Deleting Documents in Patent Cancellation Proceeding

August 4, 2015

fighting robots

Aquatron and Maytronix are competing Israeli companies that each make pool cleaning robots.

Maytronix was awarded Israel Patent IL 206154 titled “Pool Cleaning Robot”. Aquatronix filed to have the mark cancelled.

In the cancellation proceedings various issues came up such as whether Aquatronix had received permission from Maytronix to use the patent. However, in a procedural agreement between the parties, it was decided that the summation statements would not to relate to this issue.

In their summation, Maytronix, did, however relate to the alleged license to use the patent, and so Aquatronix filed to have the relevant passages deleted from the file. In their defense, Maytronix’s argued that Aquatronix had submitted emails that related to the agreement as part of their evidence, and this had voided the procedural agreement.

Ms Jacqueline Bracha used Contract Law (section25a) to rule that what was agreed between the sides is binding. Had they intended to state that evidence should be suppressed they could have done so. The disputed sections on the patentee’s summation were ordered deleted from the record, but the emails submitted by Aquatronix were allowed.


Novartis – Double Patenting in Israel

July 1, 2015

novartis

The present ruling relates to the issue of identical of overlapping patents and patent applications, and examines the ramifications of double patenting in Israel.

IL 2039732 is a Divisional Application of IL 176831 titled “Compressed Pharmaceutical Tablets or Direct Compression Pharmaceutical Tablets Comprising DRR-IV Inhibitor Containing Particles and Processes for their Preparation”.  During prosecution it received a final rejection and the Applicant, Novartis, appealed this final Examiner’s rejection.

The Examiner considered that the claims of the parent and the divisional application are directed to the same invention. After this issue was first raised, the Applicant amended the claims, but the Examiner considered that the amended claim set (claims 1-23) covered the same invention as claims 23-26 of the parent application. Based on 5293/93 Welcome Foundation vs. Patent Commissioner (1993), the Examiner rejected the claims of the divisional application. A telephone conversation was to no avail. The Examiner issued a final rejection noting that there were substantive issues not addressed, and the Applicant appealed this decision to the Commissioner of Patents claiming that the issue is one of interpretation of the Law.

The Commissioner held a hearing and allowed the Applicant to present a short summary of the comparative law in US, Europe, Australia, Japan, China and India. In this instance, the Examiner did not claim that the divisional had identical claims to the parent application, but that there was some overlap. According to the Commissioner, the issue is one of interpretation of Sections 2, 8 and 9 of the law. These state that an inventor is entitled to a patent, that a patent can only cover one invention and that where two or more applicants file for the same invention, the first to file is awarded the patent. The purpose of divisional applications is to prosecute additional inventions claimed within the same parent application.

In the Welcome case, claims 1-10 related to uses of a pharmaceutical preparation in the treatment of various diseases and claim 15 related to a method of preparation of the active ingredient.  Then Commissioner, the late Michael Ophir ruled a claim for use in preparing a medicament’ and ‘use in the treatment of’ were identical. He did not see that the application related to more than one invention. On appeal, Judge Winograd ruled that one can file and prosecution an application for a material, a second one for the method of fabrication and a third one for uses, provided each application is directed to patentable subject matter and there is no overlap between the cases. There Judge Winograd went on to rule that one application cannot include more than one patentable invention, i.e. one should not award more than one patent for one invention, and this is a corollary of Section 8 that a patent should cover one invention. One can file a plurality of applications for a plurality of related patents provided that each one is directed to a patentable invention and the claims are not identical or overlapping.

In the present case, both the parent IL 176831 and the divisional application IL 203972 have the same title. In IL 203972 there is one independent claim. Claims 23 and 24 of the parent IL 176831 each depend on claim 1, and claims 25 and 26 are dependent on claims 24 and 23 respectively.

The independent claim of IL 203972 is directed to using a powder to form a pill for treating a wide range of ailments. Claims 23-26 of the parent IL 176831 are directed to forming tablets and a corresponding process. The divisional relates to various states that are not in the parent application, but both applications have the same specification. According to the Applicant, the parameters are identical but the parent claims the process whereas the divisional application claims use of the active ingredient to prepare a pharmaceutical.

