RedHill waves a red Flag

August 30, 2015

redhill
Sometimes, companies publish the oddest press releases. Here is one that is doing the rounds on the Internet, and, with a dearth of decisions due to court recesses (and yes, I have been scratching around for things to write about this past month) this press release has been noticed:
RedHill Biopharma (NASDAQ: RDHL) announced that it has received a Notice of Allowance from the Israeli Patent Office (ILPO) for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
The Israeli patent application No. 207420 is entitled “Methods and Compositions for Treating Inflammatory Bowel Disease”. Once granted, the patent is expected to be valid through at least 2029.
The new patent allowance in Israel further extends the geographic reach of RedHill’s intellectual property for RHB-104 and is an addition to already granted U.S. patents and pending filings in other countries.
RHB-104 is currently undergoing a first Phase III study for Crohn’s disease in the U.S. and additional countries, including Israel (the MAP US study), and a second Phase III study (the MAP EU study) is planned to be conducted in selected European countries in parallel with the ongoing MAP US Phase III study. Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US Phase III study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.
RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The last patient has been enrolled in an open label Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). Top-line interim results are expected either in the fourth quarter of 2015 or the first quarter of 2016.

COMMENTS

Several things struck me about the press release:

  • Regardless of the title, methods of treatment of inflammatory bowel disease’ are not patentable in Israel or most other countries. Without looking at the allowed claims, one assumes that the claims directed to a method of treatment were cancelled.
  • Following the cancellation of the claims directed to the method of treatment, the title is misleading and should be amended. If the Israel Examiner did not require this, one suspects he/she was less than conscientious in examining this application.
  • One suspects that the case was allowed under section 17c based on a granted US patent directed to the Compositions. In other words, the Israel Examiner probably rubber stamped the application.
  • Unlike opposition procedures in the US and Europe which challenge the validity of an issued patent and may result in its cancellation, in Israel publication for a three month opposition period is part of the pre-issuance examination process. There is no assumption of validity. The Israel Patent Office essentially invites the public to comment on the validity of the patent application once the examiner has been satisfied.
  • In many fields of human innovation oppositions to Israel applications issuing are rare. However, in the field of pharmaceuticals, oppositions are extremely common. Both Teva and Unipharm are very active opposing patent applications for pharmaceuticals, and, they have a very good success rate.
  • Opposition processes in Israel are open book inter-partes affairs. Many large and established pharmaceutical companies abandon allowed patent applications in Israel on a Notice of Opposition being filed, being prepared to lose a small market of 7-8 million rather than having the prior art and arguments of record as these may result in drug patents being canceled overseas. This has happened with patents to Glaxosmithkline, to Lundbeck, to Novartis and others.
  • In the circumstances, one wonders why RedHill published this press release. It is premature and only serves to warn Teva and Unipharm that there is a new kid on the block.
  • In this instance, according to the press-release, RHB-104 is being evaluated for relapse remitting multiple schlerosis. One would assume that Teva, whose drug Copaxone (glatiramer acetate) is also used to treat relapsing-remitting multiple sclerosis, will certainly note this patenting having passed the examiner stage in Israel, now that has been flagged in a press-release, and will be considering opposing this patent.

So am I right?

I had a quick look at the file wrapper. It transpired that the Applicant amended claims to those of Issued United States Patent Number US 8,343,511 and requested allowance under Section 17c.

The title was amended to “PHARMACEUTICAL COMPOSITION COMPRISING RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE AND A METHOD OF FORMULATING THE COMPOSITION”. Thus the patent office did its job. The press release gives the wrong title. One therefore wonders how much else is accurate.

We now wait to see if, on publication, the application is opposed.


Over 600 Readers!

August 27, 2015

601

We are delighted to note that the IP Factor has just registered its 601st reader. Thank you for your support.


