Chipsico – a Competing Marks Proceeding Where Both Marks were Refused

July 11, 2017

267474On 13 August 2014, the New Dubak Natsha ltd filed Israel trademark application no. 267474 in class 29 for chips (potato crisps). The stylized mark is shown alongside, and reads CHIPSICO Batates Modalaah – (Chipsico Crinkle-Cut Potato Chips).

The same day, the Halawani Industrial Company ltd filed two trademark applications for coffee, tea, cocoa, sugar, rice, tapioca, sago, coffee substitute, flour and grain products, bread, wafers, cakes and sweets, honey, treacle, yeast, baking powder, salt, mustard, pepper, vinegar, tomato paste, seasoning mixtures, spices, frozen foods, snacks and crackers. The first application was Israel Trademark No. 267770 CHIPSICO and the second, 267772 was for شيبسيكو, which is Chipsico written in Arabic.

crinkle cutThe trademark department considered the marks as being confusingly similar and the parties failed to reach an agreement, so on 8 May 2016, a competing marks proceeding under Section 29 of the Ordinance was initiated and the parties were invited to present their evidence.

New Dubak Natsha ltd submitted: Read the rest of this entry »


Reviving an Inflatable Refrigerator…

July 6, 2017

renewIsrael Patent Number 190365 to Abraham Klanss titled “Inflatable Refrigerator and Freezer” lapsed due to failure to pay the second renewal. The Application was submitted on 23 March 2008, and so the deadline for paying the second renewal for years 6-10 was 23 March 2014.

When both the deadline for paying the renewal and the six month grace period passed, the Application was considered lapsed and a notification to that effect published in the November 2014 Israel Patent Office Journal.

From the Affidavit submitted with a request to reinstate the Application it transpired that Applicant had transferred the issue to Advocate Dror Matityahu, but the address of record in the Israel Patent Office was that of Patent Attorney Yoram Tzavyon.

From correspondence between Advocate Dror Matityahu and Patent Attorney Yoram Tzavyon it appears that the Advocate had paid the fee, despite the previous arrangement being that Tzavyon would handle the renewal.

The Applicant received no updates from his lawyer. In January 2017, after trying in vain to contact the lawyer, the Applicant received a status update from the Israel Patent Office and learned that the patent had lapsed.  The first attempt at reinstatement was submitted on paper in April. The current regulations require such requests to be submitted electronically and this happened the following month.

The circumstances described above are extreme. If Attorney Matityahu did indeed pay the renewal fee, he certainly did not send proof of payment to the patent office so the renewal was not registered in a timely manner. The Applicant for restoration has affirmed that he is unable to make contact with his lawyer so cannot clarify if the renewal was indeed paid as stated.

Section 60 provides for restoration if a request to restore a patent is submitted in a timely manner. The time that had passed since learning of the problem in January and first attempting to reinstate in April was considered by the Deputy Commissioner as being just about timely, it being noted that all the information was available from the database published on Israel Patent Office website, without requiring contacting the secretariat. The Applicant stated that he did not want the patent to become abandoned.

All things considered, despite the doubt, the Applicant can be considered as having fulfilled the requirements of Section 60 and so the Application for reinstatement is published for Opposition purposes provided the missing Renewal is paid.

Decision by Deputy Commissioner Bracha re Reinstatement of Israel Patent IL 19035, 26 January 2017.


Totachi

July 6, 2017

277424Totachi Kougyo Co ltd submitted Israel Trademark Application Number 277424. The Application was in classes 4, 7, 9, 11 and 12 and is shown alongside. The Application is the national phase of an International Trademark under the Madrid Protocol. On 6 December 2016, the mark was allowed and under Section 56vi of the Trademark Ordinance, the International Bureau was notified with details about the deadline for Oppositions.

On 27 March 2017, Total SA filed an Opposition in accordance with Section 24(a) of the Trademark Ordinance 19722 and regulation 35 of the 1940 regulations. Consequently, on 29 March 2017, the International Office was informed, together with the deadline for responding.

The Applicant had two months, until 29 May 2017 to respond to the Opposition. However, until the date of this decision, 18 June 2017, no response was received from the Applicant. On 11 June 2017, the Opposer requested that the Israel Patent and Trademark Office note that the since no timely response was received, the Opposition should be accepted and the mark considered cancelled.

The Adjudicator of Intellectual Property, Ms Shoshani Caspi, accepted this request. Consequently the mark is considered withdrawn and the International Bureau will be duly informed. No costs are awarded.

Decision re Israel Trademark Application 277424 to Totachi Kougyo Co ltd, 18 June 2017


Cancellation of Suprene Mark

July 6, 2017

LSUPRENEIsrael trademark no. 245038 is for the stylized word mark SUPRENE in class 17, for Synthetic rubber; styrenebutadiene rubber; butyl rubber; polyisoprene rubber; polychloroprene rubber; isobutylene-isoprene rubber; ethylene-propylene rubber; ethylene-propylene diene rubber; all included in class 17.The mark is owned by SK Global Chemical Co. ltd, a Korean company.

