Orwell on Competition

There’s nothing like getting back to basics. Having been asked to kick off a “Pharmaceutical Law Academy” summer school held at my old university, the organisers kindly allowed me to stay on and listen to talks on clinical trials, marketing authorisations, pharmaceutical trademarks, pharmaceutical advertising and pharmacovigilance. All of which was very interesting but the show-stealer was the last item on competition law and the pharma industry.

I’ve long been aware that the competition watchdogs in Brussels have had some curious obsession with what they regard as the unhealthy state of “big pharma” but I had not heard the lurid details from, as it were, the victims’ point of view. The presentations by Peter Rowland of Herbert Smith Freehills and Fleur Herrenschmidt of Novartis International AG were eye-opening and gave a slightly different picture to that of the EC Competition website.

Apparently the clever pharma-watchers in the European Commission do not see the ownership of a patent for a medicine as a right to be respected but as a target which, if attacked, qualifies the attacker as a would-be entrant to the market whose entry is being deliberately blocked by the patent – a slightly unconventional view of IP rights which could have been written by George Orwell.

It seems that behind this double-think (or is it half-think?) view of IP rights and wrongs lies the belief that the pharma landscape is divided neatly between research-based patent-owning monoliths who are the devils resolved to keep the price of drugs up and crusading generics companies who are the angels struggling to knock out patents and lower prices for the good of Europe’s sick and injured. As if we didn’t all know that these days the generics companies have some very substantial patent portfolios of their own and that many research-based pharma groups have their own generics subsidiaries. Where do the clever chaps in Brussels acquire their tinted spectacles?

Patents and Politics

I spoke at a recent conference in Cambridge entitled “Patents on Life: Through the Lenses of Law, Religious Faith and Social Justice”. As the title suggests, the focus was on biotech, transgenic animals, stem cells, seeds and the patent provision most often mentioned was the morality and ordre public exception. Interestingly, the majority of those present were not patent attorneys and IP lawyers but bishops, theologians, ethicists, and academics and not just European but American. My talk was about decisions of the EPO Boards of Appeal in this area including, as you would expect, the Oncomouse, WARF and Broccoli/Tomatoes decisions.

One of the other speakers suggested the new CRISPR technology should be considered immoral but judged by politicians and not the normal patent procedures, presumably to reflect a more direct view of the popular will. Another speaker, after asking why CRISPR had not been “banned” already, observed that patent examiners and judges are reluctant to make decisions on moral questions. She also suggested politicians should decide “morality” patent cases.

Quite why they thought politicians would be better at making decisions on tricky patent issues was not explained. As a mere observer of the political process, I’ve never been overwhelmed by the moral standards of politicians but maybe I’ve missed something. Nor did those speakers, or anyone else, suggest how the politicians would go about their extra duties as guardians of patent morality. Would they as legislators pass a new statute every time a controversial patent application is filed? Or would they set up some additional parliamentary committee, or maybe a new Quango, to deal with such cases? Maybe the legislators should turn themselves into a supreme court for the day to exercise the powers of a morality tribunal (I seem to recall that happened in South Africa under the apartheid regime which, as morality matters go, might not be a happy precedent).

And what about the procedure? Would the politicos simply “ban” the tricky cases or might it be possible actually to extract a patent from them? Who would decide in the first place which cases raise morality issues to be sent over for parliamentary scrutiny? Would everyone who has a say now be entitled to be heard? And if a case had not just a moral angle but also one of those tiresome everyday questions like novelty or inventive step, would the poor old patent offices be allowed to deal with that? And if so, who would go first, the morally-bereft patent examiner or the morally-astute politician?

We can of course be sure of one thing – it wouldn’t take any longer (or cost any more) than the present system….