Can a Knowingly Abandoned Patent Application be Reinstated?

May 22, 2018

BioMarin

IL 206845 to BioMarin Pharmaceuticals Inc. was refused under Section 21a of the Israel Patent Law 1967. The patent application was the national phase of a PCT application submitted on 6 January 2009. The national phase entry was submitted on 6 July 2010 and claims priority from US applications filed on 7 January 2008 and 22 April 2008.

On 30 January 2013, the Applicant was sent an Office Action to which the Applicant had four months to respond. No response was forthcoming. Following the extensions available under Circular 005/2011 then in force, on 5 March 2014 the Applicant was informed that the file would be closed if no response was submitted within 30 days. This letter went unanswered and the file was closed on 23 June 2014.

3 years

Three years and three months later, on 15 October 2015, the Applicant requested a retroactive extension to respond to the notice of abandonment.

The request was accompanied by an Affidavit that testified to the developments leading to the case becoming abandoned.

  1. In 2005, Merck Serono purchased all rights to the Kuvan medical product, and to the process for manufacturing the active ingredient claimed in the application.
  2. This transfer of rights was not recorded in the patent register and the Application was filed in the name of Biomarin.
  3. In 2012, Merck Serono decided that it was not interested in the patent issuing in Israel and told Biomarin not to respond to the Office Action.
  4. In 2015, Biomarin repurchased their rights to the invention and in 2016-2017 reviewed the usefulness of getting the patent to issue in Israel.
  5. Following the reconsideration, the present request for extension of time to respond was submitted in October 2017.

change-my-mindThe Applicants argued that their repurchasing of their rights and their reconsideration of the portfolio provides sufficient justification for reconsidering the refusal of the patent. Furthermore, unlike in the US and Europe, there is no legal requirement for abandonment so thus, even if the abandonment was following an intentional decision by Applicants or the predecessor thereof, this does not mean that, following a change of circumstances, this cannot be reconsidered and they are entitled to a further opportunity

mistake EinsteinThe Applicants presented their arguments at a hearing on 14 February 2018, during which they claimed that the Applicants can be considered as having made a mistake that they now wish to rectify. They also claimed that returning the application to examination will not cause damage to third parties. Finally, they argued that in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), certainly is no more important than other considerations.

Sections 21 and 21a of the Law set out the normative arrangement for these matters as follows:

21.  If the Applicant did not remove the grounds for the Application not being approved within the timetable set out in the regulations or did not correct the lacunae under Section 20, the Commissioner will refuse to allow the patent.
21a. If the Commissioner refuses the patent under Section 21, he can, at the request of the Applicant, reconsider the refusal provided that the request to do so was submitted within 12 months of the refusal.

reasonable

The period laid out in Section 21a of the law is extendable under Section 164 of the Law at the Commissioner’s discretion. The Commissioner’s discretion is summed up in the phrase “if he sees a reasonable basis for so-doing” which is found in Section 164a. The Commissioner’s considerations will change with circumstances, and as Judge Naor stated in Appeal 826/04 Commissioner of Patents vs. Recordati Ireland Ltd (26 June 2004):

The policy regarding different requests for extending deadlines that are brought before the Commissioner, will change with circumstances and with the nature of the proceedings for which an extension is requested.  

 Similarly, the Commissioner has the authority to make the extension dependent on “conditions that he considers to be correct” as stated in Section 164b of the Law.

In cases such as this, there are two main interests. Firstly, that of the Applicant who wishes to protect his invention and, secondly, that of the public which can benefit from inventions that are not patent-protected and are thus in the public domain. It is noted that this case is the national phase of a PCT application and the application and its status is published under section 16a of the Law.

limited

The Deputy Commissioner Ms Jacqueline Bracha considers that the period given in Section 21a, though long, is limited. This protects the public and brings matters to a close. The period given in the Law is a balance between the competing interests.

To extend the 12 month period after the file closes under Section 164 requires ‘reasonable grounds’, as defined in Opposition to IL 110548 Shmuel Sadovsky vs. Huglat Kimberly Marketing ltd, 12 August 2010. The relevant considerations for ‘reasonable grounds’ are the duration of the extension requested and the existence of a real cause for the delay.

