Patent Bar Exams

May 18, 2015
The Bar Exam by Will Bullas

The Bar Exam by Will Bullas

Wannabee Israel Patent Attorneys will have their chance shortly.

The written exam for drafting patents for computer, electronics and mechanical inventions will take place on 29 June 2015, and the written exam for biological and chemistry inventions will take place on 1 July 2015. The written exams will take place at 9 am and at 3 PM the candidates will have to take a language proficiency exam (unless they obtain a dispensation from this).

oral examination

The oral examinations will take place on Monday 6 July and Thursday 9 July, and candidates are requested to keep both days free, but closer to the time, will be assigned one or other date.

More details may be found here בחינות עופ – יוני 2015.

 

 


Alpha Dent Implants

April 26, 2015

Alpha Dent Implants        caps

Background

Boris Simnovsky attempted to file Israel Trademark Application Number 243663 for “Alpha Dent Implants”.

Alpha Bio-Tech LTD successfully opposed the registration, presumably on grounds of Alpha being laudatory, Dent Implants being descriptive, and the combined mark being  providing a likelihood of confusion with Alpha Biotech as to the origin of the goods.

The Opposer requested costs of $5694 so The Commissioner, Asa Kling, related to the items in the list for costs in dollars as well, whilst noting his disapproval that the costs were not submitted in Shekels which is the currency that they should be billed and settled in Israel.

Alpha Bio-Tech LTD opposed the mark On 25 December 2013, the sides filed their statements and counter-statements and on 9 July 2014, after the period for filing evidence had passed, The Applicant, Boris Simnovsky, requested to withdraw the mark without a decision on costs, as he had “lost special interest in the Israel market”, and was no longer interested in the mark.

On 14 July 2014, Commissioner Kling ordered the mark withdrawn and the proceedings closed, but gave both sides the opportunity to file for costs, and on 14 September 2014, Alpha Bio-Tech LTD applied for costs.

 

Ruling

A party that gives up during contentious proceedings such as an opposition is considered as losing, see Israel TM 171160 “Pine” in KT&G Corporation vs. Dunhill Tobacco of London LTD, and Israel TM 156955 Avon Products vs. Dean L. Rhoades. The Arbitrator of TM proceedings has the authority to rule costs from Section 69 of the Trademark Ordinance 1972. When ruling on actual costs, the adjudicator is required to determine if the costs claimed are reasonable, proportional and were incurred by necessity, See Basgatz 891/05 Tnuva vs. Input Authority P.D. 60(1) p. 600-615, Nevo 30 June 2005. The relevant considerations are the legal and factual complexity of the file, the amount of work done, especially in filings to the court, the behavior of the parties with respect to each other and to the patent office, equitable behaviour, etc.

As ruled in Tnuva Section 25, the parties must detail the basis of charges and the work done, and whether these were actually collected, and then the onus moves to the loser to explain why such costs should not be paid.

The Opposer’s costs of $5694 consisted of $1298 for preparing and filing the statement of opposition including official fees, $2926 for preparing evidence and $1500 for preparing the petition of costs.

The first two actions were supported by an affidavit and receipts but the charges were the charges were global and not itemized. There was no support for the final charge, and there was not even a framework agreement with the client to do this work.

The Opposer claimed that the applicant did not submit papers in a proper manner which resulted in additional work being incurred. Furthermore, the applicant requested that the opposer withdraw the last submission and the applicant would pay $4000, but this attempt to reduce expenses was unsuccessful.

The Commissioner accepted the Applicant’s allegations that the request for costs was laconic, but did not consider that the Opposer was therefore not entitled to reasonable costs and therefore decided to rule by thumb estimation based on the actual submissions.

After relating to all the relevant considerations (but at least as laconically as the Opposer) the Commissioner ruled total costs of 18000 Shekels ($4500).

Ruling of costs awarded to Alpha Bio-Tech LTD for successfully opposing Israel Trademark 243663 “Alpha Dent Implants” to Boris Simnovsky, costs awarded by Asa Kling 15 March 2015.


DSM IP Assets Opposes IL 177724 to Refine Technologies – Striking Evidence from the Record

April 22, 2015
 Selling Culture?


