The Master Classes

March 14, 2018

master class.pngFollowing the one day Best Practices in Intellectual Property Conference that was held on Monday, there were a number of so-called ‘Master Classes’ held Tuesday morning. Each one is a fairly intimate half day seminar dedicated to exploring some aspect of patenting.

The air-raid siren practice drill took place in the middle, and I am reliably informed that in some of the master classes, everyone squashed up under the table. That as may be…

QuestelMaster Class 1 – was a seminar by Daniel Ovadya of Questel. The seminar was on various tools for:

  • aligning invention disclosures with an over-all strategy, improving their quality, and speeding up the decision-making process.
  • following IP costs, matching them with business units, and challenging the filing strategy
  • The difference between prior art and freedom to operate searches and combining efficiency with quality
  • Analysis, common error and misinterpretations

I did not attend this session. It may well have been (in)valuable for in-house counsel, but my needs, experience and skill set are somewhat different.

greenberg traurigpngThe Master Class 2 was given by Barry Schindler of Greenberg Traurig and focused on Inter-partes Review – IPR (not to be confused with Intellectual Property Resources; also IPR). Barry offered some advice for being proactive during prosecution to prevent medical devices and life science patents being killed during the Inter-partes Review.

I did not attend this session. I do handle medical devices and implants, and have written up and even obtained some enforceable method of treatment patents. If I could be everywhere, I might have attended this.

For some reason quite beyond me, there was no Master Class 3.

FinneganMaster Class 4 covered PTAB patent proceedings and features various Finnegan attorneys, including Trenton Ward who used to be a PTAB judge, together with other partners of Finnegan.

I did not attend this session. I sat through the mock PTAB trial US 101 trial on the Monday, and was looking for something more interesting.

brooksMaster Class 5 was presented by the Brooks Kushman team and was dedicated to Proactive Defensive Measures to Succeed at Patent Enforcement.

On Kim’s advice, I attended this session.  I discuss it below.

lexis nexisMaster Class 6 was dedicated to drafting the strongest possible patent application, and was lectured by Lexis Nexis staff.

Lexis Nexis is basically a reincarnation of Reed Elsevier and Butterworth and MacMillan via Mead Data Central. The company does computerized legal research tools and data. I am sure that their staff can access and analyze decisions and rulings around the world and probably can pick up valuable tips in each and every one of the master classes. However, I a master patent draftsman myself. I have drafted applications in a very wide range of technologies and have had valuable patents issue in the US and elsewhere. I get work referred by experienced IP professionals and experts and have corporate clients that come back. I have my own ideas on how to draft patents, and am aware of client’s budgetary concerns, the difference between what is considered best US practice and best practice for Europe, and the need to keep things relatively short and clear for translation and prosecuting in the Far East.

trollSo, I went to Master Class 5. I found myself joined by patent attorneys from a couple of other Israel IP firms and also one from the UK, all with several years experience. I found the session rather stimulating. It seems that one of Brooks Kushman’s clients is what is commonly referred to as a troll. However,  they refer to it as an IP Finance Group.

reexaminationApparently, when an alleged infringer is informed of the alleged infringement, they have a 12 month window to instigate an inter-partes review. If they do so, the patentee is exposed to their arguments regarding validity. In addition to the common strategy of keeping a continuation alive so that one can draft claims that read on the alleged infringer’s products, what Brooks Kushman’s attorneys suggested is that the patentee could have the issued patent reexamined and amend the claims, and only afterwards, once the defendant has missed the boat for challenging the validity of these new claims, add the new claims to the complaint. In other words, they proposed a rather expensive but powerful submarine patent tool. Their time-keeping could have been better, and one of their speakers didn’t have time for his presentation at all.

