Coffee Whitener Trademarks in the Gaza Strip

November 6, 2017

city creamerClients sometimes ask about whether or not it is worth registering trademarks in the Gaza Strip. Recently, we’ve been handling the destruction of fake plumbing goods destined to Gaza, that were stopped at the Israel Port of Ashkelon. Delivering papers in Gaza is not easy. It can, however, be done.

Qumsieh is a Jordan firm of patent attorneys that handles IP registration across the Middle East. On 20 May 2014, Qumsieh submitted a Gaza Trademark Application for City Creamer, a coffee whitening milk substitute that comes in powder form, on behalf of their client, Bilal Mohammad AL Hamwi, in class 29. The application was assigned number 18963, then published in the Official Gazette number 54 on 28 May 2015.

coffee mateSociété des Produits Nestlé S.A. (“Nestlé”), the owner of trademark “Coffee Mate” filed an opposition against our AL Hamwi’s mark based on their earlier registrations for “Coffee Mate” based on the following grounds:
An alleged Similarity between “City Creamer” and “Coffee Mate” in terms of appearance and general look;
Coffee Mate is a well-known trademark worldwide;
Registration of the opposed mark will mislead the public about the origin of the products and will confuse the consumers between both products, and
Due to the above, allowing the registration of “City Creamer” contradicts local Trademark Law.

In their response, Qumsieh noted that “City Creamer” has no counterpart “mug design” mark to that of Nestlé’s mark, however Nestlé argued that this was irrelevant. Opponent dismissed as irrelevant. Qumsieh also argued that the figurative elements illustrated the differences in the imagery, which far outweighed the alleged similarities.

The Gaza Registrar ruled that the “City Creamer” mark could be registered. Apparently Nestlé appealed said decision before the Gaza Supreme Court, which affirmed the decision of the Registrar.

COMMENT

The colour schemes of the two marks are similar, but coffee is a product that is generally drank warm and the orange-red colour implies a warm cosy feel. The term creamer, like coffee, is generic. Showing a powder additive for coffee as a spoon for adding to coffee seems to me to be descriptive, and despite the similarities which are probably not coincidental, I think that the Gazan authorities made the right decision. It is worth comparing this ruling to the Israeli rulings concerning energy drinks and the Eden Turkish Coffee.


Become Ill? Been Injured? – ? חלית? נפצעת

October 17, 2017

This ruling concerns a Trademark Opposition filed by the Israel Bar Society against an Israel trademark application submitted by the Center for Realizing Medical Rights LTD, and follows a High Court Ruling on the legality of the services provided and a court ruling on alleged Contempt of Court. The ruling is of relevance to the IP community in light of unlicensed IP practitioners (cowboys) and this is discussed by me after reporting the ruling.

Livnat Poran.jpgThe Center for Realizing Medical Rights LTD filed a trademark application for “Become Ill? Been Injured?” on 2 January 2012 in Class 36 for “consultation services relating to tax attributes; consultation services relating to rights bestowed by insurance policies; all included in class 36, and for consultation services relating to realization of rights for health deficiencies or injury; consultation services relating to realization of social security rights; all included in class 45”.

On 17 September 2014, and after the mark was refused by the Examiner, the applicant appealed and a discussion was held with the Deputy Commissioner who, after considering the claims and evidence, agreed to allow the mark to be published for opposition purposes on 1 December 2014.

Israel BarOn 19 March 2015, the Israel Bar Association filed an opposition, and on 24 April 2015, Zechuti-Experts Regarding Medical Rights LTD also filed an Opposition. In an earlier ruling, Ms Bracha ruled that the Oppositions could be combined. However, on 1 November 2015, Zechuti withdrew their opposition, and the Israel Bar continued alone.

District Court.jpgIn parallel to the Trademark Opposition, the parties also fought a battle in the Israel Courts with the Israel Bar Asssociation filing 9279/07 Israel Bar Association vs. the Center for Realizing Medical Rights LTD with the District Court (Jerusalem), claiming that the Center was invading the legal space by providing legal services. The District Court decision was appealed to the Supreme Court in 4223/12 the Center for Realizing Medical Rights LTD vs. the Israel Bar Association.

After the claims and counter claims were submitted, the Opposer submitted the District Court ruling, the Supreme Court Ruling, a further decision regarding wasting the court’s time, and a couple of Affidavits submitted by Adv. Feldman as part of the legal proceedings. The Applicant submitted an Affidavit of their CEO as evidence.

