| Thursday 24/11/2011 09:30 | Judgment C-322/10 | Approximation of laws Medeva Court of Justice - Fourth Chamber |
| Thursday 24/11/2011 09:30 | Judgment C-422/10 | Approximation of laws Georgetown University and Others Court of Justice - Fourth Chamber |
"One (of many) of the causes of consternation arising from Advocate-General Trstenjak’s Opinion in the Medeva reference (discussed many times in earlier posts on this weblog) was her contention (in para 102) that:
“according to the Court’s case-law, only one supplementary protection certificate may be granted for each basic patent”.This has caused more than a few squawks of concern by commentators across the continent (and indeed beyond), not least on this blog.
A-G Trstenjak attributes this “case-law” to paragraph 28 of the ECJ Judgment in the Biogen case, from which she has taken a literal quote of the final words of that paragraph. As the world and his wife have since pointed out, however, this is not consistent with past and current practice around Europe (and many examples of multiple SPCs based on single patents have been brought forward).
Of course, the ECJ judgment in Biogen was founded on, and came to very much the same conclusion as that reached by Advocate-General Fennelly in that case. I was struck, therefore, while perusing A-G Fennelly’s opinion in Biogen (as one does on a Friday evening) with paragraph 53 of his opinion, which closes with the words:
“It is nowhere stated that a patent can be the subject of only one certificate, or of a certificate only in respect of one medicinal product, as the same patent may be used for widely differing medicinal products.”Hurrumph! Don’t these Advocates-General talk to each other? Perhaps Angela Merkel is right – perhaps peace in Europe should not be taken for granted".
"Even with an SPC extension, a recent study by the ABPI IPEN with data supplied by UK IPO has found that the actual years of valuable patent life that a pharmaceutical patent that a company can actually use with a product on the market tends to last no longer than a total of between 10 and 12 years (even with the maximum 5 year SPC granted on top of the 20 years from the date of the patent application).
Even once a marketing authorisation has been granted by MHRA or EMA (National or European routes), companies need then to persuade governments (who are the sole purchasers of medicines through their national health services) to purchase new medicines for which companies need to prove increased efficiency over the existing drugs on the market through the Health Technology Appraisal (run in England through the lovely acronymed NICE, the National Institute for Healthcare and Clinical Excellence) , even before you can start to educate the doctors about the innovative new medicine and how it can help patients who are not responding to current treatments on the market. We’ve all heard of postcode prescribing. Well, the NHS is pretty reluctant to allow doctors to prescribe innovative new medicines that may have cost up to about £1.3bn to produce… unless all other avenues have failed with a particular patient first, and even then the local NHS PCT has to agree that the doctor is allowed to spend the money on the patient before treatment can start.
This makes pharmaceutical patents rather unique in that they become more valuable the closer to the end of the patent term you reach – so much so that pharmaceutical companies can find it worth while spending millions on patent litigation to protect weeks worth of SPC (see the Merck negative–term SPC cases in which in order to gain a handful of weeks of a 6 month SPC for paediatric study, Merck spent a lot of money trying to persuade the IPO and other patent offices around Europe to grant a negative term SPC (ie less than zero term) so that they could obtain the promised extra few months of the maximum 6 month extension allowed by the paediatric regulation.)
Compare this with the patents granted in the world say of mobile phones, where you have product almost immediately available on the market as soon as the invention is made to keep up with your cutting edge. They manage to squeeze the most of the full 20 years of market control available from the patent term …
I’d say the pharmaceutical industry as a result gets a pretty rough deal! (Noting also that any profits reported on the share market actually get ploughed back into the process of inventing the next new drug… and they don’t go into the pockets of the share holders at all.) And with the science getting more difficult and personalised (smaller sections of society benefiting from resulting innovation, now that genetically related “lock and key” mechanisms are being investigated) there is less and less money to pay for the next “big thing” through sales of resulting medicines before the generic market gets a look in (who can also use the same clinical data submitted by the innovator patentee to prove their significantly cheaper to produce generic manufacture-only costs medicine is safe to go on the market..). Since none of the profits of the generic industry gets ploughed back into the reimbursement of costs of development of the new medicines by innovator companies, we need all the protection we can get!
So less of the phoenix rising, and more on funding the costs of getting innovation from bench to bedside please!
I attach a handy graphic of information (reproduced below) on the R&D lifecycle we publish in our “Did you Know” booklet about the pharmaceutical industry.
Knowing how broadly this weblog's readership is spread between the proprietary and generic manufacturers, private practitioners, administrators, investors and academics, I suspect that there may be some interesting responses to Sophie's position. All opinions are welcome on The SPC Blog's moderated comment service.This shows the process timeline and average cost of bringing a new medicine to market – even once the basic scientific invention costs are done. It also shows how and why pharmaceutical companies need SPCs".
© Association of the British Pharmaceutical Industry from “Did you know?” Jan 2011 www.apbi.org.uk
"In 1997 a patent, BG 61365 for Thiazepine compounds, was granted to AstraZeneca Pharmaceuticals LP as a pipeline patent on the basis of EP 240228. The national legislation at that time allowed granting of such patents for medicinal and other compounds, applied for or protected by patents abroad before entry into force of the Bulgarian Patent Act. The law required that, at the time of applying for the patent, the product must not have been marketed on the territory of Bulgaria, that no certificate of authorship had been issued for the same subject-matter, and that the applicant or the patentee had a serious commercial enterprise in the country of origin of the invention.The full text of the decision in Bulgarian can be read here.