US patentEvery patent jurisdiction has its foibles, special features and loop-holes. the US patent law used to be completely different to that of the civilized world, but has largely aligned itself to other systems over the past 25 years. In fast-moving industries, patents are often only filed in the US, and due to ridiculous disclosure laws and inflated damages awards, it is still the country of choice for trolls. Knowing that such esoteric procedures exist and which firm has expertise is very valuable.

shlooker.jpgI was reminded of the infamous Pearl Cohen Vagabond infringement law suit, where counsel tried to enforce a client’s patent against a competitor that clearly was not infringing the claims. A more competent team of attorneys might would presumably have written better claims when drafting the original patent application, and also avoided the ethical conflict of litigating a patent they had themselves drafted. That as may be, it is good to know that if one wishes to enforce a patent in the US, in certain instances, one can actually tidy up the claims before so-doing.

turpinI don’t have a problem per se with patentees outsourcing their enforcement to a specialist IP Finance Group. I create patents for various clients for a variety of reasons, but ultimately a patent is a limited monopoly that can be asserted against third parties. So long as abuses of the system are due to failures of the courts, there is nothing wrong in companies using enforcement as a business model. It may be a legal kind of highway robbery and may ultimately contribute little to mankind, but the same can be said about lots of finance related business models. It is no more immoral than day trading. It is good to know that it is more difficult to file infringement actions in the Eastern District of Texas and that the courts are more willing to rule costs to the defendant. These issues go some way to prevent abuses. Legal systems eventually adapt to prevent abuses, but whilst legal loop-holes exist that enable the patentee to tidy up claims to trap infringers, as a practitioner, I believe I should know about them, even if they are very  expensive procedures that are only of practical value to a small number of companies. I think that my colleagues in other private practice firms should also know about such tools.

It was indeed a master class.  The patent attorneys from Reinhold, Pearl Cohen and Withers & Rogers that attended the seminar with me were all experienced practitioners. I doubt that any of them had any intention of handling reexamination proceedings themselves, but I can certainly see one of us referring a relevant case to the Brooks Kushman team.

local-councilIn general, I do not consider US attorneys better at drafting patents for the US, and at handling regular prosecution in the US that Israeli based attorneys with native English skills with advanced scientific and engineering degrees and specialist knowledge of IP law.  Patent drafting is an acquired art, but after successfully drafting and prosecuting scores of patents and by reviewing major cases, reading the literature and attending seminars, I don’t accept that an Israel based attorney is less competent than one living in New York, Washington or California.  I am a strong believer that the drafting attorney should visit the client’s premises and actually look at the invention where possible. He or she should lead on prosecution strategy in all jurisdictions and because of the sheer numbers of my cases being prosecuted in the US, I generally draft ready-to-file responses using associate’s templates.





not a rubber.jpgHowever, the associate is not a rubber stamp. I expect the agent of record to review my response and to pick up on any claim numbering errors, missing antecedence issues that can creep in, or objections inadvertently not addressed. I expect the associate to revert to me if an argument seems weak or unclear, or maybe to selectively suggest a relevant legal precedent. In other words, I want the associate to review the response rather than to rubber stamp it. Where the Examiner’s objection is not clear, I will want the associate to interview him or her and report back with details of what the issue is.

competence.gifSome Israel based practitioners are very competent and some US attorneys are as well. US-based practitioners may well have advanced knowledge of various esoteric procedures, but in the days of the Internet, most attorneys can discover such tools where neccessary. I find that US patent attorneys tend to be overly parochial and less cosmopolitan than patent attorneys based in a country such as Israel, who often have a better grasp of European practice and more experience in prosecution in the Far East and other major jurisdictions. I suspect that having local counsel that speaks the same language and has a similar culture to the R&D staff, and who is readily available is highly advantageous with the more standard drafting, prosecution and consultancy. Furthermore, despite the strong Shekel and weak dollar, local attorneys of similar qualification and experience are still typically cheaper than their US equivalents.

However, for litigation related issues, one needs counsel in the jurisdiction in question, and I can understand Israeli clients going direct, rather than engaging and instructing US counsel via local service-providers. Nevertheless, I am pleased that US firms come on these road shows to do their song-and-dance. If and when appropriate, I will selectively refer my clients to such firms.

wise man.pngIn the famous hadith, Muhammad advises to “seek knowledge wherever you may find it, even unto China.”