Opposer’s Claims

OppositionThe Israel Bar Association submitted that the applied-for mark lacks distinctiveness and thus contravenes Section 8(a) of the Trademark Ordinance 1972; was against the public order and thus non-registerable under section 11(5) and was misleading and encouraging unfair competition contrary to Section 11(6). They also claimed that it was descriptive of the services provided and thus non-registerable. After a hearing on the issue, the Opposition became more focused.

The Opposer acknowledged that since the Center for Realizing Medical Rights LTD had been using the mark extensively (in radio advertising campaigns) it was widely recognized and had acquired distinctiveness, but argued that since the High Court had ruled that the Center for Realizing Medical Rights LTD should cease to offer its services, two grounds for opposition remained.

  1. The Israel Bar Association considered that the Center for Realizing Medical Rights LTD was still providing legal advice and so allowing them to register the mark would be against the public order, and
  2. The Center for Realizing Medical Rights LTD was no longer offering the services it had a reputation in, and so the marks had lost their distinctiveness and so could no longer be registered.

The Opposers also claimed that the public links the services provided to Ms Livnat Poran whose name appears in the advertisements, and not to the Center for Realizing Medical Rights LTD, so considers the mark as misleading.

The Applicants Claims

applicantThe Applicant refutes the Opposer’s allegations and affirms that the marks are distinctive, not misleading and not against the public order. They accuse the Israel Bar Association of fighting a campaign to prevent them from benefiting from their trademark and for misusing the Opposition proceeding. As to the two main claims, the Center for Realizing Medical Rights LTD considers that the alegations that the mark is no longer linked to Ms Foran, and that the Center for Realizing Medical Rights LTD is continuing to offer legal services, are both widening of the grounds for the Opposition. Read the rest of this entry »


Oppostion to Smartbike Trademark

September 17, 2017

268138El-Col Electronics (Nazareth Illit) Ltd submitted a trademark application for Israel Trademark No. 268138 in class 12.

The mark is a graphical image bearing the words Smart Bike as shown.

On 7 March 2017, an opposition was filed by Smartrike Marketing Ltd and Smart Trike MNF PTE LTd under section 24a of the Trademark Ordinance 1972, and Regulation 64a of the 1940 regulations.

On 30 April 2017, the Applicants requested an extension of time for submitting their Counter-Statement of Case in Response to the Oppositions. On 20 June 2017, the Applicant submitted their claims in accordance with Section 35 and requested that the Opposer deposit a bond for covering costs.

Section 38 of the Regulations provides the Opposer with a period that ended on 20 August 2017 to submit their evidence. In addition, the Opposer should have responded to the bond request within 20 days. However, until the time of writing this Decision, it appears that the Opposer chose not to submit evidence in an Opposition they themselves initiated. Nor did they respond to the request to deposit a bond.

Consequently, under Regulation 39, Smartrike is to be considered as having abandoned the Opposition:

If the Opposer does not submit evidence, he is considered as having abandoned the Opposition unless the Commissioner rules differently.

Since the Opposer did not submit  evidence and also failed to contact the court secretary, and since she saw no justification to rule differently, Adjudicator of IP, Ms Shoshani-Caspi ruled that the opposition be considered closed, and that Israel Trademark Application No. 268138 be immediately registered.

Based on the various considerations, she ruled that the Opposer should pay costs of 1000 Shekels + VAT within 14 days.

Opposition to Israel TM Application No. 268138, Ruling by Ms Shoshani Caspi, 28 August 2017


MANDO

August 24, 2017

MANDOHalla Holding Corporation filed two Israel Trademark Applications Nos. 257747 and 257748 for the word mark MANDO and for the stylized Mando mark in classes 12 and 35.

