A Meeting With Israel Trademark Examiners

November 26, 2014

israel patent office logoTM R

The Israel Patent and Trademark Office held a meeting with practitioners on 25 November 2014.

The event was held at the rather odd time of 12 AM to 2 PM which made meeting colleagues for lunch before or after a little difficult. However, refreshments of the cake and biscuit, tea coffee and soft drinks kind were provided.

The chairs in the main hall in the patent office were arranged in a couple of concentric circles, and, although most of the trademark examiners sat next to each other, there was still no clear ‘us and them’ divide. The lawyers had mostly not worn their dark suit and no black ties were in evidence. Even the commissioner was casually clad in an open-necked shirt and no jacket. The informal setting was, I felt, very conducive to creating an atmosphere of working together to further the examination process. There were about 10 patent office employees and perhaps 50 practitioners present. These included former employers, colleagues and employees of mine and a fair sprinkling of competitors, some of whom we’ve crossed swords with in opposition, cancellation or infringement proceedings. There were more attorneys-at-law and less patent attorneys than what one usually sees at patent events, but considering the subject matter, this was to be expected. All in all, it was a good opportunity to meet up with people.

From the questions asked, it seemed that many practitioners felt that the need to translate lists of goods into Hebrew was burdensome and superfluous, and something that the commissioner could do away with by issuing an appropriate Circular. This was considered to be particularly the case as Madrid Applications are filed in English only, without a need to translate the list of goods. The Commissioner merely noted that he was not sure that he agreed that doing so was a good idea, and anyway, it was beyond his authority. I think that such complaints seemed to miss the point that registering trademarks is not just a way of protecting rights for clients, but enables third parties doing business in Israel to see whether a mark is available. This is the point of having a trademark register, and Hebrew is the official language and many Israeli businessmen may not be fluent in English. Nevertheless, former commissioner and current head of the AIPA, Dr Meir Noam, had a good point when he noted that English is a richer language than Hebrew, with more specific terms for lists of goods. I think that lists of goods should be transcribed into Hebrew in a Biblical fashion, so instead of having to find different words for Parkas, Duffle Coats and Anoraks, a term such as ‘hooded coats and their kinds’ could be used. Instead of laboriously translating a list of three hundred electronic components, a general phrase such as electronic components for telecommunications could be used.

One lawyer who complained about the large amount of work involved in translating lists of words. He felt that this caused trademark filings to be unnecessarily expensive. He also complained about the official fees, compared to some other jurisdictions.  It is not clear to me whether the official fees should reflect the relatively small local population or the size of the economy. I suspect that some product sales reflect one and some the other. I note that in some places marks are registered but not examined and so the fees are generally cheaper.

It was difficult to feel sorry for the lawyer having to translate lists of terms into Hebrew. Trademark filing is fairly profitable and doesn’t involve much more than form filling, so if there is sometimes a little translation work, so what? The lawyer’s argument that he charges a standard fee per mark, and sometimes there is a lot of translation work to do seemed a little ludicrous. If he was unimaginative enough to not consider a basic filing fee and supplementary translation fees where appropriate, why should the law be changed?

Other gripes raised concerned the competing marks procedure wherein the applicants of two co-pending applications for the same or similar marks have to persuade the Patent Office that their rights in the mark are better. Of particular chagrin is the fact that once one application is considered as preferable to be examined first, after a long and often expensive and protracted procedure, the application is only then examined and may be rejected as generic, non-distinctive, or too similar to a registered patent.

Some present felt that an indication of the likelihood of being registerable should be given prior to embarking on the competing marks procedure.

We suspect that a reasonable practitioner should be able to anticipate reasonable rejections of this nature and if they are not reasonable, should be able to overcome them. I felt that the complaint reflected a basic laziness more than anything. One presumes that if there were no hiccups with trademark filing, one wouldn’t need trademark attorneys. There seems to be no problem biting the hand that feeds.

Another bone of contention raised was if the parties to a competing marks procedure are willing to coexist, why should the patent office decide to over-rule them? These type of questions are what Israelis refer to as kit-bag questions. The patent office never merely over-rules the parties. Occasionally, the parties will be over-ruled if the patent office adjudicator considers that an agreement reached is not in the public interest and leaves a likelihood of confusion or could create a cartel or otherwise impede fair competition. Where the parties are over-ruled that patent office gives reasons. If the party (parties) is (are) not satisfied, it (they) can appeal to the courts.

