Israel Patent Office Requests Submissions Regarding Patentable Subject Matter

September 12, 2014

 

The postage stamp - a great idea, but probably not patentable

The postage stamp – a great idea, but probably not patentable

Section 3 of the Israel Patent Law states:

. אמצאה, בין שהיא מוצר ובין שהיא תהליך בכל תחום טכנולוגי, שהיא חדשה, מועילה, ניתנת לשימוש תעשייתי ויש בה התקדמות המצאתית – היא אמצאה כשירת פטנט.

An invention, whether a product or a process in any technological field, that is new, useful, may be used in industry and has an inventive step is a patentable invention.

Prior to 1995, the Law related to agricultural or industrial, but the term agricultural was dropped.

The Guidelines to Examiners follow TRIPS and patents are allowed for any technology invention. Unfortunately, this does not clarify what is and isn’t patentable.

There are exceptions. Natural organisms and methods of therapeutic treatment are specifically excluded by section 7 of the Law.

The courts in Israel have not clarified what is and what isn’t patentable subject matter.

Clause 5 of appendix b to the Guidelines for Israel Patent Attorneys 23/1 states that

את המונח “שימוש תעשייתי” ניתן לקרוא בהקשרו של התחום הטכנולוגי (הנדון להלן) ולאור היות האמצאה מועילה. בדרך כלל, אם ניתן לשייך את האמצאה לתחום טכנולוגי כלשהו ושיש בה את התועלת המובטחת על ידי המבקש הרי שגם ניתן לעשות בה שימוש תעשייתי

My best attempt to translate this is as follows:

The term ‘industrial use’ may be read with respect to technological fields, and the invention has to have utility, to be categorizable in a specific class and to have the required usage, and will thereby be deemed as having industrial applicability.

Of particular confusion to Examiners, are medical devices, surgical diagnostic and treatment; inventions that contradict the Laws of Nature (helpfully explained as patent applications claiming new physical theories without indication of their uses; genetic sequences and other biological material without use being discussed.

Perhaps not surprisingly, Examiners would like a little more clarity. Less surprisingly perhaps, the Israel Patent Office has solicited comments from the public. We welcome this initiative.

In addition to the above fields of endeavour, responses may relate to the meanings of industrial usage, utility, technology field, process or device, and also to other restrictions to granting patents, including on the basis of Section 17c, i.e. that some other recognised jurisdiction (typically USPTO) has ruled that the invention is patentable – and that the claims in Israel are identical to those granted.

Helpfully, the patent office has included links to Guidelines for European examiners and UK examiners:

http://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_ii_4_9.htm

http://www.ipo.gov.uk/practice-sec-004.pdf

http://www.ipo.gov.uk/medicalguidelines.pdf

http://www.ipo.gov.uk/biotech.pdf

Responses may be submitted to the Israel Patent Office up until 30 October 2014 – when presumably there will be a Halloween party.

COMMENTS

Back in 2009, I held an event titled “The boundaries of patentability”. We examined stem cell research, business methods, software and the like. The question keeps coming up.

In the US, in Diamond v. Chakrabarty, 447 U.S. 303 (1980), paraphrasing Koheleth (Ecclesiastes), Judge Burger ruled that anything under the sun made by man was considered patentable. Some US patent attorneys have tried to patent plots for films. Children, though man-made are also not considered patentable. Over the years, I’ve come across a range of clients wanting to patent cold fusion, directed Brownian motion motors (that client actually managed to obtain a patent in the US on an earlier version and had apparently been around to every patent firm). I’ve had clients wanting to patent games, including chess openings. One academic with feminist leanings has suggested that the technological industrial requirement discriminates against women who are less technical, and has suggested that patents become available for non-technical inventions.

It is about time that gene sequences per se are recognized as not patentable in Israel. The Circular on the subject is wrong.

As the issue has not been raised, I assume that the guidelines for examining computer inventions are clear to examiners. I don’t find them clear, and nor do other practitioners who’ve I’ve spoken to.

Despite the working of this call for comments, I don’t think that the patent office considers new Laws of nature as patentable subject matter. The question is whether devices that operate according to principles hitherto unknown to science, or rejected by mainstream science should be considered patentable. Should the applicant have to provide proof of utility?