Dynasol Elastomeros submitted a request to have the SUPRENE mark cancelled.

The request for cancellation was submitted under Section 39a of the Trademark Ordinance 1972. The Statement of Claims and Counterclaims, and evidence were filed, but the parties decided to forgo the hearing, and requested that the adjudicator, Ms Shoshani Caspi, ruled on the basis of the materials on file.

SolpreneThe requester for cancellation, Dynasol Elastomeros, owns Israel trademark no. 242409 for SOLPRENE, registered on 6 May 2013.  SK Global Chemical Co. Ltd tried to oppose that mark, but left it too late by two days so the Opposition was ignored.

Dynasol Elastomeros’ Claims and Evidence

Dynasol Elastomeros claims to be a leading worldwide manufacturer of synthetic rubber that was founded in 1999. Due to their enormous investment made in marketing and promoting their trademarked goods, their competing mark has acquired a distinguishing character and is identified with the goods that are stamped with the mark. Thus the mark has become well-known and identified with Dynasol Elastomeros and their marks.

Dynasol claims that SK Global’s mark should be cancelled since it is confusingly similar in appearance, phonetically and conceptually with their earlier, registered mark.  Since the two marks are used with respect to similar goods and consumers, this could confuse the customers or result in them thinking that there is a commercial connection between the two groups of products.

In summary, Dynasol claims that the mark is unacceptable due to Section 8a as it lacks distinguishing nature; is unacceptable under Section 11(9) as it confusingly similar to Dynasol’s mark and under Section 11(6) as damaging to Dynasol’s reputation; under section 11(5) as selected in bad faith, and against the public order, and under sections 11(13) and 11(14) as being confusingly similar to a well-known mark. To support their allegations, Dynasol submitted an Affidavit by their legal counsel  Mr. Ramon Felipe Estrada Rivero .

SK Global Chemical’s Claims and Evidence

Supremes.pngSK Global Chemical is a Korean manufacturer of oils and petroleum which is the basis of the petrochemical industry, such as ethylene and propylene. They claim to be a leading manufacturer of rubber which is marketed under the SUPRENE mark.

SK Global Chemical has been using the SUPRENE mark since 1991 and it is used in 30 countries, including Israel. The mark is registered in these countries and a large marketing budget has been invested in promoting the mark. Consequently, the SUPRENE mark is identified with SK Global Chemical’s products. Consequently, the SUPRENE mark is well-known in Israel, whereas Dynasol’s SOLPRENE mark is not well known in Israel.

SK Global Chemical claims that there is no confusing similarity between their mark and that of the Applicant since the marks are visually and audibly different. They deny allegations of inequitable behavior in choosing their mark, and accuse Dynasol of choosing their mark in bad faith in an attempt to benefit from the Suprene reputation.

According to SK Global Chemical, since Dynasol are trying to cancel an issued mark, the burden of proof is on them to show that the registration was invalid. Their counter-claims were supported by an affidavit from their president, Mr. Hwa-Youp Cha.

RULING

Are these marks well-known?

Section 39a of the Ordinance states that requests to cancel a mark should be submitted within five years from registration:

 39.—(a) An application under section 38 for the removal of a trade mark from the Register on the ground that it is not eligible for registration under sections 7 to 11 of the Ordinance, or on the ground that the mark creates an unfair competition in respect of the applicant’s rights in Israel, must be made within five years of the issue of the certificate of registration under section 28.

Since the request for cancellation was timely filed, it is necessary to consider it, and so it is necessary to consider if the mark was indeed not fitting to be registered. Trademarks are property rights and cannot be cancelled in a cavalier manner. See for example, Amir Friedman “Trademarks – Legislation, Rulings and Comparative Law (2005) pages 667-670 and BAGATZ 144/85 Klil Non-Ferrous Metal Ltd. Vs Commissioner of Patents, Designs and Trademarks p.d. 42(1) 309-318 (1998):

The burden of proof to show that a mark is registerable is on the Applicant, but in a cancellation proceedings, the burden of proof that a mark is not registerable is on the challenger. The registration of a mark is a prima facie indication that it is registerable and so the burden of proof is on the Challenger to rebut this indication. In all cases where the burden of proof is on one party or another, it switches back and forth in light of the evidence submitted…so a doubt with regarding to validity or otherwise acts in favour of the mark owner.

