Impotent Appellant Has No Standing

July 1, 2015

class action  no standing

The present ruling relates to a Class Action filed in bad faith. Since the Appellant acknowledged failing to take the preparation during the minimal period prescribed by the manufacturer is sufficient to cancel the standing of the Appellant as representing the class.

The Appellant purchased a preparation intended to strengthen the male libido. Prior to the Appellant finishing the prescribed course as detailed in the accompanying literature and as explained by the Supplier’s Helpline, the Appellant filed suit with the District Court claiming that the product is misleading, and requested that the case be considered as a class action.
The District Court refused to see this as a class action since the Appellant had no standing, and therefore could not represent the class.

Supreme Justice Danziger cancelled the Appeal without awarding costs to either party, and added that the need to test that the plaintiff behaves equitably is anchored in Section 8(a)4 of the Class Action Law. The ruling of this court does not indicate a general ruling of what is considered equitable behavior as far as Class Actions are concerned. In one case Inequitable behavior occurs when a case is filed due to false motivation, such as an intent to damage a competitor or to “squeeze a compromise”. In other instances, the mere fact that a plaintiff is acting commercially, looking to profit from the class action does not, in and of itself, indicate that he is behaving inequitably, however the plaintiff has to behave equitably during the hearing. This is significant where the plaintiff is representing a class and not merely himself and when a lawyer solicits plaintiffs for a class action.

In this instance, the District Court has determined, from the evidence before it, that the Appellant:

  • recorded conversations with the service hotline of the vendor
  • did not read the accompanying literature, tried the preparation for too short a period in direct contradiction of the instructions that he received with the preparation
  • contacted a lawyer prior to finishing the course; filed suite 5 days after stopping the treatment
  • via his attorney, submitted advertisements that were not related to his decision to take the treatment

These facts resulted in the District Court concluding that the plaintiff did not have standing in his own right and could therefore not represent the class of men with impotence issues due to a lack of standing.

The Court has concluded that the circumstances indicate that this is a rare case of someone initiating a Class Action inequitably, and contrary to Section 8(a)(4) of the Law. This conclusion is not based on the motive of the plaintiff, for one may be motivated by material gain, but by the inequitable behavior determined by the District Court. Simply not going the full course indicated by the manufacturer is sufficient to make the Appellant not appropriate to represent the class.

Oddly, and perhaps not inappropriately, this case was heard by three male judges, who agreed unanimously with the verdict.

4534/14 Appeal to Supreme Court, Eli Daniel vs. Direct Nature LTD

COMMENT
The Appellant, Eli Daniel, may not have had to pay compensation or costs, but, due to his actions, has entered the Israel legal text-books as having erectile dysfunction. Not the end of the world.

Substantively, the efficiency of all medicines, both classical and alternative (where there are active ingredients, as opposed to homeopathy) work to a greater or lesser extent in different patients due to personal physiology. A class of one is hardly a representative sample to test the efficiency of a treatment. There is a well documented placebo effect and presumably this works in both directions, so a patient lacking belief in a treatment is unlikely to see positive results. I assume that not everyone reacts the same way to aphrodisiacs, and there are large number of foods that are attributed as having both aphrodisiac and libido dampening effects. I understand that patients taking classical medical treatment for erectile dysfunction still need to feel aroused, and the medicine alone won’t work.  I therefore wonder whether the treatment in question works some of the time and for some men. Certainly, there is no indication in this class action that this is not the case.


Does Size Matter? Dun & Bradstreet Publish their Silly Stats Again

June 2, 2015

1.Does Size Matter

Dun and Bradstreet has published their annual IP rankings once again. See here for the Globes article based on the Dun & Bradstreet 2015 rankings.

As readers of this blog will know, I consider the rankings infantile. D & B ranks based on the number of patent attorneys and this year, Reinhold Cohn with 43 patent attorneys has been knocked off its perch as Israel’s largest IP firm by Pearl Cohen, the new branding of PCZ”L that allegedly employs 46 patent attorneys. It seems that Dun & Bradstreet would fail their matriculation in both Maths and Geography.

The problem is that whereas Reinhold actually employs 37 patent attorneys in Israel and a further several attorneys-in-law that work in Intellectual Property, and these are all bona fide employees or partners and are all licensed, Pearl Cohen does not employ 46 patent attorneys in Israel.

Unfortunately, Pearl Cohen and D&B are somewhat misleading regarding what a patent attorney is, what an Israel licensed patent attorney is, what an Israel firm is, what an employee is and what part of the world may be considered part of Israel.

Allow me to elaborate:

1. There is a confusion between general attorneys-at-law and patent attorneys. The 55,000 odd Israel licensed attorneys-at-law may practice before the Israel patent office, but only a small fraction have any IP competence whatsoever, and a smaller fraction still understand anything about patents.

