Lies, Damn Lies and Statistics

April 13, 2014

statistics

Indus TechInnovations sent me the following “informatic” for publication: Patent trends – Israel. It is very gung-ho and positive. The problem is that last year’s statistics have published and are less positive. See my article from February. Since the 2013 statistics have been published, ignoring them does a disservice. Particularly where they buck the trend.

There was an article in Friday’s Yediot Achronit by Sever Plotzker (טור ששי) that claimed to provide the true facts behind the propaganda in various areas, one of which was patents and innovation. Dr Esther Luzzatto, managing partner of the Luzzatto Group, one of the big five accountancy firms [sic] specializing in technology and IP was quoted. Now, we can argue whether or not the Luzzatto group is one of the largest patent attorney and law firms in Israel, but it is not a large accountancy firm and I am sure that Drs Kfir and Etty Luzzatto would be the first to acknowledge that.

The article included a number of interesting statistics and theories.

Briefly, the points raised were:

  1. A drop in PCT filings of 30%
  2. Significant drop in investment in start-ups
  3. Privatization of technology incubators
  4. International companies opening R&D facilities in Israel
  5. In 2013, there were 780 start-up companies registered, where the general average is about 650 a year.

The drop in PCT filings was considered a reliable indicator of innovation in general, and patent activity in particular. It was linked to the drop in funding, which was linked to the privatization of incubators and venture capitalists wanting a quick exit and to international companies creaming off talent by opening R&D facilities, where the patents were registered in name of international holding company.

I would not be surprised if the original research by the Luzzatto group resulted in a coherent report. What was clear was that the journalist who extracted the data and summarized it in a column and a half didn’t have much of an idea about the subject matter.

Nevertheless, the article made a few points worth considering. The first one was that there is apparently a drop in PCT filings by Israelis of 30%. This statistic is worrying, but I am not convinced that Dr Luzzatto is correct that this is a representative marker of innovation or even of patenting activity. The underlying assumption that this statistic clearly shows a drop in patenting, but it actually only shows a drop in PCT filings. There is an inherent assumption that patent filing is always reflected by use of the PCT mechanism. I suspect, however, that a lot of activity is going on in telecommunications and software, particularly in developing mobile phone applications. In these fields, many start-up companies have filed PCT applications only to run out of money 18 months later. With the speed at which these fields change, it is a reasonable to file in US only. The calculation of the company’s value may be based on US market only.

Some medical device companies also only file in US. Here it is less easy to justify, but with a limited budget some companies are perhaps more careful where and how widely they file, but are, nevertheless, innovative and may be able to bring a product to market. of course, sometimes the invention is only patentable in the US. I’ve had that with medical methods, for example.

One of my clients makes industrial digital printers. The company’s market is world-wide, but competing products are manufactured by companies based in Israel, the US and recently Italy. The company has traditionally filed in Israel and then in US under the Paris Convention, and recently also files in Europe. There is little justification for them to file PCT applications. One of my client makes game changing computer hardware. The company files in the US and immediately afterwards in the Far East under the Paris Convention since their competitors are all in Asia. It may make sense or them to consider filing a PCT application for the more critical applications to keep their options open, or to file in India and Europe just in case competing factories open up there. Client considers the $100 million required to set up a fab rules out this possibility. So there you have it, start-ups, small Israel manufacturers and a large company all actively patenting, but not using the PCT mechanism.There may indeed be a drop in inventing, but it is less severe than the 30% discussed in the article.

There is a drop in venture capital. However,  in the past there have been bubbles where venture capital invested has been out of all proportion to real worth.  This is a world-wide phenomenon, not one exclusive to Israel. With low-interest on safe investments and now some govt. intervention in the property market, one imagines that venture capital will grow again. Recently investors have been looking to buy existing patents in order to sue infringers. This model is diverting funding from research, but won’t last.

Privatization of technology incubators may result in investors being short-sighted and focused on a quick return for investment. However, it is doubtful that this is related to the drop in PCT filings. One needs a first filing, maybe a provisional application, to solicit funding in the first place since investors want to see that there is something allegedly patentable. The Paris Convention Deadline, or PCT filing date, comes around a year after the provisional is filed. Private investors may want a quick return, but it won’t be that quick that the money’s run out before a PCT application can be filed.  The preference for private vs. govt. funding models are more tied up with political ideology than with anything else. Generally capitalist economics assume that the private market will do a better job than the government in creating new industries. Whether or not this us true, State funding of basic research in universities makes sense, but I am not sure that the tech transfers should be funded by the government.  Certainly some government-funded start-ups should never have received funding since the basic concept was obviously wrong.