A mark that is “well-known” under the Law is a mark that is well-known in Israel in relevant circles, and fame abroad is insufficient. See Appeal 9191/03 V&S Vin Spirt Aktiebolag vs. Absolut Shoes Ltd., 19 July 2004. When deciding whether or not a mark is well-known, the following are considered: how well-known the mark is to the relevant population, the scope and longevity of the usage, the investment in promoting the mark over time, the degree that the mark is different from other marks, the degree to which the owners had sole usage of the mark, the investment by owners in registering and enforcing the mark, etc. – Amir Friedman “Trademarks – Legislation, Rulings and Comparative Law (2005) , see also the Opposition to Israel trademark no. 93261 “Pentax” – Pentax SRL vs. Asahi Kogaku Kogyo Kabushiki Kaisha, 3 September 2003.

rubber duckBefore determining the reputation of a mark with the relevant population in Israel, it is necessary to identify the population. From the evidence submitted, the population is not the end-user purchasing off the shelf, but rather industrial entities. This can be learned, inter alia, from Section 9 of the Applicant’s affidavit and from pages 16-26 of the appendix thereof, which details the usage of their rubber, and appendix 3 of the Applicant’s affidavit and their catalogue of products. All these teach that neither the Applicant for cancellation nor the responder are targeting their goods to the end-user, but rather to companies making rubber goods that purchase the raw material from them. It would appear that the end user that purchases rubber gloves, dummies (pacifiers), rubber bands and the like, are interested in the manufacturer of the product and not in the supplier of the raw material.

From the evidence submitted, the Adjudicator is not convinced that either mark is “well-known” in the sense of the Law. In this regard, it will be noted that the parties themselves decided not to hold an oral hearing with cross-examination. However, each party attacked the other’s marks, so the court can only look at the evidence submitted and decide whether a case has been made to support the allegations and to attach evidentiary weight to the evidence.

Mr. Rivero, Dynasol’s legal counsel , testified that the company had spent a fortune in branding and promoting their mark around the world, but no numbers or supporting evidence were given to substantiate this claim. A similar conclusion was reached regarding the claim that the trademarked products had enjoyed tremendous success with the consumers, and that the mark was in use in Israel since 2003 and the products were successful. So the challenger has not reached the burden of evidence for its marks to be considered well-known to the Israeli public.

Similarly, Mr. Hwa-Youp Cha’s affidavit is insufficient to persuade that by SK Global Chemical Co. ltd’s mark is respected and well-known by the Israeli consumer. His affidavit was also unsupported by evidence and the adjudicator was not provided with any evidence of investment in promoting and marketing goods under the mark, or of the amount of sales in Israel.

In light of these conclusions, relating to cancellation under sections 11(13 and 11(14) based on the mark being well-known, is moot. Similarly, the challenger’s claim that leaving the registration in place will create unfair competition with their well known mark, contrary to section 11(6) of the Ordinance is also moot.

Is there a likelihood of confusion? The triple test

Section 11(9) states that an applied for mark must not be deceptive, as follows:

  1. The following marks are not capable of registration:

(9)   a mark identical with one belonging to a different proprietor which is already on the register in respect of the same goods or description of goods, or so nearly resembling such a mark as to be calculated to deceive;

Whether or not there is deception is determined using the so-called triple test that is found in the case-law, and is based in the sight and sound of the mark, the type of goods, the clients and marketing channels and other considerations, to which the common sense test has been added. See 261/64 Pro-Pro Biscuits (Kfar Saba) Ltd. vs. Fromein and Sons ltd. p.d. 18(3) 275 (1964), 5454/02 Taam Teva (1988) Tivoli vs. Ambosia Surprise p.d. 57(2) 438, 451-453 (2003) and Appeal 5792/99 Communication and religious Jewish Education Family (1997) Ltd. vs. SBS Publicity, Marketing and sales Promotion Ltd, p.d. 55(3) 933 (2001).

The adjudicator was prepared to accept that there was some similarity between the marks, but did not consider this similarity as deceptive. Comparison between marks has to be done between marks in their entirety. When considering allegations of deceptiveness, one should note that the consumer’s memory is imperfect. See A. H. Seligsohn Trademarks and Related Legislation (1973) p. 81 and 6658/09 Multilock vs. Rav Bareach Industries Ltd. 12 January 2010.

The Sight and Sound strand is the dominant element of the test (see Taam Teva ruling). When the marks are compared visually, it is clear that there are differences between them. In the challenged mark, the S is stylized. The first syllable is different. The challenger’s mark starts with the syllable SOL, whereas the challenged mark starts SU which is pronounced differently. The Adjudicator considers that this results in a different visual appearance as well.

The Adjudicator accepts the mark holder’s assertion that PRENE and ERENE are common suffixes in class 17 and these suffixes are established in science, particularly in chemistry, polymer sciences and rubbers. In their summation, the respondent gave many examples of trademarks that included such suffixes, particularly for rubbers, thermoplastics, plastic, polymer mixtures and the like, many of which ended with PRENE or ERENE and were registerable. The Adjudicator also accepted that the trademark register was in the public domain and reference to it did not require an affidavit (see Appeal 941/05 The Cooperative Association of Vinters of Rishon L’Zion and Zichron Yaakov Wineries Ltd. 17 October 2006). Consequently, the suffixes of challenger and respondent should be given little importance.