The Divine Comedy – the Bishops’ Gambit

August 27, 2015

Von Hugel

I am participating in a Conference titled “Patents on Life: Through the Lenses of Law, Religious Faith and Social Justice – defining the boundaries” which will be held on 4-5 September 2015 under the auspices of the Von Hugel Institute, St Edmund’s College, Cambridge University, UK. The full (draft) program may be found here.

religious symbols

I will speaking at the opening plenum titled: Religious Perspectives on Intellectual Property.

The plenum is chaired by the Right Reverend John Sherrington, Auxiliary Bishop of Westminster, Department of Christian Responsibility, The Catholic Bishops’ Conference of England & Wales’

With me, will be His Eminence, Archbishop Silvano M. Tomasi, Apostolic Nuncio: Permanent Observer of the Holy See to the UN Office in Geneva & WTO who will be talking about “The contribution of the Holy See to the Intellectual Property debate at the multilateral level”, and Mons. Osvaldo Neves de Almeida, Holy See Secretariat of State, with responsibility for TRIPs (WTO), UNCTAD and formerly for WIPO who will talk about “IP Rights and the Fundamental Right to the Commons in the Light of Catholic Social Teaching”.

My talk is entitled “Patents, Life and Social Justice: Musings of a Mosaic Maven”

This is Dr Roman Cholij’ revenge for me inviting him to speak at a conference I organized a few years ago called “Intellectual Property in Jewish Law” which we co-hosted with Yad HaRav Herzog. Roman spoke on the same plenum with Former Heads of the Supreme Rabbinic Court (Bet Din) Rav Zalman Nechemia Goldberg Rav Shlomo Daichowski.

 

The bishop's gambit

The bishop’s gambit

I must admit, I am more at home with bishops on the chess board. I shall have to look up the correct etiquette for addressing my fellow panelists!


Drink with The Devil

August 27, 2015

old nick

Professor Jeremy Phillips has kindly invited me to quaff beer with the London IP crowd at their favorite watering hole, known as the Old Nick. The Old Nick, is, of course, a pseudonym for the devil in Christian teaching.

We’ll be there next Tuesday evening (1st September) between 5 PM and 7 PM, and I will happily treat IP colleagues who come along to a drink.

More details on the IP KAT quoted below:

Forthcoming happenings.  The IPKat‘s Forthcoming Events page is often mentioned in despatches; it lists all sorts of conferences, forums, seminars, lectures and the like.  It doesn’t usually list happenings, though.  One such happening is a gathering of like-minded IP enthusiasts that is scheduled to occur spontaneously on the late afternoon of Tuesday 1 September, when fellow blogger Michael Factor (The IP Factor, here) will be passing through the hallowed portals of The Old Nick, Sandland Street, Holborn — deep in the heart of Charles Dickens’ Legal London — to discuss IP practice and professional ethics with an enthusiastic bunch of random colleagues between the hours of 5 and 7 pm.  This Kat will be there  Do feel free to join us. No need to RSVP; just pop in and be social!

I will treat IP Enthusiasts to a free drink.


Chocolate, Fair Trade and Class Actions

August 13, 2015

class action

Israel allows private citizens to file class actions against service providers on grounds of fair trade. If the class action is successful, the citizen bringing it may be rewarded for bringing the action.

Chocolate has a definition. For something to be described as being chocolate, it has to have a certain amount of cocoa solids. There have been two class actions brought recently regarding using chocolate as a product description.

nestle's fitness

The first concerns nestle’s chocolate fitness bars. Here the court noted that there was a picture of the contents on the wrapper and it is clear to all and sundry that the product is chocolate coated and is not a chocolate bar.

ben and jerry's chocolate ice cream

The second case concerns Ben & Jerry’s chocolate ice-cream. The court was not convinced that anyone would believe that the contents was chocolate and would be disappointed to discover that they’d purchased ice-cream.

COMMENT

I am pleased that the judges threw these cases out. Both products are quality foods that do not pretend to be what they are not.


