Submitting Corresponding European File Wrapper In Israel Patent Opposition Rejected on Procedural Grounds but Decision Overturned by Court

August 18, 2014

tangled web

DSM filed Israel Patent Application Number 142789 for high directional – fibers. The patent claimed priority from Dutch Patent NE 1010413 from 28 October 1998. The patent covers the fibers themselves and both ropes and anti-ballistic equipment fabricated from the fibers.

The Application issued under Section 17c, based on the corresponding United States Patent No. US 6,916,533 and published for opposition purposes in April 2006. DSM also has a couple of corresponding European patent applications. One was rejected and the other, EP 113828, was allowed but with narrower claims.

Mifalei PMS Migun (PMS Protection Factories) filed an opposition which was heard by Adjudicator of IP, Ms Yaara Shoshani Caspi. The opposition proceedings included a hearing on 28 and 29 June 2011, during which the Opposer requested to submit the file wrapper of the corresponding European case, but Ms Shoshani Caspi refused to allow this to be entered. On 17 October 2013, the Adjudicator upheld the patent and rejected the opposition. The Opposer has appealed this decision, particularly the intermediate decision not to allow the file wrapper of the European case to be submitted.

The Appeal

The Opposer filed a long-winded and detailed Appeal that claimed that in addition to factual errors and illogical conclusions regarding novelty and inventive step, the arbitrator also erred on legal principle. Specifically, the Arbitrator did not give sufficient weight to the fact that the Applicant had not made the European file wrapper of record, contrary to the duty of disclosure and the obligation of equitable behaviour. Specifically, the Applicant did not make the fact that one European patent was refused and one was significantly narrowed, concealed a graph and failed to provide an English translation of a Japanese patent cited as prior art, merely providing the Japanese original.  Accepting the case under Section 17c without considering the other family members and applying technical discretion was considered unacceptable, as it transferred the burden of proof to the opposer. Furthermore, the Opposer claimed that the standard of proof that the arbitrator demanded was beyond reasonable doubt rather than simply the burden of evidence generally required in civil procedure. The Opposer challenged the patent office for failing to examine the patent, and for simply relying on the US patent under Section 17c.

The Opposer claimed that when requesting allowance under Section 17c, the applicant should have proactively submitted all corresponding cases, and referred to District Court ruling on the issue.

The Patentee’s Response

The respondent (patentee) argued that the arbitrator had given a detailed and reasoned ruling based on factual and professional issues that the courts didn’t generally consider on Appeal. As to the graph, it was considered irrelevant to the adjudicator’s upholding of the Novelty and Inventiveness of the Application. The patentee rejected the claim that the duty of disclosure required submitting English language translations of all references, unless requested to. The Existence of corresponding European patent applications was alluded to in the file wrapper of the Israel application. Once allowed under Section 17c, there is no longer an ongoing duty of disclosure.

The patentee argued that the appeal was not one against the intermediate ruling concerning the European file wrapper. The appeal was only against the final decision from October 2013. The Patentee considered that the time to appeal intermediate rulings had long past. Furthermore, amending the statement of appeal was insufficient, since this was a separate appeal on the decision, not on intermediate rulings, and a request to amend the ruling was first raised in a hearing in April 2014.

The appellant countered that the original hearing had mentioned the intermediate ruling as grounds for appeal, both in the statement of appeal and in the Statement of Claims, and the intermediate decision was appended to the file. Case-law does not require the appeal to include the protocol. The request to amend the Statement of Appeal was not to introduce this as new material, but merely a safety precaution.

The Ruling

Under regulation 411  of the Civil Court Procedure, in addition to being able to appeal intermediate rulings after they are given, appellant may appeal intermediate as well as final rulings by right when appealing after the final ruling issues. Respondents (Patentee’s) claims that the appeal does not relate to intermediate rulings is not accurate. Point 76.2 of the Notice of Appeal notes that the adjudicator erred in failing to allow the European file wrapper to be entered into the Opposition. The fact that she did not give sufficient weight to the European patent office’s conclusions is mentioned earlier in Point 7.5. Reference is also made in Point 12 and Point 43. This was also fleshed out on 19 March 2014 in Chapter 3(6) of the main claims.

On examining the protocol, this intermediate ruling does not appear under the heading Decision or Ruling. It is scattered over 13 pages of protocol and is not detailed. It seems that the arbitrator was simply over-whelmed with the amount of material submitted. It is only in the final ruling that the decision not to allow the introduction of the European file wrapper is first discussed formally with legal support and so it is reasonable to appeal it when appealing the decision as a whole.