Although foreign case-law does not bind the Court of the Israel Patent and Trademark Office, the Adjudicator considers it worthwhile to refer to the Spanish Patent Office ruling concerning the stylized SUPRENE mark in a parallel case between the parties, regarding which it will be noted that Challenger did not appeal that ruling:

“There is sufficient word dissimilarity between them, since the only coincident term in the wording is common in almost all trademarks that cover this kind of products, in consequence it is considered that there is no reasonable risk of association between the trademark applied for and the one previously registered.”   

The Peruvian Patent Office came to a similar conclusion as well.

As to the type of goods, the parties agree that there is a large overlap in that both make rubber products of various types, however in both cases, it is the manufacturers and not the end users that are the customers and thus target group.

tiggerSince the customers are industrial companies, before purchasing large quantities of stock one can assume that they would consider the technical specification, resistance to degradation and other properties including price. These industrial customers have technical knowledge and do not purchase rubber materials without consideration, and one assumes that they would look at the stamped on supplier’s brand names and differentiate between the two competing parties. The Applicant for cancellation noted that products are typically purchased by the tonne and customers visit the factory before making a purchase, and it is only after negotiation that the seller and buyer sign a contract that specifies the supplier and the goods purchased.  In view of the nature of the customers, the likelihood of misleading is negligible.

Other Considerations

From the evidence before her, which was not subjected to cross-examination at the request of the parties, it appears that the parties are both manufacturers of raw rubber materials. The Adjudicator was not impressed that one party has a reputation that the other was attempting to ride on.

The Challenger did not bother to submit evidence of actual misleading. No affidavits of clients that were confused were submitted. The onus is on the challenger to show that misleading occurs, and with activities in 70 countries, if there was confusion, it shouldn’t have been difficult to show it. This does not mean that actual confusion is required to cancel a mark, but were such evidence to be available, one assumes that the challenger would present it.

There seems to be no basis to conclude that there is a likelihood of confusion amongst the Israeli customers. The Adjudicator considers it impossible that one or other manufacturer would inadvertently purchase the products of the wrong supplier.

Similarly the challenger’s claim that the registered mark lacks acquired distinctiveness is rejected, as is the claim that the mark was registered in bad faith to trade on the challenger’s reputation. Where there are specific clauses 11(6) to 11(9) one cannot use 11(5) (public order) as a catch-all to prevent confusion.

In conclusion, the cancellation proceeding against Israel Trademark 2458038 is rejected. The challenger Dynasol Elastomeros is ordered to pay 9000 Shekels costs.

Ruling by Ms Yaara Shoshani Caspi regarding Dynasol Elastomeros attempt to cancel Israel Trademark 2458038 to SK Global Chemical Co., 28 May 2017

 


Teva Abandons Opposition but Application Ruled Invalid Anyway

July 5, 2017

 

AstellasAstella Pharma filed Israel Patent Application No. 178249 titled “Pharmaceutical Composition for use in Solid Formulation Crystalline Solifenacin or Salt Thereof and a Process for its Preparation”. The Application was the national phase of PCT/JP/2005/005377 which was filed on 24 March 2005 and claimed priority from a couple of earlier US provisional applications.

The Application relates to a solid pharmaceutical containing Solifenacin or Solifenacin Succinate that is up to 77% amorphous as determined using NMR.

solef moleculeThe Application was allowed, and on 27 February 2002 Teva Pharmaceuticals submitted an Opposition. On 26 June 2013, Astella requested permission to amend the specification. Teva opposed some of the amendments and in an interim ruling of 19 May 2014 Ms Jacqueline Bracha approved some of the amendments, which were then published for Opposition purposes, and since no oppositions were submitted, were then allowed. This ruling relates to the amended specification.

On 29 July 2015, instead of submitting an amended statement of case, Teva abandoned the Opposition. Nevertheless, on 27 March 2016, in a detailed ruling, Ms Bracha explained to Astella that under the Authority granted by Section 34 of the Law, she was refusing to grant the patent. The ruling was based on two publications that Teva had submitted in the Original statement of case that showed that persons of the art would expect the rate and degree of solubility to increase with increased amorphousness of a tablet. On 22 May 2016 the Applicant requested an oral hearing which was held on 4 January 2017 and this ruling follows that hearing.

Applicant’s Claims

Astella, represented by Gilat Bareket, claimed that in a Section 34 proceeding, the burden of proof is on the Commissioner. The claim that since the Opposition was abandoned and following allowance by the Examiner, there is an assumption of validity. Therefore, the Commissioner has to overcome this rebuttable assumption.