Discussing the event afterwards, one ex-employee told me that he found the discussion re formalities very boring. Another told me that he’d waited a long time for a meeting like this, to discuss the issues raised. In general, I got the impression that most participants were quite happy, and the trademark examiners told me that they found the opportunity to get feedback from the practitioners very worthwhile.

Regarding substantive changes to trademark law, I don’t think that many of the suggestions raised will be implemented. I suspect that if they were, those who raised the issues would then complain of having less work.

Regarding procedural issues, some suggestions will be implemented, and I suspect that putting faces to names, many practitioners will be more likely to pick up the phone to the Examiner to try to resolve issues, which may save time all round.

Apparently Dr Kfir Luzzatto took it upon himself to collate the questions from the profession, and is to be thanked for so doing. Appreciation is also extended to Dr Meir Noam of the Association of Israel Patent Attorneys and to the present commissioner Asa Kling for setting the event up, and to the trademark examiners for preparing for the event.


Israel Supreme Court Rules on Parallel Importing

November 19, 2014

Tommy Hilfiger

The Israel Supreme Court has issued a ruling concerning the rights and wrongs of parallel importing and related marketing and advertising. This is the first time that they have ruled on this issue.

The Supreme Court ruled that parallel importing is legitimate, as is marking the goods with the trademarks. The licensed importer or franchisee cannot prevent parallel importing, but it is important that the name of the company doing the parallel importing does not imply that the parallel importer has a relationship with the mark holder and has to actively take steps to make clear that they are not the licensed importer. The licensed importer does not have to guarantee or provide a service for the parallel imported goods and the parallel importer that the public are made aware that the parallel imported goods are not covered by the importer’s warranty and servicing obligations.

The Israel Supreme Court partially upheld the ruling of the Court of First Instance that the parallel importers had infringed the registered licensee’s trademark and were also guilty of passing off. This was due to the name of their business, not the parallel importing itself. The Supreme Court decreased both the damages award and the restrictions imposed by the Court of First Instance.

The Appellants, Elad Suissa and Importer Warehouse 42 LTD. imported clothing carrying the Tommy Hilfiger brand, despite not being the licensed importer registered in the Trademark Register and also not having any contractual relationship with the licensee. The Appellants purchased the goods abroad from legitimate suppliers in countries where the prices were lower than in Israel. They traded under the name ‘Importer’s Warehouse – Tommy Hilfiger’ and advertised themselves as selling premium bands at discounted prices. They operated a website www.tomm4less.co.il.

The licensed importer Sea & Shells LTD, together with Tommy Hilfiger Licensing LLC. Tommy Hilfiger USA INC. and Tommy Hilfiger Europe BV sued Elad Suissa and Importer Warehouse 42 LTD on  various grounds of unfair trade and trademark issues.

The Court of First Instance ruled that the parallel importers should pay 457,000 NIS in damages and issued a permanent injunction against them. The Appellants argued that they should not be restricted from parallel importing in circumstances where this is legal.

The Supreme Court partially accepted Appeal 7629/12 by the parallel importer, and rejected the appeal 8848/12 by Tommy Hilfiger.

The Ruling

The starting position is that parallel importing is legal. Parallel Importing is not trademark infringement and is not Unjust Enrichment by the Parallel Importer. However this does not mean to say that there are no restrictions on the parallel importer. The parallel importer is subject to trademark law, fair trading laws and the Law Against Unjust Enrichment.

In Pezachim, using the registered trademark in connection with legitimate goods carrying the mark was considered “True Use” under Section 47 of the Trademark Ordinance. In Toto Zahav, it was ruled that such a use of original goods is an infringement. The case-law of the District Court adopted tests from US case law: If the items cannot be identified without using the trademark it is legitimate to use the trademark. However, usage must be limited to that which is necessary to identify the goods as being genuine and no more, and there should be no indication that the retail outlet is sponsored by or affiliated to the mark holder. Toto Zahav did not relate to parallel importing and, in cases of parallel importing, the Toto Zahav ruling should be modified.

