of biopharmaceuticals. The proposed test has three levels. Firstly one should consider if the material is a biological medicine. Then one should consider if the protein has a new structure, and finally various tests for determining whether a protein is new or not, such as whether it is a specific protein, whether the regulatory approval was Read the rest of this entry »


When does the ninety day period for requesting a patent term extension commence?

May 29, 2018

Extension for IL 124123 to Bayer. When does the ninety day period for requesting a patent term extension commence?

In this ruling, the Commissioner accepts that the 90 day period for requesting a patent term extension should be calculated from the date at which the Ministry of Health informs the Applicant of the issuance of the decision to grant a patent term extension, and NOT from the date on the certificate. We now wait for someone to request that all sorts of cases be reopened, and extension fees refunded.

There is a second part to this ruling, in which the Commissioner rules on whether this is indeed the first registration of the drug. For blogging purposes, I am relating to the issues separately.

Kovaltry

The Application for the Extension for IL 124123 to Bayer was filed on 7 August 2016 and relates to the KOVALTRY formulation in the medical products registry from 8 May 2016, and which contains Recombinant Human Coagulation Factor VIII (no relation).

The Deputy Chief Examiner sent an Office Action on 13 September 2017 in which she raised the following objections:

  • The Application does not fulfill Section 64xv(a) of the Patent Law 1967 since it was received 9 days after the formulation was registered in the pharmaceutical registry.
  • The Application does not fulfill section 64d(3) of the Patent Law 1967, since it is not the first registration of Recombinant Human Coagulation Factor VIII in the pharmaceutical register.

The Applicant was also required to provide additional details regarding extension orders in the US and in recognized European countries.

On 11 December 2017, the Applicant responded to the Office Action. Following the Request for Patent term extension being rejected on 3 December 2017, the Applicant challenged the grounds for rejection. In their response, they submitted a detailed list of allegations on 7 February 2018 and a summary on 20 February 2018. The Applicant also attended a hearing on 25 February 2018. After the hearing on 1 March 2018 the Applicant submitted a completion of their case.

Bayer raised two main claims. The first was the way of calculating the timing of the request for the extension conducted by the Deputy Senior Examiner in accordance with Section 64xv(a) of the Law. The second related to the previous registration of bioactive ingredients for medical purposes in accordance with Section 64iv(3) of the Law.

Timeline for Submitting the Request for Patent Term Extension

When the Application was submitted on 7 August 2017, the Application wrote that “This Application based on the Kovaltry formulation that was registered on 8 May 2016, and so the Application is submitted within 90 days of registration.”

Ms Assem Mehta Deputy President, Head of the Department of Patents and Licenses, and Assistant to the Secretary, affirmed in an Affidavit supporting the request for patent term extension, dated 22 August 2016, noted in Section 4 of the Affidavit, that the medical device was registered on 8 May 2017.

However, from the Office Action, the Registration Date that appears on the Certificate of Registration is indeed 8 May 2017, but the request for the Patent Term Extension was only filed on 7 August 2017 which is 91 days from the registration date. Based on this data, the Deputy Chief Examiner ruled that the request does not conform to Section 64xv(a) of the Law which requires that:

Section 64xv(a)A request for a patent term extension should be submitted in the appropriate manner, after paying the fee, and not more than 90 days from registration in the Pharmaceutical Registry.

In the response to the Office Action from 11 December 2017, the Applicant claimed that although 8 May 2017 is the date at which the registration for marketing Kovaltry appears in the register, the Authorization only issued on 10 May 2017, and this was the date at which the Manager of the Register for Pharmaceutical Formulations informed the Patentees of the Approval. The Applicant appended a further Affidavit dated 14 January 2017, from Mr Gal Friedman, the Head of Regulation of Bayer Israel, which markets the Applicant’s products in Israel. In the Affidavit, Gal Friedman asserted that regulatory approval was only received on 10 May 2017. An email notification from the Head of Registration of Pharmaceutical Formulations, Dr Einbinder was appended. The email address was given as the formal electronic mailing address of Bayer Israel.

The Applicant claims that from their attempts to clarify the matter, that in the past, the date on the certificate was the only date available for calculating the 91 day period. However, nowadays, one can use the date of informing the Applicant as the starting period of the 90 days.