It occurs to me that patent attorneys have an interest in the range of patentable subject matter being widened as this may translate into extra work. It would be nice if the Association of Israel Patent Attorneys sets up a working committee and petititions its membership for comments so as to be able to submit an official position.

 


Job Vacancy for Trainee Examiners in Israel Patent Office

September 10, 2014

Israel patent office logo

The Israel Patent Office is looking to recruit a couple of trainee examiners. Suitable candidates must have a relevant scientific or engineering degree, must be fluent in Hebrew and must be able to cope with English language technical literature.

Patent experience is useful but not essential.  For more details, see here.


Adding Evidence in a Patent Opposition Procedure

September 10, 2014

glass transition temperature late entries

DSM IP Assets LTD filed Israel Patent Application No. 168200 for “Process for the Manufacture of a Ballistic-Resistant Moulded Article”. PMS Migun LTD opposed the patent issuing.

On 4th and 6th February 2014, a hearing was held at the Israel Patent Office and then, on 19 May 2014, the parties filed a joint request to amend the protocol. In addition, on the same day, the Applicant requested permission to add a further piece of evidence.

The additional evidence related to the witness statements for both sides concerning the glass transition temperature of the matrix material Witcobond 737 which were already on file. It appears that following the hearing, the Applicant had done some research into the glass transition temperature and wished to submit this now, at the summation stage of the proceedings.

The request to add new evidence generated a spew of claims and counter claims and requests to admit statements into the record and to deny the opposing party from adding new material.

Arbitrator’s Ruling

Regulation 63 states that neither party can submit additional evidence without the Commissioner’s authorization. The courts and the Patent Office have ruled that evidence should be submitted at the correct junctures. When the arbitrator is presented with new evidence, her responsibility is to weigh up its importance in clarifying the outstanding issues, where the proceeding is up to and whether the party could have submitted the evidence earlier.

In the specific instance, the issue (according to MS Shoshani Caspi) is whether the party could and should have submitted the glass transition temperature of the Witcobond matrix during the evidence stage and how important this is anyway. Since the application does not relate to the glass transition temperature or indeed to the Witcobond matrix, the evidence was considered unnecessary to ensure a fair ruling. Ms Shoshani Caspi considers the disagreement between the parties concerning this issue as not relevant to the patentability of the invention as claimed. In this regard, she gave weight to statements from the patentee that the evidence was submitted out of concern to provide a full picture and not to create a lacuna in the evidence, whilst the opposer considered this a litigator’s trick to distract from the real issue. She was not convinced that the evidence was critical.

The Adjudicator of IP, Ms Yaara Shoshani Caspi who heard the case refused to allow the evidence to be submitted and awarded costs of 4000 Shekels against the Applicant. The Opposer was given 60 days to submit their summary, not to exceed 45 pages.

COMMENT

Funnily enough, in an earlier intermediate ruling, the Opposer was not allowed to submit evidence that was not referenced in the statement of case.

When submitting additional evidence, the guiding principle should be whether or not this affects the patentability of the invention. If as a result of the hearing, the patentee does additional laboratory work or literature searches to respond to a point raised, or, as in this case, checks things up with the R&D staff, I believe the party should be allowed to submit it. A patent should not be refused on procedural grounds. The opposing party can be awarded costs for any inconvenience. What is not allowed is to simply present evidence at late stages as a delaying tactic. This is something that opposers have an invested interest to do, since a patent under opposition cannot be enforced until the opposition is dismissed. The applicant has no advantage in delaying tactics and so it seems clear that the additional evidence wasn’t there earlier.
Preferring to relate to substantive issues affecting patentability rather than procedural issues regarding when material can be submitted appears to be the of the court is clear from an Appeal against the Patent Office and Ms Shoshani Caspi to the Courts.

The problem is that the present intermediate decision issued on the 3 August 2014 and the court’s decision on appeal issued on the 18 August 2014. We suspect that the patentee will appeal if, as a result of this new evidence not being considered, the patent is cancelled. No doubt the Opposer will then want the additional evidence that wasn’t allowed to be submitted to be considered.