Selling Culture?

Refine Technologies LLC are opposing Israel Patent Numbers 177724 and 205606 to DSM IP Assets. These applications, titled “Methods For Reducing The Degree Of Aggregation Of Aggregating Cells In A Cell Culture” are a national phase entry of PXCT/EP2005.002374 from 4 March 2005 and a divisional application thereof.

The two applications claim priority from EP 04075702.3 and EP 04075703.1 from 5 March 2004, and from EP 04077656.9 and EP 04077657.7 from 27 September 2005. The parent was allowed and published for opposition purposes on 31 January 2011 and on 27 April 2011 Refine technology LLC submitted an Opposition.
The Opposition proceeding was frozen until the divisional application was allowed and that was opposed on 29 November 2011. The two opposition proceedings were combined and the Statements of Opposition and responses were filed for the two cases together.
Both sides submitted expert opinions. In their answer to the Applicant’s response, Mr Jerry Shevitz submitted a second affidavit and the DSM IP Assets allege that this relates to art that wasn’t cited in the original statement of case and also raises new issues. The sections relating to the additional citations and new issues should be struck as an illegitimate widening of the grounds of opposition. Furthermore, they weren’t an answer to the response.
In an additional argument, DSM IP Assets alleged that Mr Jerry Shevitz relied on a decision of the South Korean court concerning a corresponding application and that this was hearsay and thus inadmissible.

Refine Technologies LLC countered that DSM IP Assets waited more than six months after Shevitz’ answer was filed and that it was thus too late to request that the references be struck from the record. They also allege that the claims were in the original statement of case and so rejected that they were illegitimately widening their opposition. They argued that the new citations weren’t new to DSM as they were cited in Korea and were only brought now, due to the response that DSM filed that ignored these references that they were familiar with. Consequently, the new citations were properly to be considered as being an answer to the Applicant’s response. As to the Korean case being a foreign court ruling, the opposer accepted that it wasn’t binding on the Israel Patent Office or in an way precedential, nevertheless it was a relevant ruling on the same issue by a respectable court and was thus admissible comparative law for the commissioner to consider.

DSM objected to the application as lacking novelty in light of US 6,544,424 from 2003, a patent now assigned to DSM. Whilst admitting that this patent did not relate to Refines ATF (alternative tangential flow) technology, they submitted that this was not relevant to the results obtained. DSM further argued that the combination of US 6,544,424 and other prior art renders the claims obvious. For good measure, they also argued that the claimed inventions were not enabled and the claims were inadequately supported.

In her Ruling, the Deputy Commissioner, Ms Jacqueline Bracha acknowledged that the submission to strike evidence could have been submitted earlier, but felt that the three months remaining to DSM before the hearing gives them adequate time to relate to the issue on its merits.

The material that Refine objected to may be categorized into three groups:

  1. Material that could have been referred to in the original opposition
  2. Material that unfairly widens the grounds for opposition
  3. Material that relates to foreign court rulings

Ms Bracha noted that Section 62 of the patent regulations only allows the opposer to file additional evidence to overcome something refuted by the applicant or in response to a new point raised by the applicant. Consequently sections 2, 19.2, 20, 24 and 41, and the related appendices which were considered as new material or widening were ordered struck from the record. As to foreign court rulings, Ms Bracha considered these relevant and helpful and that these could be submitted, whilst noting that she was in no way bound by them.

No costs were awarded.

Intermediate ruling Refines Opposition to DSM IP Assets Opposition to Israel Patent Applications 177724 and 205606, Ms Jacqueline Bracha, 16 March 2015

 


So Israel took his journey with all that he had, and came to Beersheba (Genesis 46)

April 14, 2015

park Carusso

Yesterday I enjoyed a pleasant trip down South to attend the WIPO Roving Seminar in Beer Sheva. The drive was pleasant. Negev is very verdant and the ornithology was good, with a lot of storks and black kites and the odd short-toed eagle in evidence. The event started at 9:30, and, with considerably less congestion getting into Beer Sheva than into Tel Aviv, I arrived at 9:15 am at the Carusso Science Park.