The Applicant claims that neither the Patent Law nor the Pharmacists Ordinance 1981 define the registration date that appears on the registration certificate. They thus allege that there is no basis to explaining that the 90 day period stated with this date is the correct date for calculating the 90 day period for requesting a patent term extension from a the Deputy Commissioner ruled, rather than the date at which the Applicant was informed (i.e. 10 May 2017).

The Applicant went on to claim that time periods for calculating things that depend on the Authority are generally to be calculated from when the citizen is made aware of the action of the Authority or when the notice is sent.

The Applicant wishes to draw a parallel to the C-471/14 Seattle Genetics from 6 October 2015, where it was ruled that the period for giving marketing approval under the European regulations, is from the day that the Applicant is informed, i.e. the date of notification. The Applicant claims that the basis for this determination is that the marketing approval does NOT enter into effect from the day that the decision is taken, but rather from the date that the Applicant is informed of the decision. Consequently, certificates of registration have two dates and the Applicant believes that one should prefer the later of the two, which fulfills the intention of the legislation, which is to provide a sufficient window for Applicants who have a basic patent, to request a patent term extension – something that they cannot do before knowing that a marketing approval has issued.

The Applicant alleges that this position is supported by the District Court ruling in 32321-10-16 Bristol Myers Squibb Holdings Ireland vs. Commissioner of Patents and Trademarks 26 December 2017, where Section 64x(2) of the Law was interpreted to mean that the period of marketing approval commences with the informing of the decision to the Applicant and not with the date that the Approval was made. The Applicant considers that this should apply to Section 64xv(a) of the Law as well.

The Applicant also considers that the explanation of the Law made by the Deputy Chief Examiner could result in many cases where the patent term extension period was determined by the date appearing on the certificate and the number of days would need to be recalculated.

DISCUSSION AND RULING

The issue in question is the correct explanation of the term “Day of Registration of the Medical Formulation” as mentioned in Section 64xv(a) of the Law.

In legislating that the Applicant should submit their request for a patent term extension within 90 days from registration in the Pharmacist’s Register, the legislators attempted to achieve two purposes:

  1. To give the Applicant sufficient time to prepare their application
  2. To allow the public to know with certainty whether a patent term extension was being sought for a particular product, thereby providing market certainty.

Section 64xv(a) has been amended. In the earlier version under the third amendment to the Law, the period for applying for a patent term extension was 60 days from registration of the formulation under the Pharmacist Regulations (formulations) 1986.

In the seventh amendment from 2006, 3 January 2006, Book of Laws 2048, page 195-197, the Section was amended to extend this period to 90 days. The Pharmacist’s Regulations were similarly amended and now state “from the day of recordal under the Pharmacist’s Ordinance. In the 11th amendment the Authority of the Commissioner to extend the period was taken away, so the period is non-extendible (Amendment 11, 2014, Law book 2430, 27 January 2014, pages 274, 278.

From the Applicant’s claims it transpires that there are four periods that could be considered the period of registration from which the 90 days are calculated:

  1. That given as the date of registration
  2. The day that the approval is printed on the certificate
  3. The date when the Pharmaceutical Division informs the owners of the registration – the sending date. and
  4. The date of knowledge – the day on which the owners of the registration receive notification of the registration.

The date of registration is that appearing on the certificate from which the ninety day period has traditionally been calculated when calculating the deadline for requesting a patent term extension (considering the certificate as it stands today).

The date of printing is presumably the date when the Ministry of Health produces the certificate. This is the date on page 3 of the Kovaltry certificate which states printed on 10 May 2017.

The claims and evidence before me do not support the contention that the date of printing of the certificate is necessarily the date on which the Ministry of Health informed the Applicant that their request for registration was successful. Indeed, one can assume that the date of printing will actually change each time that the same document is sent to the printer and so the same certificate could exist with different printing dates. Consequently, the Commissioner does not think that this date can be relied upon as the date for registration with regard to the correct explanation of Section 64xv(a) of the Law.

As to the period of sending or the period of becoming aware, the Commissioner accepts the Applicant’s allegation that calculating the deadline from the Official Date is problematic where the Applicant only becomes aware of the date retroactively, since it is difficult to require someone to take an action within a time period from an event occurring that he does not know about.