Non-licensed Practitioners – Levelling the Playing Field

August 11, 2015

Finnegan's Wake

I have commented in the past about non-licensed practitioners. These are typically trainee patent attorneys that have a few months experience and have been fired by their employees or are moon-lighting on the side by dong private work. Not being licensed, they are not subjected to any sort of review and cannot be disciplined for unethical behaviour or for shoddy work.

There is a different type of non-licensed practitioner at the other end of the scale. I am referring to Finnegan, a US based firm of patent attorneys and attorneys at law that has set up a local Israeli subsidiary ran by Gerson Panitsch, a rather pleasant US patent professional.  Panitsch’s position is that Israel should allow foreign law offices to open offices in Israel and are treaty bound to do so. He claims not to provide Israel patent services, only US patent services. There is also a basic law of freedom of occupation 1980.

The Israel Law Bar regulations consider legal advice and consultancy as legal services that only an Israel Attorney-at-Law can provide. There are some exceptions, such as Israel Patent Attorneys who are licensed to give patent and trademark related services and advice, and tax consultants and accountants who can provide tax services and consultancy.

So, if Finnegan’s attorneys are US licensed, what’s wrong with them having a ‘front window’, i.e. a virtual company in Israel? What about US licensed attorneys or patent agents living in Israel? Well, for one thing, there is no supervision and no way to maintain standards. There is no one to appeal to when such firms screw up.

I regularly use intellectual property terms in my work and my computer generates and displays Finnegan adverts all the time. I assume therefore, that whenever someone looks for IP services in Israel, he will get a link to a website in Hebrew with the word פינגן offering IP services. Finnegan’s Facts is a webpage listing selective facts about the firm. It doesn’t point out that their services in Israel are illegal.

The code of ethics binding on Israel lawyers prohibits such aggressive marketing. There are also prototyping companies that pretend to be patent attorneys that also have ads popping up all over the place.

The Israel Ministry of Justice has circulated a Draft Statutory Code of Ethics for Israel Patent Attorneys. Ironically, the Official response of the Israel Patent Attorney Association (IPAA) was to request that the draft code be amended to bind patent attorneys to the code binding attorneys-at-law.

Whether or not what Finnegan is doing is illegal, they should not be able to advertise in Israel a way that local firms cannot. This is a problem that, I believe, the Israel Patent Attorney Association, the Israel Patent Forum of the Israel Law Bar and the local chapter of the AIPPI should address.


Kappa Costs Capped

August 9, 2015

Kappa

Israel Trademark Number 213924 to the Karelia Tobacco Company is for the word mark KAPPA and covers Cigarettes, tobacco and tobacco products, lighters, matches and smokers requisites; all included in class 34.

Basic Trademark S.A. who own the well-known Kappa mark for sportswear shown above, successfully filed to have the mark canceled and our report of the decision may be found here. 

Having won their case, Basic Trademark S.A. filed for costs, which they claimed amounted to 237,165.57 Shekels which is $62,228.59 US  at today’s exchange rate.

The attorney’s for Basic Trademark S.A. were Seligsohn, Gavrieli and Co. and the request for actual costs was accompanied by an affidavit from Adv. Gavrieli (presumably Nachum) that asserted that costs had added up to 200,692.15 Shekels in legal fees for over 185 hours work by some four attorneys of the firm. Debit notes and receipts were also appended. The remaining 29,719.2 Shekels exc. VAT was for Italian counsel’s fees, legitimately incurred as the case was international. Furthermore, a final 6,754.2 Shekels was incurred in preparing the request for costs, and a debit note was appended for this as well.

The Attorneys for Karelia (Reinhold Cohn) argued that Basic Trademark S.A. and their attorneys had not provided sufficient detail to justify the costs which were excessive. There were alleged contradictions between the bills by foreign counsel and the sums requested and the invoices from foreign counsel were not supported by an affidavit. Karelia’s attorneys alleged that the costs were excessive, included unnecessary work, were unreasonable, and weren’t even incurred in the current proceedings.