2. To practice before the USPTO one needs to be an US Patent Agent or a US Patent Attorney.

3. Pearl Cohen has a US office, a Boston office and a UK office. The employees of these offices cannot be considered as being part of an Israel firm, unless, of course, one considers Finnegan, the US’s largest IP firm as being an Israel IP firm by virtue of their Israel office and website. Finnegan has only one attorney, Gerson Panitch, based, part-time in Israel (he is actually based in Washington DC according to Finnegan’s website). If Finnegan is an Israel IP Firm, they are clearly larger than Pearl Cohen. Actually, from his profile, I am not sure that Gerson is a patent attorney licensed to practice before the USPTO, but that’s beside the point. According to the warning previously published on the Israel Patent Office website, it is also illegal for anyone other than Israeli attorneys-at-law and Israel patent attorneys to advise clients in Israel:

הובא לידיעתנו, כי אנשים שאינם עורכי דין או עורכי פטנטים עוסקים לכאורה, בשכר, בפעילות שנתייחדה לעורכי דין ולעורכי פטנטים, ובכלל זה הכנת מסמכים המוגשים לרשם הפטנטים בישראל ובחו”ל, גם אם אינם חותמים על המסמכים בשם הלקוח.כל אדם מהציבור הזקוק לשירותי ייעוץ ורישום בתחום הפטנטים, סימני המסחר והמדגמים מוזהר בזאת שלא לפנות לאותם גורמים הפועלים בצורה בלתי חוקית, שכן הסתייעות באותם גורמים עלולה לגרום להם נזק בלתי הפיך.

This is a rough translation:

Let it be known that people who are not patent attorneys or attorneys at law apparently practice, for payment, services that can only be provided by patent attorneys or attorneys at law, including preparation of documents for submitting to the Israel Patent Office and to foreign patent offices, even if they don’t sign in the name of the client. Any member of the public who needs advice or registration services relating to patents, trademarks and designs is hereby warned not to turn to such illegal practitioners, since doing so may result in irreversible damage.

This is based on Section 20(4) of the Israel Bar Law (Professional Ethics) 1988 which forbids anyone who is not a licensed attorney-at-law in Israel (or an exception, such as a Patent Attorney for IP Law) from giving legal advice. Note, I am not sure that the Israel Patent Office’s interpretation of this law is in accordance with International Obligations, and arguably (as Mr Panitch argues), a US attorney can advise re US law. Even if he is correct, I suspect that the advice will be lacking when it comes from a US attorney not licensed in Israel, as there are Israel tax and other issues that affect the decision making process. Consequently, even when the jurisdiction of interest is the US, China or Europe, an Israel firm is advised to work with foreign counsel via a local practitioner.

The one shop model of a firm with US, Israel and European offices is also, not necessarily in the client’s interest. If a local firm drafts the application and a separate US firm (and not a branch of the same firm) makes a decision regarding whether or not to litigate in the US, it is likely that the additional level of review will avoid the filing of frivolous law suits such as the Source Origin case.

4. An employee is someone who works for a company and receives a salary. Pearl Cohen has a highly dubious arrangement by which attorneys and patent attorneys that work for them are considered as not being employees and new employees are coerced into signing a statement to that effect.  Pearl Cohen’s professional employees are perhaps best considered as being free-lancers. Pearl Cohen does not pay the license fees of these professionals.

5. There are 19 patent attorneys that list their address in the Israel Patent Office database as working for Pearl Cohen in Herzliya. This is a mere 41% of the 46 patent attorneys that Pearl Cohen claims to employ. This list includes Assaf Weiler who is living in the UK according to Pearl Cohen’s website. It also includes Zeev Pearl who according to Pearl Cohen’s website is considered the managing partner working from the New York office. Pearl is licensed in Israel, but is not licensed as a patent attorney in the US.

I can’t opine about the legality of this situation since I am not licensed in the US. For those interested in exploring this further, see New York City : 1st Department, Chief Counsel, First Judicial Department, Departmental Disciplinary Committee, 61 Broadway, 2nd Floor, New York, NY10006, (212) 401-0800, Fax: (212) 287-104, Website: www.courts.state.ny.us/ip/attorneygrievance/complaints.shtml Also see the unauthorized practice of law committee in New York.  Their contact information is as follows: Kathleen Mulligan Baxter, New York State Bar Association, One Elk Street, Albany, NY12207, Tel: 518/463-3200, Fax: 518/487-5694 kbaxter@nysba.org See also ABA Formal Opinion 01-423 Forming Partnerships With Foreign Lawyers (2001). Report 201H (Licensing of Legal Consultant) Report 201J (Temporary Practice by Foreign Lawyers) as presented by the ABA Multijurisdictional Practice Commission and adopted by the ABA House of Delegates in 2003. See Also Report 107C as Amended by the ABA Ethics 20/20 Commission (ABA Model Rule on Pro Hac Vice Admission) that was adopted by the House of Delegates in 2013.