Filing the protocol regarding the intermediate ruling only on 28 Feb 2014, is somewhat unacceptable in that it contravenes Regulation 419(1) of the Civil Procedures. The appellant’s statement that they do not need to submit intermediate rulings and protocol is problematic and they should have submitted it. Nevertheless, since the protocol does not clearly state this as a Ruling or Decision, this flaw may be dealt with when awarding costs.

Citing the Regulations, the Judge noted that the court has the discretion to allow the Statement of Appeal to be amended at any time, awarding costs if necessary, so there was nothing inherently wrong with the appellant’s request to amend the Statement of Appeal. Indeed, contravening the procedural regulations does not disqualify a case in and of itself.

Judge Judith Schitzer was prepared to allow the protocol to be entered and the intermediate ruling to be appealed, despite procedural flaws, and went on to relate substantively to the issues raised by the European file wrapper.

The Arbitrator justified refusing to allow the European file wrapper to be considered on three grounds: the timing, failure to submit an affidavit and a suspicion that the respondent would not be able to cope with the new evidence.

In the ruling, Judge Schitzer  determined that the Adjudicator Ms Shoshana-Caspi should have considered the timing, the relevance of the material in reaching a true and just ruling, the damage to the parties if additional material is allowed to be considered, and whether the other party has the ability to relate to the new evidence.

As to the timing, the Opposer wished to introduce the additional material during the evidence stage and not after this stage was concluded. The Opposer requested to confront the expert witness of the Applicant with the European file wrappers. The Applicant countered this request by claiming that the new evidence should have been submitted at the evidence stage and not during cross-examination of the witness. If there was a delay here, it was a relatively minor delay, and is not comparable to submitting evidence after the evidence stage is closed, or during an Appeal. Citing Gabai vs. Aminach, Judge Schitzer noted that in patent appeals, the appellate court has wider jurisdiction than in other appeals and can hear new evidence if required to in order to get to the truth. How much more so (a fortiori) should the opposition proceeding by prepared to hear new evidence if it will help to clarify whether or not an invention is patentable.

Where one corresponding European patent is cancelled and one is severely narrowed, there is a prima facie basis to assume that the assumption of validity at the basis of a Section 17c allowance is suspect, and the Opposer should be able to have the evidence considered. Furthermore, the European file wrapper is not a surprising piece of evidence. The Applicant mentioned the corresponding European case, albeit laconically and possibly with insufficient detail, but nevertheless, should not be surprised by its inclusion; particularly as DSM was the applicant in Europe. In the circumstances, the European case should have been considered in attempting to do justice. The attempt by the Adjudicator to manage the case efficiently and smoothly is understandable but should not come at the cost of reaching a just conclusion, and the late stage at which the European file wrapper was submitted can be grounds for adjusting costs.

The Judge then cited from a pertinent Supreme Court ruling (1297/01 Michaelowich vs. Clal Insurance LTD) and noted that in patent cases there were a fortiori grounds to be even more lenient.

Furthermore, in the Statement of Case, the Opposer stated that they would refer to corresponding file wrappers, so the Applicant had plenty of time to prepare themselves.  The judge refrained from ruling whether or not the applicant should have been more open in acknowledging the European case. Suffice to say, that when it did come up, they should have related to the issues of novelty and patentability instead of fighting to prevent it being considered.

Judge Schitzer went on to note that the patent regulation 63 actually states that after the end of the evidence stage the parties cannot submit additional evidence without the permission of the Commissioner, implying that prior to the end of the evidence stage they can submit additional evidence, and even after this stage, the Commissioner has the discretion to allow such additional evidence to be submitted and should apply judicial consideration wisely instead of narrowly relying on procedural grounds. Further evidence to this wide discretion was found in Regulation 72.

As to the lack of an Affidavit, the Judge noted that if Ms Shoshana Caspi had felt the need for one, she could have asked for it, but not all evidence actually requires affidavits. Some evidence is self-evident and can be considered on its merits. Indeed, the Opposers raised this issue themselves, stating that the file wrapper speaks for itself.

Since, as ruled in 6837/12 Merck Sharp & Dohme Corp. it is preferable for the specialized courts to consider the issue of novelty and patentability, Judge Schitzer referred the case back to the Adjudicator to consider patentability of the claims in light of the European file wrapper.

In conclusion, Judge Schitzer stated that she was refraining from addressing the issue of novelty and inventiveness head on and also was leaving it to the arbitrator to decide whether or not an affidavit was warranted, and if so, to indicate to the parties what the affidavit should include.

Nevertheless, since the Opposer (the appellant) was responsible for the procedural irregularities, despite accepting the Appeal, she awarded costs of 15,000 Shekels against the appellant.

