IPdigIT » Pharma

La politique de l’Inde en matière de médicaments génériques

Nicolas Brahy — Wed, 08 Feb 2012 09:38:06 +0000

On entend souvent dire à propos de l’Inde qu’il s’agit de la « pharmacie des pays pauvres », mais qu’induit cette affirmation et quel avenir réserver à une telle réalité ?

Il en va ici d’un thème majeur et en pleine effervescence, à savoir celui des médicaments génériques. Quelle politique l’Inde adopte-t-elle à cet égard ? Il faut savoir, avant toute autre chose, que 85% des médicaments produits en Inde sont des médicaments génériques, à savoir des copies d’originaux qui présentent l’avantage, d’une part, d’être tout aussi efficaces que le modèle original, et d’autre part, d’être nettement moins chers et donc abordables à un plus grand nombre. L’Inde en a fait sa spécialité et devient ainsi 1^er producteur et 1^er exportateur mondial de génériques.

Néanmoins, en agissant de la sorte, l’Inde fait le choix d’ignorer la législation applicable aux brevets et se met ainsi en porte à faux avec ce que prévoient les ADPIC entrés en vigueur depuis 1995. Si ces derniers ne cessent d’être revendiqués par les pays développés qui en réclament une application stricte, le tout dans le but de préserver les ressources financières des firmes de recherche et de récompenser l’innovation, ils apparaissent en même temps comme pleinement inconciliables avec les intérêts des Etats les moins développés qui souhaitent, quant à eux, mettre en œuvre une politique de santé nationale destinée au plus grand nombre. Comment dès lors venir à bout de cette opposition, sans porter atteinte aux droits de l’un ou de l’autre ? L’Inde générique se verrait-elle menacée de fermeture, avec les conséquences que cela implique inévitablement vis-à-vis des autres pays du Sud ?

Par ailleurs, l’accord de libre échange entre l’UE et l’Inde qui se négocie encore en ce moment et ce, depuis 5 ans, témoigne de la persistance des principales pierres d’achoppement auxquelles n’échappent pas les produits pharmaceutiques. Tandis que New-Delhi reste inflexible en matière de protection de ces derniers, l’UE continue de militer pour une extension de la durée des brevets ainsi que pour un renforcement des mesures aux frontières.

Cessons de reporter sans cesse ces négociations qui n’ont, en fin de compte, pour unique objet que de remettre à plus tard l’issue d’un enjeu qui s’avère particulièrement lourd de sens et de conséquences, et persévérons à ouvrir les yeux des leaders politiques indiens et européens afin de les sensibiliser davantage encore quant à l’impact du choix qu’ils sont en train de poser. Il en va notamment de la vie de millions de personnes atteintes du sida, à l’heure où, en même temps, le Fonds Mondial pour le Sida subit une grave crise de financement.

Finalement, la solution ne consisterait-elle pas, d’une part, dans une application très stricte du droit des brevets à l’égard des pays européens dont la mentalité et les revenus se montrent plus favorables à une telle politique, et d’autre part, dans un assouplissement large des règles issues des ADPIC à l’égard des pays les moins avancés et les plus nécessiteux en termes de traitements et de médicaments essentiels ? N’est-il, en effet, pas temps de leur donner la possibilité de se développer selon un mode qui leur est propre et de faire application du principe suivant : « A deux poids, deux mesures » ?

Post rédigé par Marie Anunciata Coppens (étudiante 2è master en Droit UCL)

Sites à consulter :

- http://news.doctissimo.fr/accord-de-libre-echange-inde-ue-un-danger-pour-l-acces-aux-traitements_article6873.html (vidéo)

- http://www.msf.fr/2009/09/03/1482/novartis-perd-son-proces-contre-la-loi-indienne-sur-les-brevets/ (exemple de procès intenté contre la loi indienne sur les brevets)

Bayer’s aspirin: a lasting success without patent and strong trademark protection

Alain Strowel — Fri, 28 Oct 2011 08:14:19 +0000

‘The serial painkiller’: this is how the Financial Times (27 oct. 2011, see here) describes the history of aspirin, the well-known medicine invented more than a century ago, when Bayer’s chemist Felix Hoffmann synthetized a stable form of its active ingredient.

