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!

SPCs and the Unified Court Agreement

Given the length of time it has
taken to put together a unitary
patent scheme with a unified court,
this logo would seem most
appropriate for the venture

So much has happened in such a short time in terms of the rapid sprint towards a unitary patent system for the European Union and the Unified Court Agreement that even some of The SPC Blog's best-informed readers aren't sure what's happening.  One such reader has written to seek confirmation that what he believes to be the position is indeed so.  He writes:

"Do any readers of The SPC Blog have any comments or views on Article 3(b) of the Unified Court Agreement?

In Article 3(b) of the Unified Patent Court Agreement concerning the jurisdiction of the court over European patents, there is a reference to “supplementary protection certificate issued for a patent”. Article 2(7) of the Agreement indicates that “patent” means a European patent and a European patent with unitary effect.

My observation arises as follows:

An SPC is a national property right granted by a national patent office – unlike the Unified European patent or the regular European patent granted by the EPO. Often an SPC will be based on a European patent granted by the EPO -- or presumably a Unitary European patent in future – but not always, since national patents can be used also as the basis for an SPC.

Although the SPC is a creation of EU law and its inclusion in the Court Agreement has some logic, it still looks a bit strange to have a national property right bundled up in the supranational Unified Patent Court Agreement. On the other hand, maybe it does make sense since standard European patents (which are in effect national property rights too, after grant and validation) will fall under the Court’s jurisdiction.

I’m still left wondering though. Maybe I missed something in all the excitement recently (in particular the hoo-hah over Articles 6 to 8).

Does this mean that the Unified Patent Court will get jurisdiction over existing or future SPCs based on national patents? Or maybe the Agreement is meant to refer only to SPCs granted on European patents but not national patents?

Does this further mean that the Court could get to rule on the validity of such SPCs (based on national patents) but not where the validity of the national patent is reserved for the national court? (is there some additional unintended bifurcation here?)"

Can any reader advise?

Benoxacor and (S)-metolachlor: French ruling now available in English too

On Thursday 16 February The SPC Blog posted this item from France on the rejection by the Cour de Cassation -- the nation's highest court -- of an appeal against the refusal of an SPC for Benoxacor and (S)-metolachlor.  Edouard Kling and his colleague François Pochart (august & debouzy avocats) provided the original news and said they'd let us have an English translation. Well, here it is. It's five sides long which, though very short by the standards of many countries, actually seems quite lengthy for a Cour de Cassation ruling.

Thanks, Edouard and François, for your help and support.

SPCs and PTEs in East Asia

The SPC Blog has recently received an email from Michael Lin (Marks&Clerk, Hong Kong), who helpfully tells us:

"I’ve received quite a few questions recently about SPC/PTEs in East Asia, so I thought this may be useful for those subscribing to the SPC blog:

SPC/PTE available: Australia, Brunei, Japan, Macau, Singapore, S. Korea, & Taiwan.

SPC/PTE not available: China PRC, Hong Kong, India, Indonesia, Malaysia, New Zealand, Pakistan, Philippines, Thailand, Vietnam".

Readers of this weblog will already be familiar with the case of Macau (see earlier posts here and here). As for the rest, The SPC Blog will watch carefully for news and developments.

France: Cour de Cassation upholds rejection of SPC for Benoxacor and (S)-metolachlor.

From Edouard Kling and his colleague François Pochart (of the Paris-based international practice of august & debouzy avocats) comes this fascinating news of a recent decision of the French Cour de Cassation -- its Supreme Court. Edouard writes:

"Here is a link to a ruling of the French Supreme Court for your blog which may have remained unnoticed among the various Medeva and Queensland discussions. This ruling is concerned with SPC Regulation 1610/96.

The Cour de Cassation confirmed the decision of the Cour d'Appel to reject SPC application No 02C0020 directed to a mixture of Benoxacor and (S)-metolachlor. It came to the conclusion that the product was already the subject matter of a previous SPC (No 97C0048 based on a different basic patent), though the former SPC did not specify the stereochemistry of the metolachlor component. Said the Cour de Cassation

“Whereas, first, the Cour d'Appel decision found that SPC no. 02C0020 was requested for a plant protection product whose active substance is the combination of benoxacor and S-Metolachlor and that SPC no. 97C0048 granted previously on the basis of patent no. 84810599 covers the combination of benoxacor and metolachlor without reference to one or more specific spatial forms of metolachlor; it further pointed out, on specific and adopted grounds, that the metolachlor molecule has two R and S enantiomers and four possible spatial forms, and that S-Metolachlor is only one enantiomer of the metolachlor substance; finally, it pointed out, on valid grounds, that it is not demonstrated that the transition of the active substance in question, from a racemic form to an enantiomer form, implies that the product has a different activity profile; from these findings and assessments, the Court of Appeal, which carried out the study referred to in the second part of the argument, was able to infer that the combination of benoxacor and S-Metolachlor constituted the same active substance as the combination of benoxacor and metolachlor since it was composed of the same sequence of atoms and, thus, one and the same product within the meaning of Articles 1. 3, 1. 8 and 3 of EC Regulation 1610/96”

This ruling may be related to the different European Escitalopram decisions dealing with the definition of a product under the scope of medicament SPCs, i.e. the Austrian and German decisions you have posted earlier. It however remains unclear about the burden, requirements and means left to the patentee to demonstrate an improved profile".

Edouard and François look forward to providing readers of this weblog with a complete translation as soon as possible.