Interestingly, the entire discussion, including the protocol of the hearing and the evidence is in the file wrapper which is available on the patent office website. As a materials scientist with both theoretical and lab experience in composite materials – I started a PhD in Applied Chemistry at Casali Hebrew University in polymer matrix composites, before eventually joining a coatings project managed by the propulsion physics laboratory of Soreq – NRC and doing a PhD in Applied Physics at the same institution – and having a client who is busy patenting anti-ballistic materials, it is tempting to discuss the evidence and the patentability of the claimed invention. As it is sub juris, I don’t think that would be appropriate.

As to submitting a 45 page summary, it is an art to cut down the volume of material without throwing something important out. This was something we practiced in High School in England. Patent Attorneys do it for PCT abstracts, and when I had columns in various IP magazines such as AIM, WIPR and MIP, I got quite competent at cutting down blog articles to a fixed number of words. We think that 45 pages is more than enough wordage to summarize the case, and to keep the Adjudicator focused on the real issues, the summation should be kept short and focused.


Draft Israel Patent Office Circular on Conditions for Allowing Dispensation from Oral Exam

September 4, 2014

 Oral_Dental_Exam

Background

At present, candidate patent attorneys must have a recognized science or engineering degree, must train for a minimum of two years under a licensed patent attorney who has been licensed for at least three years (in certain circumstances, those licensed abroad may have this period shortened), and the candidate must pass a written exam which is an exercise in patent drafting, and an oral exam.

On 28th August 2014, the Israel Patent Office published a draft circular that details a proposal for allowing candidate patent attorneys who study a Masters in IP Law to obtain a dispensation from the Oral exam.

Comments from the public are solicited, but the window for such submissions, which may or may not be taken into account, is two weeks, i.e. up to 12th September 2014.

I am translating the main interesting bits below. Afterwards, will publish some comments in this forum and invite feedback here. I haven’t decided if I will submit comments formally yet.

The Draft Circular

circumlocation office

Section 143c of the Patent Law 1967 grants the Minister of Justice authority to free categories of candidates from the examination requirements.

Section 135 of the regulations specifies that a candidate may submit evidence of the required knowledge to the Minister of Justice and obtain the dispensation. Regulation 128 specifies the syllabus or perhaps better, the subject matter of the oral exam.

Tsippi Livni

The Minister of Justice, the Right Honourable Ms Tzippy Livni, (who seems to be too busy trying to negotiate a peace settlement with the Palestinians to be able to cope with run-of-the-mill legal issues like licensing patent attorneys), has delegated this authority to the Commissioner of Patents to address this issue on her behalf.

Under this delegation of responsibility, the Israel Commissioner of Patents and Trademarks Asa Kling proposes that candidate patent attorneys that fulfill the following conditions will receive a dispensation from the oral exam:

  • The required knowledge is obtained in a Masters of Law program that focuses on IP Law that is recognized by the Council for Higher Education at a university or recognized college
  • The curriculum includes courses in all subjects on the syllabus defined by Regulation 128
  • The candidate completed the course of studies with the highest distinction (summa cum laude?) and in the top 20% of candidates of that year
  • The candidate was present in at least 80% of lectures

The candidate will have to provide official transcripts and certificates.

None of the above will limit the Commissioner’ discretion from granting dispensations on a case by case basis in exceptional circumstances on an ad hoc basis.

Candidates can still appeal to the Minister of Justice under section 143c.

This circular does not recognize any specific academic institution as fulfilling the required conditions.

COMMENTS

law school

Should obtaining a Masters degree in IP Law be sufficient to obtain a dispensation from sitting the oral theory exam? The IP Community is invited to submit their comments. Here are mine:

I think the reason that this issue is being addressed is that various institutions such as Haifa University offer a Masters Program in IP and, currently, it is a costly program that I have wondered who it attracts? If such course provide dispensation from the notoriously difficult oral exam for Israel Patent Attorneys, they will be more attractive and more students will study them. I suspect that Haifa University and, perhaps places like Tel Aviv and Bar Ilan that offer academic courses that are not degree programs in patents and other IP things and maybe even undergraduate law programs such as ONO that teach an IP Law program, have been lobbying for recognition.

oral exam

The committee of examiners, by Law, should include one patent attorney only. In recent years it typically included two Israel Patent Attorneys and a further Attorney-at-Law, where one of the patent attorneys was also an attorney-at-law. After a scathing critique on this blog, the patent office ruled that where one patent attorney is also a lawyer, this was within the law, but has stopped the practice. It wasn’t within any reasonable interpretation of the Law, but I understand why a retroactive cancellation of all issued licenses or automatic passing of those that failed the Exam was not an acceptable alternative. One also wonders how examiners could test potential candidates on the Law when they were apparently unfamiliar with it. I have also suggested that the oral exams should be scrapped.