The national legislation further provided that the term of protection of such patents should expire with the expiration of the foreign parent patent. Consequently, due to an SPC issued in UK for Quetiapine based on EP 240228, the protection of BG 61365 was extended beyond the regular 20-year period until 24.03.2012.
In 2007, the accession of Bulgaria to the European Union was also accompanied by a reform in the patent legislation. A new provision stated that the pipeline patents with extended term of protection should be deemed to have expired at the 20th year following the filing date of the parent patent. Instead, the patent holders were entitled to file an SPC application under Regulation 1768/92, which had just entered into force for Bulgaria. The SPC applications had to be filed within a transitional 6-month period from the accession of Bulgaria to the EU.
The patentee applied for an SPC and furnished a marketing authorisation for Quetiapine, issued in 1999 in UK, which was the first marketing authorisation for the product in the Community. The Bulgarian Patent Office rejected the application for failure to comply with the requirements of Art. 19a(k) of Regulation 1768/92. That provision stated that an SPC should be granted only if the first marketing authorisation for the product was issued after 01.01.2000.
On the appeal against the decision of the Patent Office, the Administrative Court revoked it and held that the requirement for the date of issue of the first marketing authorisation did not apply to the case. According to the court, there was not such requirement in the national provisions that entitle the former holders of pipeline patents to apply for SPCs.
The Bulgarian Patent Office appealed the decision before the Supreme Administrative Court. It also requested a reference for preliminary ruling, asking whether Art. 19a(k) of Regulation 1768/92 allowed for derogation in the national legislation from the requirement for the date of issue of the first marketing authorisation after 01.01.2000 in favour of SPC applications, based on the former pipeline patents. The Supreme Court confirmed the decision of the court of first instance and upheld all of that court's arguments. It refused to refer the case for a preliminary ruling, stating that Art. 19a(k) of Regulation 1768/92 did not have any significance for the correct decision of the case".
(i) a medicinal product is first authorised in the EEA by way of the centralised procedure;(ii) that authorisation represents the first authorisation in the EEA for a "product" that represents the (combination of) active ingredient(s) present in the medicinal product; and(iii) less than 10 years has elapsed between the date of filing of a patent that protects the "product" and the date that the European Commission decided to issue the centralised authorisation.
"As the patent on which the SPC was based was granted in 1986, Demo had argued that the product claims contained in the patent cannot be enforced because of the prohibition of patenting pharmaceutical products per se, which was in force in Greece at the time of filing.
We had argued, on behalf of Daiichi, that the provisions of Articles 27 and 70.2 of TRIPS prevail over the relevant legislation and that full protection should be available based on the product claims.
The court found that there is a matter of interpretation of Articles 27 and 70 of TRIPS, which constitute an integral part of community law and decided to refer three questions to the Court of Justice of the European Union.Many thanks, Constantinos, for your clarification.
I would be happy to provide more information if anyone is interested".
"According to Regulation 469/2009, Article 7(4) my understanding is that the transitional period of six months prior to the SPC expiry will rise to two years from 27 January 2012. The implication would appear to be that the six months transition will only exist for current and granted SPCs up to that date. The day after it will change to two years. So, if you are a company working on a paediatric extension using the six months transition, you will have to make sure your application is filed by 27 January 2012. Failure to comply, even by one day, could mean that the application for the paediatric extension will not be allowed. This is bound to cause some problems, a concern shared by the UK Patent Office. The wording in the Regulation has obviously not been constructed to deal with this anomaly.
Also it is not absolutely clear, when the two year transition period comes into force, how SPCs with less than two years duration will be treated. I have been informally advised by the UK Intellectual Property Office that, in such instances, applications for the SPC and any subsequent paediatric extension will have to be filed concurrently".
"On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A.
Now for the first time, the Cour d'appel has had a chance to consider the issue".As Laëtitia Bénard and David Por (Allen & Overy LLP) were swift to tell us, this is not in fact the case:
"The Paris Court of Appeals indeed rendered a previous decision on 15 March 2011, in E.I. Du Pont De Nemours And Company and Laboratoires Merck Sharp & Dohme-Chibret v. Mylan SAS and Qualimed SAS, in relation to the losartan SPC which was reported on this blog. In the losartan case, the Paris Court of Appeals ruled the opposite way, confirming the preliminary injunction ordered in first instance and stating the following:Further research into the matter has revealed that both sets of lawyers are right and that the fault lies with this blogger. In editing the original piece for publication and forgetting the existence of the earlier post, I had taken the words "Now for the first time" as meaning that it was the first time the Cour d'appel had ruled at all, whereas those words were intended to indicate that it was the first time the Cour d'appel had the opportunity to rule in the opposite direction to that taken in the earlier decision of 15 March.
"An SPC, which aims at supporting innovation in the field of health, grants a protection to a product as a medicament under all the forms that fall within the protection of the basic patent.
Consequently, in the case at hand, the certificate which has been extended grants the same rights as those of the basic patent covering losartan, and the protection granted by this certificate concerns the product covered by the MA for any use of this product as a medicament that has been authorised prior to the expiry of the certificate. Consequently, the protection encompasses any use of losartan as a medicament".