Where high level professional training is available in Israel, patent attorneys, whether employed in-house in industry or in private practice in IP boutiques or as sole practitioners, should take advantage.

Protecting Machine made Creations?

March 14, 2018

israel patent officeThe Israel Patent Office hosts weekly lectures on Mondays for their staff. These are sometimes given by Patent Office personnel, sometimes by visiting Examiners from abroad, sometimes by academics and sometimes by practitioners.

Where the speaker is considered eminent and the topic is considered likely to interest a wider audience, sometimes the Patent Office opens these lectures to the IP profession.

shlomit yantizky ravidOn 16 April 2018, Dr Shlomit Yanitsky Ravid who is now based at Yale, is lecturing at the Israel Patent Office on whether artificial intelligence is capable of inventing or of creating works of art such as drawings, music and literature and whether these can be protected by existing tools such as patents and copyright law and whether these should be changed to reflect the changing reality. Who owns such inventions and works of art? The lecture will take place between 11:00 and 12:15 at the patent office, and admission is free, but registration is required via Tamar.


I studied various law courses under Dr Yantizky-Ravid, including Labor Law. (It was rather odd, as I already had a PhD, and back then she didn’t. However, I discovered that a PhD in Physics and experience conducting independent critical research was a terrible preparation for a law degree. Particularly back when Aharon Barak was the sole guiding star of the profession. I am, by nature, a formalist (which is still a dirty word in legal circles).

perspective.jpgI found that I like and greatly admire Shlomit, but have a totally different perspective on life, the universe and just about everything. Nevertheless, we collaborated on a conference on employee inventions, and various other things, including my helping a little behind the scenes with an international conference on traditional knowledge which ONO co-hosted with WIPO.  I think our relationship can truly be summed up that we respectfully differ.

traditional knowledge.jpgThat as may be, Shlomit has a knack for early identification of hot areas of interest. Her PhD thesis and the subsequent book on service inventions is regularly cited by the courts and committee, and eight years after her conference on traditional knowledge, Prof. Shuba Ghosh is now invited back to Israel where he will be speaking at the forthcoming  third International Conference on the Economics of Innovation conference hosted by the Israel chapter of the AIPPI.

1920-the-golem-dvd-w400Shlomit kindly sent me her research papers on IP and the fruits of artificial intelligence. I found it stimulating to read, but as is often the case, have a different perspective and don’t agree with her conclusions. However, judges tend to be lawyers and draft legislation is often proposed and prepared by lawyers. I suspect that in time we will discover than some of Shlomit’s ideas with become the reality of this profession. I therefore intend attending the lecture and can guarantee that participants will have an enjoyable and thought-provoking time.

Practice Makes Perfect

March 13, 2018

I attended the sixth Best Practices in Intellectual Property Conference on Monday.

carpetThe conference was similar to the previous ones. Focused on practical patent advice for in-house counsel, there were sessions of prosecution, licensing and litigation. The conference was in the same hall as always, and we were pleased to see that the Sheraton have finally replaced their grotty conference room carpet, but note that the adhesive was still curing, and there was an ambience of acetone that was rather unpleasant.





full houseThere were more tables squashed in than in previous years, and there were few empty seats. So I think that  the claimed attendance of 170 was about right.




The audience was not just large, but was also high-quality, with a very high number of IP managers, licensed patent attorneys and IP litigators in attendance, including several that had flown in specially from China, India, Us and Europe.

Due to traffic, I missed breakfast and the keynote lecture given by Erich Andersen, VP and Chief IP Counsel of Microsoft. I did, however, hear presentations by IP counsel of Google and other major players. It was nice to see that the main cases are still Alice, Mayo and Myriad, so I haven’t missed any major US patent decisions over this past year.

