Unipharm Successfully Opposes Novartis Patent for Panobinostat Lactate Salts

March 26, 2017

PanobinostatThis ruling relates to an opposition against a patent application by Novartis for Panobinostat  which is a hydroxamic acid  that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor).  On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.

The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.

Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.

Background

NovartisNovartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.

UnipharmUnipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.

The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »


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.


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

November 7, 2016

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

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

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

A translation of the ruling follows:

Read the rest of this entry »


Are methods of calculating rediculous alleged legal costs trade-secrets?

November 1, 2016

novartis    teva

Teva successfully opposed IL 184027 to Novartis titled “COMPOUND TRISODIUM [3-((1S,3R)-1- BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1- BUTYLCARBAMOYL)PROPIONATE-(S)- 3¶METHYL-2¶PENTANOYL{2¶¶ TETRAZOL-5-YLATE)BIPHENYL- 4¶YLMETHYL}AMINO)BUTYRATE] HEMIPENTAHYDRATE, ITS PHARMACEUTICAL COMPOSITIONS, METHOD FOR ITS PREPARATION AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS.”

The application was filed on 18 June 2007 as the national phase entry of PCT/US2006/043710. A divisional application was filed as IL 219782. The application published for opposition purposes on 30 November 2014, and on 25 February 2015 Teva Pharmaceuticals LTD filed an opposition. One day later Unipharm also filed an Opposition. Subsequently, since there was a pending divisional application and because the opposer had not filed their statement of case, the Opposers filed for suspension of the Opposition proceeding for 18 months as per Commissioner Circular 020/2012 “Opposition to a divisional patent or to a patent that is divided” from 18 November 2012. The Applicant opposed the request to stay the opposition. However, on 9 August 2014, the Commissioner agreed to stay the opposition proceeding.

On 7 September 2015, the applicant abandoned the divisional application and requested that the Opposition against the parent application be renewed and that the Opposer file their statement of case. The commissioner accepted this, and on 9 September 2015 gave the Opposers 60 days to file their statement of cases.

On 8 November 2015 Teva announced that they were withdrawing their opposition for “pure business reasons”. On 30 November 2016, the Commissioner ruled that the Teva opposition be closed and that the Unipharm opposition continue.

detailed-costsOn 11 January 2016, Novartis requested costs from TEVA. The costs request was supported by a statement from Liad Whatstein, Novartis’ counsel, but with many details thereof blacked out as they are allegedly business secrets and some are pertinent to the ongoing Opposition by Unipharm. They also requested a confidentiality order with respect to the blacked out data.

The Commissioner decided that Novartis had failed to make a case that the data should remain confidential, and issued a ruling on 4 February 2016 rejecting the confidentiality clause. Novartis’ counsel chose not to provide a time-sheet detailing the work done, considering this also as being a trade-secret.

Novartis’ Claims

The Applicant considers that TEVA’s withdrawing from their opposition puts them into the category of a party that loses their case. They do not think that the ongoing opposition by Unipharm should release TEVA from having to bear costs in a proceeding that they initiated. Thus Novartis alleges that TEVA should have to pay half the actual costs incurred by Novartis from when the opposition was filed until when it was abandoned, which comes to $17,136.72.

The Applicant claimed that due to the tight deadlines and the complicated scientific data they had to prepare for the opposition prior to the statement of case being filed. The complications are evidenced by Unipharm’s opposition and by the corresponding opposition filed in Europe. Furthermore, the Applicant claims that TEVA’s behavior and the time passed from when the opposition was filed until when it was withdrawn after the continuation was abandoned, created a state of affairs wherein TEVA could reasonably expect that Novartis would work on the opposition and incur costs thereby.

Novartis also claimed that TEVA had abused the opposition process by filing a baseless opposition simply to delay the patent issuing and to cause the divisional application to he withdrawn. Consequently Novartis considered that TEVA should pay costs.

 TEVA’s Claims

TEVA considers that Novartis is NOT entitled to costs at all and the cost request should be denied and Novartis should be charged for Teva having to respond to their costs claim. Alternatively, each side should bear their own costs.   Since the Opposition was terminated early it is by no means clear that were it to have continued, Novartis would have prevailed and would be entitled to costs for the preliminary part where Teva was involved. Teva alleges that if the Novartis application is refused, not only would Teva not have to compensate them, but conceivably Novartis would have to pay the costs  that Teva incurred in filing the statement of case.

Additionally, Teva considers that the Applicants actions and the costs incurred thereby in preparation of an anticipated opposition were needlessly incurred. Teva considers that from studying other statements of opposition, there is nothing to justify the preliminary and anticipatory actions that Novartis took, and certainly one cannot hold Teva responsible for such actions. Furthermore, the actions taken by the Applicant preceded the time when Teva had to submit their statement of case – which, in the event, were never submitted.

Teva went on to allege that the claimed expenses were unreasonable when considering the stage that the opposition procedure had reached. Furthermore, these so-called expenses were, in the main, not supported by an affidavit.