The patent exams should be held three times a year. A candidate failing an exam is not supposed to be able to resit within six months and in practice exams are held at intervals of just over six months to prevent candidates from having to wait eight months. Previous Commissioner, Dr Meir Noam, ruled that candidates with less than a year’s training could not sit the exam yet. This was probably a good idea, but was, in my opinion ultra vires, and should have been the decision of the Minister of Justice.  There have been other legal shenanigans including a retroactive amendment of filing fees to take care of a thoroughly sensible but nevertheless ultra-vires initiative of then Commissioner Dr Meir Noam to stop printing hard copies of a journal that no-one read, but to allow publication on the Patent Office website.

I don’t have official statistics, but it seems that more candidates are passing the theory exam now that the committee includes only one patent attorney and two attorneys. This is not a surprise, since in a competitive and shrinking market, there was little incentive for a committee having a majority of its members being patent attorneys, to graduate and qualify more competition. Occasionally things go wrong. I know of cases in recent years where the candidate had previously worked for the examiner. It shouldn’t happen but it has. (The candidate’s comments regarding the services he’d have had to provide to qualify are inappropriate for publication on this blog).

As someone who has many years of academic study behind me (Talmud, Materials Engineering, Physics, Law), I do not dismiss academia as irrelevant. I do not, however, think that an academic theoretical knowledge should compensate for practical experience and knowledge of IP issues. The oral exam is not a theory exam. It is an oral test of practical knowledge. The examiners test that the candidate knows drop-deadlines and knows about designs and trademarks. Examiners often tested that the candidate was aware of the differences between main regimes such as regarding grace-periods, business method patents, software patents, gene patents and stem cell patents.

An IP Law degree, should, in my opinion, train candidates in specific areas such as Internet Law. It should be high level and specific. The IP practitioner’s qualification should be general. It should be detailed but not require the candidate to have formulated opinions or even to be knowledgeable about contentious issues.

Some IP practices do not provide training to trainees. They use them to draft applications, often for a percentage that gets whittled down in practice by the trainer taking his cut first, so that the trainee gets paid nothing. The system is immoral and probably illegal since trainees are considered as salaried employees unable to work elsewhere, but who don’t earn a minimum wage. Many of the practitioners operating the scam do not provide any training whatsoever. Other firms do provide a salary and training. A trainee should get hands on experience of all aspects of IP, not merely do the less profitable work to free the attorney from meeting clients. A big firm can provide a more formal training structure. However, sole-practitioner can train if he or she is willing to involve the trainee in all aspects of his/her practice including contentious issues. Indeed, as a sole practitioner, I did successfully train a couple of now licensed patent attorneys. After every sitting I get emails from new colleague-competitors thanking me for blogging IP decisions and recommending text-books to them.

No individual practitioner’s practice will cover all aspects of IP. The trainee will generally have to study some topics by his/herself. There are a couple of recent textbooks here and here on Israel IP Law, both reviewed on this blog. Reading these, reading the Law and regulations and being aware of court and patent office decisions, perhaps by following this blog, should provide the knowledge to let anyone reasonably intelligent (and most patent attorneys are) pass the theory exam.

I do read books and papers by Israeli IP academics and have met many of them. I do not think that they are really qualified to educate the next generation about what happens in practice. Some are too busy trying to change the system in light of his/her ideas of justice, to be aware of what actually happens. Supreme Court precedents do not necessarily influence examiners at the patent office. A masters’ course is a cash cow for the academic institution. The customers expect to pass with good grades and their expectations are often fulfilled.

oral exam 2

Someone competent should not need dispensation from the exam because he/she will be able to pass it.