Civil Appeal 34029-01-14 Mifalei P.S.M Migun vs. DSM, Judge Judith Schitzer of Tel Aviv District Court, 12 August 2014.

COMMENTS

I suspect that the judge’s last remark regarding affidavits was tongue-in-cheek. Indeed I have been fighting the Israel Patent Office regarding the need to supply affidavits to support self-evident facts.

The Judge is correct in her analysis and there is a moral here, in that with patent issues it is neccessary to prefer substantive arguments rather than to have awkward material dismissed on procedural grounds.

Here

 

 

 


Why Are There so Few Women Inventors?

August 17, 2014

Mothers of Invention

In previous blog postings, I’ve mentioned Dr Shlomit Yanisky-Ravid’s book “Intellectual Property at the Workplace: Theoretical and Comparative Perspectives”. However, I have not published a review on this blog yet, since I have had a peer-reviewed review accepted by the Oxford Journal of Intellectual Property Law and Practice. Once this publishes, I will link to it and make some additional comments.

There is, however, one chapter in the book that deals with women inventors, or rather the lack of them. the chapter is weakly connected to the rest of the book since the author suggests that the fact that most inventions are filed by companies exasperates the problem. However, the empirical evidence that she brings actually indicates that there are almost twice as many named women inventors of company inventions than there are of privately filed inventions. In other words, the evidence goes against the hypothesis. The chapter on women inventors is structurally different from the rest of the book in that it includes graphs and statistics. As it is really a different subject from the book as a whole, I am blogging some comments now.

The book as a whole, and the chapter on women inventors, like so many other pieces of scholarship, reflects the author’s personality and values. Dr Yanisky-Ravid is a passionate advocate of worker’s rights and also of women’s rights. The extensive footnotes use the plural of the verb to see ראו, since the singular form ראה is masculine, and we can’t have that can we? She uses the double-barreled name favoured by women lawyers, where her family named is added to that of the husbands or her man as she calls him, using the term אישי – Ishi or ‘my man’ in the dedication, rather than the historically correct term בעלי – ba’ali which means ‘my husband’, but has connotations of ownership since it is linked to the word בעלים (ba’alim) meaning owners, and בעלות (ba’alut) meaning ownership. In this, the author is actually preempted by Hosea.

The author posits that, as with other types of property law, inherent biases cause an inequitable division of resources that further entrenches inequalities. She notes that over the five-year period from 2000 to 2005, only 1.9% of patentees receiving Israel patents were women, 30% were men and the rest were companies. With regard to employee inventions, 13% of named inventors were women and 87% were men. This is understood as showing that women more often invent as part of teams, but are rarely at the narrow apex of the pyramid. The author cheerfully notes that her analysis does not directly prove the source of the discrimination. Nevertheless, a feminist approach to IP rights is presented, the book purporting to address the legal and other structures that exclude women from owning IP rights.

The author considers that property rights per se have been under-analyzed from a gender perspective and that the traditional patriarchal society has defined property in a way that favours men. The situation in IP in general and patents in particular is seen as an extreme example of this built-in discrimination. Citing McKinnon, Gilligan and Fisk, the author reaches the radical conclusion that the fact that women are not often named as inventors is proof that the legal system, the definition of patentable subject matter and the concept of ownership inherent in the concept of intellectual property as property all discriminate against women. The biases in patent law that result in this discrimination are not apparent, but they would not be expected to be discernible since they are so deeply entrenched. Bias is not, however, purely a masculine aspect of IP law. Other sectors of society are under-represented amongst inventors and owners of intellectual property and these similarly show that the system is biased. Affirmative action is proposed. Specifically, there should be a minimum quota of female examiners in the Israel Patent Office and in government entities. Forcing commercial companies to employ women in R&D is also suggested, but not stressed. She toys with the idea of widening the definition of inventor to include research assistants, lab workers and junior staff.

In the years studied by the author, there were, according to her research, actually more female examiners than males. This makes the minimal quota idea a little odd. there is also no explanation on how a minimal number of women examiners would increase the number of women inventors. The hypothesis is based on the assumption that there is some bias by examiners. Personally, I don’t think that examiners of either sex pay much attention to the gender of the inventor. This is something that could be tested though. It is certainly possible to compare the relative proportion of patents examined and patents allowed where the inventor is male or female and the examiner is male or female. Dr Yanisky-Ravid doesn’t bother. She simply makes wild, unsubstantiated hypotheses and suggests ways to improve the situation. As an empiricist, I find the approach disturbing.

In the English overview we find a paragraph opening with the sentence: An important principle that arises from the consideration of the different theories focuses on the stage during which an employee transfers rights to her employer.