As to International companies opening R&D facilities in Israel, this as generally positive. It is preferably for Israelis to work for large corporations such as Intel, Microsoft, Google, GM, etc. in Israel, than that they go to Silicon Valley to work for them.  The large companies offer a reasonable salary and conditions, but the entrepreneur willing and able to try to establish a start-up will forgo the salary and conditions to take the risk of starting up something of his own, if he can obtain funding. It is unlikely that the existence of R&D centers makes obtaining funding for a new venture less likely.

The drop in start-up companies from 960 In 2013, there were 780 start-up companies registered, where one would expect 650 when taking a longer perspective.

Many patent firms are keen on clients filing PCT applications. It generates income. Perhaps the hesitancy by inventors reflects a greater sophistication and realization that funding is difficult to come by, and companies are filing less widely but not necessarily less first filings?

My problem is with the article in Idiot Achronot. It is unclear to what extent it reflects the views of the Luzzatto group in general, or of Etty in particular.


Finjan Files New Patent Infringement Lawsuit Against Sophos

March 16, 2014

finjan logo                                      finjan coffee pot

Finjan, Inc. has filed a patent infringement lawsuit against Sophos, alleging infringement of Finjan patents relating to endpoint, web, and network security technologies.

The complaint, filed in the U.S. District Court for the Northern District of California, alleges that Sophos’ products and services infringe upon six of Finjan’s patents. In the complaint, Finjan is seeking undisclosed damages from Sophos.


Filing Date of National Phase Entry into Israel ‘Corrected’ After Cross-Examination of Courier

February 16, 2014

passoverDeadline

The 30 month filing deadline for the national phase entry of PCT/CU2011/000006 to GRUPO EMPRESARIAL DE PRODUCCIONES BIOFARMACEUTICAS Y QUIMICAS into Israel was 27 March 2011. The deadline fell during the patent office closure for Pessach, from 25 March 2013 to 1 April 2013. Deadlines falling into this period are extended to the first working day thereafter, which is 2 April 2013.

The agent for the applicant (Seligsohn, Gabrieli & Co.) claim to have filed the application on the 2 April 2013. However, the date stamp received on the filing certificate was 4 April 2013.

Seligsohn, Gabrieli & Co. appealed the date, claiming that it was obviously a patent office mistake. Dr Michael Bart, the Head of the PCT Division discussed the procedure for handling incoming mail with Yohanan Mizrachi, the head of the incoming applications division, and came to the conclusion that since the box was emptied out several times a day, the mistake was not possible and so he refused to allow the application as timely filed. (This state of affairs would lead to the PCT application being cited as prior art against the national phase entry, resulting in it being rejected as lacking novelty).

Adv. Sharona Lahav of Seligsohn, Gabrieli & Co.  requested a hearing and the taxi driver that hand-delivered the applications, Daniel Bosgalo submitted an affidavit.

Bosgalo claimed not to have made any deliveries on 3rd or 4th of April, and the next delivery after the 2nd was on the 7th. Both Adv. Sharona Lahav and MR Bosgalo concurred that their records showed no deliveries on 3rd or 4th of April. Ms Lahav suggested that due to the amount of material filed after the week’s holiday, perhaps the applications were mistakenly sent to the trademark department or something, and only found their way to the patent department a couple of days later.

On reviewing the evidence, Ms Bracha ruled that the weight of evidence did indicate that the material was delivered to the Patent Office on 2 April 2013, but only stamped and sorted a couple of days later. She over-ruled Dr Bart’s decision and allowed the application as filed on 2 April 2013, and therefore as timely filed.