Perhaps the current theory exam which is an oral viva could be modified and partially replaced by a written short answer paper, possibly multiple choice? Such an approach would at least standardize the requirements.

I believe that the US requirement of on-going training is also something worth considering. I am not sure how many licensed and practicing patent attorneys would pass the theory exam if they were to sit it again.

asa kling

Commissioner’s Kling’s proposal lists various requirements and does not automatically grant any successful graduate of a masters program in IP Law with a dispensation. It limits it to a percentage of the students. This means that the standard is subjective and not objective.  It is designed to keep numbers down. I don’t think doctors, accountants or attorneys at law get dispensation from professional qualifying exams by virtue of a having a degree. I think a Master’s program should be academic and not vocational. Qualifying to advise and provide services to the public requires practical knowledge.

jeremy phillips  Some years back, Professor Jeremy Phillips successfully negotiated with the UK Institute of Patent Attorneys that the Queen Mary Institute of Intellectual Property Law’s Masters’ program provide a professional qualification. He correctly points out that many competent practitioners don’t know how to teach. There are, however, some substantive differences between the UK Institute membership and the Israel Qualification in that anyone can write and prosecute patents in the UK, whereas in Israel one has to be a licensed Attorney-at law or a Patent Attorney.

Many years ago, Howard Poliner, who now works for the Ministry of Justice drafting IP Laws and amendments, used to offer a course to trainee patent attorneys. It did not replace the Exam but provided preparation for it. I think this is a useful service that universities should offer. Indeed, I thought about teaching such a program myself.

The exact scope of what patent attorneys can and cannot legally do in Israel is a contentious issue between patent attorneys and attorneys-at-law. Licensed patent attorneys interpret the relevant law (sections 19 and 20 of the Israel Bar Act and section 154 of the Israel Patent Law) somewhat wider than do various patent searchers, patent portfolio managers and others. See here for more information.

Dr NoamAlthough I am concerned that the profession should be open to anyone with an appropriate competence and not to a limited number of new practitioners each year, I am rather horrified that the Association of Israel Patent Attorneys has not seen fit to hold an extraordinary general meeting about an issue that is clearly of extraordinary relevance to the membership. I suspect the fact that the chairperson, Dr Meir Noam is actually not a practitioner in private practice and hasn’t been for over a decade including a period that he was the Commissioner, may have something to do with the lack of urgency he is showing to this issue. Of course, the Association Israel Patent Attorneys could be working on an official position paper that they intend submitting without coordinating with the membership, but I don’t suppose they would be so sneaky, would they?

Talking of being sneaky, sneaking out this draft circular at the end of August, with AIPPI conference in a couple of weeks and the High Holidays coming up is a good way to ensure that there isn’t significant discussion and debate on the issue. I have no doubt that the universities have been lobbying this for a while.

Hopefully, having shot off criticism in all directions, some readers may see fit to respond and we can have an open debate on the topic. All comments that are to the point and reasonably polite will be published.


Invitation to the PCTea Party!

September 4, 2014

PC TeabagssewProfessor Phillips at a PCTea Party at the British Houses of Parliamentcinema city

To celebrate 10 years as an owner or partner in my own firm (including the partnership JMB, Factor & Co. circ a 2008-2011), and, a decade of this blog, the readers of IP Factor are cordially invited to toast in the Jewish New Year at a PCTea Party to be held in Cinema City Glilot, Ramat HaSharon. In addition to food, there will be food for thought provided by the preeminent Professor Jeremy Phillips, who will provide some insights on recent world-wide IP Developments, taking his title from Kohelet (Ecclesiastes):

“A time to sow and a time to reap”.

The event will be a party, not a sales pitch. We won’t be giving out literature (and request that competitors don’t either). I won’t even blow my own trombone.

When? 4 PM – 6 PM on October 1, 2014,

Where? Cinema City, Glilot

Academics and associates, competitors, colleagues, commissioners and clients, friends and family, lawyers and litigators, examiners and judges are all welcome.  However, we do need an idea of numbers, both for refreshment quantities and so that we select the appropriate cinema theatre (movie theater for those requiring translation), so we do request that people register here.


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.