Ms Bracha does not consider that the Applicants’ request can be considered reasonable with respect to the delay incurred or the justification to reopen the file. The request to reopen the file was received 39 months after the case was closed. This is 27 months after the usual deadline which is a long time.

As to the submission that the client changing their mind is grounds for opening an intentionally abandoned application, the Deputy Commissioner does not find this convincing. She finds support in Appeal 83/86 Sokol vs. Yismach, p.d. 40(1) 577 cited in the Sadovsky case, where it is stated that:

The discretionary authority to extent deadlines is intended to overcome mishaps and externalities that are beyond the litigant’s control.

One cannot consider a decision not to continue prosecuting as being an external cause, a mishap or an error. Ms Bracha notes that the circumstances described in the Affidavit show that the error we are dealing with is imported from Contract Law and is at best “a mistake in the equity of the deal” which is not grounds for cancelling a contract.

In a similar manner, it has been determined that not paying a renewal of a patent due to a determination that it is not worthwhile to do so is NOT considered as a reasonable ground for reinstatement, and that is where we are dealing with an actual right that the patentee was awarded and not with a pending application as in this case. See Request for Reinstatement of IL 177522 of “Yad Conena Ltd from 9 June 2014:

The circumstances of the case before me do not fulfill the above requirements. A decision was taken not to pay the Renewal fee. The patentee knew that the there was a need to pay the renewal fee as this was not the first time that he had needed to pay it. One can assume that after the case lapsed and was reinstated in 2011, the patentee made inquiries regarding the next renewal. From the Affidavit it transpires that the patentee made an informed decision NOT to pay the fee. In these circumstances one cannot conclude that the fee was not paid in reasonable circumstances that justify reinstatement.  The economic difficulties that the Applicant noted are not considered reasonable grounds for not paying the renewal, particularly where no evidence of the debit was submitted.

As a footnote, Ms Bracha relates to the claim that the request finds support in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), that in patent law, fidelity and consistency is no more important than other considerations. Ms Bracha considers that certainty is not all-seeing and that sometimes certainty will be sacrificed for other interests. In  re Association of Israel Industrialists, it was stated:

True, there is validity to the suspicion that certainty may be damaged when a court comes to interpret the Law (Aharon Barak Legal Interpretation, Interpreting Legislation Volume 2 583 (1993). Nevertheless, this is one consideration amongst many that can be used where there is nothing in the wording of the Law or elsewhere to directly contradict this. In this instance, it appears that the legislators did not put the question of certainly regarding when a patent lapses as the main consideration.

In other words, the consideration of certainty is an important consideration but where the wording of the Law or its purpose indicate that the legislators preferred some other consideration, the Court will interpret the Law accordingly.

Ms Bracha does not consider that in this instance the Law or the case-law expounding the Law indicate that the legislators preferred the interest of the Applicant over that of public certainty, She considers that to the extent that there is a legal tradition for interpreting Sections 21a and 164 of the Law, it is one that requires the Applicants to provide a real and reasonable cause for incurring a delay, and this is necessary since there is public reliance on the patent lapsing.

revival-2

The Applicants also requested to learn from what is stated in foreign legislation, that what is not stated in our Law is not a requirement. That is, that whereas other laws explicitly state “unintentional” this implies that there is no such requirement in Israel Law. Whilst it is true that Section 21 does not require abandonment to be unintentional, it does provide a normative timeframe for reinstatement, whereas the US and European law do not.  Any deviation from this period is considered in the mirror of Section 164 which is interpreted in light of the nature of the deadline to be extended and the type of proceeding before the Commissioner. This was detailed above, and will not be repeated. It is sufficient to note that one cannot rely on the inclusion or omission of a word in the Israel Law as the basis for its interpretation whilst ignoring the case-law.

It seems that the circumstances are such that the case was abandoned intentionally and can only be rectified if this was not legal. The request is refused.

IL 206845 to Biomarin: refusal to reinstate application, Deputy Commissioner Ms  Jacqueline Bracha, 17 April 2018.     