Of course, size isn’t everything. Pearl Cohen’s employment arrangement is not limited to that firm, and some competing firms have similar practices. I consider the model unethical, not least because it is both open to abuse by the ’employer’ and is frequently abused.

Dun and Bradstreet’s table has other problems. For example, Colb does not appear in the table listing the top 12 firms, and I am fairly sure that they are larger in terms of number of Israel Patent Attorneys than some of the firms that are listed.  Despite losing much of his litigation team recently, I think Dr Shlomo Cohen Law Office has enough Lawyers and patent attorneys working in IP to enter the table. There are, of course, also very large Israel law firms that have one or more patent attorney or IP lawyer working for them. Shibboleth and Shin Horowitz come to mind.

What is, of course, of more interest to clients is the competence and track record of the individual attorney who handles their files. Some of Israel’s best patent practitioners in private practice, including patent attorneys work for small firms or are sole practitioners.  This is true of both patent attorneys that draft and prosecute patents, and litigators that fight validity issues. It is also true of trademark attorneys, many of the better ones in Israel work for small firms.

The size of an IP firm can provide depth of knowledge and experience, but this is not necessarily the case. There are few economies of scale in this industry, and Parkinson’s Laws go a long way to explain why the same service from larger firms is more expensive, yet the sole practitioners and partners of smaller firms are usually better off financially than their colleagues in the larger practices.

The lists of IP firms put out by the professional magazines is also skewed towards the larger firms. The more attorneys that club together to form a single shop window, the more and larger clients they are likely to attract. The irony is that the when a successful attorney decides to grow his or her firm, the head attorney does more administration and less legal work, and is likely to take on less competent staff who are less of a threat. The more competent staff tend to break away and form their own firms. The upshot is that the average ability per attorney is generally lower in the bigger firms. A more objective statistic of a firm is the average billing per attorney, or something similar that normalizes absolute values by the number of practitioners.


Justice in the Eye of the Beholder

June 2, 2015

multifocals   Optika Halperin

This decision relates to parallel importing, to slander and to inequitable behavior.

Luxvision is the licensed importer of Zeiss lenses. Optika Halperin, a national chain of opticians in Israel (founded by a Rabbi who was a boxer, a world freestyle wrestling champion and bodybuilder, and then a Karate expert who introduced and promoted the sport to Israel) advertised multi-focal lenses that they sold as being Zeiss lenses.

Luxvision ran a vicious campaign of letters and advertisements from 2010-2011 arguing that Optika Halperin’s lenses were not original Zeiss lenses. Optika Halperin sued Luxvision, its CEO Erez Avner, and Ami Lapidot, who is the director of the Lapidot Group which owns Luxvision, claiming that this campaign caused then damages of 10 million shekels including cancellation of contracts with ELAL (Israel’s national airline) and with HaMashbir (Israeli department store), and had unjustly enriched the defendants. Luxvision counter-sued for 200,000 in 2011, as maximum statutory fine for willful slander without proof of damage, concerning four advertisements by Halperin, which they alleged were slanderous, defaming and insulting.

The relevant details are as follows:

On 22 December 2010, Avner sent an email to ELAL, and without revealing that he was an employee of Luxvision, informed them that the advertisement of a discount between Optica Halperin and ELAL infringed intellectual property since the guarantee was not recognized by Zeiss. On 13 April 2011 the defendants contacted HaMashbir in writing and informed them that Zeiss International had canceled the manufacturing and distribution rights of the Indian company from where Halperin had purchased the Zeiss lenses mentioned in the discount, and that the lenses were not merely imported without a license, but that there was a question regarding the origin of the lenses. Luxvision also contacted Halperin’s employees with a letter titled “Notice of Cancellation of Agreements” ordering them to cease and desist from selling or purchasing Zeiss lenses. Luxvision further published misleading notices in newspapers and on Internet websites regarding the origin of Halperin’s lenses that stated “Zeiss importers: Optika Halperin together with ELAL sell lenses from India. The [Halperin] chain: they are original”, and in an article in the financial supplement of Idiot Achronot, 2 February 2011, “Zeiss Germany does not stand behind the special offer and the Guarantee is not authorized.” In the business paper the Marker on 13 April 2011 the defendants  allegedly planted an article titled “Optical Illusion, the German Company Zeiss: Optika Halperin sells Zeiss lenses that are not originals.”

In their defense, Luxvision denied any responsibility for articles published by newspapers and the alternative defense that the facts discussed in the articles were true. Luxvision further denied that they caused damage to Halperin and claimed that the damage was self-inflicted since they published false information regarding the source of their lenses, and this was self-risk or contributory damage to the extent that they were not entitled to any compensation or legal recourse. This was also the basis of their counter charges of 200,000 Shekels in compulsory compensation without proof of damage.