Why, where according to her own statistics, very few inventors are women, does she relate to her employer?

Dr Yanisky Ravid’s position is that the evidence that women are not often named inventors of patents proves that the patent system discriminates against women. I don’t see a gender bias in the Israel Patent Law 1967, as a document and to be fair, neither does Dr Yanisky-Ravid. She deduces the subtle and insidious bias from the fact that women are not inventors and the net result of men inventing does not fairly redistribute wealth between the sexes. It is, however, certainly true that women are certainly under-represented as inventors. In 15 years of very broad practice, drafting thousands of patent applications, I’ve met five women inventors, and three of those were in clothing related fields (including the inventor of seamless knickers, which is a patent I wrote for Delta and had allowed without office actions. Arguably it is one of  the better inventions I’ve worked on). Can the lack of women inventors be fairly attributed to discrimination? I am not convinced.

I have no doubt that in the past women have been discriminated against in some respects, and this discrimination included the moral right seen as part of copyright in the continental system. However, as far as copyright is concerned, the world has come a long way since Mary Ann Evans adopted the name George Elliot and Anne Brontë wrote under the pseudonym Acton Bell. A strong case can be made that Rosalind Franklin, Lise Meitner and particularly Jocelyn Bell Burnell should have received Nobel Prizes together with or instead of their male associates.

There are some market forces that discriminate against women but I am less certain than Dr Shlomit Yanisky-Ravid that the paucity of women named as inventors on patents is mostly the result of their contributions being unnoticed, of fewer women studying science, or of women being less likely to be able to burn the midnight oil and more likely to accept 9:00 to 5:00 jobs, and to seek part-time work to bring up children and to cook and clean for their significant others.

I think my aunt who was brought up in an egalitarian and very left-wing secular Kibbutz was closer to the truth when she once told me that she thinks that, left to women, we’d still be living in caves — albeit, nicely furnished ones with well swept floors. Men are, by nature, conquerors who are programmed to improve their lot, and women are naturally home-makers who are programmed to make the best of what they have. This programming is, I believe, nature, not nurture.

I don’t accept that the IP field discriminates merely because there are fewer women inventors than men. This is not an argument that my scientific and legal training, or my British and Jewish education, considers intellectually robust. This apparently won’t bother Yanisky-Ravid since she no doubt considers these as symptomatic of the pro-masculine bias of my education. I am missing her point. We are on different wavelengths.

I am reminded of the scene in Life of Brian where the members of “The People’s Front of Judea” are sitting in the amphitheatre.

Stan: I want to have babies.

Reg: You want to have babies?!?!

Stan: It’s every man’s right to have babies if he wants them.

Reg: But … you can’t HAVE babies!

Stan: Don’t you oppress me!

Reg: I’m not oppressing you, Stan. You haven’t got a womb! Where’s the foetus gonna gestate? You gonna keep it in a box?

At an event in Bar Ilan University a few years back, Dr Yanitzky-Ravid suggested that the patent field should be widened to non-technical inventions to be fairer to women who were generally less technical. In her latest book, that particularly idea is not discussed. It seems that she has thouht better of it.

I started my comments by noting that the author is unhappy with using the word בעל (Baal, as in the male Canaanite god, baal z’vuv literally Lord of the Flies or Belzebub) for her significant other of the male gender since the term implies ownership – think of connection between husband and husbandry. I realize now that I’ve misunderstood: what Yanisky-Ravid objects to is the use of the term baalut – בעלות meaning ownership, since it implies masculinity.


Trade Secrets in the Employer-Employee Relationship

July 21, 2014

forum shopping

In Israel, workers have freedom of occupation and can change jobs or set up their own businesses and may compete with their former employers. The work relationship often exposes the employee to trade secrets. Ex-employees are obliged to maintain confidentiality with regards to trade secrets and cannot compete with former employers by using such secrets. But was a legitimate trade secret?

Work related disputes are dealt with by the Labour Courts, but what establishes the employer-employee relationship?

Nissim Versano appealed an interim Decision of the Tel Aviv District Court given by Judge Ginat to refer the case to the Labour Court to decide whether or not there was an employer-employee relationship. Judge Amit of the Israel Supreme Court refused the Appeal.

On 25 March 2014, Nissim Versano filed suit in the Tel Aviv District Court, claiming that for a number of years he has been involved in the tobacco industry, and has developed contacts with a number of parties in the field. He claims that he took Moshe Ninio into the business as a partner, with a verbal agreement that Ninio wouldn’t use acquired knowledge against the wishes of Versano.