Aspirin is undissociable from Bayer, but the benefits of its active ingredient were apparently known since the ancient Greek which used the leaves of the willow bark as a fever fighter. Those leaves contain a substance called salicin a natural compound similar to acetylsalicylic acid, the chemical name for aspirin (see here for the history of aspirin). ‘Aspirin’ itself is derived from “a” for acetyl, “spir” from the spiranea plant (a source of the ingredient) and “in”, a common suffix for medicines when the product was put on the market at the end of the 19th century.

Aspirin is still a blockbuster today: in 2010, Aspirin generated €766m in sales for Bayer. For a long time, Aspirin is however no more protected by patent. This makes Aspirin quite special, and probably the antithesis of the common story of modern drugs which generate huge profits during the short life-time of patent protection, before being overthrown by generic rivals. In addition, Aspirin lost rapidly its trademark protection. “During the first world war, explains the FT, the company’s trademarks – Bayer and Aspirin – were expropriated in the US, France, the UK and much of the British Commonwealth, who were allies against Germany“. The company nevertheless managed to get back the protection of “Bayer” – in the US, not until 1994 apparently. This made it possible to get a trademark protection for the combined words “Bayer Aspirin”. Aspirin however remains a leading illustration of a trademark which, due to its success, lost protection when it became the generic word to refer to the product itself.

In the FT article, the following reasons are put forward to explain the lasting success of Bayer Aspirin despite the loss of IP protection: on top of the consistent investment in getting back some form of trademark protection, the regular expansion of aspirin’s medicinal uses (it is now approved to protect against repeat heart attacks and strokes; see the promotion on a US website under the (trademarked) motto “Expect Wonders” here), the periodic reformulations (from tablets to powder, and its association with other ingredients as in Cafiaspirina, where it is mixed with caffeine) and the intensive marketing of the product.

The mark "CAFIASPIRINA" is a fanciful combination of the Spanish words for "caffeine" and "aspirin"

Aspirin has inspired some imaginative advertisers, for instance in Brazil — an ‘ex-wife’s lawyer’ might indeed be an explosive combination of aspirin and caffeine, not clear however how it could alleviate migraine… Interestingly, Bayer also commercialised Heroin as a branded cough remedy around 1900, as shown in the old black and white ad. Heroin is probably the opposite example of a remedy which is also a poison.

The whole story of aspirin is probably more relevant for students in management than in law — it shows that intellectual property protection is not always the key factor for success. (But there are counter-examples, where the adequate management of an IP portfolio has made it possible to extent a product’s success over time; also, Bayer has invested heavily in protecting its trademarks even after they were expropriated and/or became generic).

This post is thus more addressed to Paul Belleflamme’s students at the Louvain School of Management who could find the keys for market success beyond the legal tools…

Challenging pharmaceutical patents : a « death spiral » for generic companies ?

