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.


PCT Direct

March 31, 2015

DIrect

The Israel Patent Office has announces an experimental service called “PCT Direct”.

PCT Direct is intended to make the process more efficient and to increase the value of the International Search Report (ISR) and International Preliminary Examination Report (IPER) that the Israel Patent Office produces as a Searching and Examining Authority of the PCT (Patent Convention Treaty).

The service is aimed at PCT applications claiming priority from an Israel Application and the system is designed to help respond to the Notice Prior to Examination of the Priority Application

The Applicant will be able to relate to all issues in the Notice Prior to Examination. The response is, however, not part of the PCT request. It seems that the idea is to file a PCT request as a response to a Notice Prior to Examination, submitting a marked up and clean copy, details of other prior art known to examiner and details of first publication.

If the art cited by the Applicant is of value, half the search fees will be refunded.

The PCT response and interaction will be considered as a response to the prosecution of the priority document if not yet allowed.

Apparently the Israel Patent Office is only the second authority, after the EPO, to offer this exciting new service.

 

COMMENT

I am confused as to the point and purpose of this development.

abbreviation

I have an aversion to abbreviations.  PCT, IPER, ISEA, ISR – at least the Talmudists had the excuse that scribes wrote by hand and parchment was expensive. Nevertheless, WIPO (World Intellectual Property Organization) uses them, so I suppose we must conform.

The EPO’s description of the PCT Direct service may be found here.

More substantively, The PCT application should be filed within 12 months of priority. Israel Applications publish automatically at 18 months, so one wonders what first publication is being considered here.

I think that this initiative is designed for applications that are made special and examined immediately, either due to them being green applications that are environmentally friendly, or due to applicant petitioning based on age, suspected infringement and the like. It is possible that this has ramifications for a PCT application claiming priority from an earlier PCT application.

It also seems that the applicant need not actively file PCT responses in the parent file but can rely on the system doing so automatically.

Not too long ago, the search report of the PCT was considered as something of little value and was often ignored by examiners who examined to grant patents.  Then came the Patent Prosecution Highway, and then the Superhighway. I think this further development is designed to demonstrate that the Israel Search and Examining Authority, is willing to grant patents based on their PCT work, as is, apparently, the EPO and to create additional trust in the system. Hopefully this will translate into less duplication and a faster, more efficient, high quality service.

This is, however, speculation.

Readers who can briefly summarize what PCT Direct is all are about are cordially invited to do so.


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.

 


IL 157,035 – If one accused of infringing a patent does not challenge its validity, is the accused estoppeled?

March 8, 2015

Fig. 3Fig. 6

Israel Patent Number 157,035 is owned by Moshe Lavi. It relates to a shelf for the compressor of an air conditioning unit.

The main claim is as follows:

 A modular bracket for an air conditioner compressor, said bracket comprising a substantially rectangular frame composed of at least two portions, being “U” or “L” shaped provided with surplus holes allowing adjustments to suit the thickness of an air-conditioning compressor to be seated thereon, at least one further structure being attachable to said rectangular frame to provide support thereto.

The patent application was filed in July 2003 and issued in May 2007. In April 2014, Zach Raz, represented by Pearl Adv. filed a cancellation proceedings and, on 27 July 2014 Moshe Lavi, represented by Pearl Cohen Tzedek Latzer Barats filed a request to have the case thrown out.

Note, the Pearls concerned are different lawyers with the same name. To differentiate between them, we will call one firm Pearl and the other Pearl Cohen – Brats.

In an earlier dispute, 47000-02-12 Moshe Lavi vs. Zach Oz Air Conditioning LTD., the parties agreed to an out-of-court settlement in which the applicants for cancellation undertook not to infringe the patent, and, consequently, Pearl Cohen Brats argued that they were estopelled from challenging the validity of the patent.

At this stage Pearl Cohen Brats claims that Zach Oz never raised validity issues which are generally the first line of defense that infringers take, and at this stage, they are estoppled and it is too late for the them to challenge the validity of the patent whether or not the grounds for so doing were known at the time of the previous ruling.

Moshe Lavi represented by Pearl Cohen Brats further alleged that Zach OZ was behaving inequitably and was misusing the legal procedures. This argument was based on the compensation damages awarded in the out-of-court settlement were minimum as the parties were keen to put the legal battles behind them, and, were Moshe Lavi to know that the validity would subsequently be challenged, they would never have agreed to reducing the compensation.

Zach Oz argued that there was no positive declaration of validity or admission of validity in the court case or in the out of court settlement. They further argued that the grounds for invalidating the patent were only discovered after the out-of-court settlement. They further opined that throwing a case out without discussing its merits should only be considered in extreme cases where it is clear that the case is frivolous. Since the issue of infringement and that of validity are not the same, one cannot consider that the previous court ruling prevents the patent office from hearing the case.

