Counting Sheep for Insomnia – Do sheep count???

March 9, 2011

Neurim’s appeal against the refusal of the UK Patent Office to issue a Supplementary Protection Certificate for Circadin has been referred to the European Court of Justice –the CJEU by the Court of Appeal.

Background

Before a new drug is allowed to be used, regulatory approval is required. This typically takes several years and the drug usually reaches the market towards the end of the 20 years of regular patent protection. It will be appreciated that to bring a drug to market costs hundreds of millions of dollars and very few potential drugs obtain regulatory approval and can be prescribed. There is generally believed to be a market failure in the regular patent regime in that the period over which the patent enables the company that developed a drug to sell at monopolistic prices is considered insufficient to enable the drug developer to recoup their investment and make a reasonable profit.

It is therefore argued that under the standard patent term, there is no incentive to develop and bring new drugs to market. Consequently, various countries that have drug development industries, or which are bullied by countries having drug development industries have adopted patent term extensions, or, as they are called in Europe, Supplementary Protection Certificates (SPCs) which effectively extend the patent for up to an additional 5 years beyond the regular patent protection period of 20 years from filing.

There is, however, a catch. To prevent evergreening – extending patents indefinitely thereby preventing generic competition – such Supplementary Protection Certificates (SPCs) may only be obtained following the first regulatory approval.

The case

Neurim, an Israeli ethical drug company has developed a revolutionary and patented treatment for insomnia based on use of the natural hormone melatonin. The drug, called Circadin, took 15 years to obtain regulatory approval from when their first patent application (European Patent Number EP (UK) No. 0 518 468) was filed on 23 April 1992.

On obtaining regulatory marketing approval in June 2007, Neurim requested an SPC under Art. 3(d) of the SPC Regulation EEC 1768/92 (now EC 469/2009), claiming that this was the “first authorization to place the product on the market as a medicinal product”.

However the British Intellectual Property Office (UK IPO) refused the request on the basis that Circadin was not the first marketing authorization for Melatonin, since another party had obtained approval for “Regulin”, a melatonin medicine for sheep, back in 2001, issued by the UK Veterinary Medicines Directorate under Directive 81/851/EEC. The decision was appealed to and upheld by the court of first instance, and was then appealed to the Court of Appeal who has referred the case to the CJEU.

The Court of Appeal was required to interpret Art 3 of the SPC Regulation and determine whether a valid authorisation had been given for “the product” in question.

The UKIPO argued that melatonin was “the product” and therefore authorisation had been given when it was approved for use in sheep. Neurim argued that sheep were irrelevant – an SPC is just that: protection supplementing the protection of the basic patent. Therefore, as each patent can have its own SPC (but only one), the relevant Marketing Approval for that patent is a marketing approval for a product falling within the scope of that patent.

In the Court of first instance, Justice Arnold was of the opinion that the Regulation was clear, and upheld the IPO’s assessment of the relevancy of the sheep. The Court of Appeal was not so convinced:

Lord Justice Jacob:

“We consider that Neurim’s arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented.

Moreover there is much endeavour to find new uses for known active ingredients. The European Patent Convention 2000 has indeed made the patenting of inventions in this area clearer. Its effect is that a patent for a known substance or composition for use in a method of treatment is not to be regarded as old (and hence unpatentable) unless use for that method is known. It would be most unfortunate if second medical use patents could not get the benefit of an SPC.”

For more information, see: the SPC Blog here and here

Court of Appeal: Neurim Pharmaceuticals v The Comptroller-General of Patents [2011] EWCA Civ 228.

COMMENT

Neurim’s Circadin is the only ethical drug other than Teva’s Copaxone that has been developed and brought to market by an Israeli company. The patent in question, and the other patents in Neurim’s portfolio was drafted and prosecuted by my late partner, Dr Stanley Davis.

JMB, Factor & Co. weren’t involved in requesting the SPC in the UK, but have been involved in a corresponding request to the Israel Patent Office. Under current Israel Law (pending an amendment), the extension available in Israel is for the shortest extension granted by a country offering patent term extensions. Consequently, the extension in Israel may be invalid due to the UK case.

Strange things happen when prosecuting pharmaceutical patents. In Korea, a scientific paper relating to Melatonin in cod fish was cited against the corresponding application as rendering treatment by melatonin obvious. One would imagine that fish and humans have very different physiologies. By comparison, sheep and humans are somewhat similar, but Regulin is not a treatment for insomnia in sheep (I believe they count people to induce sleep).