This was, perhaps, part of the problem. Due perhaps to Brexit, the European Unitary patent and patent court has not exactly happened, so there was no session on that. There also hasn’t been a groundbreaking Supreme Court Ruling in the US that required major discussion, so although the presentations were topical, there wasn’t any groundbreaking developments that needed discussion.

professional_adam-p-samanskyjeff berkoqwitzAn interesting experiment was a mock PTAB appeal on 101 subject matter inellegibility that was fought between Adam Samansky (Mintz Levin) and Jeff Berkowitz (Finnegan). Both are tall, formally dressed American Jewish red-heads which made following who was defending and who was attacking the subject matter validity of a computer enabled business method patent claim a little difficult. What I and others in the audience found bemusing was why someone would challenge such a claim on 101 grounds, when it clearly lacked novelty and non-obviousness. One of the panelists noted that former director of the USPTO David Kappos had tried a pilot scheme that stayed the subject matter issues whilst US 102 and 103 issues were discussed, and this resulted in the patent applications being abandoned or the claims rewritten so that the 101 issues simply went away. It seems to be that software is a field of creative endeavour that deserves patent protection. A lot of the case-law has developed around appeals for patent claims that were poorly drafted and defended minor technical advancement. Still the session was a reasonable attempt to give the audience an understanding of how such proceedings occur.

ilI was particularly pleased that a couple of my criticisms have been addressed. In particular, in the past, I have noted that the Best Practice Conference tends to ignore Israel IP prosecution and litigation, which is short-sighted since disgruntled employees can become competitors, and with inventor compensation being an issue that comes up more frequently.  These issues were addressed by Dr. Ronen Lahav, a senior examiner from the Israel Patent Office giving an overview of fast tracking options at the Israel Patent Office, and using Israel filing of the priority application as a fast track to reduced fee PCT filings. Since the America Invests Act brought US patenting more into line with the rest of the world, it makes far less sense filing US provisional patent applications, and there are definite advantages of starting with an Israel Application. Dr Yoav Oestreicher from Meitar (Liquorice) gave an overview of patent litigation in Israel. Whilst I disagree with his assertion that there is so little of it, that all the important case-law is thirty years old, noting the Plavix ruling, for example, by and large, the presentation was a fair and reasonable overview of litigation in Israel. We note that Tal Band also presented. However, I missed his session due to the parallel program and the need to choose which lectures to attend.

As always, the conference was a good opportunity to see old friends and make new ones. I was particularly impressed that competent and experienced practitioners like Greg Kirsch (Ballard Spahr – US) and Michael Jaegar (Withers & Rodgers, UK), who, despite not lecturing themselves, or even having colleagues from their firms that were presenting, flew in to enjoy the conference, and not for the first time. There was also a number of patent attorneys from the larger firms that attended the conference and/or the master classes. I am pleased that the larger Israel patent firms realize that the IPR conference is an annual feature, and instead of boycotting, are beginning to benefit from the program.

There wasn’t a lot of swag available, but what some of the freebies were quite useful. Mintz Levin were giving out rather nice back-packs suitable for computers. Although superficially similar to the S. Horowitz sponsored bag given out at the AIPPI conference two years ago, they were a much better quality. This is in no way an indication that Mintz Levin’s IP skills are better or worse than those of S. Horowitz. I merely note that their backpacks are better made.  Also noteworthy, Greenberg Traurig were giving out rather nifty electronic scales for weighing suitcases and hand-luggage. That too wasn’t particularly well made. It failed completely when a heavy-weight patent attorney and blogger tried to weigh himself.

Lexis Nexis had a nice freebie as well, with a photographer doing professional portrait photos. I took the opportunity to get a graphic image showing that I really do support Kim’s efforts to educate the Israel IP community.

just desserts

Just desserts

Slicing the IP thin.jpgThe food, was, as always, of a very high quality, particularly the endless selection of desserts that came out at the coffee breaks and with the lunch, and were different each time. I take my reviewing seriously, and can assure readers that these didn’t just look good, but tasted good as well.

Lunch included a well-stocked salad bar with cold meats, cold seared tuna and other odds and ends followed by beef, salmon or chicken , with rice, roast potatoes and various cooked vegetables.

searchOver lunch, I attended a special session given by Daniel Ovadya of Questel Orbit that very convincingly demonstrated how poor search strategy could result in totally wrong results regarding patent families and national protection, despite the fact that all the commercial software ploughs the same databases.

