Monday, December 08, 2003

I attended a really interesting seminar given by Oxford Balliol College Research Associate, Ms Tina Piper, last week on Tuesday December 2, 2003. Entitled 'The Unpatentability of Medical Diagnostic Methods: A Promise and Its Perils', it was one of the Oxford Intellectual Property Research Centre's Seminar Series. These are my notes on Ms Piper's fascinating talk.

Article 52.4 of the European Patent Convention excludes "medical methods" (of which "diagnostic methods" are a subset). This kind of exclusion is included in the patent law of 80 countries and the technical excuse for it tends to be that medical methods are not "capable of industrial application." This is a bit of a fudged construct but the law sometimes works like that.

The medical methods exclusion applies to the UK, Europe, Canada and New Zealand and there is a compromise on the exclusion in the US, which effectively gives medical practitioners immunity from being sued for patent infringement for using a patented technique. Medical methods are not excluded from patentability in Australia. "Diagnostic methods" are excluded in the UK and EU.

The US originally had an exclusion, then lost it and then partly regained it in the wake of the notorious Pallin v Singer case, when one eye surgeon sued another for patent infringement for performing a specific type of cataract operation. The Omnibus Appropriations act of 1996 made it possible for doctors to get patents on medical or surgical (but not "diagnostic") procedures but banned them from suing other doctors using the procedure in the course of their work. A congressional representative in 2002 introduced a bill called the Genomic Research and Diagnostic Accessibility Act but she has since been voted out of office and Ms Piper was unsure of the current status of her bill. This would have introduced patent infringement liability for diagnostic methods/tests.

The definitive UK case in the area for most of the 20th century was apparently a 1914 patent case (C and W's Application, Re (1914) 31 PRC 235, 36 Digest (Repl) 656, 104?). The UK Patent Act of 1977 suggested a definition for a diagnostic method - it must include all the steps in making a diagnosis (and it lists the steps). The Cygnus case challenged this definition saying the determining factors should be that the procedure is carried out by a skilled practitioner on or in the body i.e. it doesn't apply to samples taken from the body and tested in the laboratory.

There is supposed to be an overriding governing principle in this whole area, derived from the Baker Norton Pharmaceuticals case and guidelines from the European Patent Office, which states that:

Patents will not hamper doctors valuable life saving work.

Unfortunately in practice the principle is more represented in the breach than the observance. Ms Piper suggested there were a number of problems with the principle -

1. The exceptions from patentability of medical methods exist on paper but not in practice - judges and lawyers pretend the exception does not exist (In the Eli Lily case in 1976, the judge said that there was no logic to the idea of a medical methods exception and that it was based on ethics rather than logic).
2. There is little evidence of a principled approach in practice - drugs are patentable, diagnostics are not but the divide is artificial because diagnostics can take place in the lab rather than in the traditional face to face way. Skin tests applied to the body are not patentable yet the same test applied to a remote sample in a lab would be patentable.
3. There is little substantive protection of what are perceived to be healthcare goods - i.e. the exception covers very little in practice.
She then asked why should we care and provided some very succinct answers to her own question -

1. It is important to ask whether some technologies morally should or should not be patentable.

2. We are currently exporting our intellectual property laws to other countries through international treaties and trade agreements, so we should understand intimately the impact of these laws.

3. The state of the law may affect access to or cost of patented technologies and in the case of medical methods this is a public interest issue. An example is Myriad Genetics patent claim on the BRCA genes that can indicate a predisposition to develop breast cancer. Similarly in the case of the international outbreak of the SARS virus in 2003 there was a three way race to find and patent a causal gene sequence.

4. The state of the law will affect the type of technologies that will be affected, even if we only believe the inventive function of IP law. (If you add access to the knowledge base required to create those technologies there is a whole new dimension).

How did we get to where we are on medical methods patents? It turns out that it is all down to history.

In the mid 1800s medicine was a two tier profession. Wealthy upper class specialists and poor GPs. There was no standard training and anyone could set themselves up as a doctor. There were also lots of unsafe and useless medicines (like the carbolic smoke ball, the object an important contract law case Carlill v Carbolic Smoke Ball Company in 1893) and very little standardisation there either, in terms of treatment.

At that time 20% of all patents awarded were for medical treatments or medicines. The system was just a registration process, not the kind of examination and prior art process we have today. Anybody could register a patent and it was used as a marketing gimmick, a promotional badge supposedly giving the medicine the legitimate government stamp of approval.

Then the medical profession or elements therein decided to take control of the situation. How? They essentially created a parallel system to the patent system of the time, operating within a self-regulated medical profession. The self-regulation was effectively based on a set of ethical principles derived from the Hippocratic oath.

