The IPKat is grateful to Dr Stephen Smith (Consultant Patent Attorney, NuPharm Intellectual Property) for letting him know that the preliminary report of the EC Inquiry into the Pharma Sector has just been published on the Competition website (well, I knew that of course, says the IPKat). Moreover, the proceedings of today’s public meeting about the Commission’s preliminary findings (stated by Commissioner Neelie Kroes, right, as being solely confined to reporting the facts and not making judgements) can be watched here live as a webstream (even the Kat can't pretend he knew that ...).Merpel says, let's remind readers why this is so important. According to the Commission,
"The inquiry is a response to indications that competition in Europe's pharmaceuticals markets may not be working well: fewer new medicines are being brought to market, and the entry of generic medicines sometimes seems to be delayed. The inquiry will therefore look at the reasons for this.
In particular, the inquiry will examine whether agreements between pharmaceutical companies, such as settlements in patent disputes, have blocked or lead to delays in market entry. It will also look into whether companies may have created artificial barriers to entry (through the misuse of patent rights, vexatious litigation or other means). The sector inquiry does not aim to establish infringements of EC competition law by individual companies (Articles 81 and 82 EC).
The inquiry's findings will, if necessary, allow the Commission or national competition authorities to focus any future action on the most serious competition concerns, and to identify remedies to resolve the specific competition problems in individual cases".
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Friday, November 28, 2008
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According to the report (and it is a juicy bit which the press has been quick to jump on), in the "most extreme case" of patent clustering they've found "1,300 patents EU-wide for the same medicament".
ReplyDeleteHmm, I know that pharma IP departments are quite wealthy and ingenious, but this sounds rather difficult and damn expensive to pull off. The "EU-wide" phrase already makes me suspect that whoever wrote that didn't actually understand much about patents. Could it be that this person heard the complaints about European patent applications with over thousand patent claims and drew entirely the wrong conclusions? A little knowledge is a very dangerous thing indeed.
Re the last poster: Indeed, a little knowledge is a dangerous thing, in particular when it is an island out of its context. It is true that pharmaceutical companies engage in so-called "ever-greening" to lengthen the patent life of known pharmaceutical products. They do this by applying for, and in many cases, obtaining, patents for new pharmaceutical formulations of known products (where a new excipient improves the delivery of the drug), new processes for the production of said products, new crystalline forms of known drugs (which can be more stable and easier to handle than known forms). Some of these applications are weeded out by the patent offices, because they make no real contribution to the art. Others do represent a real technological advance and are patented. It is the job of the patent office to judge whether or not such "ever-green" applications satisfy the patentability requirements (which a second application for the same drug, with no additional features would not). The pharma companies are not allowed to re-patent the same drug again, but if they are allowed to obtain too-many ever green patents for multiple processes, several different crystalline forms and various pharmaceutical formulations, which expire some time after the patent on the original drug has expired, they can effectively extend the protection on that known drug. I hope that the Commission has looked into this aspect.
ReplyDeleteIt is also worth mentioning that ever-green patents on known pharmaceuticals have a far higher rate of opposition/nullification actions than patents on original drugs. This is because when the ever-green patents are granted, the drug is usually already known as a valuable licensed product and is already on the market, whereas when the original patent on the drug itself is granted, it is not o the market yet and is not licensed for sale and by the time it is, the period for opposition at least at the EPO would have expired, although it would remain possible at the national level, but this would require multiple nullity actions in the courts of various European states.