Ruling

The Commissioner, Asa Kling noted that throwing out a case on a technicality without hearing it on its merits was an extreme step, and that the Israel Patent Office had an obligation to ensure the integrity of the patent register (see section 73b of the Israel Patent Law 1967) so that the validity of any patent that arguably should never have issued should be challengeable.

Citing Judge Zamir in Appeal 3833/93 Levine vs. Levine:

Access to the Courts is a constitutional right despite there not being a constitution and this right is not yet written into the basic laws, and the courts will uphold this right.

Judge Heishin in 733/95 Orpal Aluminium vs. Klil Industries LTD PD 51(3) 755, 628:

Access to the courts is a basic right as basic rights are commonly understood.
Furthermore, access to the courts is considered a basic right, even if not literally stated in the Basic Laws. It is the air that allows the courts to breathe and is the basis of the judiciary and of the rule of law.

In other words, Heishin was noting that the courts need to be able to hear cases to function and so were loath to throw cases out on a technicality.

Commissioner Kling accepted the need for finality, but ruled that the need for access to courts  and for cleaning the patent register by voiding  a priori non-valid patents was a greater need. He didn’t consider that civil procedures were merely for the benefit of the warring parties and there was an overriding national interest in allowing cancellation proceedings to be judged on their merits. Section 73b rules that such cancellation proceedings could be submitted by anyone.

Based on the statements of case, this instance was not one of those rare cases where access to the courts should be denied.

In paragraph 2 of the statement of case, Lavi (represented by Pearl Cohen Brats) stated that “the patent was granted on 12 May 2007 and is in force for all purposes”. In paragraph 14 of the counter claims Zach Oz represented by Pearl stated that the patent is in force until 21 July 2013, i.e. a further year. It seems that this was simply a misreading of the register. One cannot deduce from this that they accepted that the patent was inviolate and could not be challenged.

Since anyway, anyone can challenge the validity of a patent, and in so doing, serves the public interest, the whole concept of judicial estoppels is irrelevant and this skirmish is simply a waste of precious judicial time.

Essentially the infringer, can, of right, challenge the validity of the patent in the patent office whilst defending himself from allegations of infringement. The legislators intentionally allowed this and the estoppel simply does not exist.

It appears that Lavi (represented by Pearl Cohen Brats) are attempting to learn ex silencio assent to the validity of a patent whose validity was never formally asserted. Although Section 182 allows the alleged infringer to raise invalidity issues in his defense, he is not obliged to do so.

The mere fact that in the previous court case, there were vague references to validity issues, the court never addressed those issues and it cannot be construed that the previous court had affirmed that the patent is valid.

Citing Zaltzman in Court Actions 1991, , the Commissioner ruled that an out-of-court settlement undertaking not to infringe that was subsequently endorsed by the court cannot be considered as if the parties had accepted validity of the patent or that there was indeed infringement. They had merely decided not to bother to have an adversarial dispute that could create estoppels.

Arguably, the claim that the token compensation would not have been accepted had the patentee known that the validity of the patent would subsequently be challenged might be grounds for ruling that the agreement was broken or for claiming inequitable behavior in an appropriate forum but this could not be used to argue that the case should be thrown out without relating to the issues raised, thereby preventing the validity of the patent from being challenged in the patent office.

The Commissioner ruled that each side should bear their own costs for this request to throw out the case.

The patentee was given three months to relate to the validity issue.

COMMENT

Disclosure – Way back in 2007 when Lavi sued Zach Oz, I was approached by Soroker-Agmon on behalf of the defendant to give an expert opinion concerning whether the patent was infringed. I came to the conclusion that there was no infringement unless the claims would be interpreted so broadly that they would be voidable as lacking novelty (the Gillette Defence). I requested a minimal budget to search the prior art as it seemed clear to me that the patent was for a shelf bracket with a triangular brace and it should never have issued anyway. The budget was not forthcoming, and I never got to present my arguments of non-infringement in court as the defendant got cold feet and agreed to the out-of-court settlement so my arguments were never heard. It was and is my belief that the patent in question was not infringed, could easily be voided as lacking inventive step and, with a little searching, should be easy to show was anticipated. No substantive judgment was given.

The issue before the Commissioner was a legal one and was simply whether the arguments for cancellation should be considered on their merits, or whether the party requesting cancellation should be legally prevented from presenting their arguments.

The commissioner is, of course correct to throw out the request to throw out the case on a technicality. Furthermore, as the request was frivolous, and as noted by the commissioner, the request was a waste of Judicial resources, I think he was more than generous in ruling that the parties should bear their own costs.