This conference is a difficult one in that its focus is practical rather than academic, and the audience though varied, includes a lot of very experienced, competent practitioners. By offering parrallel sessions, there is an attempt to cater for all, but I did hear a couple of pharma attendees complaining about a computer bias to the program. Unlike INTA, the conference is not merely a party.  Although it is a good time to see old friends, the participants come to learn and want to go away with valuable tips. The fact that so many come back year after year, testifies to the high standard of the program.

Last Call for Sell-Out Event

March 9, 2018

ipr-logoThe 6th Annual Best Practices in Intellectual Property hosted by Intellectual Property Resources next Monday and Tuesday, March 12th and 13th 2018 in Tel Aviv is apparently going to be a sell-out with 170 participants expected. However, organizer Kim Lindy has kindly offered to squeeze in an extra table for late-comers, so it’s now or never next year.

Sleepless in Seattle?

March 7, 2018

Sleepless in SeattleThe International Trademark Association (INTA) hosts a party conference every year, where approximately 10,000 patent and trademark attorneys work hard swapping business cards in the hope of generating work. This year, the conference runs from 19 May 2018 to 23 May 2018.

Shavuot, or Pentecost, is the Feast of Weeks. It follows seven weeks after the first day of Pesach (Passover), and this year starts on the evening of Saturday the 19th May 2018 and finishes on the evening of Monday 21 May 2018.

10 commandmentsIn Temple times, Shavuot was primarily a Harvest Festival, celebrating the end of the wheat harvest. It was also the Feast of New Fruits. By a little calculation, it appears that the Sinaitic Revelation and the receiving of the Decalogue took place on Shavuot as well. Lacking positive commandments beyond the Temple sacrifices, Shavuot is traditionally celebrated by an all night study program.

It is tempting to be Sleepless in Seattle, and the film was one of my favorite romantic movies. However, it seems a long way to go to be able to participate only in the Tuesday program at INTA this year. I am, therefore, not attending. The small number of KIPA members (Kosher IP Attorneys) that traditionally get together for dinner one evening in INTA at the local Kosher restaurant or Chabad House, will not be meeting there this year.

On the bright side, Seattle is probably a very nice city, but unlike some of the iconic conference cities, it is not a destination I am bothered about missing.



February 27, 2018

conferencesI was contacted by a trainee patent attorney who wishes to attend one of the forthcoming IP conferences in Israel but is not sure which one is better value for money.  The firm where she works are prepared to recognize her attendance as a day of work rather than a vacation, but are not prepared to pay for her participation.

ipr-logoThe 6th Annual Best Practices in Intellectual Property is hosted by the IPR and will take place on March 12th and 13th 2018.


aippi-israelThe Third International Conference on the Economics of Innovation is hosted by the AIPPI on April 30th-May 1st 2018 which may interfere with participation in International Workers’ Day, but I suspect that few IP practitioners in Israel actually march.

(The big international conferences fall over Jewish festivals this year. INTA is in Seattle, USA, but overlaps Shavuot. The AIPPI 2018 World Conference in Cancun, Mexico is over Suckot).

Although I believe that firms taking on trainees should invest in them and both the IPR and AIPPI Israel conferences include sessions that provide excellent training for the bar exams and/or professional development, clearly the cost of such conferences adds up rapidly for large firms if they send all of their staff. I can also appreciate why an IP firm may not want someone not yet qualified appear to represent them, when wandering around a conference and meeting potential clients and associates or actual clients and associates.

apprentice payNevertheless, on the salary of a trainee, particularly one with family commitments, both conferences are costly. A significant number of trainees are new immigrants that are self-not living with their parents. Those unluckily enough to be on a percentage of salary may not earn a minimum wage and I believe their ‘mentors’ should be struck off. But even those earning a reasonable fixed trainee salary may find that laying out 850 Shekels for a day of training lectures, is difficult to justify, despite the high quality lunch and coffee breaks and the possibility to pick up a couple of pieces of swag from exhibitors.