 

 


Cialis Again – District Court Rules that Only Parties to an Opposition have Standing to Appeal the Decision

February 10, 2014

assume a spherical cow

Lilly Icos produce a drug called Tedalafil, which is used to treat male impotence due to erectile dysfunction. The drug, is marketed as Cialis. When their patent application number IL 146742 covering the drug was allowed, TEVA opposed the patent issuing. After cross examination of expert witnesses but before final summaries were submitted, a commercial arrangement between Lilly Icos and Teva resulted in the opposition being dropped. However, then Deputy Commissioner, Noah Shalev Smylovezh ruled that the ‘inventive step’ on which the patent had been allowed was that fine grinding increased the solubility of the active ingredient. He ruled that this was obvious, and so, under authority of Section 34 of the Israel Patent Law, he rejected the patent anyway. This decision of his is correct. Dissolution is a surface effect and for a given mass of material, the more finely ground, the larger the surface area to volume ratio.

Expressed mathematically:

Assume spherical particles:

For a given mass M, the number of  particles n =  M / (4/3πr^3)

The surface area A of each sphere is 4πr^2

Thus the total surface area A = n 4πr^2 = 3M/r

As r shrinks, the surface area increases.

Since perfect spheres have the lowest surface area to volume ratio of any solid (which is why soap bubbles are spherical), for any other shape, the surface area increases even faster as the dimensions decrease.

The standard of obviousness for patentability in Israel is ‘obvious to try’ – see Fosamax decision by Dr Meir Noam, which was upheld by Israel Supreme Court.

Section 30 is there to prevent patents issuing that shouldn’t. This is a patent that then Deputy Commissioner, Noah Shalev Smylovezh had concluded lacked inventive step, and so  under Section 34 he refused the patent, thus ensuring the integrity of the register, allowing generic competition and allowing impotent men and their partners to benefit from cheaper erections.

An earlier posting on Noah Shalev Smylovezh’ decision may be found here.

The applicants requested further clarification, but Deputy Commissioner Noah Shalev Smylovezh’s contract as Deputy Commissioner had ended and he had returned to private practice. Ms Yaara Shoshani, an adjudicator at the Israel Patent Office took over his open files. She clarified the decision but gave the parties 30 days to respond. After reviewing their submissions, she decided not to use her powers under Section 34 of the Law, and to allow the patent to issue. Her reasoning, which overturns Dr Noam’s ruling regarding obvious to try is found here. Essentially she replaces the ‘obvious to try’ standard, with a ‘not necessarily the first thing one would try’ standard.

Unipharm appealed this decision to the Jerusalem District Court, where Judge Ben-Zion Greenberger heard the case.

Unipharm claimed that there was a chain of events that had resulted in a miscarriage of justice and requested that the Jerusalem District Court rehear the case. They claimed that the onus was on the applicant to prove that they deserved a patent and merely because the opposition was dropped, the basic requirement of a non-obvious inventive step remained missing.

Instead of addressing this issue, agent for patentee argued that Unipharm lacked standing since they were not a party to the opposition and therefore the case should be thrown out under Section 421 of the Civil Procedure Law and / or regulations 101 and 102. Unipharm countered that under the Patent Law, 174(a) anyone who sees himself hurt by a patent office decision has the right of appeal.

The Court ruled that before addressing the substantive patentability issue, it should address the issue of standing and relate to the correct interpretations of Sections 30, 34 and 174(a) of the Israel Patent Law and Section 421 of the Civil Procedure Law and / or regulations 101 and 102.  On this point, it ruled not to allow Unipharm standing, and so the patent remained valid and the decision of the Ms Yaar Shoshani Caspi, overturning Deputy Commissioner Smylovezh’ ruling was not addressed.

COMMENTS

This is an unsatisfactory state of affairs. The reason why the Commissioner (or his delegate) has authority under Section 34 is so that in cases where the parties do a deal and an opposition is withdrawn, but the person hearing the case believes that there are grounds for invalidating the patent, the patent office is supposed to continue in the hearing in-partes and rule on validity on the merits.

Ms Shoshani Caspi’s position disagrees with Dr Noam’s standard of obvious – obvious to try. It also overturns Noah Shalev Smylovezh’ conclusions. Unipharm should have filed an opposition, but missed the deadline. Nevertheless, Judge Ben-Zion Greenberger’ws ruling that Unipharm has no standing means that he is avoiding judicial oversight of this decision and doing so on a technicality.

The arguments put forwards by both parties had the usual dose of ‘smoke and mirrors’. The Judge quoted Barak and claimed to be doing an analysis of what the purpose of the Law was, and decided that the correct balance between patentee and opposers and rest of the public was to allow the opposers to appeal, but not third parties.