The issuance of a marketing authorization is an administrative action as defined in Section 3 of the Law of Interpretation:

An administrative action is an order or an appointment, notice, license, approval and the like, that is given in writing under Law and is not a legislative action.

In his book Administrative Authority, Y Zamir states that (Zamir, Administrative Authority Vol. 2 Second Edition, 201 on page 1320):

Common sense tells us that there are things where not being informed of an administrative decision that adversely affects a person’s rights, should not be in effect at all, or in certain circumstances, if the person was not informed of the decision. For example, let’s consider that an Administrative Authority cancels the work permit of a person but does not inform him of this, is it conceivable that the person will be tried under criminal law for running a business without a license? If an Authority applies a tax and does not tell him, can he be held liable for not paying that tax? Where a Law states that a person is allowed to Appeal or to critique an administrative ruling in some other way within a specific period from that decision issuing, and the person is not informed, should he be prohibited from criticizing the ruling? In summary, it appears that the present situation requires a legislative solution or case-law, that relates to publication of civil rulings. The underlining is by Commissioner.

Logic obliges that giving notification to someone regarding an administrative action relating to him cannot be applied without the person being aware of the administrative action. This is also stated in regulation 4 of the Patent Regulations 1968:

The calculation of the time period for doing an action the Law or regulations require or allow, following actions of the Commissioner or subsequent thereto, should enter into effect from the date when the requirement is given to the postal service and addressed to the client or agent-of-record at the official address, or sent by electronic mail, as per Regulation 16(b). This period starts with the sending of the electronic mail, unless it is established to the Commissioner’s satisfaction, that the message was not delivered.

True, in this instance, we are NOT talking about an action that the Patentee is required to take following an action of the Commissioner of Patents, but due to the action of a different Authority, the Ministry of Health, however the underlying logic is appropriate. It is noted that where the Pharmacists’ Regulations themselves give a time period for an action, the time period is from when the action of the Authority is made known to the person concerned, see, for example, Regulation 9(3) of the Pharmaceutical Ordinance:

 (b) If the director considers that the registration of the formulation in the register should not be renewed, he should inform the registered owner before the registration lapses, the notification should be by registered mail to the official address of the registered owner.  

(b1) If the manager informs that he does not intend renewing the registration, he should extend the registration by no more than six months.

(c) The owner of the registration is allowed to appeal the decision not to renew the registration within six months from receipt of the notification under Regulation (b).

So the patent regulations specifically state that where someone has to respond to an action of the Authority, the period for responding will be calculated from the day of sending or from the day of receipt of the notification if it is proven that the notification did not reach its destination. The pharmaceutical regulations state that the period is calculated from notification.

In the ruling of re Bristol, Judge Magen Altovia related to the “submission approach”.

 It is noted that the serving of papers approach sits well with the administrative law that stresses that the period of serving of papers is more important than the reaching of the administrative decision by the deciding party with respect to setting into practice that allowed.

As Judge Magen Altovia stated in re Bristol, the purpose of the civil law procedures is to fulfill real rights. See Appeal 6708/00 Aharon vs. Aharon p.d. 54(4) 702:

At the end of the day, the civil procedures are there to serve substantive rights, and they are there for a purpose. The wider substantive approach, of which good faith is the wellspring, cannot be accompanied by overly strict civil procedures. The legal culture is not only judged by protected rights, but also sometimes by the ways of approaching situations and the status of those being judged.

Consequently, Commissioner Ofir Alon considers that the 90 day period for requesting a patent term extension be calculated in a similar fashion to other deadlines in the Patent Law, i.e. in accordance with Regulation 4 of the regulations, that the date is to be calculated from when the notification is sent to the applicant / patentee, unless the Applicant can prove that the notice was never received, and in such cases, the period is to be calculated from when the consumer learned about the decision.

The Commissioner does not consider that calculating the period from the day that the Notice was given to the Applicant undermines the second purpose of the legislators; the need for certainty. This interest is not damaged if the date is calculated from the day of sending, since this is usually close to the day that the decision was taken by the Ministry of Health. It should be noted that Section 64 of the Patent Law has to be very carefully interpreted, to reflect the balances intended by the legislators.