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Israel Patent Number 94634, Extending and Shortening Patent Term Extensions

August 18, 2014

Rapamune Sirolimus

Under Section 64 of the Law, basic pharmaceutical patents may be extended for up to five years past the 20 years standard maximum term, in order that the drug developer is able to market the drug exclusively for a period of up to nine years. Since the Patent Term extension was first introduced, granting patent term extensions, but enabling generic competitors to try to synthesize but not stockpile the patented drug, the Law has been amended a couple of times. The first time was the seventh amendment, designed to allow Israel generics to compete with generic companies in other jurisdictions by reducing the term of patent term extension in Israel, to the shortest term allowed in another jurisdiction having patent term extensions (Bolar Countries). Under US pressure that the Israel Law was too generous to generic companies, the Law was amended again in the eleventh amendment in 2014.

Sir Roy Calne filed Israel Patent Number 94634 for COMPOSITIONS INHIBITING TRANSPLANT REJECTION IN MAMMALS USING RAPAMYCIN AND DERIVATIVES AND A CHEMOTHERAPEUTIC AGENT in June 1990, claiming priority from a case filed in June 1989. The patent issued in July 1996.

In June 2001, the applicants requested an patent term extension and in September 2002, a sole license was granted to Wyeth.

The drug was registered in January 2001 and an extension was granted in January 2004. The extension covers the drug RAPAMUNE and the active ingredient SIROLIMUS. The drug term extension was granted on the basis of the corresponding US patent no. US 5,100,899 whose product received marketing approval back in September 1999.

In the request for patent term extension, the applicant reserved the right to change the basic patent they were basing the application on, if a different patent of a Bolar country should lapse earlier.

the patent term extension issued on 25 January 2004 and the applicant was informed that it would publish in the January 2004 journal. No oppositions were filed against this extension. In the same letter, the Examiner requested that the applicant update regarding any patent term extension of the basic patent in the US, and any other patent extensions.

In November 2004, the applicant responded that the US patent application was still pending and that he required a time extension to respond to the Examiner. Furthermore, the applicant noted that it was examining the possibility of basing the patent term on the corresponding Australian patent.  After further correspondence, it transpired that the Australian patent term was extended until 5 June 2015 and the applicant therefore requested a full five-year extension in Israel based on the Australian patent.

After the 7th amendment of 2006, to the Patent Law, the applicants were required to detail all patent term extensions and to provide copies of the documentation regarding the license to sell the drugs and the patent term extensions. Neither the applicants or their representatives responded to this request.

In January 2013, the Association of Israeli Pharmacists filed a request to cancel the extension order, which was accompanied by an affidavit from Dr Ron Tomer (a director of Unipharm), who is a member of the committee of the chemical and pharmaceutical division of the Association of Israeli Pharmacists.

In June 2013, Wyeth responded to the cancellation request, submitting an affidavit of Dr Alvin David Joran, the legal adviser of Pfizer Inc. who had purchased Wyeth in 2013. The Association of Israeli Pharmacists filed a counter argument that included an Opinion by Elizabeth J Holland, an attorney at Kenyon and Kenyon, and also a further affidavit of Dr Ron Tomer. Pfizer decided not to cross-examine  Elizabeth J Holland on her affidavit but both Dr Alvin David Joran and Dr Ron Tomer were cross-examined in a hearing on 27 May 2013.

The Association of Israeli Pharmacists maintain that under the 7th Amendment, the longest available extension should be no more than 7 July 2013. Furthermore, this was the longest period available before the 7th Amendment, i.e. based on US 5,100,899. Furthermore, there is a specific and explicit requirement for equitable behaviour in Section 64B(i) and the applicants failure to respond tot he requirement to detail all patent term extensions and to provide copies of the documentation regarding the license to sell the drugs and the patent term extensions was itself grounds to deny any further extension.

The patentee argued that the interim arrangement of the 7th amendment damaged their property rights and was thus illegal. The patent term extension was legally obtained and the patentee followed their legal advisors. Their whole business plan was based on the patent term extension that was granted.

The Ruling

The interim period is covered by Section 22 of the 7th amendment:

“(a) The rulings of the Law, including Section 164a and Section 18 apply to pending requests for extension periods that were applied for before this law comes into effect, providing that the basic patent has not yet lapsed.