Both sides brought evidence regarding the relationship between Luxvision and Zeiss India, from which it seems that Luxvision had themselves purchased and sold Zeiss lenses from India. The relationship between Zeiss Germany and the Zeiss Middle East had apparently been broken however there was an agreement between them. Judge Ginat ruled that these details were not necessary to rule on the case in question.

The Ruling

Optika Halperin as an independent and private company that imports and sells optical equipment and eye-wear imported Zeiss lenses with the Zeiss logo from the Indian manufacturer, which is a factory established by Carl Zeiss Vision International Gmbh, the German mother company.

On 27 February 2008, Zeiss Germany set up a joint venture with GKB HI-Tech Lenses Private LTD, an Indian company set up to sell Zeiss lenses to the Middle East. Under the agreement, with GKB HI-Tech Lenses Private LTD would be allowed to sell lenses with the Zeiss label in the Middle East, including Israel. The Companies had their differences and went to court in India, after which the business relationship ceased as of October 2011. However, Zeiss continued to allow their name to be used on lenses from India that were sold in the Middle East.

On the basis of evidence filed, including affidavits, Zeiss never showed any reservation that lenses from the Indian company were being marketed as Zeiss lenses in Israel and elsewhere. Zeiss never complained to Halperin nor did they file suit in an Israel court. They are not a party in this dispute. Indeed, Zeiss India had initiated an action against Zeiss Germany and not the opposite. Judge Ginat therefore ruled that the evidence leads to the conclusion that the imported Indian lenses may be considered as ‘parallel imports’ and not as imports of the authorized Israel dealer. As with the Hilfiger case, this is perfectly legal.

Cancellation of the ELAL contract 

In 2009 and 2010, ELAL and Yaakov Halperin signed various agreements under which Business and First Class passengers on ELAL flights would receive vouchers for purchasing Zeiss lenses at Optika Halperin.  Luxvision wrote to ELAL claiming misrepresentation and the eventual upshot was that ELAL did not renew their contract with Optika Halperin who claimed damages of 2,515,000 Shekels in loss of contract and loss of future business.

Although eventually ELAL wrote to Luxvision that they were not renewing the contract with Optika Halperin so the charges were moot, Luxvision argued that this letter was not an indication that they canceled an agreement, nor was it an indication that the decision was the result of Luxvision’s campaigning.

What was clear was that Luxvision embarked on a media smear campaign against Optika Halperin, and the articles are available on line and still cause damage. Furthermore, they contacted third parties having contractual relations with Optika Halperin so Luxvision did do serious damage to Optika Halperin’s reputation.  The articles were unequivocal and there is a basis for bringing charges of Slander under Sections 1 and 2 of the Slander Act.

However, it will be appreciated that Section 14 of the Slander Act provides the defense that the allegations are true. This requires that the publication is true and is of public interest. The truthfulness defense is objective. It is important as it strikes a balance between Freedom of Speech and the right to one’s good name. The public interest consideration is subjective, and the court has to rule on each case according to its merits. Regarding the truthfulness of Luxvision’s allegations, the onus is on them, as defendant to establish that their allegations are indeed true.  However, Luxvision were within their rights to indicate that the lenses were not guaranteed by them and with multi-focals, there is a real likelihood of lenses being unsuitable and rejected as such.

Judge Ginat was impressed that Zeiss Germany would have gotten involved if there was any truth that the Indian lenses were substandard. Zeiss themselves and not the importer owns the rights in their name. Furthermore, Luxvision contacted ELAL before contacting Zeiss Germany. Judge Ginat concluded that this case is not one where the lenses are not originals or are fakes, but is a case of parallel importing, and, as established in Dyson and in the Tommy Hilfiger  case, parallel importing is legal in Israel. Consequently, the defense that Luxvision told the truth is not a totally accurate reflection of reality and the defense is not available to them.

Contacting the media and Optika Halperin stores around the country does not seem to be a reasonable act that can be considered as equitable behavior as the publications were inaccurate and Luxvision was aware that the Indian company was authorized by the German company to produce Zeiss lenses, even if the relationship between the Germans and Indians was somewhat rocky. Consequently, Judge Ginat rejected the defense that the slander was unintentional.

Nevertheless, the estimate of 10,000,000 Shekels of damages was less than substantiated and consequently Luxvision was ordered to pay the maximum statutory damages of 50,000 Shekels for slander. The allegation of unjust enrichment was also not substantiated and was rejected.

Charges against Lapidot were rejected as any actions he conducted through the company were considered as the responsibility of the company and not personal responsibility.

Luxvision’s counter-claims of slander for Optika Halperin’s media campaign stating that ‘only companies that want to profit likes pigs sell expensively’, was rejected as Luxvision had started the smear campaign and the description seemed somewhat apt. Furthermore, there was nothing wrong with Optika Halperin showing the difference in price between themselves and competitors. In general, Optika Halperin’s campaign was considered acceptable. Luxvision, was, however, also ordered to pay 33,999 Shekels for causing the ELAL contract to be breached and they were also ordered to pay the court’s expenses including the cost of the court recorder, and 38,000 Shekels in legal fees incurred by Halperin.

