IL 136294 Pharmacia and Upjohn Successfully Opposed by Teva

October 20, 2014

Pharmacia

Pharmacia and Upjohn filed IL 136294, titled “Use of tolterodine, its 5-hydroxymethyl metabolite or racemate thereof in the preparation of medicaments for treating unstable or overactive urinary bladder”. On 6 May 2004, Teva filed an opposition.

The Application was a national phase entry of PCT/SE99/01463 which claimed priority from SE 9802864-0 and SE 9802871-4 filed on 27 August and 11 November 1998 respectively.

On 11 June 2003, a Divisional Application (IL 156414) was filed. Following the publication of patent office circular M.N. 23, the Opposition was frozen pending Examination of the Divisional Application. On 20 March 2006 the Divisional Application was abandoned and the file closed, and the Opposition procedure in the parent application was restarted.

On 19 June 2006, Teva submitted a detailed Opposition and Upjohn filed a counterclaim on 13 November 2006. Following submission of evidence, counter-evidence and responses, a hearing was held on 1 and 2 April 2009 before then Commissioner, Dr Meir Noam.

After the hearing, the parties submitted their concluding remarks between 21 April 2010 and 26 January 2012, after Dr Noam’s term of office finished. The Present Commissioner, Asa Kling, ruled on the case under regulation 202a, on the basis of the material in the file.

According to the Commissioner, the Opposition is two-fold. The Opposers argue that there is no inventive step in contravention to Section 5 of the Patent Law, and that the claimed invention is a method of treatment of Man and thus contrary to Section 7.

The Opposer, Teva, submitted their evidence via an opinion of Professor Danon. The applicant, Upjohn, submitted their evidence via an Opinion from Professor Abrams and a statement of Dr Wood. Teva submitted counter-claims via a second affidavit of Prof. Danon and an opinion by Professor Mor.

The patent relates to a treatment for sufferers of unstable or overactive urinary bladder. The problem is caused by a lack of control of smooth muscles around the bladder that receive electronic stimulation. The standard treatment at the time of filing involved desensitizing the nerves with tolterodine or oxybotynin. Both desensitizers had various adverse side effects including dryness of mouth. In minimizing this side effect, tolterodine was preferable to oxybotynin. Tolterodine is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine, where R indicates the Right handed enantiomer, and S, the sinister, or left handed enantiomer which does not work. The two desensitizers and the enantiomers are discussed in the specification.

The Application as allowed had 17 claims, of which claims 1, 8, 16 and 17 are independent.

Claim 1 is as follows:

  1. Use of tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, in a pharmaceutically effective amount thereof through a controlled release formulation capable of maintaining a substantially constant serum level of the active moiety or moieties for at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h, for the manufacture of a therapeutical formulation for treating unstable or overactive urinary bladder, substantially as described in the specification.

Claim 16 is similar, but includes the following limiting feature:

… with reduced undesirable side effects and with no reduction in the efficiency of the tolterodine compound…

Claim 8 is as follows:

  1. A pharmaceutical formulation containing tolterodine, its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, which formulation when administered to patient provides controlled release of said tolterodine its 5-hydroxymethyl metabolite or the recemate corresponding to tolterodine, or a pharmaceutically acceptable salt thereof, such that a substantially constant serum level of the active moiety or moieties is maintained foe at least 24 hours, wherein the 24-hour serum profile, expressed as the AUC of unbound tolterodine and 5-hydroxymethyl metabolite, is form 5 to about 150 nM*h.

Claim 17 follows claim 8 , but includes the following limiting feature:

…for efficacious therapy with reduced undesirable side effects…

In order to ascertain inventive step or non-obviousness, the standard is that of a person of the art. Professor Danon and Dr Wood are pharmacologists. Professor Mor and Professor Abrams are urologists. Both sides argued whether in this case the person of the art to determine non-obviousness would need to be would need to be a pharmacologist, a urologist or a team including both skills. Accroding tot he Commissioner, this question may be answered by reference to Former Supreme Court President Shamgar in 345/87 Hughes Aircraft vs. State of Israel P.D. 44(4) 45 (1990) as including a person or team with knowledge of relevant subject matter but no creative ability. The Opposer (Teva) considers the person of the art to be a pharmacologist specializing in the relationship between active ingredients and the human body. The Applicant considers that persons of the art may be a team including pharmacologists and doctors of the relevant speciality, which in this case includes urologists.