The Applicant claims that the prior art describes a process for fabricating Solifenacin hydrochloride crystals. It did not relate to amorphous Solifenacin or to degradation of the amorphous Solifenacin or to medical formulations comprising Solifenacin Succinate.

The Applicant claims that there is a continuous decrease of the active ingredient due to degradation which they determined to be due to the amorphous Solifenacin that is produced in when preparing the tablets.

The Applicant clarified that restricting the amount of the amorphous Solifenacin to no more than 77% increases the stability and reduces degradation to rates tolerable in Japan. Furthermore, the Applicant found that when the fabrication process is wet granulation they can control the amount of amorphous material by controlling the moisture levels. They also claim that using PEG as a binder also lowers the degradation, however the Deputy Commissioner notes that this was not claimed and is thus not part of the invention.

As stated, the invention is intended to provide a stable formulation with less than 0.4% degradation of Solifenacin Succinate in the total amount.

The discussion related to the following publications:

  • Ahlneck and G. Zografi., The Molecular Basis of Moisture Effects on the Physical and Chemical Stability of Drugs in the Solid State,Int. J. PHARM., vol. 62(2-3) (1990) – “Appendix 10”;
  • Y.Shalaev and G. Zografi., How Does Residual Water Affect the Solid-State Degradation of Drugs in the Amorphous State?, J. PHARM. SCI., vol. 85(11) (1996) –  “Appendix 9”;
  • C. Hancock and G. Zografi., Characteristics and Significance of the Amorphous State in Pharmaceutical Systems, J. PHARM. SCI., vol. 86(1)(1997) – “Appendix 11”.

The Burden of Proof

The Applicant alleges that the burden of proof resides with the Commissioner. In Y Kedmi “On Evidence”, 4th Edition 2009, it is stated that the burden of evidence depends on the substantive law:

The determination regarding which side bears the burden of proof depends on two basic principles:

  • “The one seeking redress has the burden of proof” [Baba Kama 46a] and this may be plaintiff or the defendant, depending on circumstances.
  • “Evidence follows the Substantive Law” – both when establishing the basis of the legal claim / defense, and when overcoming presumptions.

burden of proofAs a general rule, the burden of proof that a patent application is registerable is on the Applicant see 665/84 Sanofi ltd. vs Unipharm ltd. p.d. 41(4) 729 and Appeal 645-06-13 Unipharm vs. Lilly Icos, 26 January 2014.

The Opposition is considered as a completion of the Examination, and the allowability is reconsidered. It serves to protect the integrity of the register and the executive examination, see Opposition of IL 136482 Bromium Compounds ltd vs. Albermarle Corporation USA, 7 November 2010:

It appears that the attitude of the court has changed since then. Now the Supreme Court sees the Opposition process as a completion of the executive examination that is designed to ensure the public interest and the integrity of the register.

The public interest that the Opposition proceedings serves is detailed in 2826/04 Commissioner of Patents vs. Recordati Ireland Ltd. p.d. 59(2) 85.

The purpose of the Section 34 proceeding is identical to that of Oppositions, i.e. to maintain the integrity of the register, see the Section 34 ruling concerning IL 156034 Serguei Borisovish Sivolovenko vs. Diamcad NV, 25 January 2015:

The Section 34 proceeding is another hurdle that the Applicant may have to negotiate before receiving a patent. During this proceeding, the Commissioner is allowed to consider all the material before him from the Opposition proceeding, and to decide whether to uphold the Examiner’s decision or to change it. The purpose is no different from that of Examination or Oppositions, and is to protect the integrity of the register and the public interest to not issue patents contrary to Section 3 of the Law. Successful negotiation of the Examination stage does not bestow a right to a patent.

The patentee’s right to a monopoly for the patented invention is in rem. Consequently he has to show that the invention fulfils all the requirements of patentability under the Law. The burden of proof only changes once a patent issues. This was clarified by Commissioner Kling in IL 142896 and IL 179379 Medice Arzneimittel GmbH & Co.KG Alkermes Pharma Ireland Ltd, 4 April 2017.

In a cancellation proceeding, the burden of proof that a patent is invalid is on the Requester for cancellation. For example, this was established in Appeal 8802/06 Unipharm ltd. vs. Smithkline Beecham PLC, 18 May 2011:

Section 37 of the Law completes this idea by establishing that Examination and granting of a patent do not guarantee it has validity. So the issuance of a patent by the Commissioner does not create a non-rebuttable assumption of validity. It merely establishes that the Commissioner considered it issuable. (appeal 47/87 Hasam Systems for Defence of Trustworthiness ltd. vs. Bahari, p.d. 45(5) 194, 201-202 (1991). However, the burden of proof that an issued patent is invalid is on the party claiming invalidity (See Appeal 665/84 Sanofi vs. Unipharm ltd. p.d. 41(4) 729, 736 (1987), Appeal 700/78 Isisco International Company for Solar Energy Systems ltd. vs. Banit, p.d. 34(1) 757, 763 (1979).
Thus, before a patent issues, the burden of proof is on the Applicant.