28167-04-11 Optica Halperin vs. Luxvision LTD, by Gidon Ginat of Tel Aviv District Court, 29 April 2015


Waters of Eden – Nature’s Champagne

May 25, 2015

Mei Eden

Mei Eden (Waters of Eden) is a mineral water bottler and distributor.  Mei Eden advertised their mineral water as Nature’s Champagne.

The Comite Interprofessionnel du vin de Champagne (CIVC) which represents the wine manufacturers in the Champagne region of France, who perform a second fermentation of their wines in the bottle to produce a sparkling wine, have a geographical appellation. Only wine from that region may be called Champagne. The Comite Interprofessionnel sued Mei Eden on grounds of Infringement of their Geographical Appellation of Origin, Unjust Enrichment, the TRIPS Amendment to Israel’s IP Laws 1999 and Commerce relates torts 1999.

We note that MEi Eden is sold in blue tinted plastic bottles. Notably, in the period on question, the company did not sell sparkling mineral water, only still mineral water.

In an erudite 52 page ruling Judge Ginat reviewed Israel trademark cases, TRIPS legislation, Perrier related decisions from Germany, and UK rulings by well respected IP Judges Arnold and Laddie.

I can’t be bothered to reproduce the whole ruling here. I will confine myself to two quotes:

“The necessary elements for a claim in passing off were restated by the House of Lords in Reckitt & Colman Products Ltd v Borden Inc [1990] RPC 341 as follows:

the claimant’s goods or services have acquired goodwill in the market and are known by some distinguishing name, mark or other indication;
there is a misrepresentation by the defendant (whether or not intentional) leading or likely to lead the public to believe that goods or services offered by the defendant are goods or services of the claimant; and
the claimant has suffered or is likely to suffer damage as a result of the erroneous belief engendered by the defendant’s misrepresentation”

As noted above, both of these points were well explained by Laddie J in Irvine, in particular in the following passages:

“First, it is well established that, even in the absence of competition and hence diversion of sales, a misrepresentation leading to the belief that the defendant’s business is associated with the claimant’s is damaging to the claimant’s goodwill. Secondly, it is also well established that, if there is a misrepresentation which erodes the distinctiveness of the indication in question, then that is damage for the purposes of a claim in passing off.”

Expressed in these terms, the purpose of a passing-off action is to vindicate the claimant’s exclusive right to goodwill and to protect it against damage. When a defendant sells his inferior goods in substitution for the claimant’s, there is no difficulty in a court finding that there is passing off. The substitution damages the goodwill and therefore the value of it to the claimant. The passing-off action is brought to protect the claimant’s property. But goodwill will be protected even if there is no immediate damage in the above sense. For example, it has long been recognised that a defendant cannot avoid a finding of passing off by showing that his goods or services are of as good or better quality than the claimant’s. In such a case, although the defendant may not damage the goodwill as such, what he does is damage the value of the goodwill to the claimant because, instead of benefiting from exclusive rights to his property, the latter now finds that someone else is squatting on it. It is for the owner of goodwill to maintain, raise or lower the quality of his reputation or to decide who, if anyone, can use it alongside him. The ability to do that is compromised if another can use the reputation or goodwill without his permission and as he likes.”

In his ruling, Judge Gideon Ginat issued an injunction against Mei Eden using the term Champagne to describe their water, fined the water bottler 400,000 Shekels and awarded a further 200,000 Shekels in legal fees.

02-22286-33 Comite Interprofessionnel vs. Mei Eden LTD et al. Judge Gidon Ginat, 19 May 2015

COMMENT
This decision issues as WIPO members are hammering out the Geneva Act of the Lisbon Agreement. See here for more details.
I have nothing against appellations of origin per se being taken seriously. However, this specific case was filed well after the events and long after the advertising Champagne campaign was initiated. Once a complaint was made the defendant stopped using the slogan. Arguably therefore, there were adequate grounds to throw the case out. I can, however, see grounds for issuing an injunction to prevent Mei Eden describing their product as Nature’s Champagne.

Damages? Unjust enrichment? Not convinced.

Unlike some Israeli sparkling wines which are as good as the French ones, mineral water, no matter how good, is not confusingly similar to Champagne wine, regardless of how bad. Mei Eden is not a sparkling water nor is it sold in glass bottles like Perrier. It cannot be compared to Babycham which was a cider that could allegedly be confused with Champagne by occasional Champagne drinkers or by the inebriated.

I don’t think that Laddie’s comments regarding an alleged misrepresentation leading to the belief that the defendant’s business is associated with the claimant’s is damaging to the claimant’s goodwill are in anyway relevant to this case.