The profession:

1. Defined, facilitated and created a set of education standards that doctors who were to be registered had to meet. Basic training was standardised.
2. They encouraged collegiality and fraternity - in the spirit of the scientific method - medics shared their knowledge.
3. They got public support by creating a code of ethics which doctors were required to work to and opted out of the free market.
4. They gained state support and licensing and then self-regulation
5. They excluded regulations by other professions i.e. they booted out the lawyers

So they had created a parallel system to the patent system, (where lawyers and snake oil salesmen reigned), by replicating a number of functions of the patent system. Also medical inventions were evaluated on merit through peer review. (Now the peer review process has its own problems with hierarchy, convergence on the status quo, personality clashes etc. but we won't go into that as Ms Piper didn't). This new system meant that the incentive to invent was based on the acquisition of reputation. A fundamental aim was disclosure of new methods, products and processes - encouraged by the code of ethics and in the public interest, since it facilitated wider public access to effective treatments. There was also an indirect monetary effect in that the doctors with the best reputations were guaranteed a secure professional income.

Medicine was situated outside the market and until the 1920s and 1930s medics were completely against the patenting of medical methods because of this history. It was considered unclean for doctors to think about registering such patents - just not the done thing. In taking the profession outside the market, it also removed unseemly public legal disputes between doctors, such as the later (US) Pallin v Singer case, from the courts. Doctors don't like these kind of spats as they reflect badly on the whole profession. Even nowadays as we saw earlier Pallin v Singer led eventually to a change in US law. This was largely due to the general horror amongst powerful elements of the profession that a surgeon should be obliged to take three years of his life and run up $0.5 million in legal fees to defend his right to do his job using the best methods at his disposal.

One of the guiding principles was that patents should not hamper doctors pursuit of a decent income.

The original restrictions (late 1800s and early 1900s) imposed by this new medical profession governed regime required no patenting of substances, treatments or methods, though some patents on devices were allowed. And the rules were specifically enforced against doctors. The British Medical Association and the Medical Research Council enforced the rules.

There was some conflict and for example insulin and treatments for things like scarlet fever did get patented. The Association of British Medical Manufacturers also lobbied the BMA and MRC aggressively to open up the way to allow medical patents again. They justified their stance by saying that medical ethics insisted upon by the BMA et al were too strong and it was resulting in doctors being denied access to valuable rewards that would accrue from research. Doctors who wanted to take advantage of the patent system were being made to feel dirty about it.

The lobbying led to a series of developments in the law -
1. Dedication of medical patents to the MRC
2. Compulsory licensing, whereby patent holders were precluded from denying access to their innovations to but could derive some income from them
3. A medical methods exception to patents to avoid the Pallin v Singer type court case.

Effectively formal law was irrelevant to the reality of how medical patents were treated by the profession, the industry or the courts. When anyone wanted to change the law they formed a coalition and lobbied the BMA and the MRC. Ms Piper's (tongue-in-cheek) conclusion from all this was that, in reality, the lack of patents did not hinder doctors' access to a decent income.

What it did mean though was there was a lack of clarity and no logical conclusions as to what could be patentable in the area of medical methods.

What initial lessons is she drawing from her research to date?

1. Intellectual property law developed as the profession and the industry developed and evolved.
2. Intellectual property is about the interaction of legal and social norms. (We could add Lessig's architecture and market forces to that).
3. Intellectual property law can be and does get changed by well organised and resourced lobbyists.
4. When a law is widely ignored the whole legal system is undermined to a degree which can be dangerous.
5. We should recognise that the world has changed drastically and ask whether the appropriate balance in intellectual property has been maintained or whether it requires a re-alignment.

She finished with a question about how best to ensure access to medical methods and what role an exception for diagnostic or medical methods patents would play in that.

It seemed to me from the substance of Ms Piper's talk and her responses to the questions from the convened gathering afterwards, that she is very concerned about the public interest in all this. Basically, as in the US, well funded and organised self-interested groups can get together to change the law and the reality of medical methods patents but Jo Public does not get a seat at the table. (Interesting parallels here then with the situation in the US, where the relevant interest groups sit down, negotiate changes to the law, draft the new law and hand it to Congress for ratification. Jessica Litman, in Digital Copyright, describes this process with crystal clarity). Where indeed does the public interest get represented or, more importantly, factored in?

Perhaps it will be by making the general public more aware of the kind of work being done by the Tina Pipers of this world? Medical methods patents are a particularly stark illustration of the way in which intellectual property has serious impacts on ordinary people. We only have to look at the tragedy of AIDS in Africa and the lack of access to drugs with a track record of inhibiting the progress of the disease, to see this. If apathetic, disinterested Jo Public cannot be made to sit up and take notice of the life and death consequences of getting the balance right in intellectual property in this area, then it's never going to happen. My worry, however, is that it is just too emotive and attractive to the elements of the media interested in stoking up newspaper-selling public rows. The result is black and white sound bites from the extreme ends of the spectrum getting exposed and a complete lack of understanding of the real complexity of the issues we need to address to move forward.

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