The marks covered Horns for motor cars, Anti-theft devices for motor cars, Wheel rims for motor cars, Cycles, Parts and accessories for cycles, Cycle rims, Wheels for motorcycles, Cycle spokes, Cycle stands, Cycle frames, Cycle handle bars, Cycle hubs, Two-wheeled motor vehicles, Air bags{safety devices for automobiles}, Steering wheels for automobiles, Reversing alarms for automobiles, Parts and accessories for automobiles, Electric cars, Tandem bicycles, Mopeds, Touring bicycles, Delivery bicycles, Bicycles, Bicycle rims, Wheels for bicycles/cycles, Bicycle spokes, Frames{for luggage carriers}{for bicycles}, Bicycle stands, Bicycle frames, Bicycle handle bars, Parts and accessories for bicycles, Handlebars, Shock absorbing springs for motor cars, Spiral springs for vehicles, Shock absorbing springs for vehicles, Spring-assisted hydraulic shock absorbers for vehicles, Air springs for vehicles, Suspension Shock absorbers for vehicles, Shock absorbing Springs for vehicles, Suspension shock absorbers for vehicles, Shock absorbers for automobiles, Brakes for motor cars, Brake linings for motor cars, Brake shoes for motor cars, Brake segments for motor cars, Disk brakes for vehicles, Band brakes for vehicles, Brakes for vehicles, Brake facings for vehicles, Brake linings for vehicles, Brake shoes for vehicles, Brake systems for vehicles, Braking systems for vehicles and parts thereof, Brake segments for vehicles, Brake Shoes for vehicles, Block brakes for vehicles, Conical brakes for vehicles, Non-skid devices for vehicle tires[tyres], Braking devices for vehicles, Cycle brakes, Band brakes{for land vehicles}, Block brakes{for land vehicles}, Brake pads for automobiles, Brakes for bicycles/cycles, Bicycle brakes, Gearboxes for motor cars, Crankcases for components for motor cars{other than for engines}, Clutch mechanisms for motor cars, Torque converters for motor cars, Gears for cycles, Reduction gears for land vehicles, Gears for land vehicles, Gear boxes for land vehicles, Transmission shafts for land vehicles, Gears for vehicles, Cranks for cycles, Bearings for land vehicles, Axis for land vehicles, Couplings for land vehicles, Axle journals, Trailer couplings, Electric motors for motor cars, Motors for cycles, Alternating current[AC] motors for land vehicles, Driving motors for land vehicles, Motors for land vehicles, Servomotors for land vehicles, Motors{electric}{for land vehicles}, Direct current[DC] motors for land vehicles; All goods included in Class 12, and Import-export agencies, Administrative processing of purchase orders, Wholesale services for freezers, Retail services for hot-water heating apparatus, Wholesale services for automobiles, Commercial intermediary services in the field of bicycles, Retail services for tires[tyres] and tubes, Wholesale services for antifreeze, Retail services for liquid fuels, Commercial intermediary services in the field of parts of vehicles, Commercial intermediary services in the field of articles of vehicles, Commercial intermediary services in the field of renewal parts of vehicles, Trade agency, Trade consultancy, Trade brokerage, Offer services [trade]; All services included in Class 35

On 23 November 2015, the marks were allowed and on 29 February 2016 an Opposition was submitted by MAN Truck & Bus AG under Section 24a of the Trademark Ordinance and regulation 35 of the regulations.

On 2 May 2016, the Applicant submitted their counter statement and on 6 October 2016, the Opposer submitted their evidence. The Applicant should have submitted their counter-evidence by 6 December 2016, but on 30 November 2016 and again on 2 February 2017, they requested and received two monthly extensions, and so had to submit evidence by 5 May 2016. Despite the extensions, the Applicant did not, in fact, submit their counter-evidence.

On July 2017, and going beyond the letter of the Law, the Patent Office Court sent the Applicant the following notice:

On 6 October 2016 you were required to submit your evidence under Section 39 of the Trademark Ordinance 1940. After receiving extensions, the deadline was set for 5 May 2017. To date, you have not submitted evidence. You have 10 days to let us know if you intend to proceed with this opposition proceeding. If you fail to respond, the case will proceed to a ruling.

The Applicant failed to respond, no evidence was received and no further extensions were sought. The secretaries referred the case to Ms Shoshani Caspi for a ruling.

In light of the above, Ms Shoshani Caspi considers the Applicant as having abandoned Israel Trademark Applications Nos. 257747 and 257748, and the Opposition is accepted for all opposed goods.

Using her authority under Section 69 of the Ordinance, and considering the fact that the Opposer had to submit a statement of case and evidence, instead of the Applicant simply actively abandoning the Application at their own initiative, Ms Shoshani Caspi ruled costs of 7500 Shekels exc. VAT.

Ruling re two Israel Trademark Applications Nos. 257747 and 257748  for MANDO by Ms Shoshani Caspi, 25 July 2017.

COMMENT

Applicant could have saved themselves fees by withdrawing. Additionally, even without submitting evidence they were entitled to request that Adjudicator consider the Opposition on its merits. It is certainly possible that MAN Truck & Bus AG do not have a strong enough case to prevent the mark being registered.