Versano claimed that Ninio set up a competing shop with similar design, stock and prices to Versano’s and that this created a situation of passing off, Unjust Enrichment and theft of trade secrets.

Ninio claimed that he was an employee of Versano and not a partner. He claimed that the District Court was thus not the correct forum to hear the case which should have been filed in the Tel Aviv Labour Court, and requested that the case be thrown out as not within the jurisdiction of the Tel Aviv Court. To substantiate his case, Ninio appended three salary slips testifying to him being an employee.

Judge Ginat of the Tel Aviv District Court referred the case to the Tel Aviv Labour Court to rule on the issue of whether there was an employee-employer relationship, and Versano appealed this referral.

Versano claimed that the District Court should decide whether it was competent to hear the case and, if not, should refer it.

The Supreme Court ruled that Ginat should either hear the case, refer it or throw it out. In other words, he should have ruled on whether or not it was a labour related dispute, and not referred that decision to the Labour Court. Cases cannot be batted back and forth.

However, the appeal was thrown out. The appellant should have appealed by right instead of requesting right of appeal. If a case is heard by District Court instead of by the Labour or Rabbinical tribunals, there is a right of appeal. However, if a case is transferred to a tribunal, one should appeal immediately.

The Supreme Court could use the Request for Right of Appeal as grounds to rule substantively on the Appeal, but did not see fit to do so.

The issue is a partial transfer, which is correctly seen as an interim decision and therefore there are grounds to file an interim appeal.

The Supreme Court related to a case transferred to the Rabbinical Court by a woman claiming financial support on the grounds of having acquired status of a wife by having had intercourse with a man in a manner establishing common law wife status as being an example of an interim decision that could be appealed, but ruled that in this case, the claim of employee – employer relationship should be heard by the labour tribunal who not only have sole discretion to hear labour disputes but also to rule on whether there is an employer-employee relationship.

Furthermore, cases concerning trade-related disputes having an employer-employee aspect are in the sole jurisdiction of the labour court. Trade secret related cases are also the sole jurisdiction of the labour court if there is an employment aspect to the case.

Once transferred to the Labour Courts, cases should stay there rather than be transferred on.

Appeal to Supreme Court  3930/14 Versano vs. Ninio, by Judge Amit, 26 June 2014

COMMENTS

Having one court only being the correct forum for hearing a case prevents ‘forum shopping’. This decision is likely to have repercussions on employee compensation for patents as well as for trade-secret issues. Many companies might be less than happy with this, since the Labour Courts are seen as being pro-employee. With the Iscar case (Plony vs. Company) on appeal to the Supreme Court, this could get interesting.


What Happens When One Party of a Jointly Owned Application is Not Interested in Continuing with Examination?

July 7, 2014

Three parties: CNRS, University of Pierre and Marie Curie, and the Centre Etudes et de Valorisation des Algues, Ceva filed a national phase of FR2011/051384 into Israel as IL 224677.

On three separate occasions, the Centre Etudes et de Valorisation des Algues, Ceva indicated a lack of interest in the European and Israeli applications being examined. In the circumstances, the other two parties applied to continue prosecuting under Section 25, with their request supported by a statement from Ludovic Hamon the VP of CNRS.

RULING

In cases of multiple owners, Section 25 allows for a jointly owned patent application to be prosecuted in accordance with the desires of only some of the parties, but the Commissioner will only abandon an application or patent at the request of all of the parties.

Section 25 has not been clarified by the case law, and the accompanying explanation to the Law from prior to its legislation, does not relate to this section.

The Deputy Commissioner suggests that the purpose of the Law is so that a pending application may be moved forwards without agreement of all parties, so long as they are all kept in the picture.

In this case, despite the disagreement on ownership, two of the applicants are willing to the prosecution of the application without the involvement of the third party.

Since the Commissioner cannot see how the third party can lose from this, she ruled that examination should continue, with the third party being informed of developments.

Whereas all applicants may submit for an application to be abandoned, there is apparently no mechanism for one applicant of many to disengage himself from the examination process. Consequently, the Deputy Commissioner suggests that she should act as per the Law of Chattels. However, without clear indication from the third party that they are relinquishing all rights in the application she is unwilling to do more than simply to follow advice of the other parties.

Ruling, Jacqueline Bracha, 30 June 2014

COMMENT

This type of case could get very messy. Any of the joint owners can license the patent if allowed. Where parties are jointly owned, one should try to have clear contractual obligations in place. In this sort of case, ideally the interested parties should try to buy out the rights of the disinterested party.