Validity of Patent Application

On page 2 of the Application, the Applicant notes that solifenacin was known as was its efficacy for treating diseases of the urinary tract, salts of solifenacin and the crystalline state of solifenacin hydrochloride and methods of manufacture.

VesicareSolifenacin Succinate was used in Vesicare, see accompanying flyer which was published in December 2004, before the priority date of the present application. The synthesis of Solifenacin Succinate is also described in the prior art (Appendix 3 of the Opposer’s Statement).

The Applicant claims that during development of the formulation they discovered that there is degradation where the amorphous state is present. The Applicant claims that the prior art was unaware of this phenomenon and thus did not address it.

Appendix 9 page 1137 teaches that exposure of solid pharmaceuticals to high moisture results in degradation:

“It is widely recognized in the pharmaceutical field that exposure of solid drugs (small molecules or proteins) to high relative humidity and the resulting association of water vapor with the solid generally accelerate the rate of chemical degradation.”

Further on it is mentioned that the instability typically occurs in the amorphous part of the formulation:

“…most instabilities observed for drugs occur in solution much more readily than in the solid state; when they do occur over practical time scales in the solid state, it is very likely that the reaction is taking place in the more disordered amorphous regions of the solid. Indeed, it has been shown in a number of cases that under otherwise identical conditions reactivity of a particular substance in the amorphous state is greater than that in the crystalline state.”

Appendix 11 teaches that in cases where the active ingredient is found in an amorphous form, this is likely to accelerate the degradation. However, sometimes, the amorphous form spontaneously crystallizes:

“The high internal energy and specific volume of the amorphous state relative to the crystalline state can lead to enhanced dissolution and bioavailability, but can also create the possibility that during processing or storage the amorphous state may spontaneously convert back to the crystalline state.

… In the first, a material may exist intrinsically in the main amorphous state or it may be purposefully rendered amorphous and we would like to take advantage of its unique physical chemical properties. Under these circumstances we usually want to develop strategies to prevent physical and chemical instability of the amorphous sample. In the second case, we may be dealing with a crystalline material that has been inadvertently rendered amorphous during processing. This type of amorphous character usually exists predominantly at surfaces at levels not easily detected and has the potential to produce unwanted changes in the physical and chemical properties of the system. In this situation we usually want to process the system so that the amorphous portions of the solid are converted back to the most thermodynamically stable crystalline state.”

amorphousThe Application describes attempts by the applicant to prove that there is a connection between the amorphous state and the results of degradation F1 (table 2 on page 38 of the Application.

The Applicant compared the stabilities of samples 1-4 that included 63%, 73%, 715 and 7% amorphous material, with samples 1-3 that contained 92%, 90% and 92% amorphous material. However, the results of table 2 do not show a clear correlation between the amount of amorphous material and the F1 decomposition product. For example, example 1 had 63% amorphous material but only 0.31% F1, whereas example 2 had 73% amorphous material but only 0.29% F1, and in comparative sample 1 with 92% amorphous material  there was 0.48% F1, and in comparative sample 3 with 92% amorphous material  there was 0.4% F1.

Furthermore, as can be seen from table 2, the moisture of the granulate influences the F1 breakdown product, and can at least partially explain the difference between the results of comparison samples 1 and 3. The Applicant claims that there is some correlation between the water content of the granulate and the amount of amorphous material but it is not certain that the amorphous material content influences the amount of F1 degradation product.

japaneseFurthermore, it appears that the 0.4% limit that the Applicant set was based on the Japanese Health Ministry requirements and was not empirically determined. The Applicant admits that the Japanese acceptable limit was 0.5% and 0.4% is preferable. Table 2 shows that even where the amorphous quantity exceeded 77%, less than 0.5% of F1 was obtained.

Even if we assume that the Japanese Ministry of Health limits are desirable, the applicant has not established that there is a problem attaining these limits that the invention overcomes, due to the stability of the salt. The 77% amorphous material limit is also not empirically established. The Applicant was not able to produce Solifenacin Succinate with more than 0.5% F1 degradation product, and there is no linear connection between moisture content and amorphous material content.

Applicant does not deny that amorphous Solifenacin Succinate can spontaneously crystallize (see Appendix 2 and letter of 5 December 2012 and “Analysis of Appeal in European examination file from 17 April 2012 that the Applicant submitted in the corresponding European application. The slight differences in F1 product are even less significant due to this spontaneous crystallization.