The Applicants distinguish between the pharmacological and the pharmo-kinetical aspects of the invention, which in their words, are directed to a pharmacologist or formulator, and the medicinal aspects of the drug which are directed to a urologist. Professor Abram’s opinion follows this distinction.

“Obviously, once the pharmaceutical invention is made… pharmacokinetic and pharmacologic considerations become relevant. However, unless the pharmaceutical invention is made first, the pharmacologist is not a relevant person.”

According to the Applicant, the motivation to develop a drug is based on medical needs and so the application is primarily directed to the urologist, and other professionals, such as pharmacologists are consulted only once the drug is being developed to answer a specific medical need.

The Opposer considers that the medical need is the problem to be solved, and the person to be consulted to solve the problem is the person the art. Support for this position is found in “Patents for Inventions” by T.A. Blanco White, 5th Edition page 90:

“In principle, it would seem clear that the proper people to think of in judging obviousness are those who would in practice be called upon to solve problems of the sort concerned.”

Furthermore, the Expert for the Applicant Professor Abrams himself stated that the urologist might identify the clinical condition and would describe it to the pharmacologist, which strengthens the position that the person of the art is, in fact, the pharmacologist.

The Commissioner ruled that the person of the art is indeed the pharmacologist, although the urologist might well initiate the process of developing a drug.

Support for this was found in Alza Corporation vs. Mylan, a US ruling concerning urine leakage, where it was stated that:

“In their post-trial memoranda, the parties do not directly dispute the level of ordinary skill in the art at the time of the ‘355 patent’s filing. Thus, based on the testimony of Dr. Amidon and Dr. Peppas, the Court finds that a person of ordinary skill in the art has either an advanced degree in pharmacy, biology, chemistry or chemical engineering and has at least two years of experience with controlled-release drug technologies, or possesses a bachelor’s degree in one (or more) of the same fields and has at least five years of experience with controlled-release drug technologies.”

Consequently, the Commissioner ruled that whilst a urologist could be included in the team, the persons of the art defining obvious would include a pharmacologist.

As far as inventive step is concerned, the issue in question boils down to whether something would have been considered obvious by a pharmacologist, or by a team consisting of a pharmacologist and a urologist.

Both sides agreed that:

  1. As of the priority date both tolterodine or oxybotynin in instant release form were being used to treat unsteady or over-active bladders. Furthermore, oxybotynin was also being used in a controlled release form.
  2. It was understood that oxybotynin caused more serious side effects of dry-mouth and thus tolterodine was the preferred treatment.
  3. Dry mouth symptoms of tolterodine were most prevalent when tolterodine was at its highest concentration in the blood.
  4. It was already established that tolterodine had a positive effect on unsteady or over-active bladders after its effect on saliva forming and the symptoms of dry-mouth had disappeared.
  5. Moving from instant release to slow release formulations may not be successful for treatment of unsteady or over-active bladders and the efficacy required clinical trials.
  6. The Applicants considered that the minimal problems of dry mouth associated with tolterodine in quick release form were such that there was no motivation to develop a slow release version of the drug. Furthermore, slow release Oxybotynin did not have less slide effects than the quick release version so the urologist would be likely to conclude that slow release tolterodine would behave in a similar fashion.

Finally, according to the Applicants, it transpires that the slow release tolderine is actually more effective. This is not supported by the specification and is first raised as a consideration in the Applicant’s statement of claims. There is no evidence that Applicant was previously aware of this point.

The Applicant does not claim that this fact is relevant to the issue of inventiveness, but the commissioner nevertheless emphasizes that such post filing revelations are irrelevant to the issue of inventive step (non-obviousness) and the Applicant can’t turn the clock back. There has to be an inventive step at the time of the priority filing (albeit, possibly one discovered by accident).

The parties now debated a very interesting point. Regardless of the surprising improvement of the not particularly serious dry mouth side effect, according to Teva there was a drive towards creating a slow release version of the treatment since this would enable taking a pill once a day instead of twice a day. They consider this fact self-evident and not requiring scientific proof.

Upjohn countered that this advantage of merely reducing the dosing frequency would not have warranted a switch to a controlled release treatment. They considered that the frequency of dosage was a minor issue for chronically ill patients and thus with the anticipation of increased side-effects, the drug developer would have no drive to develop a controlled release version. Citing Goldstein and Kalman:

“Certainly the oral ingestion of a drug 3 or 4 times daily presents no hardship to the patient; the substitution of a single daily dose of a sustained-release preparation would not be warranted unless some advantage other than convenience had been demonstrated.”