Public Interest as Grounds for Accelerated Examination in Israel

June 29, 2014

Eruv

In Israel, patent applications are provisionally categorized into technology areas by the Israel Patent Office on receipt. Applications are then examined in turn by the examiners assigned to the specific technology area.

There are various ways to have an Application examined out-of-turn, by requesting accelerated examination with due cause, if the application is environmentally friendly (green classification), if the applicant is old or ill, or by using the PPH mechanism where there is a corresponding application abroad that has already been examined.

Section 19a(a)5 provides public interest as grounds for accelerating patent examination in Israel. In a ruling concerning Application 216870 Cimas LTD, the patent office ruled that examining in turn was essentially in the public interest, and that to examine something out of turn, requires extraordinary justification.

IL 231173 is titled “A Halachic and technological Eruv”, and accelerated examination was requested on the grounds that it contributed to the quality of life of the Halachically Observant population in Israel.

The Commissioner of Patents, Assa Kling refused the request, since he did not think that this was what the legislature intended when they allowed Public Interest as grounds for Accelerated Examination. He went on to rule that “Public Interest” implies a specific public interest, and this wasn’t shown here. The application is queued for regular examination.

COMMENTS

Jewish Law prohibits Jews from carrying in the public domain on Shabbat (the Sabbath).  An Eruv is a Halachic device developed by the Rabbis for reclassifying public domain as communal domain, thereby allowing carrying therein. Essentially, an area is enclosed by a symbolic boundary, often comprising poles connected by string and this makes it semi-private or communal.

Approx. 25% of the Knesset is Shabbat Observant and this is reflected by the percentage of observant members of the Israeli public. Carrying on Shabbat affects this sector of the population once a week. An Eruv makes a significant difference to the quality fo life of this significant minority of the population. Unlike a lot of religious initiatives, developments and legislation that adversely affects the quality of life of non-Jews and secularists, it is difficult to see how this type of development can adversely affect anyone, at least not in Israel. (In London, there were assimilated Jews who complained that the Eruv made them feel that they lived in a ghetto. Possibly this argument holds true abroad, but Israel is a Jewish state and anyone having a problem with religious neighbors is simply xenophobic and anti-Semitic).

I find it difficult to imagine that over-riding public interest should be limited to things that affect a higher percentage of the population than 25%, more of the time than one full day a week.  It could be that applicant,  Shira Attia, who appears to be unrepresented, failed to make her case properly. Nevertheless, despite whether the Commissioner himself has a problem with carrying on Shabbat, he should be aware that a lot of Israelis do.


Secondary Use Claims – Some Thoughts…

June 27, 2014

second use

Yesterday I attended a meeting of the Association of Israel Patent Attorneys in ZOA  House, Tel Aviv. The invitation and program were blogged here.

The topic under discussion was Secondary Use Claims. Unfortunately, I arrived late and missed the first talk by Adv. Yair Ziv, but caught most of Adv. David Gilat’s presentation, that of Dr Ron Tomer, and that of Ena Pugatsch.

The event was well-organized and well attended. From the remains of the refreshments by the time I arrived, they seemed the usual ZOA fayre. Kudos to the committee headed by Ex-Commissioner Dr Noam, for organizing the event. There were 85 participants in the meeting. This is impressive for a highly specialized topic at an event open to a small organization (noting with approval however, that there were both lawyers and in-house patent coordinators present that are not patent attorneys and thus not members, and also trainees).

Adv. David Gilat posited that drug patents were necessary to compensate the drug developers for their investment, and that secondary uses were also the result of research.  Dr Ron Tomer (confusingly called Dr Yaron Tomer in the original invitation to the event) expertly and clearly countered all of Davidi’s positions, and demonstrated that the pharma industry were creatively filing secondary uses that lacked inventive step and were obvious. He gave various examples. Firstly, he referred to sildenafil citrate, originally developed for treating angina and now used almost exclusively as a treatment for erectile disfunction, as a hard problem. (I thought it was a flaccid problem and a hard solution, but I digress). He went on to argue that an oncological drug for one type of cancer may fairly obviously be tried for another type of cancer since the underlying effects of the drug would treat both mutant cells the same way.  He noted that patents were not awarded for research but for inventions. He claimed that there was nothing new in the drug, despite the new use. He gave convincing examples of ever-greening, and also argued that if it is surprisingly found that a drug treatment for gastro-reflux also kills bacteria in the stomach, then the patient using it takes the same drug for the same purpose that he took it for originally. Since the drug is public domain he could take the generic drug, but to kill the bacteria, he’d have to take the patented drug for a couple of weeks and then move back to the generic. similarly, someone taking a generic statin for cholesterol, on being diagnosed as having genetic cholesterol, would have to switch to the patented version offering protection for this ‘secondary use.’ The talk was intelligent and entertaining, and it was a valuable demonstration of the ubsurd results of secondary use patents.