According to the Examiner, the divisional application claims the use of a formulation for treating a disease, where the formulation is given in claims 23-26 and the diseases treated are listed in claims 1-22. In both cases, the formulation is the same, the particle size is the same and the active ingredients and additives are the same as those given in claims 23-26 of the parent.

Novatis found the Welcome decision poorly claimed and poorly reasoned and could not see why two applications could not claim identical or overlapping inventions. They argued that where applicants are the same, there is no need to relate to identical or significantly overlapping claims, holding that the Israel Patent Law does not prevent multiple patenting. Novartis argued that Section 2 is merely a declarative statement that the applicant may file a patent. It does not have legal ramifications, and certainly does not limit the number of patents that the applicant may file. Section 2 does include the word “one” and it should not be read into the claim such that one patent may be requested for one invention. Support for this interpretation is found by contrast to Section 9 which relates to different applicants with patent applications for the same invention.

The parties are in agreement that different applicants cannot be awarded separate patents for the same invention. Novartis holds that the same applicant can be awarded two or more patents for the same invention. The Examiner disagrees. Novartis accepts that there is no economical justification or logic in an applicant having more than one patent, and even sees this behavior as unacceptable. However, so long as there is some difference between the two patents, it is legitimate to award the protection of both patents.

The Commissioner upheld the Examiner’s conclusion and ruled that so long as there is nothing in claim 1 of the divisional that exceeds the scope of the claims of the parent, there is no reason to allow the divisional.

COMMENTS

In the US, the issue of double patenting is dealt with by filing a terminal disclaimer. Although this procedure prevents extending a term of protection (sometimes called ever-greening), it still has negative ramifications. Third-parties such as an alleged infringer may have to show that he is not infringing a number of overlapping patents. Likewise, a competitor may have to show a number of similar patents are invalid or not infringed. This places an unnecessary burden on third parties.

I think that although Novartis is correct that the Law does not explicitly prohibit multiple patents for the same invention, the Commissioner is correct that not to allow it is a reasonable interpretation of the intention and spirit of the law. Because of the large sums of money involved with pharmaceutical patents, this decision may well end up being appealed to the courts. If that happens, we will see how the Israel courts consider double patenting.


Can evidence submitted in an adversarial civil legal proceeding be kept confidential from the opposing party?

June 14, 2015

trade secretevidence

Israel Patent Number 132540 “System and Method for Direct Monetary Transfer Using Magnetic Cards” to Yehuda and Yigal Tsabari issued and then lapsed due to failure to pay the renewals.

Back on 24 July 2014 the Israel Patent Office agreed to the patent being reinstated. Generally, third parties who are utilizing the patented technology in good faith relying on the fact that the patent was abandoned are granted a non-transferable license that allows them to continue their business activities.  Nevertheless, the Israel Patent Office Decision to allow a patent to be reinstated is published for opposition purposes, giving third parties three months to oppose the lapsed patent being reinstated.

In the case of IL 132540, on 23 November 2014, Going Dutch LTD filed an opposition to the reinstatement. They claimed that the patent had not lapses unintentionally, but that Tsabari had knowingly abandoned the patent and that this was evident from the way Tsabari tried to enforce his patent.

Tsabari responded to these charges but requested that part of his response be kept confidential by the Patent Office and not made available to the opposer, claiming that the information constituted a Trade Secret. The documents to be kept secret included a document describing an enabling system, a draft contract with a credit card organization, a proposal for developing a system based on the patent, a contract with an investor and a letter from the investor, canceling the contract.

The patentee argued that these documents were confidential and for the parties themselves, and that their publication could compromise the patentee’s ability to compete in the relevant market. They were submitted as evidence that the invention had not been abandoned, but beyond that, their contents were not relevant to the issue in question, and so their contents should remain restricted.

The Opposer noted that the patentee had not provided sufficient evidence to prove that the documents in question were fairly described as trade secrets. This was particularly the case due to the fact that the documents apparently related to a failed business transaction from ten years previously. Furthermore, the patentee was not a side in the agreements in question and therefore could not claim that any trade secrets were his secrets.  Substantially, any documents used to support a legal claim should be available for public inspection. In addition, the opposer noted that the documents should have been supplied together with an affidavit and their dates and the parties thereof and the editor thereof should be identified.