There are a few more paragraphs regarding the various compositions and the binder (that wasn’t claimed and then, the Deputy Commissioner states that) from another angle, Appendix 9 teaches that there is a close connection between moisture and the amount of amorphous material present – page 113:

“Generally, for reactions occurring in the amorphous solid state, the rate of reactivity increases with increasing water content, and this can be attributed to the ability of the amorphous solid to absorb water vapor into its bulk structure, forming an amorphous solution. In a few cases it has been reported that a certain amount of water must be present to ensure chemical stability, e.g., lipid peroxidation rates decrease with the addition of small amounts of water; however, a destabilizing effect of absorbed water is more generally the case for the major types of drug degradations, e.g., hydrolysis, oxidation, or deamidation.”

So it seems that average persons of the art at the time in question would conclude that limiting moisture would limit the amorphous material in the formulation and this would, in turn, limit degradation. Consequently, this has no inventive step whatsoever.

CONCLUSION

The invention is wholly lacking in inventive step and so the IL 178249 Application is rejected.

COMMENTS

I am not a pharmacist, but have a fairly strong background in chemistry. It seems to me to be fairly obvious how to control the crystallization rate and extent, and how this will affect solubility. Possibly high school thermodynamics in inadequate, but a basic undergraduate course of chemical thermodynamics is more than adequate to predict this invention, so it seems to me that the Deputy Commissioner was correct to refuse the patent.

Formally, the Opposer is wrong to claim that the onus of proof is on the Commissioner. The case-law considers the Opposition proceeding as part of Examination and does not assume that the Examiner concluding that an invention is patentable establishes a presumption of validity. TEVA’s withdrawal of their Opposition may have been a commercial decision. In practice, although formally Israel requires an inventive step, an Examiner has to show anticipation or obviousness not to grant a patent. TEVA made some of the scientific literature of record, and the Deputy Commissioner was correct to relate to it.

This decision seems to be correct. However Astella, may appeal it to the courts.


Unipharm Awarded 200,000 Shekels Costs

July 3, 2017

UnipharmIn the past we reported the ruling concerning Unipharm’s Opposition to IL 195087 to Novartis. On winning the Opposition, Unipharm filed a request for costs.

OVERVIEW OF OPPOSITION

The patent published for opposition purposes on 31 October 2012, and Unipharm submitted their Opposition on 3 January 2013, and a statement of case on 26 February 2013. The Applicant amended the application on 26 June 2013, and as no opposition to the amendments were submitted by Unipharm or by the public, the amendments were allowed. There was an intermediate attempt to have the case thrown out that Novartis lost, where costs of 5000 Shekels were awarded to Unipharm on 24 February 2014.

On 24 February 2017, an oral proceeding took place. The Opposer submitted their summation on 24 August 2016, and the Applicant submitted their summation on 30 November 2016; response to which was filed on 20 December 2016.

In a ruling of 21 February 2017, the Opposition was accepted and the application was rejected.

Following Unipharm winning the Opposition proceeding, they submitted a request for costs, asking for 311,217 Shekels as follows:

  1. Refund of 2000 Shekels filing fee for filing opposition
  2. 5000 Shekels previously ruled against Unipharm for unsuccessful interim proceeding consisting of trying to get the Opposition thrown out
  3. 5000 Shekels awarded against Opposer in decision of 28 July 2015 regarding getting some of the evidence struck from the record
  4. 34,392 Shekels for interim proceedings
  5. 72,549 Shekels for preparing for cross-examination and attending hearing
  6. 108,980 Shekels for summation
  7. 48,296 Shekels for analyzing and responding to Applicant’s summation
  8. 35,000 Shekels for preparing the request for costs

The request for costs was supported by an Affidavit from CEO Mr Zebulun Tomer.

In the early stages of the Opposition, Unipharm was not represented. Mr Zebulun Tomer filed the Opposition himself and only after filing a statement of case, was Adv. Adi Levit employed. Mr Tomer additionally requested costs for his own time, but did not elaborate.

The Applicant alleged that the costs requested were not justified and were exaggerated. Applicant also alleged that a lot of the costs, such as costs incurred in trying to get evidence struck from the record, were not refundable.

The Ruling

The Commissioner’s authority to rule costs is based on Section 162b of the Israel Law of Patents 1967:

The Commissioner has the authority to rule reasonable costs and to decide which of the parties will pay the costs and how they will be paid.

rulingAs ruled by the Supreme Court in Bagatz 9891/05 Tnuva vs. The Authority for Imports pd. 60(1) 600, 615 30 June 2005, the costs award considers circumstances, the amount of work performed, particularly in submissions and preparing evidence, complexity, stage reached, equitable behavior of the parties, and so on.

Costs are not intended to be refund of all expenses laid out, so that, for the winning party, it would be as if they never laid out money. Sometimes a party does NOT receive full costs: See IL 13433 Smithkline Beecham Corporation (SKB) vs. Teva Pharmaceuticals ltd., 30 May 2005.

