Japanese Patent Term Extensions II

As implied by the use of "Japanese Patent Term Extensions I", we have another recent decision from Japan to share with you. This time, the summary is supplied by the kind permission of Mr Teruo Naganuma of Asamura Patent Office in Tokyo. Mr Naganuma's executive summary is provided below and his full article can be found here.

"The Japanese Intellectual Property High Court (referred to as the IP High Court hereunder) rendered an interesting decision (Case No. Hei 22 (Gyo ke) 10178) on March 28, 2011 that a patent term extension application for a combination drug of known drugs should not be rejected on the ground that each of the known drugs has been already approved for the same medical use as that of the combination drug. Also, the IP High Court rendered the same decision on even date (Case No. Hei 22 (Goy ke) 10177). 

Thus, in Japan, a patent term extension for the patented combination drug of known drugs would be granted even when the approved medical use of the combination drug is the same as those of each of the known drugs , unlike in the USA where an AstraZeneca patent term extension application for a combination drug was rejected by the USPTO in June, 2008 (Patent Term Extension Application of USP No. 5,674,860). 

Therefore, this decision would be extremely beneficial to new drug makers developing and marketing a combination drug of a blockbuster drug with other drugs after the expiration of the original patent term of the blockbuster drug."

Japanese Patent Term Extensions I

While not a staple territory around these parts, we thought that some recent developments on Japanese case law concerning pharmaceutical patent term extensions may be of general interest to our readers.

The following case summary is derived from the May 2011 Newsletter of Anderson Mori & Tomotsune, which was passed to us by Hugh Goodfellow of Carpmaels and Ransford.

Based upon the summary, it appears that it is possible in Japan to obtain a patent term extension for a new form of a previously approved medicine if the pre-approved form is not covered by the patent in question (e.g. the patent to be extended covers a tablet and not the pre-approved injectable form of the drug).

"Under the JPO practice of granting patent term extensions, an application for a patent term extension based on the later approval of a medical product ("later product") with an active ingredient and an effect, which are the same as those specified in a precedent approval of another medical product "precedent product"), is rejected since it is not acknowledged that "obtaining the approval as designated by the Cabinet Order was necessary for the working of the patented invention" as prescribed in Article. 67ter (1)(i) of the Patent Act.

In the subject case, the patentee of a patent directed to the "release control composition" (the "Patent") filed an application for a patent term extension (the "Application") based on a governmental approval (the "Approval")of the medical product "PACIF CUPSULES 30mg" (the "Medical Product") under Article 14(1) of the Pharmaceutical Affairs Act. The Examiner rejected the Application on the ground that there was a previous approval (the "Preceding Approval ") of another medical product which had the same active ingredient and effect as the Medical Product. The Board of Appeals of the JPO decided to uphold this rejection. However, the decision by the JPO was revoked on appeal before the IP High Court. The JPO filed an appeal against the IP High Court's decision before the Supreme Court. 

 The Supreme Court made a notable judgment in which it found that even where there exists a previous approval as aforementioned, if the precedent product does not fall within the scope of a patent to be extended based on a later approval, it cannot be said that obtaining the later approval was unnecessary for the working of the patented invention on the ground that there is a previous approval. Then, for the subject case, since the other medical product does not fall within the scope of any of the claims of the Patent, the Supreme Court applied the above standard, and affirmed the IP High Court decision which revoked the decision of the JPO.

 This Supreme Court's decision has clearly denied the current JPO practice of granting patent term extensions, and where, for instance, there exists a first approval for a drug in the form of an injection, a patent directed to a drug in a form of tablet may be extended based on a second approval for the tablet despite it having the same active ingredient and effect as those of the first approved injection drug."

Short Summary of the Medeva/Georgetown CJEU Hearing

Many thanks to Hugh Goodfellow (Carpmaels & Ransford) and Brian Cordery (Bristows) for submitting the report below on the Medeva/Georgetown hearing before the CJEU on 12 May 2011.

"On 12 May 2011, the Court of Justice of the European Union (CJEU) heard the joined cases of Medeva (Case C-322/10) and Georgetown (Case C-422/10) - both references from the UK Courts on the interpretation of certain provisions of Article 3 of the SPC Regulation (EC Regulation 469/2009).

For those readers who are not intimately familiar with the issues referred (and thus may have inadvertently stumbled across this blog), Article 3 of the SPC Regulation sets out certain conditions for an SPC to be obtained. Article 3(a) requires that at the time the SPC application is made, the product which is the subject of that SPC must be “protected by a basic patent in force”. Article 3(b) requires that “a valid authorisation to place the product on the market as a medicinal product” has been granted at the time that the application for the SPC is made.

Representatives for Medeva, Georgetown, the UK and Portuguese Governments, and the Commission gave oral submissions to a panel of five judges: (Jean-Claude Bonichot (France), Lars Bay Larsen (Denmark), Camelia Toader (Romania), Alexandra Prechal (The Netherlands), and Egidijus Jarašiunas (Lithuania)).