 

Ruling

Section 23 of the Trade Related Torts Act 1999 give the courts (including the Patent Office) authority to prevent the publication of evidence considered as including trade-secrets and to allow only restricted access.

In recent Supreme Court Decision 2376/12 Rami Levi [a discount supermarket chain] vs. Moshe Dahan, July 8, 2013, Judge Amit ruled that there was a connection between the relevance of a document to a proceeding and the extent it could be kept confidential.

Essentially, where a document is relevant to a proceeding but one side claims a trade secret, the court has to weigh up the opposing rights of the parties and also to be aware of the potential damage to further entities not party to the a proceedings.

As a general rule, in civil proceedings, documents are available to all and confidentiality is the exception – See 7598/14 Theopholus Johnopholus (Theopholus III), the Greek Orthodox Patriarch of Jerusalem vs. Hymnota LTD., albeit the precedent relating to religious confidentiality and not to trade confidentiality.

Firstly, therefore, the court has to assess the relevance of the documents in question, which is a function of the arguments between the parties. In this instance, the argument relates to the restoration of a patent under Section 61 of the Patent Law 1967:

Any person may oppose a patent being restored within three months of the publication of the restoration notice on the grounds that the Commissioner [or deputy in this case] did not have grounds to order the publication of the request [i.e. to oppose the decision to reinstate].

Consequently, the discussion regarding reinstatement should focus on the three grounds for reinstatement:

  • failure to pay the fees resulted from reasonable circumstances
  • the patentee did not intend the patent to lapse
  • the patentee requested reinstatement as soon he realized that the fee was not paid.

The opposer considers that the patentee’s behaviour over the years was unprofessional, surprising and irresponsible. In other words, the patentee either wanted the patent to lapse or at least was unconcerned about his rights.

In response to these claims, the patentee described his attempts to commercialize the invention and submitted the documents about which he requested a secrecy order. The documents in question date to the period 2007 and 2008 and are thus of little relevance to the opposition proceeding.

Due to their lack of relevance to reinstatement, it seems that the right for confidentiality outweighs the right of access. They were prepared for the patentee or for exclusive licensee and were not published after they were not successful. There is no reason why these documents should enter the public record. Based on the statement of cases, the documents are not relevant and should not be published.

As to the lack of an affidavit, i.e. a signed statement testifying to that claimed, in Patent IL 118045 AstraZenca AB from 16 Jan 2005, there was a ruling to the effect that a statement should have been submitted.  However, in the Rami Levy case the Supreme Court ruled that the affidavit requesting secrecy was sufficient and there is no need for an additional affidavit accompanying the submissions. In the present case, the documentation as supplied is sufficient since the content is clearly sensitive, rendering superfluous the need for an affidavit supporting this contention.

Furthermore, the Patentee decided to submit these appendices to his statement of case and not to later submit in the evidence stage as he could have done, relying on Section 93 of the Patent Regulations 1968. Consequently, at this stage of the proceedings, the patentee does not have automatic rights to view the documents.

Thus in the meantime, the documents shall remain confidential. Should the Opposer consider these documents relevantat a later date, he is entitled to request their publication. At this time, no costs are awarded.

Opposition to reinstatement of IL 132540 “System and Method for Direct Monetary Transfer Using Magnetic Cards” to Tsabari, opposed by Going Dutch LTD., interim ruling by Jacqueline Bracha, 7 May 2015.

Comment

I am a little confused here.  The adversarial system requires that evidence brought in a legal proceeding be available to opposing parties to examine and challenge the validity thereof.

In this instance, the Opposer is using his legal right to oppose a patent being reinstated on the grounds that the patent was willfully abandoned. The Patentee has countered that there was no willful abandonment and has substantiated this claim with various evidence that allegedly shows this to be the case. In the circumstances, the evidentiary documents are considered by the patentee to be pertinent. If the patentee does not want the opposer to see the documents, he should retract them and base his case on other evidence.

That said, the 2008 documents are irrelevant as the patent only went abandoned on 24 October 2013, presumably retroactively on 24 April 2014, when the six month grace period past.