COMMENT

In extraordinary circumstances, long-dead applications have been reinstated. See for example IL 194015 to Natapov, Perstnev, Perstnev and Vilacer titled “the Insulating Material”. Here the patent had lapsed three years earlier, but had not published. The record is probably Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri  which was revived seven years after it lapsed.

I am frankly surprised by the audacity of the Applicants’ representative for trying to  argue that this knowingly abandoned patent application could be revived more than 12 months after going abandoned and am pleased that the Deputy Commissioner came to the decision that it could not be.


Abandoned Patent Opposition Converted into Ex-Partes Procedure

April 20, 2018

Israel Patent Application No. 220476 to Mapi Pharma titled “Long Acting Depot System Comprising a Pharmaceutical Acceptable Salt of Glatiramer” was allowed and published for opposition purposes. Teva filed an opposition under Section 34 of the Law.

glatiramer

The application relates to a dosing regime of Glatiramer and salts thereof. The drug is an immunomodulator medication used to treat multiple sclerosis.

The application is a national stage of a PCT filed on 19 August 2010 which claims priority from an American patent application of 4 January 2010.

The patent was examined and published for opposition purposes on 31 March 2016. On 28 June 2016, Teva filed an opposition. After the parties submitted their statements of case, Teva withdrew their opposition for commercial reasons.

Under Section 34 of the Patent Law 1967, the Commissioner has to decide whether the suspended opposition provides a sufficient basis for the patent to be granted.

In their Statement of Case Teva raised various issues regarding the patentability of the claimed invention. Since no evidence was submitted, the Deputy Commissioner concentrated on the allegation that the publication of WO2005/041933 from 12 May 2005 anticipates the invention and negates novelty.

Claim 1 recites:

“A long acting parenteral pharmaceutical composition comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer, the composition being in a sustained release depot form which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.”

Paragraph 20 of the Statement of Case which from paragraph 58 of their counter statement, it appears the patentee accepts, construes claim 1 as follows:

  1. A long acting pharmaceutical composition
  2. For parenteral dosing
  3. comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer,
  4. the composition being in a sustained release depot form
  5. which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.

Read the rest of this entry »


A cost ruling and a tax question

April 17, 2018

This cost ruling highlights a tax issue where it seems to be unclear whether charges for legal work performed on behalf of a foreign entity concerning an issued patent (or trademark) in Israel incur VAT. It also highlights the problems that can occur where firms split and one professional leaves taking clients and on-going issues with him. What is required is professionalism and good between the management of the original firm and the new representatives to deal with costs incurred by the original constellation. Unfortunately, sometimes this good will is lacking.

alkermesAlkermes Pharma Ireland LTD has an exclusive license from Novartis to manufacture a drug in accordance with IL 142896 and its divisional patent no. IL 179379 entitled “Multiparticulate Modified Release Composition”. The active ingredient is Methylphenidate and is commonly known as Retalin. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.

MediceMedice Arneimittel GmbH filed a request to cancel the relevant patents and the claim scope was narrowed in a preliminary action by Alkermes, but the cancellation actions were unsuccessful. Now Alkerermes has requested costs of $1,029,561.95 which comes to 3,626,118.18 Shekels costs.

History and Timeline

IL 179379 is a Divisional Application of IL 142896. The allowed patents published for opposition purposes on 8 March 2007 and 31 March 2011 respectively. Since no oppositions were filed, they issued on 9 June 2007 and on 1 July 2011. On 6 August 2012, an exclusive license for manufacturing was issued in the name of Alkermes.

On 14 November 2012, Medice Arneimittel GmbH applied to cancel the patent. The application was supported by a technical opinion provided by Professor Golomb.

On 7th February 2014, before a counter-claim and evidence were submitted, the patentee requested to amend the specification under Sections 65 and 66 of the Israel Patent Law 1967 which allows the scope of a challenged patent to be restricted by the patentee within the scope of the monopoly originally allowed.