 

Procrastination can be expensive.


Polo

August 11, 2017

256843David Ibgy, who markets fashion goods, submitted Israel Trademark Number 256843 on 26 June 2013 for clothing under Section 25. The mark was allowed on 17 November 2014 and published for opposition purposes.

The mark is shown alongside.

 

82802On 27 February 2017, Lifestyle Equities CV opposed the mark. Lifestyle Equities CV is a Dutch company that has several Israeli distributors that sell clothing under their IL 82802 mark, which was registered in November 1995 in category 25 for clothing, shoes and head coverings. Their mark is shown alongside:

 

The Opposer’s Claims

The Opposer claims that their mark was developed in Los Angeles, USA, in 1982 as a mark that implies quality. Goods were sold under the mark in known chain stores in Israel, such as HaMashbir and Keds Kids, Errocca and in other fashion stores across the country.

The Opposer claims that the dominant element is the horse and rider and so the applied for mark is similar enough to their registered mark that it could be misleading and so is not registerable under Sections 11(6), 11(9) and 11(13) of the Trademark Ordinance.

To strengthen this contention, the Opposer notes that both they and the applicant use the mark for off-the-shelf clothing and consumers have inaccurate recall and so the marks are visually confusingly similar.

The Opposer notes that the two marks are directed to the same goods and that clothing with the marks are sold by the Applicant via similar distribution channels to those used by the Opposer, and the target clientele in both cases is the Israeli clothing and fashion-wearing public.

The Opposer alleges that the two marks share a similar conceptual idea that will confuse the public into thinking that the Applicant’s goods are supplied by the Opposer. Both marks have a side view of a rampant horse mounted by a polo player with a raised mallet within a ring of circles. The Opposer considers the relative proportions between the horse and the circular frame as being almost the same in the two cases.

Furthermore, Opposer alleges that due to their intensive use in Israel and the world, their mark has a reputation and may even be considered as being a well-known mark as defined in the ordinance. Due to the well-known nature of the mark, the likelihood for the public being mislead is increased.

The Opposer [Applicant in ruling, but this is a mistake – MF] therefore concludes that the situation may occur wherein the public will purchase the Applicant’s goods thinking them as being provided by the opposer or somehow connected with the Opposer, and so the pending mark is disqualified from registration by Sections 11(13) and 11(14) of the Ordinance. If the pending mark is registered, it could dilute the Opposer’s registered mark.

The Opposer claims that the Applicant acted in bad faith by choosing the horse and rider and was attempting to free-ride on the Opposer’s reputation which has been carefully established over many years. The Opposer considers the mark as representing unfair competition and is thus contrary to sections 11(6) and 12 of the Ordinance.

Furthermore, the Opposer considers the Applicant’s testimony as untrustworthy and that the Applicant has a long history of copying well-known marks and that the current mark was created by selecting elements from established marks, and so is allegedly non-registerable due to Section 11(5) of the Ordinance.

In the framework of their agreement, the Opposer claims that in addition to the applicant trying to copy the general circular appearance of the Opposer’s marks, he also chose to incorporate the olive branches that were allegedly copied from Israel Registered Trademark No. 227079 to Fred Perry (Holdings Ltd).

The Opposer also considered the applied for mark as lacking distinctive character, and thus contrary to Section 8(a) of the Ordinance, this due to the mark lacking anything unique.

Applicant’s Claims

On 22 April 2015, the Applicant responded with their counter-statement of case.  Applicant considers that there is no danger of confusion of unfair competition because the pending mark has to be considered in its entirety and in addition to the rampant horse and rider of the Opposer, the Opposer’s mark includes the words Beverly Hills and Polo Club, which are not elements of the pending mark. Applicant considers these words as central elements that are engraved in the consumer’s consciousness.

The Applicant adds that the common element of the rampant horse and rider were not created by the Opposer but have a long history in the fashion industry.

The Applicant accuses the Opposer of taking inspiration for their mark from Ralph Lauren, US Polo Association and others, and referred to such marks in use in Israel (see appendices to counter-statement of case and affidavit. The Applicant notes that the fact that the claimed motif is common and in widespread use is accepted by the international case-law.

As to the marks being confusingly similar, the pending mark has the letters PJ and not Polo Club, the marks are pronounced differently; the Opposer’s mark is jumping, whereas the applied for mark has three legs, the Opposer’s mark has a circular ring whereas the applied for mark has olive branches.