This patent was ‘abandoned’ for less than three months. The issue is when Tsabari realized that the patent had gone abandoned and when he tried to have it reinstated. Reinstatement is thus unlikely to be difficult, and one suspects that the patentee would be better served if he had chosen to use professional counsel for the reinstatement.

money plany

I had a look at the patent in question. It is a variation of the hoary old wedding present patent for directly transferring money from a credit card to the celebrants at a wedding. This is what a call a hardy perennial as approximately once a year some inventor comes in with this great idea he’s had.

Ironically the patent appears to be eminently voidable due to both lack of novelty and obviousness in light of the prior art and also on the substantive grounds that it is a software implemented business method and the fact that it is hardware implemented is insufficient to change this characteristic.


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

 


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.

 


Dagesh – The emphasis on coexistence

March 10, 2015

Dagesh assistive technologies
The word ‘dagesh’ means emphasis. It is used particularly to denote a dot that is added to letters of printed Hebrew text to add stress. The letter Bet with a dagesh is pronounced Buh and without a dagesh as Vuh. The letter kaf is a kuh sound, and a gutteral chu sound as in Chanuka without a dagesh. Yemenite Jews differentiate between hard and soft Gimels and have a j sound as in giraffe. (An early multilingual Windows based word-processor was developed in Israel some years ago and sold under the brand Accent. The Hebrew-English version was marketed as Dagesh).

In 2012, Israel trademark application number 243617 was filed for “Dagesh Assistive Technologies”. The mark is shown above.
The application covers accessories or equipment intended to improve the functioning and the ability of people with disabilities, namely, computers; arms and mountings; peripheral equipment for computers such as keyboards, keyboard replacements, mice, mouse replacement, joysticks, switches and trackballs; teaching aids; augmentative and alternative communication and computerized communication system, namely, devices intended to improve communication of people with speech disabilities and other disabilities; devices for recording, transmission or restoration of voice; accessible toys and accessible leisure facilities; accessories or equipment intended to improve the functioning and the ability of people with disabilities; all for people with special needs and the population of special education, including people with physical disabilities( e,g with impaired vision or hearing) and/or mental disabilities and/or learning disabilities or developmental difficulties; all included in class 9, sale of computers , peripheral equipment, communication systems and augmentative and alternative communication system (AAC); all included in class 35. Lending of communication systems and augmentative and alternative communication systems (AAC); all included in class 38; training and services for special education students. consulting and adjusting accessibility to population with special needs; all included in class 41 and Lending of computers and peripheral equipment for computes; technical support provided to population with special needs with regard to technical aids and special instrument designated to such population; design and development of computer software in collaboration with para-medical experts for population with special needs; all included in class 42.
A second Israel trademark application number 260864 for the same mark covers adapted toys for children with special needs and recreation adapted facilities for population with special needs.in class 28, and for Providing treatment and solutions for populations with special needs with motor disabilities with the assistance of measures and paramedical experts: speech therapists; occupational therapists; Physiotherapists; art therapists in class 44.

Dagesh Hadracha
Meanwhile, Rivka Zadick filed Israel trademark application number 243484 for “Dagesh the center for therapy and training” which provides Diagnosis, and treatment of diseases and disorders of physical or cognitive disabilities for children; occupational therapy services; speech therapy, music therapy; art therapy; physical therapy; sport therapy; all included in class 44.
The dominant word element in each mark is the word Dagesh. The services provided are somewhat related which results in a similar customer base.
Because of the similarities between these co-pending marks, the Israel Trademark Office instituted a competing marks proceeding. However, the parties agreed to co-existence with minor amendments to the list of goods, and requested that the Israel Trademark Office ratify the agreement.
Since the marks are stylized and the logos are very different, the adjudicator of Intellectual Property, Ms Shoshani Caspi was happy to allow both marks to register as she did not think that this would create a likelihood of confusion among the public. The three marks have thus progressed to publication for opposition purposes and, unless there are third party oppositions, will be allowed to coexist.

In the circumstances, no costs were awarded.

RE Israel Trademarks 243617, 260864 and 243484 for Dagesh, coexistence ruling by Ms Shoshani Caspi, 8 February 2015.


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