The Commissioner rejected this argument, preferring Glaxo group LTD’s Patent [2004] R. P. C. 843:

“That salmeterol would be the obvious substitution for salbutamol follows from the most basic consideration, that a drug that only needs to be taken twice a day will encourage compliance.”

And

“…the patent must be invalid, because I consider that the problem of compliance has, on the evidence, always been a problem.”

The Opposer considered that despite possible problems in achieving, it is obvious to try to reduce the dosage frequency, and thus a mere change in dosage frequency achieved by a coating is not inventive.

The Applicant countered that the development of a slow-release version warranted a patent since there were many cases where controlled release was less than successful, and they brought three examples of this.

The Opposer showed why the three examples were all exceptions to the rule and the commissioner felt that the onus was on the Applicant to show why this instance should be considered inventive.

Both parties accepted that tolterodine was preferable because of its lesser severe side effect of dry mouth. The Applicant considered that this being reduced further by controlled release dosages was patentable.

“According to the present invention it is now surprisingly been found that contrary to the case of oxybutynin, the substantial elimination of peak serum levels of tolterodine and its active metabolite through controlled release of tolterodine for an extended period of time, such as through a once-daily administration form, while maintaining the desired effect on the bladder, indeed gives a significant reduction of the (already low) side effects, particularly dry mouth, compared with those obtained for the same total dosage of immediate release tablets over same period.”

The commissioner noted that Upjohn had stated that this was a surprising discovery, but that they had not actually explained why this was the case. He noted that the Opposers reasoned that if regular tolterodine has lower dry mouth side effects than oxybutynin, this would remain the case with quick release versions.

The commissioner felt that the Applicants had not explained why, despite the fact that occasionally slow-release preparations might have unwarranted side effects or efficacy issues, it would not have been obvious to try to reduce the frequency of the dosage to once a day only.

Furthermore, earlier patent WO098/03067 notes that the S-enantiomer is preferable to the R-enantiomer and suggests a more frequent dosage or a controlled release. On this point, the Applicant tried to argue that since the current application relates to the S-enantiomer only, the earlier patent was irrelevant. Furthermore, the earlier patent suggests multiple frequent dosages which teaches away from the present invention. The commissioner did not find these arguments persuasive and still considered it would be have been obvious to try.

The Opposer considered the experimental evidence as totally anticipated by persons of the art and that there was nothing surprising in it.

The cut and thrust of the parties is reported in depth, but the general tendency of the Commissioner is to uphold the ruling in IL109059 F. Hoffmann-La Roche AG vs. AGIS Industries (1983) LTD from 17.10.2004 that it would have been obvious -to-try.

“First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile.” (Brugger v. Medic-Aid Ltd., [1996] R.P.C 635 at 661)

“… Whether the subject matter was obvious may depend upon whether it was obvious to try in the circumstances of that particular case and in those circumstances it will be necessary to take into account the expectation of achieving a good result. But that does not mean that in every case the decision whether a claimed invention was obvious can be determined by deciding whether there was reasonable expectation that a person might get a good result from trying a particular avenue research. Each case depends upon the invention and the surrounding facts. No formula should be substituted for the words of the statute. In every case the court has to weight up the evidence and decide whether the invention was obvious. This is the statutory task.” (Norton Healthcare v. Beecham Group Plc, CA, (1997)) ([2004] R.P.C. 43 at para 42)

Consequently, the claimed invention was found to be obvious and the Opposition was accepted.

Opposition by Teva to IL 136294 Pharmacia and Upjohn, Assa Kling, 30 September 2014.

COMMENTS

I am neither a pharmacologist nor an urologist, (although I do enjoy taking the $%*& against poor decisions occasionally). It is established that the standard of inventiveness of obvious to try. Both sides accept (at least tacitly) that when taking tolterodine, once the problem of dry mouth is addressed, it would be obvious to try a slow release formulation, so the solution is fairly obvious. The question remains whether identification of the problem as a problem is worthy of a patent. Here the pro-pharma lobby will stand on their chairs and wave banners that of course this is patentable, whereas the generic side of the industry will have serious reservations. This may not just be a question of who pays one’s bills. It is at least possible that attorneys and scientists with different philosophies get drawn to the different market sectors that reflect their look on life.