(b) Despite that written in part(a) above, the period of patent term extensions that issued prior to this amendment entering into effect, will not suffer due to them not fulfilling the constraints of parts (5) and (6) of Section 64(d) of the main Law, as it appears in part 3 of this law.

On the face of it, the interim period applies to the present case, where the patent term extension was granted on 5 June 2005, and the patent would have lapsed on 6 june 2010, which is after the amendment entered into force in January 2006. That said, the patentees claim that this is illegal in that there property rights are retroactively cancelled.

The Commissioner noted that this was not the first time that the validity of the various amendments to the patent term extension of the Patent Law has been challenged. See for example 70390 Wyeth vs. Dexcel LTD (ruling by then Deputy Commissioner Axelrod), 83148 Roche Diagnostics GmbH (ruling by then Commissioner, Dr Meir Noam). In those rulings the interim arrangement and its legality in the face of Section 8 of the 1980 Basic Law “Human Honour and Freedom”.  In those cases, it was ruled that the interim arrangement was legal and did not contravene the property rights enshrined in the Basic Law.

Without entering the basic issue of retrospective legislation, it is clear that the interim arrangement includes balances. In Wyeth, Axelrod summarizes “in all cases where there is a point in time that legislation comes into effect, there will always be parties that find themselves on the right and wrong sides of this time period.”

Similarly in Roche, Dr Noam ruled that the entire edifice of Intellectual Property is built on balances between competing interests, and the legislators are allowed to periodically change the point of balance. This is still the case if the balance is to address the disadvantage of the Israel generic drug industry. Furthermore, he went on to rule that interim periods are sometimes to address discrimination against one party or another, and sometimes simply to enable a smooth transition from one regime to another. Although the interim period has to be constitutional, judges should minimize their interference with legislation. (3734/11 Dodian et al.. vs State of Israel).

The current Commissioner, Asa Kling could not see justification in deviating from his predecessors regarding their positions concerning the interim period. He also noted that this wasn’t an issue of the interim period at all, but of the whole amendment, which moved the point of balance in favour of the generic industries.  Since the court had accepted the legality of the amendment in Lundbeck I and Lundbeck II, Novartis and Neurim he considered the issue moot. It is for the legislative body to determine the correct balance between competing interests, and he should be very careful before encroaching on that power. Particularly concerning the economy, one should be particularly circumspect. It is not for the courts to determine economic policy, determine economci preferences or to change internal balances. see 4769/95 Menachem vs. Ministry of Transport and 3145/99 Bank of Israel vs. Hazan.

The Commissioner noted that the amendment was not being challenged, implicitly accepting that the balance struck was fair. Rather, the issue was only that of changing the period. Anyway, the Supreme Court has noted that adversely affecting predicted sales was not to be considered as detrimentally affecting property rights, and Joran’s affidavit was insufficient to base a counter-claim.

The Commissioner also noted that the amendment itself was amended again in Amendment 11 of 2014, although this does not materially affect the issue.

Section 64(9)a states that the Extension period will remain in force, subject to Section 64(10), for a period comparable to the minimum period of any extension granted to the basic patent in a country having patent term extensions. Section 64(10) states that despite Section 64(9), (3) the patent term extension will lapse no later than the period under which the first patent term extension lapses in on a recognized country.

There is no argument that the US patent was extended for 1492 days and lapsed on 7 July 2013. This was the first patent to lapse and is the shortest period of any extension allowed.

Both Holland and Joran claimed that there was also an additional six months pediatric exclusivity period in the US . The Commissioner rejected this claim noting that Section 64(10)3 relates to the patent term extension and does not relate to other exclusive rights. This interpretation is in accordance with the ruling concerning Kirin-Amgen, Inc. 110669.

As the request for cancelling the further extension was accepted, the claims concerning the equitable behaviour of the patentee were considered moot.

In light of the above, Commissioner Asa Kling ruled that the patent in question will lapse in July 2013 and notice of this will issue in the July 2014 journal.

Israel Patent Number 94634, The Association of Israeli Pharmacists vs. Sir Roy Calne  and Wyeth, Ruling Asa Kling 13, July 2014.

 

 

 

 


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