Alain Strowel — Sun, 03 Oct 2010 08:56:28 +0000

I remain puzzled by an article in the Financial Times (1 Oct. 2010) which highlights recent doubts of the US generic pharmaceutical industry with regard to the strategy of challenging drug patents in the courts. The article quotes Mr Paul Bisaro, president of Watson Pharmaceuticals (one of the US’s largest generic drug companies) and head of the US Generic Pharmaceutical Association : « Perhaps we have got too good as an industry in challenging patents ». A clear result of the court cases initiated by generics companies is that the period of patent exclusivity, during which the innovator companies can sell at high price, has been considerably reduced. According to Mr Bisaro, drug patents are now challenged within six months of the first marketing of the new drug. (Apparently, the generic companies are even able, in certain cases to have prototype, generic versions of drugs that are not yet on the market.) This seems to have modified the incentives for innovative companies : they now try to get a return on their investment very quickly, before any court can overturn their patents. Originator companies appear now to focus on complex, biologically-based drugs which can not be easily copied by generic companies, as opposed to the more classical chemical-based drugs. More troubling, those originator companies might now be discouraged from developing new drugs, which in turn means that generic companies are destroying their own future source of income. Are the generic companies « eating their own young » ? Is the pharmaceutical industry engaged in a «death spiral » ?
If this analysis and those comments were backed by facts, this could shed new light on the ongoing debate in the EU about the impact of patents in promoting the development of new medicines. This question comes at at time when DG Competition is pursuing its review of the practices in the pharmaceutical sector, in particular the patent settlement agreements and their possible anticompetitive effects. On 5 July 2010, DG Competition released a Report on the monitoring of patent settlements in the pharmaceutical sector (here). It seems that the number of settlements that may be problematic from a competition perspective – those that limit generic entry and foresee a value transfer from an originator to a generic company – decreased significantly (see Commission press release IP/10/887). The 2010 Report on settlements is a follow-up to the pharmaceutical sector inquiry conducted by DG Competition (see the Final Report of 8 July 2009 here). For a summary of the outcome of this inquiry with a focus on patent issues, you can look at my presentation ( Pharmaceutical inquiry 2010 ). Also, a conference on the same topic has been jointly organised by the CIPI of the FUSL and the IEJE of the University of Liège in January 2009 (see programme and presentations here). The 2009 pharmaceutical sector inquiry has been criticised as giving too much weight on short term competition objectives and somewhat neglecting the positive impact of pharmaceutical patents as an indispensable incentive for further research and development of drugs. It is not yet clear whether the erosion of patent exclusivity has already reduced the level of investment in drug development, but the story about the US generic industry referred to in the Financial Times gives additional food for thought.

‘Pay for delay’ deals in the pharmaceutical industry

Paul Belleflamme — Fri, 01 Oct 2010 17:26:29 +0000

(Edited version, October 11, 2013)

‘Pay for delay’ deals are commonplace in the pharmaceutical industry; they involve branded drug makers paying generic groups to delay the launch of lower-cost versions of their drugs. Last July, the US House of Representatives passed a legislation banning such deals. These deals are also at the center of European Commission scrutiny.

It does not take too much thinking to understand why big pharmaceutical firms propose such deals. What is more intriguing, at first glance, is that generic producers accept these deals. One can indeed wonder whether it wouldn’t be more profitable for them to reap the profits of an earlier launch of their generic drugs rather than accepting the money that is offered to them if they delay. The explanation for this puzzle has been given in 1982 by Richard Gilbert and David Newbery in their article ‘Preemptive Patenting and the Persistence of Monopoly‘ (published in the American Economic Review). Douglas Clement (in his article ‘Creative Disruption’), summarizes very nicely the main argument of this influential paper:

“The Gilbert-Newbery model, then, says that a monopolist must choose between adopting an innovation and allowing a rival to adopt it. The monopoly firm must calculate not only the value of the innovation to its own operation, but the repercussions of allowing a rival to have it. In this situation, the economists showed, monopolists often have a strong incentive to innovate, if only to preempt their rivals.”

Of course, what really matters for society, are the welfare effects of such deals. Are the US and European legislators right in trying to prohibit them? As usual with the economics of innovation, the answer is not simple; reasonable arguments can indeed be found for and against such ban (see for instance this Forbes article: ‘Pay-For-Delay Or Pay-For-Innovation?’; see also the related post by Alain Strowel on this blog). On the one hand, delaying the entry of cheaper drugs certainly has a negative impact on the well-being of consumers in the short run. Yet, on the other hand, shortening the exclusivity period during which pharmaceutical firms enjoy monopoly profits is likely to reduce their incentives to produce new drugs, which may harm the consumers’ well-being in the long run.

Since this post was written (October 2010), the issue of ‘pay for delay’ has been largely debated. Your job is thus to update this post while articulating your opinion about this issue. You can start by looking at the presentation that Matthew Bennet (from Charles River Associates) made in May 2013 about the economics of pay for delay cases. You can also have a look at past comments to this post. Otherwise, just google ‘pay for delay’ and you’ll find a large list of recent articles on this topic.

Half-day conference on the commission’s pharmaceutical sector requiry

Alain Strowel — Wed, 01 Sep 2010 05:13:33 +0000