There is some logic in interpreting patent law in light of standard civil court procedures. But, clearly all generic manufacturers and importers are affected by this decision, whether or not they were a party to the opposition. indeed, the public – at least the male impotent members subsection of the public – is served by preventing monopolistic pricing on the drug in question. It therefore seems to me that the Court of Appeal should address the issues of patentability, specifically the issue of obviousness on its merit.

Maybe a user of Cialis should have filed the case, perhaps as a class action? Perhaps the way forward is for Unipharm to file cancellation proceedings and to make sure that the issue of inventive step is considered on its merits. Alternatively, they can appeal this decision to the Supreme Court.

We note that in a recent decision the Supreme Court ruled that when hearing an appeal of an opposition ruling, the district court can even hear new evidence if appropriate. In that decision, which also challenged a strange Israel Patent Office decision, the Supreme Court ruled that appeals of Patent Office decisions are different from regular appeals of court decisions and an appeal may, if warranted, be a new trial with new evidence. I think that in the present case, it is likely that the Supreme Court would refer the case back to the District Court to consider on its merits. If that happens, I believe the ruling should be reversed.


Adding Evidence in Israel Patent Opposition

February 2, 2014

abbott

Patent oppositions proceedings in  Israel follow a set path.

the Opposer(s) file their statement of case. The Applicant responds, and the opposer submits evidence. Evidence should be submitted at the first opportunity, and applicants are not allowed to submit further evidence at a later stage, to prevent cases being unnecessarily dragged out.

It happens, however, that evidence may sometimes not be submitted at the first opportunity as the  applicant or opponent does not consider it relevant. The statement of witnesses brought by opposing counsel may make it relevant and necessary to add such evidence at a later stage. The Israel Patent Office regulations enable such late submissions, if there is a prima facie basis for determining that the evidence was not submitted earlier, not in order to drag out proceedings, but because either the evidence was not known to its presenter at an earlier date, or because the presenter was unaware of its relevance which only became clear due to statements made by the opposing counsel.

Israel Patent Application No. 122546 to Abbott was published for opposition purposes on 31 December 2012. On 29th April 2012, Teva Pharmaceutical Industries and Vertex Pharmaceuticals Inc. filed oppositions.

In response to the oppositions, the applicant requested to correct the specification. In Israel it is legitimate to correct the specification at this stage provided that such corrections are in no way widening of the requested monopoly.

Opposers opposed the request to amend the specification on legal grounds and thus did not submit evidence. Abbott’s witness argued scientific grounds for allowing the amendment, and so Opposers requested permission to submit evidence against this request. Abbott’s counsel argued that it was too late to submit such evidence and that the Opposers were widening the grounds for opposition.

The topic in question relates to whether the 3A4 enzyme is an example of the P450 family of enzymes.

In his ruling, Commissioner Adv. Assa Kling ruled that there were no sweeping grounds to forbid submission of evidence and on weighing it up, he would see whether the evidence was indeed submitted in response to Abbott’s witness, or if there was indeed, evidence that opposers were filing evidence as a delaying tactic or to widen the scope of the opposition.  He noted that he could award costs to one side or the other when ruling costs on the amendment to the claims.

COMMENT

I think the patent office is taking the correct approach here. the rules for submitting evidence are there to prevent abuse. If the applicant is claiming abuse, he has to support his case.


Israel Supreme Court Resuscitates Patent Application that Suffered Sudden Death

January 28, 2014

cot empty cot

On 4 January 2013, I reported on a strange decision by the patent office wherein Ms Jacqueline Bracha accepted an opposition filed by Colb on behalf of Aminach a mattress manufacturer, that alleged that Israel Patent Application No. 179840 for a mattress claimed to minimize cot death (Sudden Infant Death Syndrome or SIDS) should be refused due to lack of utility. My original article may be found here.

Essentially the inventors had not proven their case that the mattress provided the desired effect. Perhaps foolhardily, the inventors not only drafted their own application but also fought the opposition themselves.

On losing the opposition, the inventors appealed to the Tel Aviv District Court which ruled that on Appeal, they could review the legal conclusions of the deputy commissioner but could not hear new evidence. This ruling was appealed to the Israel Supreme Court who has now ruled that unlike regular civil procedure, in an appeal of a decision of the patent office to the courts, new evidence may be heard.