On 6 March 2013, the Medice Arneimittel responded and on 14 March 2013 Notartis answered and on 17 March 2013 Medice Arneimittel GmbH requested permission to respond to the answer. On 5 May 2013, then Commissioner Kling scheduled a date for a hearing to discuss the amendment. In the hearing which was held on 4 June 2013, the Commissioner ruled that he case be conducted under Section 102(vi) as if the amendment was accepted, and after the cancellation proceedings be ruled, on the amendment would publish for opposition purposes.

In light of this ruling, Medice Arneimittel submitted an amended cancellation proceeding together with a further affidavit from Professor Golomb.

On 4 March 2014, Novartis/ Alkerermes submitted their counter claims submitted with an expert opinion from Professor Mark A Stein and Professor Joseph Cost.

On 2 June 2014, Medice Arneimittel submitted their counter-evidence including a further affidavit from Professor Golomb together with a request to submit a further three prior art publications. On 18 June 2014, the Commissioner allowed this extra prior art to be submitted, and allowed Novartis/Alkerermes to relate Read the rest of this entry »


Reinstatement of Lapsed Patents in Israel

March 22, 2018

not a rubber stamp

It can and does happen that annuities are inadvertently not paid and patents go abandoned.

If the patentee and/or his representative act promptly on learning that a patent lapsed, and sign affidavits to explain how the deadline was missed, reinstatement is generally possible. The Adjudicator, typically the Deputy Commissioner, will usually allow reinstatement and her decision publishes for opposition purposes. If, in the meantime, a third-party has made preparations to exploit the apparently abandoned patent, they are generally entitled to a non-transferrable license to continue to exploit. It is important to realize however, that reinstatement is NOT automatic.

This past month there were six rulings concerning abandoned patents. In five cases, in two of which the patentee was represented and in three they were not, the Deputy Commissioner ruled that the conditions of Section 56 were met and ruled that, subject to no oppositions being submitted, the patents could be reinstated.

In the sixth case, IL 177416 to Arieh Sansolo titled “Rapid Detonating Cord Coil Deployment Apparatus” went abandoned due to failure to pay the third renewal for years 10-14 after filing. The last day for paying this renewal was 10 August 2016, and six months later, on expiry of the grace period, the patent was abandoned as per Section 57 of the Law.  The fact that the patent was abandoned was published in the March 2017 journal.

From the request for reinstatement and the accompanying affidavit, it seems that the reason why the case was not renewed was due to the patentee not being reminded by the agent-of-record (Dekel Patents).

In her ruling of 7 February 2018, Ms Bracha wrote:

It is not clear from the Affidavit why the agent-of-record did not inform the patentee, nor is it clear what steps were taken by the agent-of-record to ensure that the renewal fee be paid. It is also not clear how and when the patentee and the agent-of-record became aware that the patent had lapsed

Ms Bracha gave the patentee a further opportunity to add the missing data within 7 days.

 

up a palm tree

The patentee and legal representative did file an additional submission which attempted to include testimony from both patentee and agent -of-record wherein the patentee swore to tell the truth, but the agent -of-record merely listed the circumstances without swearing to tell the truth.  Nevertheless, without relating to the formal deficiencies, Ms Bracha considered the statement. The agent -of-record noted that he assisted the patentee by receiving reminders and forwarding them to the patentee. In this instance, he did not receive a reminder and thus did not forward it to the client. The agent -of-record noted that he does not charge for this service.

In a string of decisions the Israel Patent Office has ruled that not receiving a reminder from the Patent Office is not sufficient justification to not pay the renewal. See for example, IL 185526 Khalid Akad et al. 24 October 2012. The Applicant or his representative are required to take positive steps to ensure that renewals are timely paid, such as to run a computerized reminder system or to use a renewals company.

In this instance the patentee and the agent -of-record did not have such a system but simply relied on the Patent Office. This is insufficient to fulfill the reasonable means requirement of Section 60 of the Law.

Furthermore, in this instance, the Patent Office records show that an email reminder was sent to the agent -of-record on 10 April 2016 and shows up in the Patent Office system.

It is noted that providing a renewal service without charge is insufficient to free the agent -of-record from his obligations under the law.