Having a general background in chemistry but no background in pharmacology I tend to side with the generic industry. I suspect that most impartial patent attorneys with backgrounds in computing or engineering would find the Applicant’s arguments tortuous and unconvincing.

One question not addressed is why they chose to try to develop a controlled release version if there was no a priori assumption of it being preferable? (If the answer is ever-greening, is this acceptable, or is it obvious to try to keep a drug patent protected indefinitely?

Arguably the standard of obvious to try is to high, but it is the standard that Dr Meir Noam, the previous commissioner set. He was a chemist.

The present commissioner, Asa Kling is an aeronautical engineer.  He is no more a person of the art than I am. Nevertheless, his position as commissioner requires him to decide who the person of the art is, what is the standard for inventiveness and particularly whether identifying the issue of this side effect is in and of itself an inventive step. Really the issue is one of policy. The drug development industry will no doubt cry out that the Israeli standard is too high, whilst the generic industry will be more supportive of this ruling. If this ruling is appealed to the courts, the Commissioner’s determination will be scrutinized.

 


Astrologist Successfully Sued for Copyright Infringement of New Card Designs – She didn’t see it coming

October 20, 2014

Astrological cards

Zur-Klein is  an astrologist. Tal Rinkov is an artist who created 37 cards for the Astrologist in accordance with an agreement between them which, inter alia, related to the copyright ownership.  (Ms Rinkov was also the kindergarten teacher of Ms Zur Klein’s daughter, which is how they met (some would say it was fate).

Ms Zur-Klein ordered 40 card designs for a payment  of 5000 Shekels.  The cards were to be mass-produced and distributed with an instruction manual and a teaching movie. The parties entered an agreement on 5 September 2014 that established several principles:

  1. The original artwork and the copyright of the artwork was to remain that of the artist.
  2. The artist would not be entitled to royalties for packs of cards and other goods itemized in the agreement
  3. The Astrologist would only be entitled to use the images on specific listed items
  4. All internet images  would be reproduced at a low resolution only
  5. All pictures would carry Ms Rinkov,’s signature, her name, website and contact details

Ms Rinkov was hospitalized in November of that year and only delivered 37 designs, and the last three were completed by another artist. (For reasons not apparent, the medium missed this eventuality). The images were transferred to a graphic artist who made various graphical changes to make the images more suitable for printing.

After various commercial entities expressed interest in the images, Ms Zur-Klein contacted Ms Rinkov to try to negotiate a transfer of copyright but due to a difference of opinion, no agreement to transfer the copyright issued.

Ms Zur-Klein  publicized the images in various internet sites including her own and other people’s, in her blog, Facebook page and elsewhere.  In all reproductions of the cards on the Internet, the artist’s signature appeared, but her name and contact details were not given. Indeed, on some websites, Ms Zur-Klein presented herself as the creator of the card (the term יוצרת הקלפים is used, which is both creator and manufacturer so the term is somewhat ambiguous). Furthermore, Ms Zur-Klein allowed other astrologists to use the designs without giving any credit to Ms Rinkov. There was also a newspaper article featuringMs Zur-Klein that was illustrated with one of the card designs that was also not credited.

On 6 June 2012, Ms Rinkov sent Ms Zur Klein a Cease & Desist letter.

The basis of the ensuing court case was the agreement signed by the parties. It is translated below:

Tal prepares for Carni 39 pictures, which together with the picture already executed, provides a set of 40 pictures for cards and other purposes – payment 5000 Shekels.

Apart from the payment for the work, there will be no other royalties for selling packs of cards, books, CDs and other astrological items depicting the images of Tal Rinkov.

The astrological products that Karni is allowed to use the pictures on are: packs of cards, books, audio CDs, video for watching, a banner for a website, business cards and other articles on authorization from the creator. Karni may not manufacture or distribute artistic works such as pictures, mugs, key-rings and the like.

All material displayed on the Internet are at low pixel count.

The name, website and contact details of Tal Rinkov will appear on all products, including future products.

The pictures on the cards and elsewhere will include the artist’s signature.

The original artwork and copyright remains the exclusive property of Tal Rinkov.

Pictures and associated artistic products (that are not astrological) will be produced and distributed exclusively by Tal Rinkov.