The Supreme Court ruled that Section 177 of the Israel Patent Law and Ordinance 193 of the patent regulations allow the court of Appeal hearing an appeal against a patent office decision to hear new evidence and to try the case as if it is the first court of Appeal. This should not be interpreted as meaning that the court has to hear new evidence and give the appellant a second bite at the judicial cherry. Nevertheless, the court may here new evidence where it sees fit.

In this case, Applicant had laboratory evidence that their prototype did have an effect. Instead of relating to this evidence, the District Court decided under Section 457 of the Civil Court Procedure that it could not hear new evidence that could and should have been presented to the patent office during the opposition. 

In the ruling, Judge Handel noted that the inventors were unrepresented, yet nevertheless persuaded the Deputy Commissioner that their invention was novel and inventive over the prior art. They argued that they never thought it necessary to demonstrate utility. Judge Handel felt that prior to refusing the patent application on grounds of utility, the Deputy Commissioner should have actively solicited evidence from the applicant, particularly as they were not represented and were fighting against a large mattress manufacturer who was represented. he ruled that in the circumstances, the Court of Appeal should here and consider evidence that the claimed invention works. He also noted that the US, UK and EPO had all allowed the invention on its merits.

Judge Handel realized that in the absence of a conflicting expert opinion, the Deputy Commissioner had accepted the expert opinion provided by the opposers and had not been swayed by attempts by applicants to point out logical flaws in his argument.

In the circumstances, the District Court should not have been considered as rehearing evidence weighed up by the Deputy Commissioner.

The Supreme Court referred the case back to the District Court to hear fully, allowing the parties to file new evidence.

Judges Juvran and Shaham concurred. No costs were awarded.

Appeal 5041/13 Gabai vs. Aminach

(this time the Gabais were represented by Adv. Amir Friedman).

COMMENT

In general, patent offices do not test hypotheses. The applicant does not have to show proof that his idea works to obtain a patent except in cases such as perpetual motion machines, turning lead into gold, anti-gravity and nuclear cold fusion where there is a consensus among scientists that the idea is impossible.    

At the time of the first write up I had been contacted by a lawyer to provide expert testimony. I did not want to address the issues. That fell through.

I can therefore now point out that the expert testimony provided by Aminach’s witness in no way proved that the mattress does not work. It is true that Applicants have also not proven that their mattress does have efficiency. There is, of course, a problem in that the correct scientific way to test the theory requires a large population of identical twins and putting one to sleep on a regular mattress and the other on the mattress of the invention in otherwise identical conditions. Once there have been a statistically significant number of cot deaths, one can see if the two mattresses function differently. This type of experiment, is, however, not very practical.

In the brief period I worked on this, I discovered some theories for cot death that provided theoretical support for the hypothesis that such a mattress would work, and also found a researcher who was modelling the effects of different mattresses on carbon dioxide build-up. I also spoke to polymer scientists who make foam mattresses. I am sure that it is possible to provide sufficient evidence to support the hypothesis as reasonable.

 

I think that having convinced the Deputy Commissioner that their claimed invention is novel and inventive, should have been awarded a patent. If it does not work, then Aminach will presumably not have a need to infringe it.

It would have been fun to fight this. I look forward to reporting that the patent has been allowed.


New Procedures for Prosecuting Israel Patent Applications

January 14, 2014

Israel patent office logo                        israel patent

The Israel patent office has issued new procedures for patent prosecution.

Notice Prior to Examination

In response to the Notice Prior to Examination, applicants are required to provide a list of relevant prior art including details of citations in corresponding applications in other jurisdictions. Non-patent literature should be supplied in full. Patents cited in the background of the specification do not need to be listed again.

Applicants are also required to provide a full list of corresponding patents and applications in other jurisdictions.

Where there are more than 50 claims, the claim set must be amended or excess claim fees must be paid.

Finally, the first publication of the invention must be reported and failure to do so will be considered as a requirement not met and may invalidate the patent.

Amendments

It is now no longer necessary to submit marked up and clean copies of amended pages during prosecution. Claim amendments should be made by submitting a full set of marked up claims, whereas only amended pages to the specification need be submitted. These amended pages should be marked as {application number}/2, {application number}/3, etc.

