Article 1 - Patented Medicines for developing countries, and the effect of 'added matter' in patents.
Patented Medicines for developing countries, and the effect of 'added matter' in patents.
The new European Council Regulation allows companies to produce copies of patented medicines under licence for export to "countries in need" which do not have sufficient capacity to produce them. This is the latest step in a process that began with the Doha Declaration of the TRIPS Agreement and Public Health in 2001.
In 2003 there was a provisional decision on compulsory licensing, and in December 2005 WTO members agreed to amend TRIPS to make that decision permanent. The Council's Regulation implements within the EU necessary conditions to meet the December 2005 WTO Agreement. Under this agreement EU authorities can grant compulsory licenses for production of copies of patented medicines if certain conditions are fulfilled.
Any WTO member will be able to export pharmaceutical products made under compulsory license for the purpose of supplying developing countries with no or insufficient manufacturing capacities in the pharmaceutical sector. The amendment will take effect once two thirds of WTO members have accepted it and that is expected during 2007.
Within Europe, companies will be able to apply for a licence to manufacture patented products without the patent holder's authorisation for countries in need of medicines which face public health problems. There is no specific restriction of products covered, although the context of the decision is that they should be products which are required to address public health problems. So products for malaria and AIDS, seem to me to be covered, but possibly not drugs to treat conditions which have not yet arisen, such as flu. And not drugs for conditions which cannot be described as 'public health' problems. So not osteoporosis or diabetes.
Developing countries need to notify the WTO of medicines they need, and it is then up to generic companies to apply for licenses to manufacture them.
I imagine that applications for licenses will be made in a way that is similar to applications for generic products today. But there is an inter-relationship between Patent Law and Regulatory Law which is not clear.
Once the products have been exported, they are not to be re-imported into the EU. Any goods which were to be imported into the EU would be treated as infringing patents. In effect, they would be treated like parallel imports from non-EU countries. Customs authorities would have the right to take against their re-importation, and I imagine that any seller, whether cognisant or not of the fact that the goods were intended for a developing market and had not been licensed for sale in the EU, would be infringing patents. There would be no question of an implied license, no parallel would be drawn between the cases involving re-importation of goods intended by patentees for developing countries (GSK v Kohlpharma, GSK v Dowelhurst).
The safety and efficacy of medicines exported in this way would be certified through the EU's Scientific Opinion Procedure, or equivalent national procedures. It was felt that this would compliment the licensing mechanism, and assist importing countries.
I have many, many questions concerning this regulation. Considering its purpose, the most fundamental is what constitutes "a developing country with no or insufficient manufacturing capacities in the pharmaceutical sector". This won't include India. It won't include South Africa. Pharmaceutical companies within those countries may be able to satisfy local needs, although there are problems with that too….
What about countries which have a pharmaceutical sector, but one which is not equipped for certain drugs which it needs? Can those be supplied? If the country concerned, and a general company supplying makes what is later decided to be an error of judgment, is that patent infringement? Or, would it be regarded as an omission of the regulatory body which granted the license, the pharmaceutical company being free from responsibility?
I hope that this is a further step towards making pharmaceutical products available for the poorest countries, and I want to see how it takes shape.
IVAX v Chugai - Added Matter
IVAX v Chugai - Added Matter
IVAX v Chugai judgment , which came out in April. IVAX claimed that it did not infringe Chugai's patent on the formulation of nicorandil. It also claimed that Chugai's patent was obvious and invalid. Chugai alleged infringement, and also sought to amend (narrow) its patent claims.
The judge found that the patent was not obvious. Prior art taught away from it. He found that IVAX did not infringe the patent, but that it would have infringed the amended patent, had amendments been allowed.
And - this is the part that I think is interesting - he found that the amendments requested should not be permitted because they were "added matter".
It may be worth reminding you, at this point, that patent claims can be amended provided that the specification includes the subject matter of the amendment - if not, this is regarded as 'added matter', and cannot be included.
The patent claimed a process for producing stable Nicorandil preparations. The proposed amended claim 1 read as follows:
"A process for producing a stable Nicorandil-containing pharmaceutical preparation which comprises mixing Nicorandil with palmitic or stearic acid present in an amount of at least 3% of the total weight of the Nicorandil-containing preparation and formulating the mixture in a suitable dosage form" (new words underlined) The original claim referred to a 'saturated higher aliphatic acid or saturated higher alcohol both of which are solid at ordinary temperatures'.
Palmitic and stearic acid are both solid at ordinary temperatures.
Thus, there were two aspects to the amendment: the substitution of a "saturated higher aliphatic acid or a saturated higher alcohol, both of which are solid at ordinary temperatures" with "palmitic or stearic acid", and the inclusion of the limiting words "in an amount of at least 3% of the total weight of the Nicorandil-containing preparation". The first amendment was accepted as a simple narrowing of the claim, and valid but the latter amendment was claimed to be invalid, as added matter. In working out whether matter has been added, the following has to be taken into account.
'The decision as to whether there was an extension of disclosure must be made on a comparison of the two documents read through the eyes of a skilled addressee. The task of the court is threefold:
- To ascertain through the eyes of the skilled addressee what is disclosed, both explicitly and implicitly in the application./li>
- To do the same in respect of the patent as granted.
- To compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition.
The comparison is strict in the sense that subject matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly".
It is notable that the test is not obviousness. The matter will be additional unless it is clearly and unambiguously disclosed in the application as filed - although disclosure may be implicit.
The same approach is adopted in the EPO. "If such added feature, although limiting the scope of protection confirmed by the patent, has to be considered as providing a technical contribution to the subject matter of the claimed invention, it would, in the view of the Enlarged Board, give an unwarranted advantage to the patentee, contrary to the above purpose of Article 123 (2) EPC. Consequently, such feature would constitute added subject-matter within the meaning of that provision.
A typical example of this seems to be the case, where the limiting feature is creating an inventive selection not disclosed in the application as filed…. In the view of the Enlarged Board" .
The Judge decided that Chugai's proposed amendment was not just a quantitive change, (i.e. one which simply reduced the selection), but was also a qualatitive change. The reader was "being taught by the proposed amended specification something about an invention which is not disclosed in the un-amended specification". Whilst, based on the original specification, "the skilled person [could have believed] that palmitic acid and stearic acid might behave in the same way as stabilising agents, he simply would not know without carrying out further research".
The Judge concluded:
"This evidence, considered as a whole, does not come near to establishing that there was a clear and unambiguous disclosure that palimitic acid and stearic acid were, for practical purposes, inter-changeable or of the efficacy of a 3% concentration of stearic acid as a stabiliser".
Patentees want to make their patent as broad as possible to catch maximum numbers of potentially competing products, and he need to make sure that they doesn't claim things which are obvious or in the public domain, otherwise claims will not be valid. A patentee can narrow patent claims, based on disclosure, but can't add matter. This case shows how important it is for patentees to ensure that disclosures cover exactly what they want, whether or not they have greater breadth. I suspect that Chugai could have worded their original patent in the form of the proposed amended claims, and had they done so, they would have been able to prevent IVAX from making this particular formulation. But they couldn't use the process of amending patents in order to make a qualitative change.
Anna McKay, March 2007
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