In her ruling, Ms Yaara Shoshani cited Bagatz Tnuva (891/05) noted that [in Israel] it is an established rule that the losing side should pay costs for the victor. The actual costs that the winning party paid out or agreed to pay out are, however, examined for reasonableness, proportionality and whether they were necessary in the circumstances. For the courts to access whether costs were fairly incurred, it is required to provide sufficient details regarding the invoices. Citing the costs request in the Opposition to IL 140492 Unipharm vs. Abbott, Where the requested costs are unusually high, the amount of details required to establish that the costs are reasonable in the circumstances will also be more.

In this instance, in the main ruling of the opposition procedure, Israel trademark no. TM 213924 was rejected, and thus the Opposer is entitled to costs from the Applicant. Nevertheless, the requested costs are subject to judicial scrutiny.

Regarding the invoices from the Israeli law firm (Seligsohn, Gabrieli & Co.) examination thereof does not reveal a breakdown of the costs in terms of the work done and the number of hours spent. It is not sufficient to just record a shopping list of actions performed without context and by merely providing a total. This is insufficient for judicial critique. The number of hours certain actions took and who performed them were not detailed, nor was the date that actions were taken, so the invoices were considered insufficiently detailed.

The Agents of the Applicant correctly noted that the Opposer’s receipts were to the associate IP firm and were not linked to specific invoices or indeed to work for the specific client. Although pro forma invoices are acceptable, if receipts are also submitted, the connection between the two should be clear.

The Opposer engaged an Italian firm that engaged the local Israel counsel to represent them. The costs submission also included a request for foreign counsel’s costs. In the opinion of Ms Yaara Shoshani Caspi, the affidavit by Adv. Gabrieli was insufficient as his personal knowledge regarding the actions of the main counsel abroad was not first hand knowledge. A supplementary Affidavit from the foreign counsel, with their invoices attached should have been submitted.

It is not just a lack of clarity however. Even were all the invoices to be fully detailed and supported by affidavits, it would be difficult to establish that the costs were necessary and reasonable as required by Bagatz Tnuva. In particular, she saw a problem in the request for a further 29,719.20 Shekels for services from the foreing attorneys. This request was not sufficiently detailed and therefore it was not clear that it was necessary and unavoidable. Since these costs were not established as necessary and essential, they should be deleted from the total costs. Thus the sum to be considered is 200,692.15 Shekels, i.e. the costs incurred for services provided by the Israel Attorneys of record.

The invoice 20402 is an acceptable submission in that it appears to relate to the subject proceedings, however it is insufficiently detailed to be considered reasonable.

Invoices 22941 and 25138 relate to a correction of the statement of case and to an appeal to the district court that was rejected. Neither of these actions, though related to the case, can be considered essential and required.

The invoice number 24018 relates to contacts between the Israel Attorneys of record and the local distributor, and to a request to suspend patent office proceedings until the court ruled on the appeal.

Invoices 25658, 27986, 28932 and 30483 relate to charges connected to fling evidence and summations. These are certainly billable actions for which compensation is due, but the level of detail in the invoices is insufficient to establish that the charges were reasonable, proportional and necessary.

Invoice 27986 relates to attempts to negotiate a settlement and should not be obtainable via the patent office costs procedure (which relates to costs from the legal action), Nor should costs incurred for negotiating a procedural agreement be obtainable as part of patent office ruling incurred costs

That said, despite similarities between Opposer’s statements in different jurisdictions, the Opposer had to write a statement for use in the Israel proceedings and this involved Israel attorney time and is billable.

The amount of work and evidence submitted by Kappa was, however, considerable and tool time. That said, the mark was dropped prior to a hearing on the evidence which presumably saved expenses.

In consequence of the above, actual costs were not ruled. Rather Ms Shoshani Caspi weighed up the amount of work and based on the above analysis estimated a fair cost ruling. In conclusion, costs of 50,000 Shekels including VAT were awarded to Kappa.

Ruling on costs incurred in Opposition to Israel Trademark Number 231924 to Karelia Tobacco Company Inc., Opposed by Basic Trademarks S.A. Ruling of 23 June 2015  


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