The Ruling

True, Teva filed an Opposition which was then abandoned early on. The Application is, however, still being opposed by Unipharm and has not issued as a patent. In this specific case, following review of the claims and counter-claims of the parties, Commissioner Kling concluded that the request for costs to be awarded to Teva should be deferred until the Unipharm opposition runs its course, depending on the outcome thereof.

The Commissioner has the authority to delay cost ruling under section 162b of the Law:

162b The commissioner is authorized to rule reasonable costs, to determine which partner should pay costs and how they should be paid.

Generally, the Commissioner rules costs in favour of the winning party. As a general rule, the side that abandons their case for whatever reason, and consequently a patent issues, is considered as having lost the proceeding and is to bear costs of the opposing party. (See 133957 cost ruling Pfizer Products Ltd vs. Teva Pharamaceuticals 14 February 2008). Nevertheless, the awarding of costs is left to the commissioner’s discretion and this is certainly the case where the abandoning of an Opposition does not necessarily lead to a patent issuing.

In this instance, despite Teva abandoning the Opposition the proceedings are ongoing. Unipharm’s opposition is still being fought and one cannot consider Novartis as being one who has won their battle. It is thus not the time for Novartis to claim costs. Consequently, at this stage the Commissioner is refraining from determining what costs the Applicant is entitled to, and what costs the Opposer is or may be entitled to. These will be determined once the fate of IL 184027 us known.

As an afterward and without final determination of the costs themselves, the Commissioner noted that it is rather difficult to rule on costs in the manner that they were submitted, with certain facts blacked out and no support for other contentions. This makes the reasonableness, necessity of and proportionality of the alleged expenses difficult to substantiate and makes it difficult to award real costs (see Supreme Court Ruling 891/05 Tnuva Cooperative for Marketing Israeli Produce vs. The Authority for Granting export Licences of the Department of Trade and Industry p.d 60(1) 600 (30 June 2005). This is particularly the case when considering the enormous costs claimed and the early stage at which the Opposition was abandoned by Teva, prior to submission of any substantive arguments.  See the ruling of the Then Deputy.  Commissioner re IL 113433 Smithkline Beecham Corporation (SKB) vs. Teva Pharmaceuticals (30 May 2005).

Interim Ruling re Costs in Il 184027 Teva vs. Novartis Oppostion Asa Kling 19 September 2016.

COMMENT

Whilst filing an opposition and then suspending until a divisional application issues or is abandoned could be considered as a delaying tactic, often filing such divisional applications is simply a means to keep an applications pending through parallel opposition proceedings, enabling a new claim approach not conceived at the time of filing to be considered. Since Unipharm is rather good at successfully opposing patents, it is a reasonable tactic for Teva to leave it to them to challenge the validity of the allowed claims. One suspects that Teva will have made relevant prior art and arguments available to Unipharm.

The successful opposer is entitled to claim costs from the applicant. Nevertheless, I am flabbergasted that Whatstein could make a claim for over $17,000 for costs incurred by having an opposition filed against his client prior to even having a statement of case requiring analysis being submitted. There were no patents or other prior art or other evidence that needed to be analyzed and no claims that needed consideration. Apart from informing Novartis that an Opposition had been filed, it is difficult to see what work was necessarily incurred.  Submitting a blacked out statement simply flags the fact that this is unreasonable. In desperation, I went to his website and discovered that as part of patent litigation “The firm orchestrated and designed complex experiments in patent infringement and opposition proceedings and uses a network of internationally acclaimed experts and external laboratories. In addition, the firm is involved in a large number of multi-jurisdictional patent proceedings.” This certainly goes some way to explain how $17,000 worth of costs could be accumulated, but one wonders if it was proportionate, reasonable and neccessary in response to an opposition being filed prior to relevant prior art and arguments being made of record.


Extending the Deadline to File Complaint

September 13, 2016

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

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

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

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

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

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

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

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

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

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

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

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

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

COMMENT

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

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

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


Copaxone patents invalidated by the US Patent Trial and Appeal Board (PTAB)

August 27, 2016
copaxone 2

Following an inter-partes review brought by Mylan against two patents protecting Teva Pharmaceutical Industries’ Copaxone, a drug for treating multiple sclerosis, the US Patent Trial and Appeal Board (PTAB) has invalidated all claims of the ‘250 and ‘413 patents for double-dose 40 mg Copaxone (glatiramer acetate injection) multiple sclerosis treatment. However, on 24 August 2016, TEVA announced that it plans to appeal to the US Court of Appeals for the Federal Circuit.

Erez Vigodman, president and CEO of Teva, said: “We remain confident in the strength of our intellectual property surrounding Copaxone.”

“We are prepared to defend the full suite of our intellectual property through the PTAB and US courts regardless of the time required.”

copaxone 3“We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”

Teva have also announced that the PTAB had declined a request for a post-grant review on an additional Copaxone patent.

Copaxone represents 20% of TEVA’s income and the invalidation sent shares plummeting by 3%.


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

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

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

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