The Applicant claims to be targeting the popular market that purchases clothing in shops, bazaars and public markets whereas the Opposer is targeting an exclusive clientele by referring to the Beverly Hills Polo Club. This alone should be enough to differentiate between the Applicant’s and Opposer’s goods and distribution channels.

Finally, the Applicant considers that relating to the olive branches as being confusingly similar to those of the Fred Perry mark was only raised in the summations and is thus an illegitimate widening of the issues beyond the Statement of Case.

The Evidence

On 21 September 2015, an affidavit was submitted by Mr Eli Hadad, the director and owner of the Opposer. Similarly, the Opposer submitted an affidavit by David Bar, the director and owner of Beverly Hills Fashion Ltd which manufacturers, imports and distributes the Opposer’s products since 2008 under a franchise from Lifestyle Licensing.

On 22 November 2015, the Applicant submitted their evidence together with an affidavit. On 11 September 2016, a hearing was held, during which the parties cross-examined each other’s witnesses. The parties submitted their summaries and now the time is ripe to issue a ruling.

The Ruling

The ruling related to the following issues:

  1. Did the Opposer widen their front of attack such that references to Fred Perry and the olive branches should be struck from the record?
  2. Is the Opposer’s mark a well-known mark as defined by the Ordinance?
  3. Is there a danger of the similarity causing confusion?
  4. Did Applicant act in bad-faith in choosing the mark?

Since the argument regarding similarity to the Fred Perry mark was first mentioned in the summation, it is indeed an illegitimate widening and should be struck. However, to bring things to a final conclusion, the Adjudicator addressed this issue substantively.

Is the Opposer’s Mark Well-Known?

The Ordinance defines well-known marks and the Adjudicator went through the usual hoops, citing the Absolut and Pentax cases. The Opposer notes that Lifestyle Equities CV is one of the top 100 licensing companies. However, the Adjudicator noted that this says nothing regarding whether the specific brand and mark is well-known in Israel. The Opposer failed to establish that the brand was widely promoted in Israel. The distributor, Erroca, is widely known, but as a distributor of eye-glasses. Facebook followers and the like were not considered persuasive either. There also remained a problem that even if Beverly Hills Polo Club is a well-known brand, that does not mean that the horse and polo player are well-known.

Is there a danger of the similarity causing confusion?

Here the Adjudicator applied the triple test; the appearance of the marks being the issue rather than their sound since PJ and Polo Club sound rather different.

There is a similarity in that both marks include a horse and rider, but the horse and rider appear different, and there are other elements that are found in only one mark or the other.

Notably, unlike in similar oppositions abroad, the mark in Israel does not include the term Polo Club and the Opposer did not bring a market survey to show the similarity.

Citing the 212574 ,211841  Nautica Inc ruling from 15 February 2012:

Registration of a trademark does not provide a monopoly for a concept, such as someone holding a golf club or riding a horse, but only for the specific rendering of the idea in the mark.

The marks were not considered confusing.

 

Did Applicant act in bad-faith in choosing the mark?

The Opposer suggested that the PJ letters were taken from the trademark number 103307 for Polo Jeans Co. owned by the Polo/Lauren Company, and since the Applicant was a former worker of Polo US he could not claim ignorance of this mark. The Opposer also noted that the Applicant admitted to having a reputation for fake goods.

The Adjudicator did not find the allegations sufficiently compelling. This was also the case with the similarity between the olive branches of the trademark and of Fred Perry, which are both different.

CONCLUSION

The Adjudicator Ms Shoshani Caspi concluded that the alleged similarity between the marks did not pose a danger of misleading the consumers regarding the origin of the goods. This made the existence of absence of distinctive elements moot, since the claim was raised by the Opposer solely to base the claim of misleading similarity.

The Opposition was rejected and, using her powers under Section 69 of the Ordinance, the Adjudicator Ms Shoshani Caspi ordered Lifestyle to pay 7000 Shekels + VAT in costs.

COMMENT

I found the argument that the Applicant’s mark was for the fashion-conscious common polo-playing man, whereas the Opposer’s mark was for smart Beverly Hills playing polo set, rather amusing.

I suspect that Fred Perry’s olive branches and those of the Applicant are actually laurels.

The decision is reasonable. However, it seems contrary to the Tigris ruling. However, in general, there does not seem to be a great deal of consistency with trademark rulings.

There was an interim request by Ivgy that Lifestyle post a bond to cover costs should they lose. This was refused.

 


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


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.