In this instance, in the request for registration and in the affidavit, the Applicant noted the date of registration as 8 May 2018, even though Mr Friedman did not note that the notification was first sent to the Applicant on 10 May 2017, which the Commissioner is willing to assume was his intention in light of the Applicant’s claim, and noting the date of the printing appears on the certificate. In light of all of the above, the Commissioner rules that the response was timely filed under Section 64xv(a) of the Law.

COMMENT

This ruling seems to indicate that the Current Commissioner is less formulistic than his predecessors. I was rather taken aback by this ruling since I think that the 90 day period is ample to cover regular postage delays and his deadline should be no different from all the others that are calculated from the date on the certificate.

The Patent Office has very many deadlines triggered by an action they take, including the deadline for responding to Office Actions (typically 3 or 4 months, and extendible), the final deadline for responding to all Office Actions for registering a design (one year from the date of the first office action), the deadline for paying the first renewal (three months from issuance of the patent certificate), the deadline for filing oppositions, the deadline for filing abroad under Paris, etc. ALL of these calculate the deadline from the official date, despite the fact that, in practice, the Applicant will only be aware of the date once he/she receives notification which may be some time later.

The 90 day period is sufficient to cover delays of days in the authority informing the Applicant and the time for the Applicant to inform his client. If it can be shown that there were extraordinary delays involved, then there is due cause to argue that the delays were unavoidable and the Commissioner could reasonably give a discretionary extension. If the Law limits the grounds for discretionary extensions, it does so for good reason. In light of this ruling, ALL the deadlines triggered by Patent Office actions are now suspect.

There is no need for this. The 90 day period is sufficient to cover minor delays and, in this instance, the delay was three days. Sixty days used to be considered enough for filing a request. This period has been extended to ninety days. Ninety days is ample.

The 90 day period should not be extendible. The Law requires unavoidable delays and there was nothing unavoidable in this instance. However, although I think the ruling was horrible, there is a precedent for extending the 90 day period based on errors by agent of record being unavoidable. In XXXX, Reinhold Cohn missed the date due to docketing errors. If Pearl Cohen had claimed that they made a docketing error and calculated the date from receipt of notification, it is difficult to see how the present Commissioner could avoid giving the extension given to Reinhold Cohn. Of course, to do this requires knowledge of the previous decision which requires reading the decisions or following this blog.

Even without this, if the Commissioner simply ruled that the delay was unavoidable, he could simply have granted an extension based on payment of an extension fee. Instead, he has ruled that all deadlines are to be calculated from date of sending, or if not received, from date of notification. We predict that this will open a hornets’ nest.

Actually, there is a second issue here, which is whether this was the first publication. On that ground, discussed in the next blog posting, the extension was rejected. The Commissioner could, therefore, have ruled on that case and left the present issue open.


Abandoned Patent Opposition Converted into Ex-Partes Procedure

April 20, 2018

Israel Patent Application No. 220476 to Mapi Pharma titled “Long Acting Depot System Comprising a Pharmaceutical Acceptable Salt of Glatiramer” was allowed and published for opposition purposes. Teva filed an opposition under Section 34 of the Law.

glatiramer

The application relates to a dosing regime of Glatiramer and salts thereof. The drug is an immunomodulator medication used to treat multiple sclerosis.

The application is a national stage of a PCT filed on 19 August 2010 which claims priority from an American patent application of 4 January 2010.

The patent was examined and published for opposition purposes on 31 March 2016. On 28 June 2016, Teva filed an opposition. After the parties submitted their statements of case, Teva withdrew their opposition for commercial reasons.

Under Section 34 of the Patent Law 1967, the Commissioner has to decide whether the suspended opposition provides a sufficient basis for the patent to be granted.

In their Statement of Case Teva raised various issues regarding the patentability of the claimed invention. Since no evidence was submitted, the Deputy Commissioner concentrated on the allegation that the publication of WO2005/041933 from 12 May 2005 anticipates the invention and negates novelty.

Claim 1 recites:

“A long acting parenteral pharmaceutical composition comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer, the composition being in a sustained release depot form which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.”