Any deal that Karni creates for Tal will generate a 20% commission for Karni.

When Tal sells a product (book, CD, cards and the like) she will profit 20%. Tal will receive a present of a pack of cards.

 According to the plaintiff, the defendant wrote the contract after the negotiations. The defendant claims, however, that the contract was the plaintiff’s idea, and that the plaintiff had written most of the clauses to the detriment of the defendant, such as her not getting benefit from sale of the cards. However, the defendant agreed that she had printed out the agreement.

The defendant claimed that she was entitled to the status of co-creator in the cards as although Ms Rinkov executed the artwork, it was to her, Ms Zur Klein’s specification regarding the symbolism, colors and charms. The plaintiff considered this a change of direction in the defence and objected to it on principle.  The judge ruled that the claim that the defendant hand guided the artist appears in clause 31 of the defence, but is more a factual than a legal defence and so she was willing to contemplate it. The plaintiff countered that Carni Zur-Klein had not, in fact, instructed her, but that she herself had researched the elements and colours.  Both sides supported their contentions with emails and other evidence. It does seem that the astrologer gave guidelines for the design, but these are by way of astrological knowledge rather than artistic input.

RULING

In this instance, Judge Lemelstrich  did not consider that under section 1 of the Copyright Law 2007, the two parties could be considered co-owners of a joint creation. Section 64 creates a rebuttable assumption that the artist is the creator and each card design was signed by Ms Ronkov as the artist.

Section 5 of the Copyright Law notes that the idea, way to implement and facts are not copyright protected, only the  artwork itself is. According to Section 35a of the Copyright Law, a work for hire is the property of the artist in the first instance, unless otherwise agreed implicitly or explicitly. In this instance, both the Copyright Law and the contract  support the artist as owner of the copyright.

In the packs of cards, Ms Rinkov is acknowledged as the artist and Ms Zur-Klein is credited as an astrologer.

The parties agree that Ms Zur-Klein conceived the project, but the copyright in the images remain the property of Ms Rinkov.

Ms Zur-Klein apparently sold some 80 packs at 190 Shekels a pack.

the main issue sees to be the internet reproductions which do not provide the details of Ms Zur-Klein.

The ruling now relates to various astrological websites. Since I find this subject matter morally, ethically and religiously abhorrent, I am refraining from reproducing the links.

The important thing is that Judge Lemelstrich considers that the artist’s moral and financial rights were compromised in numerous infringements in various websites and internet campaigns. That said, the pictures on the Internet were not reproduced at a quality to enable them to be printed and used as playing quality cards.

The changes to the designs for subsequent printing by a graphic artist under the direction of Ms Zur-Klein were minor. These were considered insufficient to create a change to the copyright, in that the original work could not be considered defaced or the artist’s moral rights compromised. Nor did the amendments constitute a copyright protectable creation.

Ms Rinkov claimed 100,000 Shekels in statutory damages for copyright infringement and a further 100,000 Shekels for moral rights infringement, particularly noting the long and arduous legal proceedings and the multiple infringements.

Judge Lemelstrich noted that despite entering a clear contractual relationship to the contrary, Ms Zur-Klein acted as if the creations were hers to do what she liked with. She ruled 35,000 Shekels damages for infringing the moral rights, 15000 Shekels for infringing the material rights and a further 5000 Shekels for an article published after the Cease and Desist letter.

Judge Lemelstrich of the Haifa District Court ruled a permanent injunction against Ms Zur-Klein, her delegates, substitutes and others from performing any action that violates the September 2011 agreement or other rights as per the statement of case.

Ms Zur Klein will compensate Ms Rinkov 55,000 Shekels for copyright infringement, an also will pay 15000 Shekels legal fees. The money will be paid within 30 days.

Civil Ruling 15824-10-12 Tal Rinkov vs. Carni Zur-Klein, Haifa Court before Judge R. Lemelstrich, Ruling 13 October 2014

 

 


Laches in Amending Claims During a Patent Opposition Procedure

October 19, 2014

Zometa

Novartis Pharma filed Israel Patent Number 153229 titled “Use of 1-Hydroxy – 2 – (Imadazol-1-YL) Ethane – 1, 1 – Diphosphonic Acid in the Preparation of A Medicament for the Treatment of Conditions of Abnormally Increased Bone Turnover”.

The Application was allowed and published for Opposition purposes on 24 July 2007, and Teva filed an opposition on 23 October 2007.