Parallel Imported genuine items do not fall under the guidelines of Toto Zahav. Their sale is not trademark infringement and the goods do not have to have been purchased directly from the rights owner. However, marketing activity relating to such goods may be considered trademark infringement. Servicing and maintenance services have to be recognized for the servicing laboratory to be able to use the registered trademark. Parallel imported goods are not subject to warranties and guarantees of the registered importer and parallel importer has to take care that it is clear that his parallel imported goods are not covered by such warrantees.

Passing Off requires a reputation of the rights holder, and, in addition to the mark owner, the legitimate importer or licensee may have rights in the brand and may be able to sue for passing off. The concept of ‘dilution’ does not apply to parallel importing and cannot be claimed by either the mark owner or the licensed importer. However, where the reputation is built on service and the like, sale of the goods by a parallel importer such that the service agreement does not apply, may be considered passing off.

In the present case, sale and publicity of the goods themselves and the website www.tomm4less.co.il are considered as being truthful. Using the company’s colours is also unlikely, in and of itself to cause confusion.

Trading under the name ‘Importer’s Warehouse – Tommy Hilfinger’ is considered trademark infringement of the rights of Tommy Hilfiger Licensing LLC. Tommy Hilfiger USA INC. and Tommy Hilfiger Europe BV.  This is not infringement of the rights of the licensed importer Sea & Shells LTD however, since they themselves do not have a reputation.

There is no additional element such as bad faith to warrant granting damages under the Law of Unjust Enrichment.

The Parallel Importer must cease to use the name ‘Importer’s Warehouse – Tommy Hilfinger’ and have to pay 100,000 Shekels as estimated damages for their infringing use and have to mention in their advertising that they are not a franchise or otherwise acting under the supervision of Tommy Hilfiger.

The costs awarded by the District Court are canceled and Tommy Hilfiger et al. have to pay 25,000 Shekels costs to the parallel importer.

7629/12 Appeal to Israel Supreme Court (ruling by Dalia Barak-Erez et al): Elad Suissa and Importer Warehouse 42 LTD vs. Sea & Shells LTD, Tommy Hilfiger Licensing LLC. Tommy Hilfiger USA INC. and Tommy Hilfiger Europe BV, 16 November 2014

 


Naomi Ragen Found Guilty of Plagiarism Again

November 17, 2014

Sacrifice   marriage made in heaven

On 11 November 2014, Judge Oded Shacham found Ms Naomi Ragen not guilty of Copyright infringement on a technicality, but nevertheless guilty of infringing the moral rights of another author in a book that she wrote that was ruled as plagiarizing a short story by the other author, a Ms Cynthia Rosengarten (now aged 82). The request for an injunction was denied. The damages awarded were 60,000 Shekels, which was rather less than the 2.5 million shekels requested in the statement of case.

Background

The plaintiff, Ms Cynthia Rosengarten published a short story entitled “A Marriage Made in Heaven” in an anthology of short stories written by various Hareidi (Ultra-Orthodox) women, that is titled: “Our Lives, An Anthology of Jewish Women’s Writing” which was published in 1991. The anthology was edited by Sara Shapiro.

Ms Rosengarten claims that the story is autobiographical and relates to the marriage match of her eldest son. The story is a 15 page personal account of her dealing with match-makers, and how, as a mother, she felt when a girl from Boro Park was suggested as a suitable match for her 18 year old son. On one hand she is aware of the need for her son to get married, but on the other hand, she considers all the potential brides inadequate. The story reflects reality in the Hassidic world.

Ms Rosengarten sued Ms Naomi Ragen and Keter Publishing LTD, claiming that Ragen’s best-seller “the Sacrifice of Tamar” which was published in 1997 includes elements from “A Marriage Made in Heaven” and infringes both commercial and moral rights therein. Ms Shapiro was mentioned as a formal plaintiff.

The Sacrifice of Tamar tells the story of Tamar Feingold, who grew up in an Ultra-Orthodox neighborhood of New York, and relates her internal conflicts with the community in which she lives.  Two years after getting married, Tamar Feingold is raped by a black (that is, African American – not Hareidi) rapist whilst staying with her sister. Later that night, Ms Feingold sleeps with her husband and hides the trauma she went through. She becomes pregnant and is unsure which is the father of the child. Chapters 1 to 22 of the book relate to the feelings of Tamar through the pregnancy, where eventually a white skinned child is born.