I understand that back when the infringement case was filed, Zach Oz had minimal resources to fight the patentee and was effectively bullied into submission. As with the Source Vagabond case, a more vigorous defense would have been that the whole lawsuit was frivolous, that the patent was not infringed. Maybe now they’ll do what they should have back then and show that the patent never should have issued.


Verbosity in summaries

February 15, 2015

Lord Chesterfield once wrote to a friend. “I’m sorry that I have written you a five-page letter; I didn’t have time to write a one page letter.

In Opposition to Israel Patent No. 16800 to PMS Armor LTD Opposed by DSM IP Assets, Ms Yaara Shoshani Caspi requested that the summaries be submitted on no more than 45 pages with standard margins and font.

For those who have lost the thread in this exciting opposition, and a parallel one between the two parties, see here , here and here.

Adv. Mati Barsam, representing PMS Armor LTD seemed to misunderstand the cap of 45 pages and filed 52 pages. Also, since he did not use double-spacing, the summary submitted was much wordier than it should have been.

Ms Shoshani Caspi considered that it was well-known that standard format was double spacing, David font at 12 point with margins of at least 2 cm on all sides. She ruled that in consequence of the over-long submission by PMS Armor LTD, DSM IP Assets could file up to 50 pages.

Citing the relevant case-law 16840/06 P .A. N. vs. Public Guardian, 20 Apr 2007, it is stated that:

“inter alia, limiting the amount of summary material is designed to ensure equality between the litigants in their access to the courts, the use of a smaller font is an attempt to overcome the limitation imposed by the court and to obtain an advantage over opposing counsel thereby”

So as to be absolutely clear, although the respondent was allowed to submit 50 pages, they were required to do so in double spacing, David font at 12 point with margins of at least 2 cm on all sides. PMS Armor LTD was ordered to pay 1200 Shekels + VAT to DSM IP.

COMMENT

If I was sitting in judgment on this case, I’d have been tempted to send the summary back and asked for it to be shortened, giving maybe 3 days, with the alternative that only the first 45 pages would be considered. If the summary is in single spacing, would reformat in double spacing and accept the first 45 pages only.

That said, Ms Shoshani Caspi’s approach is, of course, both reasonable and in line with Israel Patent Office policy to charge excess fees for filing long applications, and with WIPO’s policy of charging per page for PCT applications with more than 30 pages (including forms).

45 pages seems to me to more than enough to summarize just about anything. Particularly in Hebrew which generally requires only about 65% of the space taken by the same material in English. Once arguments are constructed and written up, it should be possible to cut down verbage and to edit down at least 20%. When I recycled reedited IP Factor blog entries for columns in various magazines such as WIPR, MIP and IAM, each one had its own word allowance, and by careful editing, it was always possible to cut articles down to size. It’s a question of being succinct and focused. Writing a 400 word précis of an article was a standard requirement to matriculate in English Language ‘O’ levels in the UK. It is a useful skill.

Since the advert of word processing, patent applications have become longer. Whilst it is not always possible to submit PCT applications in 30 pages, avoiding excess claim fees, for many inventions, this is more than adequate.

It seems to be easy to fall for the temptation to copy-and-paste and to write more, than to use the available editing facilities to shorten one’s work. I suppose when one employed scribes and wrote on expensive material like vellum, things were different.

Some clients and attorneys seem think that the longer the submission, the better. However, the opposite is usually the case. It is unlikely that a 50 page summary can be read in one sitting and for the adjudicator to work from a submission this long, the adjudicator really needs to summarize the summarize, and this is ridiculous. It is not just summaries of course. There are some IP firms that seem to file telephone directories for every application. This is generally unnecessary.

As an aside, as someone who regularly wades through IP decisions, I think that it would be nice if IP adjudicators and judges tried to cut their rulings down by 20% as well. Then again, no doubt my blogging could be focused and succinct.


A Request for a Patent Term Extension for IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck

February 10, 2015

gardasil

IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. was filed on 13 March 1996, and is due to expire on 13 March 2016.

Back in August 2007 a Request for Patent Term Extension was filed based on the commercially available preparation Gardasil. The pharmaceutical preparation contains four active ingredients: Protein L1, types 6, 11, 16 and 18.

The patent claims the Protein L1 type 18 as a product of genetic engineering. The patent relates to the other types of Protein L1 except for HPV 6 L1 for which no patent applications were submitted anywhere. The protein HPV 16 L1 was not claimed in any patent application filed in Israel. HPV 11 L1 was claimed in IL 117591 and expires on 21 March 2016. However, no applications for patent term extensions were filed for this protein.

The legal question that this decision addresses is whether a patent term extension can be requested for a patent that protects only one active ingredient of a pharmaceutical preparation.