fair priceThis does not mean that either conference is objectively expensive when considering the standard of the program and the costs involved in hosting such events in expensive hotels, the quality of the refreshments and the cost of such programs abroad. However, I can certainly see why someone paying for himself or herself may not be able to justify for both events.

mingling 2Licensed In-House practitioners may well be able to get their companies to pick up the tab for them to attend both conferences, and unless swamped with urgent work, I can see many IP managers preferring to schmooze with colleagues and to attend lectures rather than sitting in their offices.  I suspect the coffee break refreshments and lunches provided also compare well to the canteen food or lunch voucher allowance of most hi-tech companies.

trainingIP boutiques are, of course, able to evaluate the relevance of the training for their different staff members, and will no-doubt consider this when deciding who to send to which conference.

As with all such conferences, some sessions will be highly relevant to one’s day to day work, but perhaps lacking in material one doesn’t already know. Similarly, some sessions will be focused on IP issues that may be completely irrelevant to one’s day to day practice.  In this regard, apart from keynote lectures, both conferences have parallel sessions, and one is advised to carefully select presentations to attend that are at least one of the adjectives selected from the group comprising: relevant, intellectually stimulating and informative.

bpip 2018The Best Practices in Intellectual Property conference hosted by Kim Lindy and the IPR is perhaps mis-named. Apart from one session on trade-secrets, the entire program is dedicated to patents and the conference is very much focused on practical aspects of patent management. The conference is particularly targeted at In-House counsel in industry and has much to interest independent patent attorneys in private practice, partners and attorneys at IP firms. However, it seems to have little of interest to those who earn their living managing trademark or copyright portfolios. Sadly in my opinion, it also does not address design law which is a rapidly changing field in Israel.

jam packedThere will be little at the “Best Practices in Intellectual Property” conference to interest academics. However, the program is jam-packed with relevant sessions for prosecuting patents and managing patent portfolios which is what very many in-house IP managers do, and also is the bread-and-butter work of most patent attorneys in private practice.

variety packThe AIPPI conference titled “The Economics of Innovation” uses the term innovation very widely and is much broader in scope than the “Best Practices in Intellectual Property” conference In that features sessions on trade-secrets, design law, trademarks, Copyright, traditional knowledge, taxation of IP and Internet & Privacy. Many of the sessions look at the issue of overlapping types of protection.

madagascan periwinkle

Madagascan Periwinkle, used to treat Hodgkin’s Disease

One of the AIPPI sessions is titled “Traditional Medicine – the influence of IP on Commercial Use and Economic Aspects”. This is not the first time the topic of traditional knowledge has been covered in Israel. Back in 2011, I helped
Dr Shlomit Yantizky Ravid of ONO Academic College organize a three-day traditional knowledge conference that brought representatives from a large number of developing countries and sympathetic US academics that was sponsored by WIPO.  Dr Irving Treitel, a patent attorney who deals with life science patents, especially pharmaceuticals (who was then working for me at JMB Factor & Co.) responded on behalf of the profession. Prof. Shuba Ghosh was the keynote speaker then, as now. Despite much advertising in the press, only some 30-40 people participated in the conference – virtually all speakers of foreign delegates. Apart from Dr Treitel and myelf, I don’t recall any other IP practitioners attending that free conference. I applaud the AIPPI bringing IP issues to the attention of local practitioners, but I doubt that this session will attract a large attendance despite the prestigious panelists.


taxCertainly patent attorneys, whether in-house or in private practice, should be familiar with the different types of protection available to be able to advise or at least refer clients.  Patent Attorneys should also be aware of tax issues, at least broadly, to be able to refer their clients to accountants where appropriate to do so. There are very many large US firms registered in Delaware that conduct R&D in Israel. There are also many firms that are physically based in Israel, but decide to incorporate in the US for political reasons, and these include start-ups as well as larger firms. I have clients that have fairly small staff but are incorporated as an IP holding company that owns the patents, trademarks, copyrights and designs and a separate manufacturing company that licenses the IP assets. The tax issues are not something that a patent attorney deals with, but attorneys-in-law may practice IP and tax law, and in-house legal counsel may deal with IP and taxation.  Apart from understanding how tax issues affect their own income and how various taxes can be legally avoided and what is considered illegal evasion and criminal, I believe that IP professionals not practicing tax law should nevertheless have a general grasp of the tax issues that face their clients to be able to advise them where they should seek guidance from a tax attorney, accountant of tax-consultant.