Furthermore, to the extent that costs appear extraordinary, the amount of details required to substantiate the claim for costs that is required is more. See Opposition to IL 153109 Unipharm vs. Mercke Sharp & Dohme Corp., 29 March 2011.

The Commissioner does not consider that Unipharm’s submission was sufficiently detailed with regards to attorney fees incurred. Submitting invoices that do not detail the work done is insufficient. There is no detail regarding the attorney’s hourly rate and the number of hours worked. The Commissioner also does not consider the costs requested were reasonable when considering the specific case.

calculationHowever, the winning party is entitled to recoup costs. Since the applied for costs were insufficiently detailed, the Commissioner estimated costs, basing himself on the Tnuva and other rulings.

 

After doing his calculations and estimations, etc., the Commissioner ruled 200,000 Shekels + VAT as appropriate costs for the legal work undertaken.

 

Dr Tomer’s Costs

Citing the appropriate precedents, including Opposition IL 173788 Unipharm vs. Lundbeck, IL 166621 Unipharm vs. Neurocrine Biosciences Inc., etc., the Commissioner ruled that Unipharm’s CEO’s time could not be charged to the Applicant.

Refunding costs of Opposer for Application to have Evidence Struck from Record

It has been established that one does not charge a party for costs that opposing party incurred in interim procedures that were rejected – See Opposition to IL 141762 Unipharm vs. Novartis, 21 June 2013.

Conclusion

As to the previous issued ruling of 25 April 2014 that Novartis should pay 5000 Shekels costs to Unipharm for failed attempt to have opposition thrown out, the Commissioner considered this sum as outstanding, but that there was no need to readdress the issues.

The Commissioner thus ruled that Novartis should pay 2000 Shekels legal fees and 200,000 Shekels + VAT costs to Unipharm.

Opposition by Unipharm against ILL 195087 to Novartis, Ruling re Costs by Asa Kling 7 May 2017


Dummy Targets and Decoys

June 29, 2017

This ruling relates to claim construction and permissible amendments.

IAIIsrael Aircraft Industries submitted Israel Patent Application Number 190197 titled “Method for Performing Exo-Atmospheric Missile’s Interception Trial”  back in March 2008.  The application was first filed in Israel and does not claim priority from foreign applications. On allowance, the application published for opposition purposes and Rafael Advanced Military Systems Ltd filed an opposition.

The independent Claims  1 and 15 of the application are as follows:

“1. A method for facilitating exo-atmospheric ground to ground (GTG) missile’s interception trial, comprising:
Launching a carrier accommodating at least one inflatable dummy target, said carrier being configured to release an inflatable dummy target therefrom; said dummy target or portion thereof is configured to be inflated and has characteristics that resemble a GTG missile characteristics; said dummy target is configured to re-route its flight trajectory during its release from the carrier for at least (i) facilitate sensing of interception during the END GAME, (ii) assuring that the carrier being substantially out of the field of view of the interceptor during the END-GAME, or assuring that the carrier being substantially in the field of view of the interceptor during the END-GAME at the pre-defined location relative to the dummy target;
Launching an interceptor for exo-atmospheric interception of the dummy target; and
Receiving communication of data sensed during the interception process.”

“15. A method for simplifying exo-atmospheric ground-to-ground (GTG) missile’s interception trial, comprising:
Providing at least one inflatable dummy target that is manufacturable in considerable simpler manufacturing process than a GTG missile, and capable of manifesting characteristics that resemble characteristics of the GTG missile and wherein use of said inflatable dummy target prevents near and far safety problems;
Providing a common carrier missile capable of accommodating at least one dummy target irrespective of the characteristics thereof;
Whereby said common carrier missile is capable of being launched and being configured to release the at least one inflatable dummy target at selected exo-atmospheric location, for testing the ability of an interceptor missile to intercept said dummy target at exo-atmospheric interception point, thereby testing the interceptor’s operational feasibility to destroy the GTG missile.”

Rafael based their Opposition on the following publications:

  1. Development of Coherent Laser Radar at Lincoln Laboratory, 2 Nov 2000
  2. An Internet page from The Federation of American Scientists (FAS) 22 Nov 2002
  3. Explanation of why the sensor in the exo-atmospheric kill vehicle (EKV) Cannot reliably discriminate decoys from warheads from 2000
  4. US 3,290,681 from 6 December 1966
  5. US 3,411,778 from 19 November 1968
  6. US 3,212,730 from 19 October 1965
  7. US 2002/0149996 from 17 October 2002

rafael.pngRafael considered that the claimed invention lacked novelty contrary to Section 4, and lacked  inventive step contrary to Section 5. Furthermore, the specification was allegedly not enabling contrary to Section 12a of the Law. Rafael further alleged that a major amendment during the Examination process required that the application be post-dated and thus the PCT application based on the Israel application anticipated the claims as issued. Read the rest of this entry »