The claims of IL 117459 cover a gene sequence of Protein L1 type 18, a vector including the gene sequence, a cell embodying the vector a process of expressing the gene sequence and a preparation that causes a vaccination to the protein including the gene sequence.

The senior examiner considers that Gardasil includes four proteins and any changes in any of them or preparations of three or less will result in a different medicament. Consequently, she considered that there is an inconsistency between the medicine and the claimed invention, in that not all the active ingredients of the claimed invention are in the basic patent.

The Applicant countered that claim 12 of IL 117459  covers a composition that includes (inter alia) HPV 18 L1 and thus the patent does not limit itself to this substance. Consequently, Applicant claims that IL 117459 is a basic patent as defined in Section 64a of the Israel Patent Law 1967 and as referenced in Section 64d. The Law does not require that a basic patent should include all active ingredients of a commercial product, and only one such active ingredient need be listed. Support for this interpretation was argued based on the wording of 64h(d) which relates to an active ingredient included in a preparation and claimed in the basic patent

The Applicant alleged that interpretations that a basic patent should include all active ingredients of the commercially available preparation is contrary to the underlying logic of the legislation and it is unreasonable to include such a limitation by judicial interpretation.

The senior examiner rejected these arguments and the Applicant requested an oral hearing which was held on 28 October 2014 and the Applicant was granted until 10 December 2014 to submit a summary of his arguments.

Section 64d states:

The Commissioner should not grant a patent term extension unless all the following apply:

  • the composition, process for its preparation and usage thereof, medical preparation including the composition, its process for preparation and medical equipment are claimed in a basic latent that is in force.

Section 64a defines the terms ‘composition, ‘medical preparation’ and ‘basic patent’ as follows:

  • Medical preparation – any form of medical drug that has been processed, including preparations for veterinarian applications and those having nutritional value that are injected intravenously.
  • Composition – the active ingredient or salts, esters, hydrates or crystals of the composition.
  • Basic Patent – a patent protecting any composition, production method, use, medical preparation including the composition, or any medical equipment requiring regulatory approval in Israel.

Based on the court ruling concerning the Appeal to patent term extension for IL 97219 to Novartis (26/12/2005) the term composition means a single active ingredient.

In Novartis, then Commissioner Dr Meir Noam (himself a chemist) ruled that the term basic patent in both Section 64a and 64d relates to the first patent that protects an active ingredient and that the term composition is in the singular, implying that one new ingredient is sufficient and that novel combinations of known ingredients cannot be considered as a basic patent.  A preparation that includes one new ingredient that requires regulatory approval may be protected by extending a basic patent. Combinations, aggregations and synergies of known ingredients may be patentable but such patents are not basic patents.

In this instance, the issue is the regulatory approval of a combination of active ingredients, not the basic patent. Gardasil includes four active ingredients. Each one provides a parallel vaccination effect and maintains its pharmaceutical character. The four proteins are separately synthesized by fermentation in recombinant Saccharomyces cerevisiae (a species of yeast) but are combined into one treatment for economical reasons and due to ease of use.

(HPV Type 16 L1 and HPV type 18 L1 are also components of the registered drug Cervarix registered to a third party, and the proteins are each separately active.  However, Cervarix was registered after Gardasil).

Since the drug Gardasil comprises four separately active ingredients that each has an independent effect and do not work as a synergy, the Commissioner accepted that Gardasil could serve as the first regulatory approval of HPV type 18 L1. He found support in the ruling fo Judge Dotan in the Novartis case. He noted that Merck could have requested regulatory approval for the four proteins separately and the discussion would be moot. Finally, citing the Neurim ruling (13281-06-12 based on the ECJ ruling that Melatonin for treating insomnia was not obvious in light of veterinary treatment for causing sheep to rut earlier), it is clear that the purpose of the Law is to provide patent term extensions for new types of treatment, and there was no reason why the Applicant should have had to register each active ingredient separately.

Furthermore, in Appeal 223/07 Lundbeck vs. Unipharm it was ruled that patent term extensions should be analyzed from an IP perspective and not from a pharmaceutical perspective. The Supreme Court upheld this ruling.

Furthermore, in the medical register, Gardasil is listed as including four active ingredients, including HPV 18 L1, and this is, indeed, the first medical registration of this ingredient in Israel.

Consequently, based on the extension awarded in the UK for EP 1359156, the Israel patent was extended 493 days to 19 July 2017.

Ex Partes ruling concerning patent term extensions to IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18″ to Merck Sharp & Dohme Corp. by Commissioner Asa Kling, 11 January 2015.

COMMENT

This is a publication of an ex-partes ruling. It is possible that local generic manufacturers such as Teva or Unipharm may challenge this.


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