After the Opposer filed their statement of case, the Applicant requested to correct the specification. The Opposer did not oppose the amendment, but following it, filed an amended statement of case. During 2011 and 2012 the opposition proceeded. On 10 April 2014 the applicant requested to amend the specification a second time. The amendment consisted of canceling claim 1 and dependent claims 2-5 and amending claims 6 and 7. The basis for the amendment was that the UK court had voided the corresponding patent, allegedly on formalistic and technical grounds, but to forward the discussion in Israel, the Applicant wanted to  amend the specification by canceling these claims.

Teva opposed the amendment, arguing laches and inequitable behavior since it was years since they’d filed their statement of case. They further claimed that the UK court had voided the patent due to the priority date and not on formalistic grounds. The UK Court of First Instance had issued their ruling over a year earlier, and this should be taken into account when considering the request to amend the application. This consideration was strengthened by the Opposition to Israel Patent 324844 Gradstan LTD vs Bristol Myers Squibb (6 March 1979). Furthermore, the request to amend the claims was not supported by an affidavit, and this was further grounds for refusing the request.

Novartis counter-claimed that the Appeal to the UK Supreme Court had only issued on 10 July 2014 and therefore there were no laches or inequitable behavior. Furthermore, if an affidavit was required, the applicant would be happy to provide one.

Teva countered that the flaws requiring correction were stated in the statement of case and Novartis should have corrected their application at the first opportunity which was over four years earlier.

THE RULING

The main argument is whether there is a statute of limitations or laches for amending a specification after allowance and before grant. The Opposer cited a very old case from 1979 to argue that this couldn’t be allowed, whereas the applicant cited the more recent Opposition to IL 101537 Merck and Co. vs. Unipharm Inc. (30 April 2003).

The Deputy Commissioner noted that she had ruled on the grounds for post allowance amendments under Sections 29, 65 and 66 f the Law in Reva vs. Astellas Pharma and in Rafael vs. Elta, both from May 2014.

The ability to amend the claims provides an advantage to the applicant, but it also results in side skirmishes that hold up the issuance of the patent, to the advantage of the opposer and to the detriment of the applicant.

In this instance, the request to amend the claims comes after the submission of evidence, at the stage of the hearing. However, this was justified by the UK ruling only now being made final.

Nevertheless, the request could have been made some months ago and wasn’t. No explanation was given. Although the ongoing Opposition prevents a patent from issuing (and being enforceable), it also provides uncertainty to competitors and the awarding costs only partially mitigates this.

The Gradstan case was exceptional in that five years had passed from when the applicant knew that the specification should be amended and, according to the then commissioner (Yoel Tsur?) the proposed amendment did not achieve its purpose.

In Merck vs. Unipharm the then commissioner (presumably Dr Meir Noam) ruled that even where there is a delay, the applicant should be able to amend the specification unless there is inequitable behavior or the applicant had previously fought tooth and nail for the wider claim set.

The Applicant’s reason for the delay (pending final ruling in the UK) is prima facie justification to wait until now. Hence, the delay is a matter of months, not four years and awarding costs is a fair way to compensate the Opposer.

There is no argument that the amendment is one that narrows the scope of protection since claims 1-5 are canceled and claims 6 and 7 are also narrowed since they specify a range of doses for menopausal women and the amended ranges are within the original ranges. The amended claims are also both fully supported by the specification.

As to the requirement for an affidavit, Ms Bracha ruled that this is required to support a factual matter about which there is some dispute. In this matter, that is not the case. Both sides agree when the original UK ruling was and when the Appeal ruling made it final.

CONCLUSION

The requested amendment is allowed and will publish for third-party oppositions. Absent such oppositions, the Opposer may file a corrected statement of claims within one month. If he does not wish to correct the statement of claims, he should alert the patent office of this within that month, and a hearing will be scheduled to examine the evidence.

Since this is the second request to correct the application and was filed some months after it transpired that there was a need to amend the claims, the Deputy Commissioner ruled costs of 3000 Shekels and attorneys fees of 30,000 Shekels + VAT. Furthermore, should the Opposer choose to amend their statement of case and to correct their evidence, they will be entitled to further costs regardless of the ultimate outcome of the proceedings

COMMENT

The active ingredient seems to be Zoledronic acid and the drug in question appears to be Zometa®.

This ruling seems fair.