Paragraph 20 of the Statement of Case which from paragraph 58 of their counter statement, it appears the patentee accepts, construes claim 1 as follows:

  1. A long acting pharmaceutical composition
  2. For parenteral dosing
  3. comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer,
  4. the composition being in a sustained release depot form
  5. which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.

Read the rest of this entry »


Reinstatement of Lapsed Patents in Israel

March 22, 2018

not a rubber stamp

It can and does happen that annuities are inadvertently not paid and patents go abandoned.

If the patentee and/or his representative act promptly on learning that a patent lapsed, and sign affidavits to explain how the deadline was missed, reinstatement is generally possible. The Adjudicator, typically the Deputy Commissioner, will usually allow reinstatement and her decision publishes for opposition purposes. If, in the meantime, a third-party has made preparations to exploit the apparently abandoned patent, they are generally entitled to a non-transferrable license to continue to exploit. It is important to realize however, that reinstatement is NOT automatic.

This past month there were six rulings concerning abandoned patents. In five cases, in two of which the patentee was represented and in three they were not, the Deputy Commissioner ruled that the conditions of Section 56 were met and ruled that, subject to no oppositions being submitted, the patents could be reinstated.

In the sixth case, IL 177416 to Arieh Sansolo titled “Rapid Detonating Cord Coil Deployment Apparatus” went abandoned due to failure to pay the third renewal for years 10-14 after filing. The last day for paying this renewal was 10 August 2016, and six months later, on expiry of the grace period, the patent was abandoned as per Section 57 of the Law.  The fact that the patent was abandoned was published in the March 2017 journal.

From the request for reinstatement and the accompanying affidavit, it seems that the reason why the case was not renewed was due to the patentee not being reminded by the agent-of-record (Dekel Patents).

In her ruling of 7 February 2018, Ms Bracha wrote:

It is not clear from the Affidavit why the agent-of-record did not inform the patentee, nor is it clear what steps were taken by the agent-of-record to ensure that the renewal fee be paid. It is also not clear how and when the patentee and the agent-of-record became aware that the patent had lapsed

Ms Bracha gave the patentee a further opportunity to add the missing data within 7 days.

 

up a palm tree

The patentee and legal representative did file an additional submission which attempted to include testimony from both patentee and agent -of-record wherein the patentee swore to tell the truth, but the agent -of-record merely listed the circumstances without swearing to tell the truth.  Nevertheless, without relating to the formal deficiencies, Ms Bracha considered the statement. The agent -of-record noted that he assisted the patentee by receiving reminders and forwarding them to the patentee. In this instance, he did not receive a reminder and thus did not forward it to the client. The agent -of-record noted that he does not charge for this service.

In a string of decisions the Israel Patent Office has ruled that not receiving a reminder from the Patent Office is not sufficient justification to not pay the renewal. See for example, IL 185526 Khalid Akad et al. 24 October 2012. The Applicant or his representative are required to take positive steps to ensure that renewals are timely paid, such as to run a computerized reminder system or to use a renewals company.

In this instance the patentee and the agent -of-record did not have such a system but simply relied on the Patent Office. This is insufficient to fulfill the reasonable means requirement of Section 60 of the Law.

Furthermore, in this instance, the Patent Office records show that an email reminder was sent to the agent -of-record on 10 April 2016 and shows up in the Patent Office system.

It is noted that providing a renewal service without charge is insufficient to free the agent -of-record from his obligations under the law.

The request for reinstatement is refused, but the Applicant has 30 days to submit a request for a hearing.

Re Reinstatement of IL 177416 – Decision by Ms Bracha, 11 February 2018.

COMMENT

Whilst Ms Bracha is correct that the patentee and agent-of-record are obliged to docket and track renewals, things can and do go wrong. Now the Patent Office is obliged to weigh the public interest against that of the patentee and there is, indeed, a six months’ grace-period. The fact that this month there were six cases of patents that unintentionally lapsed shows that this does happen. What I would like to humbly suggest is that the Patent Office takes it upon itself to send out a further reminder or preferably two; one when the deadline for renewal passes and one a month before the end of the grace-period. The Patent Office is equipped to do this automatically without human involvement. Doing so would increase Patent Office revenues and minimize the amount of time that the Commissioner and his staff have to deal with reinstatement issues.

issues.


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.