In summary, both conferences are value for money. People only having the time or budget to attend one should consider which one to go very carefully, and it is worth working out in advance which sessions to attend.

Unipharm without legal representation, wins Interim Proceeding Against Novartis

February 22, 2018

galvusIsrael  Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION ” the patent application is a national phase of PCT/EP/2005/000400. It relates to a pharmaceutical used in the treatment for diabetes known as Vildagliptin (previously LAF237, trade names Galvus, Zomelis,) which is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1[2][3] and GIP[3] by DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.

Unipharm has opposed the patent issuing and, in an intermediate proceeding, Unipharm (not represented) submitted a disclosure request for:

  1. The specific testing referred to Appendix E of a the Applicant’s expert witness.
  2. All other tests relating to all the formulations that were performed where the particle size distribution was examined.


Alternatively, Unipharm requests that the part of the evidence that relates to the evidence submitted in the European Opposition proceeding from Dr Davis’ statement, including Appendix E, be struck.

The patent relates to tablets that are made by direct compaction and which include DPP-IV, (s)-1-[(3-hydroxy-1-adamantyl)amino]acetyl-2-cyanopyrrolidin (Vildagliptin) in free radical form or as a salt, wherein at least 80% of the particles compressed into the tablet are in size range of 10 microns to 250 microns.


In their Statement of Case, Novartis explains that use of direct compression was not obvious to persons of the art wishing to produce vildagliptin formulations, and the distribution and size of the particles affects the character of the tablet in a manner that determines the efficacy of the formulation. The chosen distribution enables tablets to be produced by direct compaction which have high quality, acceptable stability and good physical properties.

With respect to this, Novartis’ expert witness, Dr Davis, explains in his expert opinion as follows:

“There is no prior art suggesting that tablets of vildagliptin can be made using direct compression with this size range or any size range. This particle size range and percentage of the active agent is not disclosed in the prior art. It should be noted that the particle size distribution is important to achieving good physical properties in the tablet (e.g. good hardness). Evidence filed in a technical annex for the corresponding European Patent Application No.15199440.7 (available on-line from the EPO at,  comparing 88% PSD of 10-250 micron (within the claim) versus 79% PSD of 10-250 micron (outside the claim) shows that the use of a particle size distribution as claimed is important in providing directly compressed tablets with good hardness (Appendix E).”

The Expert witness related to the technical appendixes that were submitted by the Applicant to the European Patent Office which compares tablets that fall within the ambit of claim 1 to those that do not, and this is the basis of the discovery request that Unipharm submitted.

Claims of the Parties

disclosureUnipharm’s opposition to this evidence is that Professor Davis relied on test results from tests that he himself did not conduct, and they express wonderment that Novartis did not produce the drug developers to be cross-examined. In response, the Applicants claim that the disclosure process should be allowed in cases where it is proven that the documents in question are relative to the proceeding in general and to the point of contention between the parties, and in this instance the Opposer did not justify his request for disclosure of documents and did not explain how the disclosure would help clarify the question under debate.

grain size

Novartis further allege that the request for disclosure is wide and general, in that it relates to all testing and formulations made, where particle size was examined. The Applicant further asserts that Dr Davis referred to Appendix E merely to show that it was published and not as evidence that the data therein is true (!?).

As to Unipharm’s alternative request, Novartis claims that the Opposer did not base this allegation, and that we are referring to an expert opinion based on data provided to him and his relying on the publication is equivalent to any expert relying on a professional publication such as a paper in a scientific journal or a patent application in a relevant field.

file-wrapperIn response, Unipharm claims that the Applicant’s expert, Professor Davis, did not merely testify that the document was included in the file wrapper of the European Patent Application, but also reached conclusions in his expert opinion that were based thereon. As far as anything connected to the scope of the disclosure, Unipharm focuses their request and asks to receive the documents relating to the experimentation with the particle distributions and efficacy of formulations made with the specific distributions.