Refusing to allow a patent to be amended due to the request not being supported by an affidavit seems to me to be formalistic. I would not consider a problem with the priority date as merely formalistic though.


PUBA trademark successfully opposed

October 19, 2014

 

A’laa Sanduka filed Israel Trademark Number 257833 “PUBA” for Clothing for youth and womwn (sic), excluding sportwear and footwear.

Puma SE opposed the application. On 3 July 2014, the Applicant for the Opposer requested real costs of 16, 718 Shekels. The Applicant did not respond to the request.

The Applicant did not respond to the Opposition notice at all and so the mark was cancelled. Citing Bagatz 891/05 Tnuva vs. Ministry of Trade and Industry, the Adjudicator of IP at the Israel Patent Office listed the various considerations in awarding costs, but with further reference to Regulation 69 of the Trademark Regulations, noted that she had the authority to award reasonable costs.

In this instance, despite the fact that the Applicant had not responded, the Adjudicator of Intellectual Property did not consider the requested costs of 16,718 Shekels as reasonable, proportional to the amount of work involved and appropriate in the circumstances.

In particular, she noted that the Opposer could have simply filed a notice of Opposition and not filed a strong case, giving the Applicant an opportunity to simply back down. In the circumstances, she awarded 6000 Shekels including VAT.

Opposition to Israel Trademark No. 257833 “PUBA” costs ruling by Yaara Shoshani-Caspi  

COMMENT

As Puma limits itself to sportswear and Puba is specfically NOT for sportswear, I am not sure that the mark would not have registered. In general, and ironically since they are commonlyreferred to as Palestinians, Local Arabs, of whom we assume A’laa Sanduka is one, generally cannot pronounce the P sound, and we assume that the word PUBA is pronounced BUBA which is even less like Puma. Nevertheless, I tend to agree that in all likelihood, a simple notice of opposition would have resulted in the mark being abandoned so the work done was largely superfluous and the reduced costs seem fair.


Calculation of costs re Israel Trademark Number 242574 for “OSIS”

October 19, 2014

OSIS

AG & Co. KGaA applied for Israel Trademark Number 242574 for “OSIS”

The mark was applied for perfumery goods, essential oils, cosmetics, preparations for treating, washing, dyeing, bleaching, styling and perming hair, soaps in Class 3, and for mechanical implements for body and beauty care (included in this class), sponges, brushes (except paint brushes), apparatus and receptacles for applying hair dyes in class 21.

Ein Gedi Cosmetics opposed the registration.  After several extensions, Henkel abandoned the mark. On 13 July 2014 Ein Gedi requested costs of 12,000 Shekels. On 18 August 2014, Henkel responded to the request for costs.

The Adjudicator of IP issues, Ms Shoshani-Caspi, accepted that in general, the party prevailing in a proceeding is entitled to costs. In this instance, the Applicant did not detail his requests for costs which therefore have to be considered as an estimate only.

In Bagatz 891/05 Tnuva vs. Department of Industry it is stated that to obtain real costs, the applicant should detail the basis of calculating legal fees, the amount of work, and whether it was actually paid. After this is done, the opposing party should explain why the requested costs are inappropriate.

furthermore, Section 69 of the Trademark Ordinance gives the Commissioner (or whoever rules on the case on his behalf) discretion to award costs considered realistic.

In this case, since there was no basis to award actual costs, the adjudicator considered the complexity of the case, the amount of work, the professionalism of the parties, equitable behavior of the parties and with reference to Regulation 46 of the Trademark Regulations 1940, whether the case could be avoided were the Opposer to provide the applicant with sufficient notice.

Apparently the Opposer had not contacted the Applicant before filing the Opposition, but the Applicant had filed three extensions, indicating that they were originally considering and intending to respond. This was not considered as sufficient indication of inequitable behavior though.

Taking into account the amount of work done and that the opposer had to request costs,the Arbitrator of intellectual Property Ms Shoshani-Caspi ruled costs of 3000 Shekels including VAT.

Ein Gedi vs. Henkel re Israel Trademark Number 242574, ruling on costs by Ms Yaara Shoshani -, 17 September 2014

 


Lapsed patent for elevator safety reinstated

October 17, 2014

elevator rules

Israel Patent Number 216841 to Yoram Madar titled “Elevator protection against short-circuit of safety devices” was granted on 1 March 2013. Under Section 56 of the Israel Patent Law, the patentee should have paid the first renewal within three months, and failing to do within the following six months lead to the patent lapsing as of 1 June 2013, with a notice of abandonment publishing in the January 2014 Israel Patent Office Journal.