Moshe Lemberg, the Senior Program Officer at WIPO who organized the event introduced himself to me and hoped that I would blog about the refreshments. I thought this was a little surprising as the rogelach and burekas were fairly standard fayre but did make a welcome breakfast. Unfortunately however, the 3 litre hot water urn was inadequate to the task and I was unable to make myself a coffee. That had an adverse affect on my concentration during the first part of the program, and I noted that after Dr Daniel Ben Oliel presented the prize for Excelling Academic thesis in various fields of IP [sic] there were three or four competitors who presented brief talks on their papers for the Israel Patent Office Competition, but have no idea what they talked about. The chairs were too comfortable, I’d left home at 7 am and I was too far away from the screen. My neighbor kept nudging me. I suspect I was snoring a little. I went to the bathroom, washed my face and had a coffee (botz, using water from the now refilled urn), and went back in sitting closer to the front. This was a great improvement and I found the sessions interesting, stimulating and enjoyable.

Those wanting a review of the early sessions are respectfully referred to the IPKAT where the Doyen of IP Bloggers, Professor Jeremy Phillips has some insightful and relevant comments. See here.  For inciteful and irrelevant ones, read on!

Professor Phillips notes that there were 98 registrants. He was sitting in the back corner and was better situated to count heads than I was. I do try to keep tally on these events however, and did a head count on three occasions throughout the day. I noted 60 in the audience. With 5 rovers from WIPO and a large contingent from the patent office, this was less than impressive. I hope that the Haifa event on Tuesday is better attended, and as the program is largely the same, can highly recommend it.

PCT

PC Tea

PC Tea

Mr Matthew Bryan, the director of the PCT Legal Division gave a brief review of the PCT system and recent developments, and the amicable and helpful Dr Michael Bart who heads up the Israel Receiving Office spke about recent changes there. The local Beer Sheva (actually Omer – but who’se counting?) Mukhtar Patent Attorney, Dr Kfir Luzzatto joined Matthew and Michael, and gave some thoughts on the PCT, how Israel joining the system had affected the profession, and how he views International Search Reports from the Israel Patent Office.

Trademarks and Designs

Ms Debbie Roenning, Director of the Legal Division Madrid Register, Brands and Designs Section (BDS) spoke on Madrid system for trademark registration and then on the Hague system for Design Registration.  As well as showing which countries had signed up, she showed which countries were in the process of signing up which was useful. She also had some tips regarding tailoring goods for different jurisdictions, translating the list of goods into Hebrew, adding countries to an existing application and varying classes per country that were very informative.

Ms Anat Levi Sofer spoke briefly about trademarks and Madrid from the perspective of the Israel Patent Office and considered Israel joining Madrid a great success. Ms Ronit Bazik Sofer, head of trademarks at Reinhold Cohn represented the private sector and noted that she had been apprehensive of Israel joining Madrid and indeed, there had been a drop off in work since Israel joined, but with increased prosecution, things had evened out.

Knowing the official figures regarding trademarks filed directly into Israel and via Madrid, and Madrid marks originating in Israel, I think that both Ms Anat Levi Sofer and Ms Ronit Bazik Sofer were being less than objective. (Reinhold Cohn has too large a market segment for their practice not to follow the official statistics). Israel is very good at creating technology, but is less successful at launching international brands. Madrid has not been widely used by Israeli companies. It is possible that with additional prosecution resulting from more trademark applications designating Israel, workers in the trademark office and in private practice feel that they are busy. However, without the lucrative filing and with renewals handled centrally or by bucket shops, the revenues generated are lower that revenues once were. This is true of both patent office revenue and income to IP firms.

There was an opportunity to ask questions. In her first slide, Ms Roenning had shown various recent Israel trademarks filed by Israelis. The slide also included WIPO’s logo. It was tempting to ask why they had chosen what look’s like a roll of toilet paper, but I decided that it would unnecessarily cheapen the event.

Wipe-o

WIPE-O !