I don’t find the argument of “passing off’ convincing. I don’t see a reasonable likelihood of customer confusion, or even a faint possibility of customer confusion. I can accept that European trademark practice would consider this type of usage ‘dilution’ and would forbid it. I can therefore see a legitimacy in the Comite Interprofessionnel suing for an injunction, and obtaining their costs. However, I don’t see a justification for this rather large fine. At worse, Mei Eden promoted their water using this Nature’s Champagne campaign. Arguably they increased Mei Eden’s market share of the mineral water market and maybe even increased mineral water consumption, but I seriously doubt it was at the expense of Champagne sales. I just don’t buy this.
The basis of the costs ruling was statutory damage and the damages awarded were “estimated” after weighing up all the considerations. I suspect that this sum will be appealed.

Peckham Spring

Readers are referred to “Mother Nature’s Son” the 1992 Christmas Special of Only Fools And Horses, which is perhaps the most iconic episode ever, and one of the funniest programs ever aired by the BBC, where the Trotters successfully market Peckham Spring Water.
http://www.bbc.co.uk/comedy/onlyfools/christmas/1992.shtml


IL 142809 to Pharmacia Successfully Opposed by Teva Pharmaceuticals

March 18, 2015

R&R          R&R2

IL 142809 to Pharmacia AB was submitted on 25 April 2001 as a national phase entry of PCT/SE/99/02052 “NEW CONTROLLED RELEASE BEAD, A METHOD OF PRODUCING THE SAME AND MULTIPLE UNIT FORMULATION COMPRISING IT”. This published as WO 0027364 on 11 November 1999. The application claims priority from another PCT application filed a year earlier.
On allowance in 2006, the patent published for opposition purposes and on 18 May 2006 Teva filed an Opposition, submitting a detailed statement of case on 18 October 2006. On 12 march 2007 Pharmacia filed a counter-statement. Both sides submitted evidence, held a hearing before then Deputy Commissioner Noah Shalev Shmulovich and then filed their summaries.

As per regulation 202a, the current commissioner, Asa Kling ruled on the opposition based on the material of record.

The application is directed to a bead with controlled release of active ingredients, a method of manufacture and a multi-part formulation that includes the active ingredients. Essentially, the bead comprises a multilayer structure that includes a soluble core covered with non-soluble coatings, and the patent has 23 claims, two of which are independent.

Claim 1 is as follows:

 A controlled release bead comprising:
A core unit of a substantially water-soluble or water-swellable inert material;
A first layer on the core unit of a substantially water-insoluble polymer;
A second layer covering the first layer and containing an active ingredient; and
A third layer of polymer on the second layer effective for controlled release of the active ingredient,
Wherein said first layer is adapted to control water penetration into the core.

Claims 2-7 recite the various lawyers and their formulations and thicknesses. Claim 8 is a Markush claim for various active ingredients. Claims 9and 10 claim different forms of the active ingredient. Claim 10 claims use in vitro. Claims 11-14 claim different materials for the first three coatings. Claim 15 provides dimensions for the core and claims 16 and 17 claim multidose structures.

Claim 18 recites a corresponding method as follows:

 A method of producing a controlled release bead, which method comprises the steps of:
providing a core unit of a substantially water-soluble or water swellable material;
applying a first layer of a substantially water-insoluble polymer to said core;
applying onto said first layer, a second layer comprising an active ingredient and optionally a polymer binder; and
applying onto said second layer, a third polymer layer effective for controlled release of the active ingredient;
Wherein the amount of material in said first is selected to provide a layer thickness that permits control of water penetration into the core.

Claims 19, 21 and 23 claim use of the bead for a treatment for various diseases and claims `19 and 21 claim the active ingredient as tolderene or a salt thereof.

Grounds for Opposition
The opposition was based on lack of inventive step (obviousness) under section 5 of the Israel Patent Law 1967. In addition, Teva claimed that some of the claims lack utility contrary to Section 3, that some of the claims lack support from the specification in contravention to Section 13 and the Application is laconic and contravenes Section 12.
Pharmacia argued that claiming that the specification was laconic was an inadmissible widening of the Statement of Case, but the Commissioner, Asa Kling felt that the alleged inadequacy of the specification was inherent in the Statement of Case and that Pharmacia related to the issue so he considered it admissible.
As to inventive step, the Commissioner explained that if at the time of filing, the claimed invention was a simple extrapolation that could be considered as a simple development within the field and allowing a patent for it would prevent progress, it would be incorrect to allow a patent.
The Commissioner noted that both sides accepted that beads allowing controlled release of active ingredients that comprised a miscible or non-miscible core, a sealcoat, layers of active ingredients and additional layers were known at the filing date. The sealcoat serves to protect the active ingredient from reaction with the core and may be water impervious or slightly pervious. In the present invention such water penetration was controlled but in the prior art it was less controlled.