Apparently Regulin improves the reproductive performance of pure bred and crossbred lowland sheep which are to be mated early in the season before the usual peak of reproductive activity. Regulin is recommended for use in Suffolk and Suffolk cross type flocks to cause lambing to start between early December and mid January and in Mule and halfbred flocks to start lambing between late December and mid February.

We await developments with interest.

Leave a Comment » | drugs, Intellectual Property, Israel, Israel IP, News, Patents, pharmaceuticals, pharmaceuticals and Biotechnology, UK Patent, UKIPO | Tagged: , , | Permalink
Posted by Dr Michael Factor

Dr Michael Cohen, Veteran Israel Patent Attorney, Passes Away

February 1, 2011

Dr Michael Cohen, Israel Patent Attorney Number 11, has passed away.

Dr Michael Cohen, son of the legendary Reinhold Cohen, obtained his Israel Patent Attorney license in 1955, and took over managing the firm Reinhold Cohen and Partners over the period 1973-2000, building it up into Israel’s largest IP firm.

Our condolences are extended to son, Dr Ilan Cohen, step-son Adv. David Gilat and the rest of the Cohen and Gilat families, and to the staff of the RCIP Group.

Leave a Comment » | Israel IP, Israel Patent, News | Permalink
Posted by Dr Michael Factor

Jeff Koons Files Twisted Infringement Suit

January 20, 2011

Jeff Koons is a talented pop artist. One of his brilliant sculptures is a 10 m representation of a balloon dog that sits on top of the New York Metropolitan Museum. I saw the sculpture when in New York on the way to Boston for an AIPPI Conference a couple of years ago.

I am a balloonologist myself, and have made literally thousands of one balloon dog sculptures at birthday parties, children’s wards in hospitals, busking on Jerusalem’s Ben Yehuda Pedestrian Precinct, as a student, in St Marco’s Square, Venice, and thanks to Lord Greville Janner, then MP, QC, and a fellow magician, in a conference room at the British Houses of Parliament.

None of my sculptures will ever be as famous as Jeff Koons’. I can, however, claim to inflate my regular sized versions made from a standard Qualatex 2 x 60 balloon, in the traditional way, by lung power, and due to also playing the trombone, can generally manage about 200 balloons in one session.

In what appears to me to be a total hutzpa, Koons has sent cease-and-desist letters to Park Life, a San Francisco gallery and store that sells the bookends, and Imm-Livinga distributor of balloon sculpture bookends. See  http://www.nytimes.com/2011/01/20/arts/design/20suit.html?_r=1

Unfortunately, Park Life‘s owner, Alexander has taken the bookends off sale and removed from his website.

In this instance, I am not impressed with Peter D. Vogl, the partner of Jones Day who sent the cease-and-desist letters.  We are all Intellectual Prostitutes, but some of us have standards! If the case was fought in Israel, I’d be honored to represent the bookend distributor pro bono myself.

If it will help Alexander’s cause, I am willing to sign an affidavit that his bookends are faithful copies of my sculptures, and to provide him with a non-exclusive license to continue manufacturing them. After all, the size and look are close to my models. The fee? a couple of bookends would be nice!

Apparently, lawyer Jed Wakefield of Fenwick and West LLP has now picked up the condom and asked for a declaratory judgement against Koons.

“It could bring freedom to balloon animals everywhere,” Wakefield said.

2 Comments | Copyright, counterfeit, design, infringement, Intellectual Property, Magic, News, Opinion, passing off | Permalink
Posted by Dr Michael Factor

Dr Guy Rotkopf Appointed Acting Israel Commissioner of Patents

December 29, 2010

The Director General of the Israel Ministry of Justice, Dr Guy Rotkopf, has been appointed acting Commissioner of Patents in place of Dr Meir Noam whose term of office ends on 31 December 2010.

The appointment is temporary, and according to the Chairperson of the Israel Chapter of the AIPPI, is expected to last a mere month until a permanent replacement is found.

It was Dr Rotkopf who announced that the first publication fee collected by the Israel Patent Office for publishing basic bibliographic details of new Israel Patent Filings in the Official Gazette would be refunded to Applicants, after instead of publishing details in print, Dr Noam decided to make do with the faster, more user-friendly and vastly more ecological publication on-line in the Israel Patent Office database.  I wait with bated breath to see whether a month in office will be sufficient for Dr Rotkopf to come up with a satisfactory implementation of this refund, since there must be about 25,ooo applications requiring such a refund, which I estimate will work out as less than $50 per application, with approximately half of these to Applicants from abroad. Personally, I think retroactive legislation to allow publication on-line or creative interpretation of the term publication would have been a more satisfactory approach.