WIPO’s Arbitration and Mediation Center

Mr Matthew Bryan gave a presentation regarding WIPO’s arbitration and mediation services.  It was certainly worthwhile reminding those present that there are alternative methods of dispute resolution, and that going to court is not the only option.

Databases

Mr. Yoshiyuki Takagi spoke about WIPO’s databases such as WIPO Green and WIPO Re:Search. This brought some useful online tools to the attention of participants.

Lunch

ravioli

We were pleasantly surprised that WIPO / Patent Office had laid on a sumptuous buffet of ravioli, pizza, macaroni, cheese rolls, garlic bread, quiches, cheeses and salads. Had this been a couple of days after Shavuot (Pentacost) this may have seemed more of the same, but after a week of Pesach, noone passed over the opportunity to dine on hametz.

Copyright 

real life

Mr. Paolo Lanteri, the Legal Officer, Copyright Law Division, Culture and Creative Industries Sector, WIPO spoke about the gaming industry. It seems that I was far from the only participant who wasn’t a gamer. I put this down to a combination of the audience being middle aged nerds.

It was fascinating to learn that the gaming industry is more significant financially than feature films and music combined. Happily people still read.

It seems that protecting IP in games is a complicated issue. The talk was very informative.

Questions were solicited and I made a case for moving over to registration of copyright and shorter periods of protection since I consider the system as broken. Jeremy Phillips took issue with my position and argued that most people in practice can do most of what they want and that the system does give redress for abuses. We continued arguing in the car back to Jerusalem.

Closing session

men in suits

The WIPO representatives and the Commissioner got on stage together as a panel. It was reassuring with INTA coming up, to note that my charcoal suit is apparently in fashion for IP events.

Dr Luzzatto took the opportunity to ask about Arab countries boycotting Israel, giving the example of Jordan that, despite a peace agreement, in practice the legal profession there won’t represent Israelis.

Mr Matthew Bryan first dodged the question by noting that Jordan was not a signatory to the PCT. As Kfir would not let things go at that, he rather sensibly pointed out that WIPO strongly condemns Arab countries discriminating against Israel, and writes strongly worded letters noting that such countries are not living up to their international obligations. He did, however, point out WIPO does not have enforcement police and their influence is very limited.

The Commissioner noted that Israel could theoretically refuse to allow applications originating from countries that don’t accept Israeli trademark or patent applications, but that the Israel Patent Office decided not to adopt this policy.

Retired US patent attorney Bruce Lilling noted that Taiwan, an important industrial nation was kicked out of the PCT mechanism at China’s request.

Recommendation

For those who missed the Beer Sheva event yesterday, I recommend trying to attend the largely parallel but slightly shorter program in Haifa tomorrow. See here.

Gratuitous Political Rambling Digression (its my blog so I can do what I like)

I note that Ms Debbie Roenning (who also wore a trouser suit, but not a tie) is the head of the Brands and Designs Section which shares the unfortunate acronym of BDS, the ‘Boycott, Divestment and Sanctions’ Movement, the allegedly pro Palestinian, but actually notoriously hypocritical and anti-Semitic international movement.

On the way to the conference, I noted Sodastream’s new factory in Beer Sheva. They moved from the Industrial Area by Maale Adumim (a satellite town of Jerusalem on the road towards Jericho) in response to vicious propaganda abroad. In the Maale Adumim factory, Sodastream provided jobs to West Bank Arabs and was a model of co-existence. Forced to relocate, the primary sufferers are the West Bank Arabs.
WIPO is one of the least anti-Israel organs of the UN. I think it might have been very worthwhile for them to have invited Jordanian, Palestinian and Egyptian IP professionals, both government and private, to the event. I am on good terms with professional colleagues in all these jurisdictions, and with others in Lebanon, Saudi Arabia and elsewhere, who read this blog, and chat amicably with me at INTA, AIPPI and other international conferences. Peace is made by trade.