In Chapter 23, the son asks his mother to help him find a life match.  The son gets married and a year later his wife has a black skinned baby. The son accuses her of unfaithfulness and Tamar has to come clean about the rape. The son’s marriage dissolves and Tamar, the grandmother, adopts the grandson and leaves the Hareidi fold.

According to the Statement of case, Ms Ragen used parts of “A Marriage Made in Heaven” in Chapter 24 of her novel, thus violating the Copyright and Moral rights of the plaintiffs. They claimed damages and also requested an injunction.

Ruling

Because of the time-line, the ruling was given under the old Copyright Regulation of 1911 and not under the new Copyright Act 2008, but, considering the infringement as on-going, eventual damages took into account the statutory damage regimes under both law.

In the ruling there is a lot of discussion as to whether the copyright was actually transferred by Ms Rosengarten to Ms Shapiro and that it wasn’t transferred to the printing house. No assignment document was forthcoming. It was alluded to and was probably filed somewhere but was not produced.

Judge Shacham ruled that the copyright in “A Marriage Made in Heaven” belongs to Ms Shapiro and consequently the plaintiff Ms Rosengarten does not have grounds for financial Read the rest of this entry »


Wyeth’s Patent Term Extension for Bazedoxifene Cancelled Prior to ReExamination

November 10, 2014
Rocking the boat...

Rocking the boat…

There was an amendment to the Israel Patent Law earlier this year. This amendment (11th amendment) relates to patent term extensions. The amendment was announced, but did not go into immediate effect.

Wyeth filed a request to correct a mistake in the Patent Extension Order concerning Israel Patent Number 120701. The extension Order was given on 23 February 2014, and extends the basic patent for Bazedoxifene which, without the extension, would have lapsed on 18 April 2017.  The intention to grant an extension until 26 August 2019 was given in October 2013 and published back then. The calculation was based on the Law prior to the eleventh amendment.

On 18 September 2014, Wyeth submitted a request to correct the Extension Order to provide protection according to the regime after the eleventh amendment.

Section 16 of the Amendment states:

16(a) this Law will apply to Extension Order requests that are pending before the Commissioner of Patents on the day that this Law comes into effect, and for future requests for patent term extension.

Wyeth’s contention is that the amendment to the Law came into effect on 27 January 2014 and due to the publication for opposition purposes, the period for opposition finished on 31 January 2014, so, at the time the Law came into affect no Patent Term Extension had been granted and the request for patent term extension for IL 120701 must, therefore, be considered as pending at the time the amendment came into effect.

The amendment narrowed down the list of countries that could be relied upon for Israel to grant a corresponding extension. Instead of anywhere in Europe that grants an extension, only Italy, UK, Germany, Spain and France could be taken into account. Significantly, Japan was no longer considered a relevant country in regards to patent term extensions. Wyeth’s patent was extended on the basis of the extension of the corresponding Japanese patent. By ignoring Japan, a longer term could be requested.

There is an interesting twist here. In October 2013, the FDA issued approval for Bazedoxifene together with conjugated estrogens as Duavee. This fact was not taken into account in calculating the Patent term Extension and could act against Wyeth. The Commissioner ruled that it would be improper to apply some sections of the amendment and not others, and that the Israel Patent Office should consider the ramifications of this FDA approval as well. In consequence, the Commissioner did not amend the ruling, but rather canceled it as a wrongfully given bureaucratic decision. He ruled that the published patent term extension was null and void and that the Application would be subjected to accelerated re-examination under the amended Law with the ramifications, if any, of the FDA approval of Duavee also considered.

Various legal precedents were given to support this contention and the solution it offered. The Commissioner noted that Patent Term Extensions are not final and could be reconsidered, even previous to the eleventh amendment.  He related to previous rulings concerning Teva vs. Abbott, Neurim, Lundbeck vs. Unipharm and Roche.

In addition to being able to oppose any subsequent patent term extension, the cancellation of the existing patent term extension may also be opposed by third parties.

Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014.


Israel Patent Application No. 204070 Cancelled Despite Opposition Being Dropped

November 9, 2014

Back in July, we reported on an opposition against Israel Patent Application No. 204070 to Reckitt and Coleman that was opposed by Sano Bromium Factory. 