More interesting is the composition of the appointment committee which is unknown, even to applicants apparently, presumably in the cause of transparent government.   Most interesting is who will be the next Commissioner, after Dr Rotkopf’s caretaker term???

Another question that this curious blogger asks himself: I understand that Dr Noam took a summer holiday and went incommunicado for about a month during the summer when the courts were in recess. The walls didn’t come tumbling down. If a replacement is expected within about a month, why bother appointing a temporary commissioner, instead of having the Deputy Commissioner serving as acting commissioner in the interim?

Another thing I am interested in is what Dr Noam will be doing next? No doubt we’ll know soon.

Leave a Comment » | Intellectual Property, Israel Patent Office, Israel Related, News | Permalink
Posted by Dr Michael Factor

Copyright in Schindler’s List?

December 25, 2010

Oskar Schindler, a Nazi, womanizer and playboy saved a large number of Jews from extermination in the Holocaust by forcing them to work in his factory. The story is told in Schindler’s Ark by Thomas Keneally , renamed Schindler’s List after the producer Steven Spielberg made a full length feature film about the story, see http://en.wikipedia.org/wiki/Schindler’s_List.

The original list of names has come up for sale and is being offered by a Manhattan dealer in Memorabilia, http://momentsintime.com/.

 Schindler’s heir Marta Erika Rosenberg tried to block the sale by claiming copyrights. Judge Louis York rightly dismissed the claim as being irrelevant since the issue is not whether one copy the work, but ownership of the original.

I very much hope that someone purchases the list and donates it to Yad Vashem or one of the other Holocaust museums.  Indeed, there are a number of items being sold by Moments in Time that I’d like to see in museums.

I think Schindler’s legacy is that he wasn’t a saint. He was a real person with real faults. Yet, despite his flaws he saved hundreds of Jews from the death camps. His actions show up the non-action of church leaders, and of the Allies who didn’t bomb the railway lines to Auschwitz.

Leave a Comment » | Copyright, Intellectual Property, Jewish, News | Permalink
Posted by Dr Michael Factor

Israel Ministry of Justice to Refund Patent Filing Publication Fees to Applicants

December 1, 2010

Following the Chairman of the Knesset Constitution, Law and Justice Committee, Knesset Member David Rotem harshly criticizing the Commissioner of Patents for exceeding his authority in deciding not to publish basic filing details of patent applications in the Official Gazette and, instead, publishing these on the Internet in the database of the Israel Patent Office, whilst nevertheless, collecting the publication fee from all applicants over four years, amounting to some 2  – 3 million shekels a year, the Director of the Ministry of Justice, Dr Dr. Guy Rotkoff has announced that the fees will be refunded. The original story is covered here:

Israel Commissioner of Patents Criticized by Chairman of the Knesset Constitution, Law and Justice Committee

A couple of opportunists have meanwhile filed a class action:

Class Action filed Against the Israel Commissioner of Patents

COMMENT

We hope that this development brings this unfortunate incident to a close.

As an efficiency measure we humbly suggest that the Israel Patent Office simply offsets the first publication fee against the publication fee for the allowed application and only actually refunds money where applications have already issued or become abandoned. This has a number of advantages:

  • The first publication fee and the second publication fee are both tied to the same cost of living index and are updated twice yearly, thus by offsetting, the actual current prices can be compared and the difference paid.
  • Most applications come from abroad and if the Patent Office refunds the fees directly, the applicants will receive cheques for small sums that will cost more to bank than they are worth.
  • If the patent attorney and law firms representing client will be in the loop of refunding money, either they will subsidise the cost fo implementing the refund by doing the work for free, or will bill the clients for handling and the costs incurred by the client will be more than the refund obtained.     

Leave a Comment » | IPO, Israel, Israel Patent, Israel Patent Office, Israel Patent Office Rulings, Israel Related, News | Permalink
Posted by Dr Michael Factor

Israeli Hospital Inventors to Receive Royalties for Their Inventions

October 18, 2010

 

Cutting the cake

Globes, the Israel business newspaper has disclosed that after years of negotiations, an agreement has been reached where researchers at Israeli hospitals will be entitled to a 35% royalty from their invention, the hospital research fund will receive 30%, the hospital itself will receive 25%, and the government’s share will be 10% which will be divided equally by the Office of the Chief Scientist of the Ministry of Health and the Finance Ministry.