Not that kind of seal coat

Not that kind of seal coat

The present invention differs from the prior art in two ways: (i) the sealcoat is miscible in the prior art but is immiscible in the present invention, and (ii) the seal coat of the present invention is rather thicker than usual, but the thickness is not mentioned in the claim-set.

Teva argued that since the core in this case is impervious the sealcoat is superfluous and non-functional and there is no effective difference from the core of the present invention and that of the prior art.

Teva argued that in the priority document this was stated explicitly:

“Each bead comprises (i) a core unit of a water-soluble, water-swellable or water-insoluble inert material (having a size of about 0.05 to 2 about 2 mm), such as e.g. a sucrose sphere; (ii) a first layer on the core of a substantially water-insoluble (often hydrophilic) polymer (this layer may be omitted in the case of an insoluble core, such as e.g. of silicon dioxide), (iii) a second layer of a water-soluble polymer having an active ingredient dissolved or dispersed therein, and (iv) a third polymer layer effective for controlled release of the active ingredient (e.g. a water-insoluble polymer in combination with a water-soluble polymer)”. (WO0012069 page 6 line 33 to page 7 line 6). This point was also clear from US 6,770,295 to the same applicants.

The Applicant countered that the opposer’s explanation of the phrase “control water penetration into the core” was a misrepresentation and the correct explanation is found on page 2 lines 23-25 of the Application and only rates to beads wherein the water penetration to the core is impeded in a controlled manner and excludes beads where the core is protected by an impervious layer. The Applicant argued that the claim of lack of inventive step was based on this wrong interpretation.  In contradistinction to immiscible cores of the prior art in the present invention the core is miscible and is protected by a partial barrier sealcoat which allows controlled release.
The applicant could not explain the working of the sealcoat and how it inhibited release of the active ingredient but argued that the phenomenon exists and this is sufficient for both enablement and inventive step.
It seems therefore, that the key question is whether an immiscible core or a miscible core protected by an immiscible coating are equivalent or if a miscible core protected by an immiscible coating can be considered inventive over an immiscible core. Citing 345/87 Hughes Aircraft vs. State of Israel, it is accepted that a mere scintilla of invention is sufficient, and the question is whether this exists in the present case.

Utility
Teva argued that the utility was not demonstrated in contravention of Section 3 which allows patents for inventions that are new, useful, industrially applicable and non-obvious.
In oppositions, the onus is on the applicant to show utility. Citing 665/84 Sanofi vs, Unipharm the commissioner stated that the application as field has to provide a basis for utility and, if challenged, the Applicant has to prove utility during opposition proceedings. IN enforcement and cancellation proceedings the burden of proof switches and the challenger has to show a lack of utility. Consequently, the Commissioner ruled that without proof of usefulness a patent should not be granted.

According to the Specification, there are three advantages:

  • The claimed bead prevents the soluble core from serving as a reservoir of the active ingredient and extending the controlled release period
  • It reduces the likelihood of the core material releasing active ingredients and reduces the atmospheric pressure (specific vapour pressure?) and prevents the core from swelling
  • It reduces the initial phase during which there is no release of the active ingredient or only minimal release

According to the applicant these advantages transcend specific active ingredients.

The Opposer argued that these advantages are claimed for the specific active ingredient and for other non-specified active ingredients without any rationale or evidence.

Evidence
The evidence from each side consisted of expert opinions. Teva produced an expert opinion from Professor Golomb, and Pharmacia releid on expert opinions from Professor Wilson and from a Professor Walther who attempted to reproduce the experiments described in the application.
Professor Walther conducted a number of experiments to demonstrate that claimed in the first example for different active biological compounds. These, together with raw data were appended to Professor Walther’s affidavit at the Commissioner’s request.
There were differences between the raw data and the final conclusions with regard to what active species showed the desired effects and whether a heat treatment affected the results. The Commissioner felt that the discrepancies required explanation.
The Applicant claimed that Tolterodine exhibited the desired behavior, as did Reboxetine and cona, theopheylline and Carbamazepine. This was held sufficient to show that the behavior was a general phenomenon.
The tests related to a core with three coatings whereas the specification proposed a fourth optional coating. This, together with other discrepancies were considered to show light on the utility.
The thick initial layer did show slow release of the Tolterodine in a manner that was close to linear.
In the Application, after three hours some 70% of the active ingredient ws released, but in Dr Walther’s corroborative experiments, after this time lapse, only 43% of the active ingredient had been released.
When comparing Professor Walther’s results with the experiments in the specification it appears that the applicant had problems repeating their own experiments. The problem seems to be that Professor Walther simplified the experimental design and still could not achieve meaningful results. He was able to show that a thicker coating impeded release of the active ingredient but not in a qualifiable and repeatable manner.
As far as Tolterodine, the preferred active ingredient was concerned, Professor Walther was unable to show a correlation between thickness and the rate of release and was unable to repeat the examples in the Application. The Commissioner considered the lack of repeatability an reproducibility as undermining the claimed utility and barring the issuance of a patent.
Adequacy of the Specification
Section 12 requires that the specification be adequate to allow persons of the art to implement the invention. The rationale for granting a patent is in exchange for teaching something useful and failure to teach something sufficiently to allow the teaching to be repeated is considered as invalidating the application: “The sufficiency of a specification is a question of fact and necessarily depends upon the nature of the invention and attributes of the skilled person.” ( Hollister [1993] R.P.C. 7 para. 10-14). In this instance, the purpose of the patent as specified in the priority document was to enable the controlled release of the active ingredient at a predetermined rate over the shelf life of the product.
“An important aspect of all controlled release dosage forms relates to the need for consistent drug release between dose units prepared in the same and/or in different production batches, and throughout the shelf-life of the finished product.”