The request for reinstatement is refused, but the Applicant has 30 days to submit a request for a hearing.

Re Reinstatement of IL 177416 – Decision by Ms Bracha, 11 February 2018.

COMMENT

Whilst Ms Bracha is correct that the patentee and agent-of-record are obliged to docket and track renewals, things can and do go wrong. Now the Patent Office is obliged to weigh the public interest against that of the patentee and there is, indeed, a six months’ grace-period. The fact that this month there were six cases of patents that unintentionally lapsed shows that this does happen. What I would like to humbly suggest is that the Patent Office takes it upon itself to send out a further reminder or preferably two; one when the deadline for renewal passes and one a month before the end of the grace-period. The Patent Office is equipped to do this automatically without human involvement. Doing so would increase Patent Office revenues and minimize the amount of time that the Commissioner and his staff have to deal with reinstatement issues.

issues.


Adding Evidence After Filing Statement of Case in Patent Opposition Proceeding

March 22, 2018

Plasto Vak ltd (1990) ltd filed Israel Patent No. 220639 titled “Disposable One Piece Container with a Removable Tear Strip Configured for Separation of the Lid and as a Tampering Alert.” On allowance, Vacotec Packaging ltd filed an Opposition.

lateBoth sides filed their statement of case, and then, at the evidence stage, Vacotec applied to reference two additional pieces of prior art. The Opposer justified the need to add these citations by arguing that the Applicant had taken an unexpected position in their Statement of Case and had post-dated the filing date due to amendments during the prosecution.  This resulted in them doing a further search and discovering the two additional references.

The Applicant , Plasto-Vak ltd denies that there was a change between the position they took during the prosecution and that taken during the Opposition in how the claimed invention overcomes the prior art. They further deny that they agreed to the application being post-dated due to significant amendments and argue that it is too late for Vacotec to file amend their Statement of Case.  They noted that they had submitted their statement of case 5 months earlier, and this request by Vacotec was tardy. Finally, Plasto-Vak ltd denies that the new citations are relevant enough to challenge the patentability of the claimed invention.

The invention in question is a disposable one-piece container. It is claimed as follows:

A disposable one-piece container [100] comprising first and second opposing sections [110 and 120], respectively, interconnected by a folding joint [130], said first and second sections [110 and 120] are separable by pulling said second sections [110 and 120] in opposite directions; wherein said folding joint [130] comprises an axis-segment [230] formed by a folding-line [210] adjacent to the second section [120] of said container [100] and a frangible folding-line [220] adjacent to first section [110] of said container [100]; said axis-segment [230] configured as a rotation axis between said two opposing sections [110,120] enabling the closure of said container [100]; further wherein said container [100] comprises a hold-tab [150] located at the first section [110] adjacently to frangible folding-line [220] and a hold-tab [160] located at said axis-segment [230] adjacently to frangible folding-line [220] and spaced apart from said second section [120]; said hold-tabs [150 and 160] are perpendicular to each other and grippable by a user for pulling in opposite directions.

The Application was submitted on 25 june 2012 and the examination was expedited. It published for opposition purposes on 30 November 2016 and the opposition was filed on 27 February 2017.

Discussion

The Applicant is correct that in general in opposition proceedings, the Opposer cannot rely on additional citations beyond those brought in the statement of case. Consequently, submission of additional references requires correcting the statement of case. See Appeal 47387-01-11 Bromium Compounds vs. Alvemarle Corporation USA 8 August 2011 and the IL 155919 Teva vs. AstraZeneca opposition from 5 December 2011.

Amendments to the statement-of-case are allowed where they help focus the discussion on points of disagreement between the parties, where there is no justification to prohibit the correction. See Opposition to IL 187923 Pimi Aggro Cleantech ltd vs Xena international 19 May 2013:

This forum has the authority to allow corrections to the Statement of Case in instances where the amendment focuses on the issues in question and where there are no reasons not to allow the amendment. Such reasons for refusing to allow the amendment include inequitable behaviour, denying the opposing party their rights in a way that may not be compensated for with monetary award in a costs ruling for the interim action, and tardiness in requesting the amendment (see interim request to amend the statement of case in cancellation proceedings against IL 154398 in Logo Engineering Development vs. State of Israel, Ministry of Agriculture, Volcani Institute 29 April 2004. Furthermore, exercising the authority to allow such amendments depends on the stage of the proceedings reached, since patent oppositions delay and prevent the Applicant from receiving the patent.