Ena Pugatsch gave an example of a secondary use claim for a mechanical device that issued in Israel and was upheld by the courts. The device in question was a blackboard that could be used as a screen for showing projected images, where the device and method of manufacture were known but the secondary use wasn’t, and the court upheld the patent. Comparing to European case-law and to US law, she felt that the ruling was ‘problematic’ (a nice way of saying that she considered that the court had got it wrong).

When the floor was opened for questions Mr Zebulun Tomer (Ron’s father and the director of Unipharm) took the opportunity, as he has done on other occasions, to give a little impassioned speech, rather than a question. He made some noises about the results of lobbying and argued that Section 7 prohibits therapeutic treatment of the person and that no-one can convince him that a secondary use is anything other than a method of treatment of the person. Instead of merely pointing out that the issue wasn’t convincing him, but of convincing neutral judge, Adv. David Gilat agreed with him, but said that this was precisely what the Use Claim (Swiss type claims) were for – that is, to allow patents for pharmaceutical methods of treatment despite the prohibition for patents for methods of therapeutic treatment, and this was because of the costs incurred in research and development.

COMMENTS

David Gilat spoke well as would be expected from an experienced litigator. Dr Tomer’s response was also very clear and well constructed. Ena Pugatsch is not an orator, nor is Hebrew her first language (or, I expect, her second language). Nevertheless, her talk, though not the most fluent, was the most thought provoking. All three speakers had far too much content per slide, but none are lecturers. Designing good slides is an art.

David and Ron each presented their opposing positions. As Gilat Bareket represents drug development companies and the Tomer family own Unipharm which manufactures generic drugs, their views were hardly unexpected. I suspect that those in the audience actively involved in prosecuting or litigating pharmaceuticals have equally strong positions based on their source of income. (Richard Luthi, another leading litigator who represents pharma, once told me that under the former Commissioner Dr Noam, the pharmaceutical development industry didn’t have a chance. Whether Dr Naom was biased, whether Unipharm had better arguments, or whether Adi Levit is simply a better litigator, is open to discussion).

The percentage of my income coming from work on pharmaceutical patents is very small. I’ve been involved with both local and foreign clients on both sides of the fence. I tend to find the generic companies’ arguments more persuasive, but can’t tell if this is an inherent bias or whether their arguments are actually better. It is also possible that drugs that are opposed or challenged in cancellation procedures are ones that generally should not have issued, and the both the drug development industries and their litigators have an uphill battle. What is clear, is that Unipharm have had some impressive victories in recent years against Mercke, Smithkline Glaxco, Lunbeck, etc.

Ena’s talk got me thinking. I believe that the original Section 7 law against methods of therapeutic treatment is a historic artefact designed to protect doctors from being sued and represents a moral position that despite obvious utility, novelty and inventive-step, such subject matter would not be patentable. It is a remnant from a period predating the modern pharmaceutical industry. David is correct however. Without effective patent protection, drug development companies would not invest the significant sums required to research and bring a new drug to market. The long approval period also justifies patent term extensions. This development is indeed the result of lobbying, but is, nevertheless, justified. What may not have been justified, is to apply the extensions on cases that were already filed, granting the pharma industry a massive handout that perhaps resulted in them NOT investing in developing new drugs.

Drug developing companies can fairly be accused of ever-greening, and their tactics in filing for secondary uses are commercially driven. However, despite the Special 301 Reports, the generic drug industry are not Robin Hood like outlaws. It is there right to challenge the validity of patents, and some applications are allowed that shouldn’t be. Nevertheless, I suspect that sometimes oppositions are filed for commercial rather than solid legal reasons.

The Swiss Claim (use claim) format is a legal work-around the method of therapeutic treatment clause. Use claims are acceptable in European and Israeli law and are essentially method claims. They do not exist in the US, however in the US one can file methods for therapeutic treatment. What one cannot do, is enforce them against the doctor or surgeon.

After TRIPS, it is clear that one cannot exclude drugs from patent protection. One can still have a principle against patenting methods of treatment. However, countries have to allow patent protection for drugs.

As David Gilat reminded us, patent term extensions were indeed allowed as a package with and justified by a bone thrown to the generic industry – the so-called TEVA amendment, allowing the generic companies to experiment and obtain marketing approval, but not to stock-pile generic patents prior to the patent terminating.  However, one right does not balance the other. Mr Zebulun Tomer is correct that the current balance is the result of lobbying. There were lobbyists on both sides. The ‘one size fits all’ patent law does fail for pharmaceutical patents if such patents have, in the past, been allowed after the 20 year expiry date.