Background

Section 132 of the Israel Patent Law states that employee inventions are owned by the employer. Section 137 relates to inventions by government employees and states that their inventions are State property.  University researchers in Israel are generally awarded 40%-50% royalties by their university. Medical researchers working at private or trust-owned Israeli hospitals generally received royalties of about 40%. Until the recent agreement reported in Globes, those working for government hospitals typically did not receive anything.

In addition, with many government hospitals, there has been no mechanism in place for drafting and filing patent applications. As a result the patent applications either weren’t filed at all, or they were filed privately by the inventor, often when on sabbatical abroad.

This state of affairs has had serious repercussions for the public good. In 1996, Dr. Zeev Treinin, a veterinarian working for the civil service, discovered a promising treatment for AIDS. There was no mechanism for him to file a patent application and his discovery was published in a scientific journal. Without the possibility of a patent, no drug developer was willing to invest in commercializing the treatment.

Since it is true that hospital researchers are generally civil servants, it could be argued that the employer (the State) should own their intellectual property. Indeed there was a private member’s bill in the Knesset some years ago that took that position, although it offered the inventors a paltry three months salary as a bonus.

Israel’s former Accountant General Gal Zlikeh launched an enquiry into the issue. See Israel Finance Ministry Accountant General Launches Probe into IP missapropriation by Civil Servants.

Last year the Israel government sued for royalties in a patent allegedly invented by a government employee for a medical adhesive with blood-clotting factor in State of Israel vs. Omrix.

In that instance, the Government, represented by the Law Offices of Dr. Shlomo Cohen, sued Omrix and Johnson & Johnson who had bought the company. The medical doctor who claimed to have been the inventor was a witness for the State. Because the complainants alleged inventor fraud the corresponding patent in the US was rendered unenforceable. 

Comments

We think this carrot approach will be more effective than wielding a stick, particularly as the government seems unable to do so effectively.

We are also happy to see that the 2004 proposal by Ofer Pines Paz and others to restrict royalties to three monthly salaries seems to be off the table. Regardless of whether one is a liberal capitalist or a Marxist, that plan was impractical and it is good that it is buried.

JMB Factor & Co. was instrumental in bringing this issue into the public eye by organizing and cosponsoring a Seminar with Ono Academic College and WIPO on service inventions last year. At the time Dr. Yaron Zelikha, former Accountant General; MK and medical specialist Dr. Rachel Anato MD, and former MK Molly Polishuck Bloch all gave their perspectives. See Whose Invention is it? – A report on a high-profile seminar in Israel, by the IsraKat.

3 Comments | Academia, Intellectual Property, Israel IP, Israel Patent, Israel Related, News, Opinion | Permalink
Posted by Dr Michael Factor

Israel Patent Office gets ISO Certification

August 16, 2010

We are pleased to report that the Israel Patent Office has fulfilled the requirements and obtained ISO Certification for its patent prosecution process.

We congratulate the Israel Patent Authority, the Commissioner, Dr. Meir Noam, and also the patent office ombudsman Moshe Cohen who was heavily involved in this initiative. 

Broadly speaking, ISO is not a certificate of quality, but rather a management standard. This is the official abstract:

ISO 9001:2008 specifies requirements for a quality management system where an organization

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

In other words, the certification says nothing about the quality of the examination in terms of whether prior art is found by the examiner, or whether an issued patent relates to an invention that is truly novel or inventive.

 It does, however, serve as an indication that there are standardized procedures in place. What this means is that things should flow more smoothly, less patent applications should get lost, etc.  This coupled with Israel being recognized as an International Search Authority (ISA) and International Preliminary Examination Authority (IPEA) does imply that applicants will get a quality examination to consistent standards with less arbitrariness.

Israel being invited by the US to join the patenting superhighway is one indication of this additional value added. Indeed we suggest that the Israel Patent Office should consider providing  outsourcing services to other patent offices. The US is now looking to recruit an additional 1000 examiners a year to cope with their backlog. Outsourcing and offshoring could be the answer. 

The ISO Certification covers patent prosecution only, but there are plans to widen this to other departments such as designs and trademarks as well.

1 Comment | Intellectual Property, IPO, Israel, Israel Patent Office, News | Permalink
Posted by Dr Michael Factor

Chinese Commissioner of Patents Speaks in Tel Aviv

July 8, 2010

Minister Tian Lipu, Commissioner of the State Intellectual Property Office of China spoke to a select group of patent attorneys and industrialists in a meeting held at the Dan Hotel, under the joint auspices of the Israeli Ministry of Foreign Affairs and the High Tech Industry Association (HTIA).