The surelease polymer specified in the specification and used by Professor Walther in his experiments was supposed to provide repeatable and reproducible results:

“In one embodiment, the invention provides a commercial-scale process for manufacture of controlled-release dosage units. The process comprises co-formulating tolterodine or a tolterodine-related compound as an active drug and a pharmaceutically acceptable polymer-based release-controlling component. … more preferably substantially all of the polymer-based release-controlling component used in the process has an age, at time of dosage unit manufacture, which varies by not more than about 180 days, preferably not more than about 120 days, and more preferably not more than about 90 days.”

Professor Walther was unable to show this control. Under cross-examination he stated that:

“So what we know is that Surelease has lot to lot variability. So one batch of Surelease may perform slightly different from another batch of Surelease. That is an effect that the suppliers do know and understand and that is something that, as part of any formulation development, you would establish how robust a product is towards variability and providing sufficient specifications then on it.”

The problem is that this variable is not described in the specification, rendering the claimed invention not enabled.
The Commissioner ruled that the claimed invention does not have demonstrable superiority, lacked sufficient disclosure and enablement and that no inventive step was shown. Consequently the application was refused.

COMMENT
Active ingredients are released from the surface of solids. This is true for components that leach out and for components that are released when a carrier dissolves.
As particles shrink, the surface area to volume ratio increases and the rate of dissolution increases. Having a non-functioning core surrounded with a coating containing active ingredients is to ensure that the effective surface area remains more or less constant and thus the active ingredients are released at a constant rate.
The above explanation is obvious to anyone with a background of materials science and chemistry.
Drugs are more effective if the dosage is released slowly at a constant and predictable rate.
The present invention seems to be based on the premise that over time the core will absorb the active ingredient and that a coated absorbent core is better than a non-absorbent one.
The application is based on Tolterodine as an active material, but other pharmaceutical compounds may be expected to behave in the same way.
Of course, using the same binder and beads of constant diameter won’t give reproducible results if there are other significant variables. The problem here is that the Applicant’s own attempts to demonstrate the efficacy of the claimed invention failed. In such circumstances, the Commissioner couldn’t really have come to a different conclusion than that the application was deeply flawed as the person of the art selected by the applicant was unable to reproduce the results.

The previous Deputy Commissioner resigned four years ago. Obviously this was only one case of many that the current commissioner and his deputy or adjudicator had to rule on. Nevertheless, it seems to me intolerable that the parties should have to wait for four years for this ruling and one wonders why the previous deputy commissioner couldn’t have left less abruptly, and finished these pending cases.

 


February 11, 2015
Not that kind of niagara!

Not that kind of niagara!

Israel Patent 202468 to Sassy and Dalia Kazir issued on 1 March 2012 for a “toilet water supply system and method therefor”. The patentee paid the renewal fee in a timely manner but did not send proof of payment to the patent office and the patent lapsed.

Mr Katzir submitted an affidavit to the effect that within a week of receiving notification that the patent was not in effect, they requested reinstatement.

In the circumstances, the Deputy Commissioner ruled that the Section 60 requirements that the applicant did not intend the application to lapse and acted in a timely manner to reinstate were fulfilled and a ruling to reinstate will publish for opposition purposes.

COMMENT

It is, of course, ludicrous that one can pay renewals on-line at the Israel Patent Office, filling in the patent number, and then one has to print out the payment slip and send to the patent office so that it arrives there in a timely manner. This requirement results in regular rulings and wastes everyone’s time.


On Blood Pressure and Diabetes. Can citations post-dating the effective Filing Date be used as evidence of what was known at the time of filing?

February 10, 2015

 

blood pressure

Israel Patent Application No. 140665 to Novartis relates to preparations including Valsartan and Amlodipine for treating high blood pressure and diabetes. The application is a national phase of PCT/EP/1999/004842 and claims priority from an earlier US patent application.

The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two references that were published after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and espunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicated the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

Comment

Although not allowed to be added to the record, as it could have been submitted earlier, this ruling does seem to indicate that such post priority publications may indeed be used to show what was prior art.


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