On allowance, a complete, clean copy of the patent as allowed should be submitted together with the issue fees.

Comment

I see the logic and approve of the new procedure for making amendments.

Apparently, the new procedures follow a meeting with representatives of the professional organizations. The head of the association of patent attorneys, Dr Meir Noam, is the previous commissioner and does not practice opposite the patent office and hasn’t done so for about a decade. The head of the AIPPI Israel Chapter is a litigator. I therefore wonder to what extent the changes take into account the professionals that prosecute opposite the patent office.


Israel Supreme Court Upholds Ruling of Non-infringement of Breaking & Entering Patent, but does not Invalidate it

January 14, 2014

breaking and entering

In 1998, Ofer, Extinguishing, Extracting and Saving LTD supplied hydraulic systems for breaking into looked buildings manufactured by Holmatro to the Israel Ministry of Defense, where they were deployed by the armed forces for use in urban warfare. Further systems were sold in 1999 and 2000.

From 2000 to 2006, the Israel Ministry of Defense ceased to order from Holmatro and purchased systems from Hydro-Na LTD.

In 2007, needing to purchase 562 such systems, the Israel Ministry of Defense issued a tender in which Hydro-Na submitted a bid. However, in November 2011, the Israel Ministry of Defense announced that they would purchase future systems from Sun Hitech.

Hydro-Na filed Israel Patent Number 184211 on 25 June 2007 and it issued on 4 May 2009.

The first claim of Hydro-Na’s patent is as follows:

A system for forcible opening of an entryway by applying pressure to adjacent boundary surfaces, said system comprising:

  • a hydraulically operated pump unit for providing pressure to the system;
  • a hydraulic cylinder unit comprising a piston rod
  • a first anvil comprising a narrow wedge-shaped portion removably and rotatably mounted on the proximal end of said piston rod, said first anvil formed with downwardly facing friction gripping grooves on its surface; and
  • a second anvil comprising a pair of narrow, spaced-apart wedge-shaped prongs formed on the sides of a rotatable ring removably mounted on said hydraulic cylinder until, said second anvil formed with upwardly facing friction griping grooves on its surface;

Such that when the wedge-shaped portion of said first anvil is seated between the wedge shaped prongs of the second anvil so as to be aligned therewith and said first and second anvils are forcibly inserted in a seam between adjacent entryway boundary surfaces, operation of the pump unit applies pressure via the first anvil on a first adjacent boundary surface while said second anvil applies a contrary gripping counterforce on a second adjacent boundary surface, forcibly opening said entryway of said adjacent boundary surface.

There is a second independent claim and also a method claim, but the above claim illustrates the invention fairly well.

Hydro-Na also filed three Israel design applications for various sub-components.

Hydro Na tried unsuccessfully to obtain an injunction against Sun HiTech and to have their bid in the tender thrown out on various grounds as not fulfilling the tender requirements. The injunction was refused and the tender bid was upheld.

On allowance of the patent in May 2009 after accelerated examination, Hydro-Na sued Sun Hitech LTD, its shareholders and the Israel Defense Ministry for patent infringement and claimed 3,376,940 NIS (about a million dollars) in damages, filed for recall of the systems, and for a temporary injunction. The grounds were patent infringement, unjust enrichment, passing off, etc.

Judge Zerankin of the Haifa District Court ruled (T.A. 34912-11-09) that the patent was probably invalid since there were earlier systems known to Hydro-Na that were not disclosed to the patent office during prosecution, but noted that the rotatable ring was apparently novel and arguably inventive. He did not invalidate the patent, but found that there was no infringement since Sun HiTech’s system did not include this novel feature.

As to the designs, the Judge Zerankin ruled that the mechanical components weren’t designs in the meaning of Section 2 of the Patent and Design Ordinance.

Hydro-Na appealed to the Israel Supreme Court.

On appeal, Judge Amit noted that most of the issues were factual and had been examined by the Court of First Instance and appeals were not to retry evidence but only legal analysis.

In cases like this where the defense of the defendant is invalidity of the patent, the plaintiff has only to show infringement, since the rebuttable assumption is that the patent is valid and the defendant has to prove that this is not the case.

The expert witness for Sun Tech LTD, patent attorney Dr Goldreich, showed that there were a large amount of prior art, none of which was brought before the patent office.