After Opening Remarks delivered by Mr. Oded Hermoni, CEO of the High Tech Industry Association, a representative of the Ministry of Foreign Affairs, and by Dr. Meir Noam, Head of the Israeli Patent Authority and Commissioner of Patents Designs and Trademarks, we were treated to a short and informative talk about IP in China delivered by Adv. Ehud Hausman, a patent attorney and Senior Partner of Reinhold Cohn.

Then Amir Gal-Or, Founder & Managing Partner of the Infinity Group/Infinity I-China spoke about investment and return on investment in China. All the above, spoke in English, despite none of them being native English speakers.

Tian Lipu, the head of the Chinese Patent Office introduced himself briefly in English, but then spoke via an interpreter, which is not a bad idea for non-English speakers.

Apart from the competence of the diminutive lady translating, which made the translation not unpleasant, I actually enjoyed hearing the deep twangy intonations of the Chinese – although I couldn’t understand a word.

Tian Lipu spoke of the fast changes being implemented in China, a country with no tradition of Intellectual Property. the commissioner pointed out that of the 1.2 Billion Chinese in 1979 when he started in the field, perhaps 12 people knew what a patent was, 4 could assess infringement and none could examine.

We learnt that the Chinese patent Law dates from the nineteen eighties and that the first Chinese term for IPR was first coined in 2000.

Commissioner Tian Lipu generously acknowledged both Israeli and Jewish long traditions of IP. We learned that Israel and China had signed a memorandum on cooperation, which indicates the mutual respect and importance held by the two patent offices and of Israeli and Chinese industries.

Commissioner Tian Lipu acknowledged a thousand year history of peaceful commerce between the Jews and the Chinese and expressed hopes that this could be built upon for the next millenium. We learned a little about the scale of things in China, and contemplated what extraordinary good money a Chinese patent is.

Most of the presentation related to the development of Chinese intellectual property system, current Chinese Patent Law and why IPR protection important to independent innovation. Commissioner Lipu took questions and answered fairly, admitting that there were still problems with enforcement and with the quantity of fake goods coming out of China, but pointed out where the system started only 25 years ago, and that there were a lot of people requiring education about IP rights. It is clear that Chinese system is leading towards an advanced pro IP regime, similar to those common in the West.

Lipu argued, and her is correct, that the Chinese cannot be fairly considered responsible for every fake good or infringing product manufactured in China, where the goods are ordered by suppliers from abroad.

We learned, that in addition to checking goods imported into China, the country was unique in checking goods exported abroad for IP infringement. The commissioner put a fair case that statistics on infringement and cost of infringing goods should be compared to the billions that China invests in royalties to Western countries, that get’s less coverage.

The chocolate eclairs where good, and, as is well-known, no calories on a thursday! The organizers and sponsors are to be congratulated for throwing together the event so quickly.

Leave a Comment » | China, Intellectual Property, News, Uncategorized | Permalink
Posted by Dr Michael Factor

Seller of Fake Detergents Gets Fine and Jail sentence

June 9, 2010

 

The Nazareth District Court sentenced 27-year-old Khalid Hamuda, an Arab shop-keeper, to a year in prison and a NIS 30,000 fine for selling fake goods. The sentence was the result of a plea bargain. 

The shop-keeper sold laundry detergents bearing fake trademarks for Tide, Ariel, fake chocolate-spread of the Israeli brand-leading Shahar Ha-Oleh brand, and fake Pantene and Head & Shoulders shampoos in his grocery store.

In passing sentence, Nazareth District Court President George Azouli stated that “with economic crime of this nature, the public interest requires a severe punishment which acts as a deterrent and prevents systematic trademark fraud from becoming widespread and damaging the brand owners economically and undermines their hard-earned reputation”. He went on to say that the public is damaged as they spend hard-earned cash on what appears to be leading brands but is, in fact, cheap rubbish.” With respect to the issuance of a fine, in addition to jail sentence, the judge explained that crimes committed for financial gain should be punished by fines to get the criminal where it hurts.

Our Comments

The crimes were committed in 2008 when a gang stole 100 tonnes of the chocolate spread from the Shachar Oleh factory warehouse, so one wonders if he wasn’t selling the real thing as the real thing.

The other products all are leading brands owned by Proctor & Gamble.

 Although clothing with fake logos from the Far East are more common, as is fake Viagra, music disks and software, we note that last year, fake suntan cream resulted in Israeli sunbathers getting severely sun-burnt.

1 Comment | Business Method, infringement, Israel IP, News, passing off, trademarks, Uncategorized | Permalink
Posted by Dr Michael Factor

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