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.


Ketchup Wars

August 20, 2015

Heinz has removed the Hebrew transliteration of Ketchup from bottles of their iconic sauce. The reason? Israel has a standard for Ketchup that Heinz doesn’t come up to. Specifically, Israeli Ketchup contains a higher percentage of tomato extracts than Heinz’ tomato flavored condiment.

I read about this development in Yesterday’s Idiot Acharonot (Israel’s largest circulation fish & chips wrapper newspaper) whilst enjoying a leisurely breakfast on holiday in the Galilee.  The topic is a hot sweet & sour issue among fellow Anglo-American Immigrants who I am in contact with on Facebook.

To those of us who grew up in the UK or the US, Ketchup meant Heinz. Heinz launched its first Tomato Ketchup in 1876, Heinz was at the forefront of exploring natural preservation, and in 1906 was first to launch a Ketchup free from artificial preservatives. To prevent it growing a beard without fungicides, it includes enormous amounts of sugar and vinegar.

 

14-global-ketchup.w529.h352.2x

There never were 57 varieties of ketchup or indeed of anything else. Nevertheless, worldwide, Heinz is the #1 ketchup.

In the 17th century, the Chinese mixed a concoction of pickled fish and spices and called it (in the Amoy dialect) kôe-chiap or kê-chiap (鮭汁. By the early 18th century, the table sauce had made it to what is now Malaysia and Singapore, where it was discovered by English explorers. The Indonesian-Malay word for the sauce was kecap (pronounced “kay-chap”). That word evolved into the English word “ketchup”, and English settlers took ketchup with them to the American colonies.

In the United Kingdom, preparations of ketchup were historically and originally prepared with mushroom as a primary ingredient, rather than tomato. Ketchup recipes begin to appear in British and then American cookbooks in the 18th century. 

So the term Ketchup doesn’t imply containing tomatoes at all. It really simply means a savoury sauce. Nevertheless, to most of the world, the term relates to the thick dark red sauce that Heinz manufactures and distributes.

In Israel, a variety of condiments are sold as tomato ketchup. The most widely distributed and probably the best of them is Osem’s ketchup, which also comes in a distinctive container that is perhaps as well recognized in Israel as Heinz’ is elsewhere. I prefer Heinz’ Ketchup as it the taste I grew up on. My Israeli kids prefer Osem’s.

To put the argument into some kind of perspective, I’d like to use the analogy of mustard. I am sure that for British ex-patriots like me, mustard is a very strong condiment prepared from a powder. Coleman’s mustard has a long and distinguished history.

Jeremiah Colman founded Colman’s of Norwich in 1814. To create a tangy flavour, he blended brown mustard (Brassica juncea) with white mustard (Sinapis alba). From 1855 the firm introduced its distinctive yellow packaging and bull’s head logo, and in 1866 was granted Royal Warrant as manufacturers of mustard to Queen Victoria. The royal household still uses Colman’s today.

colmans mustard

Now the French make an entirely different condiment called Dijon mustard, that is rather milder. Americans have a sort of yellow ketchup that they call mustard, but which has no similarity to English mustard. One could envisage the UK banning American mustard from being sold as ‘mustard’ without a qualifier, such as ‘American style’ mustard. Similarly, one could imagine Americans requiring Colman’s Mustard to be sold with a government health warning that it should be consumed in small quantities only, and that it is rather different than what Americans are used to.

Israeli bottles of Heinz Ketchup will still have the word Ketchup on their labels in English, just not in Hebrew. Presumably English and American immigrants will see that the sauce is what they are looking for, and Israelis will appreciate that the condiment is something different. It is not a bad compromise. However, as the term ketchup doesn’t actually imply tomatoes and the average consumer is aware that condiments from different companies taste slightly different, and since both Heinz and Osem’s ketchup bottles feature the name of the manufacturer clearly and each comes in a distinctive bottle, I am not convinced that this is really necessary.

namesred mug

There are, of course, Israeli precedents for this type of thing. Nestle’s Nescafe Original was marketed in Israel as Red Mug. They couldn’t call it Nescafe as the term was generic. The Hebrew word Nes means miracle, and, where Elite’s Cafe Namess (soluble coffee) was known as Nescafe (miracle coffee), there was no way for Nestle to obtain a trademark for Nescafe.

Pips Cola

Prior to the Oslo accords, Pepsi Cola was not available in Israel, as Pepsi decided to kowtow to the Arab boycott. A Galilean Arab sold a locally produced cola as Pips Cola. When Pepsi entered the Israel market they tried to get an injunction against the Arab manufacturer. The Israel courts correctly noted that they had abandoned the local market. They ended up having to buy him out.

For British readers of my generation, I refer to classic Goodies Episode “The Bunfight at the OK Tearooms“, where ketchup as a metaphor for movie blood and gore was taken to its logical conclusion.

 


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.


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