Medeva and the UK Government advocated applying a so-called “infringement test” when considering Article 3(a), such that a combination of A+B would be protected by a patent for A because the patent would be infringed by the combination. For the UK Government, this represents a complete shift in thinking from the position previously adopted by the UK IPO on this issue. From the oral submissions made to the Court at the hearing, it was unclear what approach the Commission would prefer.

On Article 3(b), Georgetown and the Commission both considered that this should be interpreted so that a marketing authorisation (MA) for A+B could be specified as a valid authorisation to obtain an SPC for A, if the MA for A+B represents the first approval for A. The UK Government was opposed to this idea.

At the hearing, reference was made to questions submitted by the Court to the parties and the other bodies represented at the hearing on Article 4 (Subject Matter of Protection) and the Biogen decision (C-181/95). Those questions and the answers submitted to the Court have not been made public. However the representative for the Commission stated that an analysis of Article 4 was not necessary in order to be able to interpret Article 3.

The opinion in these cases will be delivered on 13 July 2011 by Advocate-General Verica Trstenjak of Slovenia. The actual decision of the Court – which of course may follow the AG’s opinion or deviate from it - will follow several months later."

SPC Blog: Resources Site Updated

Just in case you weren't aware, the SPC Blog has a sister site, The SPC Blog: Resources which lists CJEU and national decisions relating to SPCs as well as basic legal texts. It has also (finally) been updated with more recent cases.

If you run across any decisions that should be on the site, but aren't, we would be delighted to hear from you. Please send us an email here.

The SPC blog seminar...we're full up for now!

Thank you to those of you who have accepted our invitation to the SPC blog event in June. We are now at full capacity and have received responses from practitioners in 10 different European countries, including representatives from 4 national patent offices. We will let you know if more space becomes available!

SPC Blog Seminar: have you booked yet?

Good news!  Details of this year's SPC Blog Seminar were announced just eight days ago and we already have a massive 83 registrants signed up.  Remember: the event is great fun and the venue has a finite capacity.  If you don't book early, you may find yourself on the reserve list.

Full details of the seminar can be found on our earlier post here.

Medeva, Georgetown University hearings

If you're in Luxembourg this coming Thursday, 12 May, and have nothing better to do, why not pop into the Court of Justice of the European Union and check out the hearing in Joined Cases C-322/10 and C-422/10 Medeva and Georgetown University and Others.

Just to remind you, these are references for a preliminary ruling from the Court of Appeal (England and Wales) on the interpretation of Articles 3(a) and (b) of Regulation 469/2009 regarding the meaning of ‘product protected by a basic patent in force’ and whether there exist further or different criteria in respect of a medicinal product comprising more than one active ingredient or for a multi-disease vaccine.

Injunction lifted as Spanish escitalopram dispute edges towards full trial

Readers may have missed a recent note on the 8 March 2011 decision the Barcelona Court of Appeal to lift the preliminary ex parte injunctions sought by Lundbeck against various companies selling generic escitalopram medicaments for which they had obtained marketing approval.  This decision upheld the decision of Barcelona Commercial Court No 4 in April of last year.  At stake were Lundbeck's patent EP347.066 - ES2.986.891 and SPC 200200019, which claimed a certain manufacturing process for the active ingredient escitalopram.

The main trial in the first instance main proceedings is due to take place in July 2011.

Details of this dispute so far can be found in the source referred to below.

Source: "Appeal court lifts preliminary injunction against sale of escitalopram generics", by Sara Pelaz (Grau & Angulo), International Law Office, 3 May 2011

The seminar: details at last!

If you want a good seat, be sure to get there early!

The SPC Blog is delighted to announce SPC Law and Practice 2011, the weblog's third annual seminar. Once again we are fortunate that Olswang LLP has agreed to host the event, which is free, at its London office.

The seminar takes place on Tuesday 21 June 2011. It will run from 1.30pm, when registration commences, till the last drop of wine is sipped at 6pm. This year we hope to avoid any problems with the snow ...

Highlights of the afternoon include presentations on the current state of SPCs in Spain (Javier Huarte, Grau and Angelo) and Belgium (Patricia Cappuyns, Olswang Belgium), the Medeva referral and combination vaccines (Nicole Woods, Rouse) , as well as the Neurim referral and zero scope SPCs (Hugh Goodfellow and Ed Oates, Carpmaels and Ransford).

SPC Blog team member Rob Stephen (Olswang) takes the chair, while his colleague blogmeister Jeremy Phillips will be in attendance, supporting the social side of the programme.

We anticipate the usual lively Q + A session. We hope, as in previous years, to be joined by representatives of various national patent offices.

For further details click the invitation here. To tell The SPC Blog that you'll be coming, please email Natasha Dubes at natasha.dubes@olswang.com