Plant protection patents and emamectin benzoate -- more news

Yesterday The SPC Blog posted this news from Hungary concerning a ruling of the Metropolitan Court of 12 January 2012 ("Plant SPC from earlier veterinary SPC? Yes, it can be done", submitted by James Horgan).

Today we are fortunate to have received some further information from our friend Alice de Pastors who writes:

To complete information on the Hungarian Plant Protection SPC for emamectin benzoate I wanted to point out three other Plant Protection SPCs for emamectin benzoate in Europe: Italy, Belgium and The Netherlands. 

In Italy and Belgium the SPCs refer to the Plant Protection first MA in The Netherlands, 13260 of December 4, 2009 (AFFIRM®) but in The Netherlands to the UK veterinary MA VM00201/453 MA (Slice®) with a date of March 9, 2010".

Thanks, Alice!

Plant SPC from earlier veterinary SPC? Yes, it can be done

"Can you get a plant SPC where there is an earlier veterinary SPC?" That's the question posed by James Horgan (Merck & Co., Inc. The answer, which he thoughtfully provides for us, is "Yes, say the Hungarians". The proof of this proposition may be found in a decision of the Metropolitan Court of 12 January 2012.

James has sent us a handy English translation from Danubia, which represented Merck Sharp & Dohme Corp. in the application. The patent, with a filing date of 2 April 1992, was for “Stable BLA/BLB salts of 4”-deoxy-4”-epi-methylamino avermectin”. To the SPC application there was attached, in addition to the basic patent on which the application was based, the first authorisation to place a composition called Slice on the market in the Community as a veterinary product (Vm00201/4153, United Kingdom, January 14, 2000); as a product the petitioner named an insecticide called Affirm (active ingredient: emamectin benzoate). To read what happened next, click here for the 8-page decision.

New book on the way

Last week The SPC Blog posted some news from Poland, kindly sent in by Katarzyna Zbierska (Partner, Legal Counsellor, Kochański Zięba Rąpała i Partnerzy, Warsaw).

Katarzyna has also sent us a link to her book, Application and Importance of Supplementary Protection Certificates in the European Union, which will be published in Aachen, Germany, next month by Shaker Verlag. Katarzyna's book is based on her Ph.D. thesis, which she completed at the University of Augsburg last May under the supervision of someone who is no stranger to this blog, Professor Dr Ulrich M. Gassner. The book's web page is here (though you might get hijacked on the way to that page by the front page of the publisher's search service. According to the Abstract:

"The book focuses on supplementary protection certificates for medicinal products (SPC) created on the basis of the Council Regulation (EEC) no. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (currently Regulation (EC) no. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products). 

Since an SPC extends patent protection for a product, it provides an important advantage to innovative pharmaceutical companies in the European Union. The author discusses in detail various aspects of the legal mechanism of an SPC. She also presents similar legal concept in the USA as a benchmark for comparison of the European solution. The publication challenges the question of the importance and impact of an SPC on the European pharmaceutical market, among others, from a competition law perspective, as well as the role of an SPC in the context of other legal instruments available, such as market exclusivity and data exclusivity. This is particularly important as the current circumstances on the European pharmaceutical market differ much from those when the legal regime of the SPC was adopted. 

The publication also elaborates on the shortfalls of the current SPC system and identifies those areas which require amendments to address issues resulting from the rapidly changing situation on the pharmaceutical market in the European Union".

Patent term extension: to err is human

Hot off the press is this commentary by Israeli patent practitioner Michael Factor (Factor Patent Attorneys) on this week's Israeli decision in Patent Term Extension for 154325 submitted by Reinhold Cohen Patent Attorneys and Gilat Bareket Lawyers on behalf of Centocor Ortho Biotech Inc., before Jaqueline Bracha, Deputy Commissioner, 22 March 2012. Its contents will make uncomfortable reading for many a patent practitioner in private practice.

 As Michael -- not a man to pull his punches -- comments:

"From the affidavits submitted by employees of the agents for applicant ... it is clear that despite the firm being organized and having procedures in place to cover patent term extensions, there was human error. The deadline was missed and this was discovered seven months later.

Whether this is or is not fairly described as ‘unintentional’ or as the agent for applicant exhibiting ‘due care’, such circumstances cannot fairly be described as ‘circumstances over which the applicant and his representative had no control and which could not be prevented‘ unless one rules that human error is unavoidable. There was no earthquake or natural disaster to blame, there was no war, nor was there a postal strike. A paralegal and her supervisor both messed up. It happens ...".

Following the decision of the Deputy Commissioner in favour of the patent proprietor, Michael suspects that generic companies Teva or Unipharm might be considering an appeal.

Court upholds Polish Patent Office's "no" to QLAIRA

The SPC Blog has heard today from our good friend in Poland, Katarzyna Zbierska (Partner, Legal Counsellor, Kochański Zięba Rąpała i Partnerzy, Warsaw) about a recent reasoned ruling of the Warsaw District Administrative Court in Warsaw of 5 August 2011 (case no. VI SA/ Wa 87/11). In this ruling the court upheld a decision of the Polish Patent Office to refuse the grant of an SPC for a product distributed as the QLAIRA contraceptive (Bayer). Katarzyna explains that the ruling is worthy of mention as there are not many SPC cases in Poland, and it concerns the contentious issue of interpretation of a “product” definition.

The details of the case are described in the bulletin of her law firm's Intellectual Property Department, which you can access here.

Court of Justice sprints to reasoned order in Case C-422/11

A Court of Justice judge models
his new uniform ...

 The SPC Blog has received today a note from Brian Cordery (Bristows) concerning the Reasoned Order of the Court of Justice of the European Union in Case C-442/11Novartis v Actavis, this being a reference from the Patents Court, England and Wales (Floyd J), noted on this blog here. The Reasoned Order is dated 9 February but was only released to the parties' lawyers at the end of last week.

Brian observes that the operative part of the ruling [which is not yet available on Curia but you can read it in full, here] is as follows:

"Articles 4 and 5 of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a 'product' consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that 'product' in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that 'product' enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the 'product', as a medicinal product, which was authorised before that certificate expired."

He adds, and this blogger agrees, that most SPC devotees will not be surprised by this ruling: it appears to be the logical consequence of the recent Court of Justice rulings in Medeva and Georgetown.

One point of interest is how (relatively) speedily the Court of Justice dealt with this reference. Admittedly, it didn't require detailed knowledge of the field of technology and the reference was on an issue on which it has been focusing a good deal in recent times, but the time between the referring court's decision to refer and the Court of Justice's order was little over eight months.

Thanks, Brian, for letting us know!