Unipharm claims that the documents will reveal that the tests conducted, if indeed conducted, do not provide sufficient instruction to persons of the art to produce the invention successfully without additional experimentation and thus the patent application should be rejected as not enabled under Section 12 of the Israel Patent Law 1967.

Discussion and Ruling

legal fishing expedition

There is no doubt that the Commissioner of Patents can request disclosure and access to documents in opposition proceedings. The disclosure is efficient in that it provides documents to the Patent Office that are not covered by Section 18 of the Law (Duty of Disclosure) and which can help clarify if an application is patent worthy. However, disclosure is performed in a manner to prevent the Applicant going on an illegal fishing expedition in the Applicant’s filing cabinets.

The considerations to be weighed up prior to giving a disclosure order are detailed in Opposition to 60312 Biotechnology General Corp vs. Genentech Inc and in Opposition to 143977 AstraZeneca AB vs. Unipharm ltd, and these are the stage of the opposition reached; the amount of documents and their content; the weight of the claim that the Applicants are attempting to prove with the documents asked disclosure of, their evidential weight, the possibility of the Applicant to obtain the documents themselves, and the burden it will cause the opposing party.

In these rulings it was also determined that disclosure could damage the property rights of the opposing party by forcing revelation of trade-secrets. However, the possibility of such damage being caused does not remove the authority of the Patent Office to demand such a disclosure, but obliges consideration of the legitimate property rights of the party when applying that authority.

In the opinion of Commissioner Alon Ofir, Novartis is correct that the experimental results will have no effect on the average person of the art’s ability to implement the invention. The answer to this question is found in what is revealed and not in what is not revealed in the patent application.

Nevertheless, Unipharm is correct with regard to everything related to the tests described in Appendix E, since the Applicant himself relied upon this in his statement. In this regard the Commissioner does not accept that this evidence can be considered as external evidence that their Expert Witness relied on. The document was prepared by Novartis themselves, with data they control, and their expert witness relied on it in his Opinion.


The particle size distribution is claimed by Novartis themselves as being a central element of their invention, and the claims of the Application itself limits the requested patent to one wherein 80% of the particles are in the 10 micron to 250 micron range. The Applicants themselves state in their Statement of Case, that the choice of particle size and distribution is what enables the fabrication of tablets of an acceptable quality by direct compression. Their Expert Witness finds support for this claim in Appendix E which compares tablets having this particle distribution with tablets that do not.

In these circumstances, one should consider the documents as relating to the central question being debated by the parties. Thus the documents relating to Appendix E are ruled relevant and Novartis are required to provide not just those relied upon but other documents summarizing experiments done with the intention of producing Appendix E, even if not included therein.

Novartis is given 30 days to produce an Affidavit of Disclosure with the relevant documents describing test results obtained in the experimentation leading to Appendix E, whether or not included in the Appendix, but relating to the hardness of tablets made from different particle distribution.

As an after-note, the Opposer is chastised for using language that does not show respect for the proceedings which was inappropriate.

No costs are awarded.

Ruling on Interim Proceeding regarding disclosure, by Commissioner Ofir Alon, 3 January 2018.


trawlingIn court proceedings in the United States there is wide discovery and the parties effectively go on fishing expeditions with trawlers and haul up everything and then have to wade through the bycatch.  This is not the case in Israel. One can ask for specific documents, but have to justify the request. Thus I have used the term disclosure and not discovery.

self representation

In this instance, Unipharm is not-represented, or to be more accurate Dr Zebulun Tomer is representing himself. No doubt if he runs into trouble he will call on his attorney Adi Levit to represent them. It is unlikely that the inappropriate language lost Unipharm a costs award as, since they have not used legal counsel, they are not entitled to costs anyway.

We strongly discourage industrialists to represent themselves in Opposition proceedings. The Tomers, however, have so much experience of killing pharma patent applications that there are very few lawyers that have handled so many cases.