In a request for reinstatement dated 22 September 2014, and with a declaration and appropriate evidence, Medad alleged that the renewal was paid on 13 March 2013. Furthermore, he claims to have sent the receipt of payment to the patent office but there is no evidence that this is indeed the case as there was no covering letter or receipt from the patent office that was stamped received.

Madar claimed that he never wanted the case to lapse and that he discovered the problem when requesting a priority document for a national phase entry into the US.

In the circumstances, the conditions of Section 60 were considered to have been fulfilled and the Deputy Commissioner allowed the case to be restored subject to publication of the decision and no oppositions being filed.


Matrix fun and games

October 17, 2014

matrix games

Israel Trademark Number 247341 for the word-mark Matrix covers Tablet PC, electronic frames and digital cameras; all included in class 9. It was filed by a private individual called David Alon.

The mark was allowed and on publishing for Opposition purposes, Iscar (an Israeli company that is a major manufacturer of cemented carbide cutting tools) filed an opposition.

Iscar requested that Alon file 100,000 Shekels bond to cover costs in the event that he fails to win the opposition. Furthermore, until a ruling issues on the bond issue, the opposition should be considered as in suspense, and finally, due to a response from the applicant on 17 August 2014, the application to file the trademark should be considered as voided.

It turns out that Alon is handling a bankruptcy proceedings and he agreed to suspend the opposition proceedings until he can come to an understanding with his creditors in the bankruptcy hearing scheduled in December 2014.

At this stage of the proceedings, Iscar have until 24 October 2014 to file their evidence.

REGARDING THE BOND

Regulation 519a enables someone sued to request that the plaintiff post a bond. In this instance Iscar is opposing Alon’s registration and so the regulation does not apply. Furthermore, in the current instance, even were Alon the plaintiff, the Adjudicator of Intellectual Propoerty, Ms Shoshani Caspi , does not consider that the circumstances justify requiring a bond. A private individual (as opposed to a limited company) is generally not required to post bond merely because of poverty, because this would limit his right of access to the courts.

Forcing Alon to post a bond would effectively close the proceedings (probably the point), and should only be allowed if he has no chance of succeeding on the merits. The request was refused.

REGARDING THE REQUEST TO CONSIDER THE TRADEMARK WITHDRAWN

The case for withdrawing the mark is that Iscar considers it confusingly similar to their mark 195919 also in Class 9.

Iscar’s mark covers Automatic machine tools and accessories; vending machines; computer hardware and software used to control machine tools and accessories use, supply, purchase and inventory for the manufacturing industry; all included in class 9, and is shown here:

Matrix

Iscar claims that Alon’s mark is confusingly similar as their earlier mark and is in the same class. They consider that Alon should have informed the Patent Office that he was bankrupt and being in the status should refrain from legal actions. Forcing him to withdraw the applicant was preferable than an opposition proceeding.

Ms Shoshani Caspi, the arbitrator assigned to the case ruled that she could not decide to have the mark thrown out in a preliminary action without hearing arguments from both sides. It was premature to accept that the marks were confusingly similar and that Alon’s mark should not be allowed. The fact that he was bankrupt was not sufficient justification to prevent him from trying to defend his rights before the Israel Patent and Trademark Office. She therefore rejected having the application simply thrown out.

In conclusion, Ms Shoshani Caspi gave Alon until 31 December 2014 to submit the ruling of the Tel Aviv District Court regarding the bankruptcy, to decide on the application and the opposition and suspended the proceedings until then. Following the District Court’s ruling, she would decide on a timetable for filing evidence. Finally she decided that both sides should cover their own costs.

Preliminary Motions regarding Opposition to Israel Trademark Number 247341, Iscar vs. David Alon ruling by Ms Shoshani Caspi, 22 September 2014.

COMMENTS

Iscar makes metal matrix cutting tools. The term matrix has a plethora of meanings in different contexts but does not mean anything particular with regards to tablets, electronic frames and digital cameras. I don’t see that Iscar has a very strong case in opposing this. There is probably room for coexistence of the two marks. In the circumstances, they could probably buy the mark from Alon for less than the cost of opposing it, which they would be unlikely to recover anyway.


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