Of course, Israel is not the only country to have been boycotted. To advance U.S. foreign policy and national security objectives, the U.S. maintains laws and regulations that impose economic sanctions against certain countries, individuals, and entities (the “U.S. Sanctions Program”).  31 C.F.R. § 501 et seq.  The Office of Foreign Asset Control (“OFAC”) at the Department of the Treasury manages the U.S. Sanctions Program.  The U.S. Sanctions Program prohibits U.S. nationals and U.S. companies from doing business in embargoed or sanctioned countries and from doing business with individuals or entities subject to U.S. sanctions laws and regulations.  At various times, the US has forbidden their nationals to register trademarks in Cuba and has also failed to uphold Cuban trademarks. Whether or not human rights are more mistreated by Castro’s regime in Cuba or by the US in the Guantanamo Bay prison camp is not clear.


Is Automation A Good Thing?

April 12, 2015

computer compatible

I am aware that as a patent attorney I am  supposed to be technology-savvy. Sometimes however, I think that William Ludd had a point. I hate smart phones and have been trying to downgrade for ages. It apparently doesn’t work like that.

I’ve just received a reminder from the Design Department of the Israel Patent Office today. It opened up nicely on my screen. The only problem is that what opened up nicely in html was the reminder. The automatically filled in details such as the file number and date didn’t show up. I downloaded the file and it corrupted.

I contacted the design department and after a bunch of strange emails from the head of the department to the effect that the document sent to me electronically is exactly the same as that which they used to send manually, and that it opened OK on the Israel Patent Office website, eventually we concluded that my computer is configured differently from that of the Israel Patent Office machines.

I was a little put out when the Examiner asked me if my software was Kosher. I mean as a Patent Attorney who makes a living from IP, is it likely that I would be using a rip off version of Word? Of course my software is Kosher. That said, an eminent Israel IP Law Firm (which I shall not name here) was caught by the Business Software Alliance with one Microsoft Office disk for a dozen or so computers. Very embarrassing.

To send PCT applications electronically, I use Explorer as the electronic sending doesn’t work on Chrome. To update my electronic signature from WIPO I had to install Firefox. I asked the Chief Examiner of the Design Department what the problem is and what the fix is. She told me that most patent attorneys don’t have a problem, but there were a couple of others that do. One has asked for reminders to be sent by snail-mail only. The other managed to update his system.

Now the problem could be my search engine (Chrome, Explorer, Firefox, different versions). It could be the operating system. It could be version of the operating system or the fact that I configure menus in English but have Hebrew support. It could be the version of Word. What I don’t understand is why I should have to work out the problem and solve it? PDF stands for Portable Document Format. A PDF file should open up on an IBM compatible PC or on a Apple Mac computer. It is designed to open on any computer with any system and is a standardized format.

Why should I have to update my system to match the one used by the Israel Patent Office? At present, my office computer works nicely. It multitasks without problems. There is an old adage that “if it is not broken, don’t fix it.”

I have a more up to date configuration on a new computer at home. Unfortunately, it has been nothing but trouble. I am therefore loath to update my office system as it is working smoothly. I have little faith in computer support. I have a neighbour who provides support to my computers at home. Once one tries to solve one problem by updating one component, suddenly the printer stops working, the screen goes blank, Hebrew types from left to right or English from right to left. My fairly new home computer system has never worked and we’ve reinstalled everything.

I think the Israel Patent Office should send PDFs.

Back in the old days when we had to submit PCT applications on disk, the Israel Patent Office (IPO) wanted the ZIG file on a 3 1/2 floppy. Having problems finding the disks and a disk drive, I suggested they move to DVDs. I was told that it was a waste of memory using something with megabytes of storage for a few KB of data. I pointed out that the issue was unit cost of medium not the total storage capacity. I offered to donate a CD ROM reader to the IPO. Eventually they saw reason.

 


Patent Office Closures for Pesach

March 26, 2015

pesach cleaning

The Israel Patent Office will be closed from 3rd April 2015 to 11 April 2015 for Pesach (Passover), and will open again for business on 12 April 2015.

Deadlines falling during the period that the Israel Patent Office is closed are automatically extended until 12 April 2015.

However, trademarks and PCT Applications may be filed on line during the festival and will receive the date that they are filed. Notwithstanding this, according to discussion with Dr Michael Bart, the USPTO now accepts PCT applications that are filed late due to Israel Patent Office closures.


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.

 


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