Attorney Ed Langer appeared as expert witness for Hdro-Na, but since he wrote the patent and could not provide adequate justification for not relating to prior art, his testimony was found unreliable.

Judge Amit considered the Court of First Instance had been overly cautious in not canceling the patent in question, both on its merits and when considering the issue of equitable behavior with regards to the legal requirement of disclosing the prior art. He assumed that they not only withheld information from the court but also from their patent attorney. Nevertheless, he noted that he wasn’t required to relate to the validity of the patent since it could be shown that it wasn’t infringed.

As to various other claims by Hydro-Na, Judge Amit quoted Ecclesiastes (Koheleth) 7:14 ” It is good that you should take hold of this, and from that withhold not your hand, for the one who fears God shall come out from both of them.” Essentially, he dismissed them as “also ran”.

In conclusion, Judge Amit accepted the earlier court’s finding that ‘cold’ door forcing systems were on the market long before Hydro-Na’s application was filed. To the extent that Hydro-Na deserved a patent, it was for the rotatable ring which was not found in the competing system that won the tender. He noted that Hydro-Na failed to file abroad despite a market potential of NIS 150-225 Million Shekels and deduced that they were well aware that their patent was extremely narrow and easily invented around.

The appeal was unanimously rejected by a triumvirate of the Supreme Court consisting of Judge Amit (who wrote the appeal) and Judges Melzer and Solberg who affirmed his ruling.

Costs of NIS 50,000 were awarded to the Sun Hitech LTD and a similar sum to the Israel Ministry of Defense.

Civil Appeal: 7623/10 Hydro–Na et al. vs. Sun Hitech et al., 12 January 2014

COMMENT

The District Court applied the Gillette Test by declaring that the patent wasn’t restricted to the rotatable ring, it would not have issued.

The Supreme Court did a marvelous job citing the various sections of the Law and analyzing them. It was a little pedestrian and boring, so I haven’t reproduce in full.

I believe that the failure to disclose the prior art should have invalidated the patent and consider both Haifa Court and Supreme Court as being overly cautious in not doing so. What is the point of having a duty of disclosure if, on proof that the applicant withheld information, the court doesn’t invalidate the patent?

Whether or not Dr Goldreich was correct in her analysis that the rotatable ring wasn’t sufficient to be considered inventive, I wonder if there isn’t room for a procedure for referring a patent back to the patent office for reconsideration in view of additional prior art?

As to the registered designs, if Hydro-Na had sold them to the Israel Ministry of Defense prior to registering, they are invalid. Similarly if the same design is used by others. I haven’t read the original decision by Judge Zerankin but it seems that he considers such devices as inherently not-registerable, however, I think this understanding is incorrect. It is a shame that the Supreme Court hasn’t really addressed this issue, as although the Israel Patent Office has established practices regarding registering functional elements, there seems to be little binding legal precedent on this issue.

Finally,  is it ethical for attorneys-at-law or patent attorneys that drafted and prosecute a patent give a validity opinion? Is there attorney-client privilege and is it considered waived when client calls on the attorney as an expert witness? It would have been nice if the Surpreme Court had taken this opportunity to provide guidance to patent attorneys in this matter.


Perrigo attempts to cancel IL 122910 to Genentech

January 8, 2014

PerrigoGenentech

IL 122910 to Genentech is titled “STABLE ISOTONIC LYOPHILIZED PROTEIN FORMULATION”. Perrigo is opposing this patent issuing.

On 17 November 2013, Genentech filed to amend the claims of their application and to close the opposition proceedings. In response, Adjudicator Ms Yaara Shoshani Caspi ruled that the patentee could file any claims that they considered still warranted consideration as per the District Court Order of June 2013. Due to the large number of previous submissions, she gave the patentee 30 days to file a statement of not more than 10 pages with the standard spacing and margins.

Should the patentee not consider additional submission necessary, he was invited to state that this was the case within a week, and Ms Yaara Shoshani Caspi would then rule on the basis of the material in the file

Ruling of 9th December 2012.