In this instance, there does not seem to be any real reason not to allow the amendment to the statement of case and the addition of these references since the Applicant can respond to the amended statement of case. The Opposer claims that their evidence is ready and can be submitted within a week so that no real delay will result from allowing the additional material to be submitted.

Two issues that the Applicant raises deserve responding to:

  1. The delay in filing the request
  2. The relevance of the new citations

It is preferable to conduct a proper search before filing the Statement of Case, and not have to subsequently amend it at the evidence stage. The Opposer claims that the search was based on the Applicant’s position as stated in the meeting with the Examiner and this resulted in the need to conduct a further search after receiving the Applicant’s statement of case.

In the prosecution, the Applicant claimed that the main difference between the applied for invention and the prior art in that the tabs are very close to the fold line.

“In response to the office action issued on 17.02.16, the applicant respectfully submits the following:

In item 1a of the office action, the examiner states that D1 discloses the present invention. The applicant interprets that the present invention is rejected as not novel. Meanwhile, the tabs functionally directed to separating upper and lower parts of the container are located in the positions absolutely different in comparison with the prior art document. Specifically, they are adjacent to the fragile folding line while, in D1, are located distantly. This limitation is the main discriminating constructive feature regardless of a material of the container.

…”

The Opposer submits that the Applicant is now claiming that there are additional differences that claim patentability due to other features as raised in the meeting.

To show that a claimed invention is anticipated, one has to find a piece of prior art that relates to all the features of claimed.  The claims are interpreted in light of the specification, and one cannot import features not described in the specification:

The correct interpretation is that terms in the claims should be interpreted in light of the specification to give them the meaning intended by the inventor. This can be narrow or broad, so long as the interpretation is anchored in the specification and is clear to persons of the art.

However one should differentiate between the ways that one can widen and clarify the monopoly and how one understands the invention. One can refer to the specification to understand the monopoly but that not claimed is not part of the monopoly. See Appeal  345/87 Hughes Aircraft Co. vs state of Israel et al. p.d. 44(4) 45, 70.

So even where the Applicant stresses one or other element in the claims or in the rest of the application during the examination or in the statement of claims, since the claims themselves were not amended in the opposition, the Opposer knew what the claimed elements to be searched were.  (this is not to be understood as license to ignore that claimed during the patent examination).

Nevertheless, the resulting delay is not serious enough to warrant forbidding the correction of the statement of case and the addition of the two new references and allowing it will not drag out the opposition. To the extent that the Opposer could have found these new citations 10 months ago, the damage to the Applicant by the resulting tardiness may be compensated for by awarding costs to the Applicant.

As to the alleged lack of relevancy of the new citations, there is no clear a priori basis to exclude the possibility that these publications are relevant to the patentability. The Applicant submitted a 23 paragraph statement to try to show why these citations are not relevant and so it seems reasonable to accept the possibility that the citations are relevant and to relate to them substantively in the Opposition proceedings instead of to prevent their being submitted.

In light of the above, Ms Jacqueline Bracha allows the statement of case to be amended to relate to the two additional citations as follows:

  1. The corrected statement of case and additional evidence must be filed within 7 days
  2. The applicant will file their statement of case and evidence within the following three months as per section 59(b) of the Regulations
  3. The Opposer will pay 5000 Shekels including VAT costs to the Applicant

 Re IL 220639 to Plasto Vak ltd (1990) ltd; Interim ruling by Ms Bracha on addition of Evidence not referenced in Statement of Case, 21 February 2018


IPR or AIPPI???

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.

Unipharm

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.

novartis

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 https://register.epo.org/application?documentId=EZQR8ZQ06757DSU&number=EP15199440&lng=en&npl=false),  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.

tablet-compression-machine

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.

COMMENT

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.