Sano-brome abandoned the Opposition, but in her ruling from July 2014, using her discretionary powers under Section 34 of the Law, the Deputy Commissioner, Ms Jacqueline Bracha detailed why, based on the evidence in the file, the patent application was apparently void, but gave the Applicant 30 days to provide counter-arguments to convince her to the contrary.

Reckitt and Coleman took a couple of extensions for filing counter-arguments, but did not submit counter arguments that were sufficient to overcome the lacunae., so Ms Bracha cancelled the Application.

 


Israel Patent Opposition Suspended Pending Examination of a Divisional Application

October 22, 2014

boehringer       procrastinate

In another Patent Opposition, Teva Pharmaceutical Industries opposed Israel Patent Number 195030 titled “DPP IV INHIBITOR FORMULATIONS” to Boehringer Ingelheim International GMBH.

The patent published for opposition purposes on 30 September 2013 and an opposition was filed on 29 December 2013 and there is a pending Divisional application – IL 212841.

On 22 January 2014, the Opposer requested to suspend the Opposition process under Israel Patent Office Circular 020/2012 which allows suspension of Opposition processes whilst related applications are examined, provided that a detailed request to do is filed. The Opposer considers the claimed subject matter of the two cases as very similar. Although there are differences, these are minor. The Applicant accepts the similarity but does not consider this as in and of itself being a prima facie justification for suspending examination, and that at best this is grounds for a detailed request. Until such a request is filed, there is no basis to suspend the Opposition proceedings (which leaves the allowed patent in suspense, such that it cannot be enforced).

In ruling on this matter, the Commissioner (who drafted the original Circular) ruled that the existence of the Divisional Application was not, of itself, sufficient grounds to suspend the opposition. It is, in his opinion, too early to identify the claimed invention. However, under Section 24, the specification of a Divisional Application will invariably be very similar to that of the Parent Application, and this is the basis of the Opposer’s assumption that similar issues will arise in the Divisional application if it is allowed, and so suspension until that time to hear both cases together makes sense. The consideration as to whether or not to suspend the opposition is efficiency and the case is similar to other cases where an ongoing proceeding is suspended until another is decided. There is a Supreme Court precedent that relates to this issue: Appeal by authorization 3765/01 “HaPhoenix HaYisralei Insurance Company vs. Alexander Kaplan et al. (28 Jan 2002), where, in paragraph 3, it is stated that in the name of efficiency courts have the discretion to combine hearings, even where the parties are different. In the Opposition to IL 82910 Unipharm vs. Anktielofaget Hassle (1996) this principle is applied to patent cases; justification being Reg. 520 of the Civil Law Procedure. The purpose of suspension is thus to allow the apparently similar / related cases to be combined. The Opposer is correct that the currently pending claims of the Divisional Application are somewhat similar to those in the opposed patent.

It is important to consider the rights of third parties and other considerations than simply efficiency of combining from the perspective of the patent office. In this case, it is likely that the Opposer (TEVA) will oppose the divisional application, should it issue. In conclusion, the Commissioner agreed  to suspend the Opposition for 18 months and to then reconsider in light of developments concerning the divisional application.

COMMENT

There are certainly similarities between court cases and oppositions. There are, however, some pertinent differences. One does not suspend a court case pending a possible filing of a related case, only to wait for an ongoing case to issue.

Oppositions are complicated proceedings that take time. Indeed, a primary purpose of filing them is to prevent a patent from being enforceable. Suspending an opposition to claims that have been examined and allowed on the basis that some additional claims may eventually be allowed seems to be a punishment to the Applicant. It seems to me that the opposition to the allowed patent should be allowed to proceed, with statements in the Opposition filed by both the Applicant and the Opposer serving as estoppel in possible future oppositions of the divisional. Factual issues that are determined should be binding on the future hearing. If and when the divisional patent is allowed, and an opposition is filed, overlapping grounds could be co-joined to this opposition and new grounds could be heard separately. I therefore consider this ruling to be wrong.

I have thus somewhat surprised myself by coming out in favour of the pharma Applicant and against the generic Opposer.  I console myself in that in this case the issue is one of legal principle and not one of novelty or inventiveness / obviousness. I am against evergreening, but I am also against misuse of the patent opposition system to prevent patents from issuing by uneccessary time-wasting.  Comments, anyone?


IL 136294 to 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.

 


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