Pharmaceutical Patent Term Extensions – Israel Patent Office Considers Request to Grant Extension for Requesting Extension

January 7, 2014

scar jel

Israel Patent Application Number 217056 to Advanced Biotechnologies LTD. is titled Silicone Scar Treatment Preparation.  The patent application is still pending. According to applicant, the patent covers medical equipment marketed in Israel as Kelo-Cote Jell, Kelo-Cote Spray and Kelo-Cote UV. The products were authorized for sale in Israel from 9 June 2013 and are listed in the medical equipment register of the Ministry of Health. On 26 October 2013, the Applicant requested a three month extension to file a request for patent extension in the event that the patent application is allowed and a patent is granted.

64D. States that:

The Registrar shall not grant an extension order, unless the following conditions have been met:

(1) The material, the process for its production or its use, or the medical preparation that incorporates it or the medical equipment was claimed in the basic patent and the basic patent remains in effect;
(2) in respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);
(3) the registration said in paragraph (2) is the first registration that allows the material to be used in Israel for medical purposes;
(4) no extension order was granted previously in respect of the basic patent or in respect of the material.

Section 64(O)a of the Israel Patent Law grants 60 days for filing a request for a patent term extension and this deadline was missed. HOWEVER, Section 64(O)a relates to ‘medical preparations’.

Despite the contention of the applicant that he was requesting an extension for filing a request for a pharmaceutical preparation, the Commissioner considers that the products in question are not medical preparations but rather ‘medical equipment’, and doesn’t think that the time period of Section 64(O)a of the Israel Patent Law refers to ‘medical equipment’, so there is a lacuna as to what the window for filing the request is.

Medical Equipment is certainly included in Section 64 of the Law:

“medical preparation”—any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously;
“material”—the active component of a medical preparation or salts, esters, hydrates or crystal forms of that component;
“the basic patent”—the patent that protects any material whatsoever, including a process for the production of a material, use of a material, a medical preparation that incorporates a material, a process for the production of a medical preparation that incorporates a material or medical equipment that requires a license in Israel (hereafter: medical equipment).

and it would appear that the requirements to allow a proper period for filing a request for extension are analogous for ‘medical preparations’, see  Re Asta Medica Aktiengesellschaft 101537, 108704, 92904 from 2002.

Consequently, the Commissioner ruled that Applicants have three months in which to submit a request for a patent term extension of the basic patent, from the basic patent No 217056 issuing, if it eventually issues.

COMMENTS

Section 64 A defines a “medical preparation” as any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously. Section 64O. States that an application for the grant of an extension order shall be submitted in the prescribed manner, after the fee has been paid and not later than 60 days from the registration day of the medical preparation under the Pharmacists Regulations.

In this ruling, Commissioner Kling has decided that these materials are medical equipment and not medical preparations, and therefore the 60 day deadline does not apply. There is no deadline for medical equipment, so he is creating one and setting it as ninety days from patent issuing and not sixty days from receiving regulatory approval.

I can see cosmetic preparations being not considered as medical preparations, but in that case they would not be considered as medical equipment either. The title of the application implies that these are preparations, if not necessarily therapeutic. Apart from the hair splitting, I fail to see the logic of granting ninety days from patent issuance for medical equipment but sixty days from regulatory allowance for medical preparations. If there is a lacuna, then the time period for medical equipment should be learned from and be the same as the period for medical preparations.

The preamble of the main claim is “A spreadable preparation for aiding in the healing of wounds”. I think this is a medical preparation and the deadline was missed, not for the first time by the agents of applicant, see here. The time frame is extendible by the commissioner, but the standard should be despite the applicant exercising Due Care. We have no indication what happened and why the application wasn’t made within 60 days.

We note that in the Novartis case then Acting Commissioner Yisrael Axelrod gave a liberal interpretation of the patent term extension rules  in accordance with the 1998 amendment and was subsequently sideways promoted to the Beer Sheva District Court, i.e. literally out into the desert, and the Knesset reworded the law to make his interpretation untenable. The intention of the Knesset was not to grant a reasonable extension under reasonable conditions, but to make it as hard as they could to get patent term extensions. Each amendment to make getting extensions easier was under US political pressure. Each amendment not under US pressure was to make it more difficult.

This is an ex-partes ruling but we suspect that if and when the patent issues, the request for an extension will be opposed and eventually the courts will have their say, if the law concerning patent term extensions is not amended AGAIN in the meantime.  It is probably the numerous amendments to this chapter of the Law under US pressure that has resulted in these “lacunae”.

In the meantime, it appears that RAFA is supplying the product in Israel. See here 


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