As to second use, the first thing to understand is that use claims are method claims and should be treated as such. The Rav Bareakh crook-lock ruling by the Israel Supreme Court allows contributory infringement and inducement to infringe. However, in Srori vs. Regba, the fact that a sink could be mounted flush with the work surface was insufficient grounds to grant an injunction against the importer, since, As Adi Levit argued effectively, the sinks in question could be mounted under the work-surface, or could be mounted with the lip overlapping the work surface (over-mounted) or could be filled with earth and used as a flower-pot.  Thus, the proper infringers were the kitchen installation companies, and there was no effective bottle neck to sue in the supply chain.  Getting back to secondary uses for drugs, lets assume that using aspirin to dilute blood to prevent thrombosis is indeed novel and inventive. This does not prevent patients buying aspirin over the counter for treating aches and pains and then using it for the new patented use. Manufacturers of aspirin are not infringing the secondary use patent. Similarly, generally speaking, patents for secondary uses are not for the drug itself, but for its use in treating a particular illness. They are method claims. I agree with Dr Ron Tomer that the manufacturer is generally not the infringing party. The physician or patient might be, that the US exception against suing health care officials should apply. There are, of course, some particular dosages that are borderline cases. In such cases, the newly packaged drug is a new product. Whether or not, it is also inventive, is arguable.

Referring back to the blackboard; Ena is correct, it was not a new product, nor was its method of manufacture new. The novelty lay in the method of use, i.e. for projecting an image thereonto. The patent provided grounds for suing schools and teachers for direct infringing – both customers of the patentee and of competitors. This is a patent without teeth. If competing manufacturers note that their blackboards may also serve as a screen, is this inducement to infringe? Maybe it would be better for them to note that although the blackboards may be used as screens, this use is protected by Israel Patent Number IL XXXX, and as long as the patent is valid, is not allowed. This is very different from the crook-lock case where the imported part was designed and manufactured for combining with two common elements to provide the crook-lock, and could only be used for infringing the patent, or for a trivial use such as a paper-weight or land fill.

At the end of the day, it is the job of the patent attorney to draft patentable and enforceable claims. I note that in the US, the pendulum has recently swung away from secondary infringement. See US Supreme Court Ruling 12–786 Limelight Networks v Akamai Technologies Inc et al., June 2, 2014. I believe that often these cases result from poor claim drafting, as do Marksman disagreements. In the past, I drafted and successfully prosecuted a  patent for a kitchen sink AFTER Tsrori vs. Negba. See  US6782593B1.  I’ve also had fun drafting together with Adv. and Patent Attorney Tami Winitz a patent for a new method of using an existing heart valve, where I believe the creative claim-set provides enforceability. See US8408214B2.  Patent attorneys drafting applications try to protect their client’s inventions and stretch the law. Litigators opposing patents do the opposite. We all have our roles to play.

 


Employee’s IP – When Things Get Multinational…

June 19, 2014

academic

Smart & Biggar, a Canadian firm with a memorable name has a good article comparing and contrasting the rights of an employer in employee’s copyright and inventions. See here.  

This is an issue that comes up around the world, and which I have reported on and organized seminars on.

Dr Shlomit Yanitzk-Ravid has recently published a book on the subject, based on her PhD theses. There were also a recent Israeli court ruling and a committee decision that referred to that book.

As academics, including Shlomit, spend time on sabbatical and as visiting professors (currently she is seconded from ONO to Yale), there are territorial complications. If a paper is written by a visiting professor whilst staying at a college who supports royalty free publishing, should he/she have to publish in such a journal? What about if the college where he/she is tenured prefers publication in one of their own Law Reviews?

Companies are often multinational. It is not inconceivable that a company formed and headquartered in the US State of Delaware could develop an invention by collaboration between research groups in Israel and Europe. Apart from Employment Law and Patent Law in the different countries, perhaps being different, funding from binational govt. research funds may have strings attached. Some of the research could be done by a post-graduate student in a university. One inventor may be a tenured university professor consulting to industry and another might be an industrialist who teaches a course in the university. Research could be performed in a university of industrial lab, but what if it is performed on a computer terminal in the company whilst logged on to a university computer?

Where I get drawn into these types of issues, I may be consulting to US council of the Head Office, perhaps outside-council, and could be billed by a US law firm. If the company that perhaps owns the IP has a research lab or factory in Israel, should I be charging VAT on my fees even though I am being paid by money that is laundered, conditioned and neatly pressed by the US Law Firm?


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