A new ruling makes it easier to patent discoveries with no specific use, what are the implications?

Posted on November 8, 2011 by

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An invention is only patentable if it is believed to be useful in any industry. However, a new judgment by the UK’s Supreme Court has ruled that patents need only contain “plausible” suggestions of uses for the new technology. This will make it easier to patent the products of research in the life sciences and is likely to be welcomed by the UK bioscience industry. It also brings UK patent law in line with that of the EU. However, some argue that patents awarded too early in development and with vague “catch-all” descriptions can stifle research by other groups.

Background

Patents are meant to protect an inventor, allowing him or her to bring their invention to market and make money. But the patent needs to say what the technology is going to used for. For example, this stick with bristles on the end will be used to sweep up dirt. Unfortunately, as with so many things in patent law, it’s not black and white and there’s often room for interpretation.

In their patent of Neutrokine-α Human Genome Sciences (HGS) – a US company that patented a lot of gene sequences in the 90s – identified the protein as a member of the Tumour Necrosis Factor (TNF) ligand superfamily, a well studied family of proteins. Based on this they were able to make plenty of guesses of how their discovery might be useful in treating various conditions and diseases, but they didn’t have any evidence to say exactly how they might put it to good use.

As a result the pharmaceutical firm Eli Lilly challenged the patent saying that HGS hadn’t been specific enough and two courts found in Eli Lilly’s favour. The ruling then went to the highest court in the land – the Supreme Court with Lord Neuberger and Lord Hope heading up the judiciary.

What was the ruling?

Crucially Lord Neuberger said that…

A “plausible” or “reasonably credible” claimed use, or an “educated guess”, can suffice.

This, he and the other judges claimed, is in agreement with the European Patent Office (EPO) and a number of rulings that they have made in the past. The lower courts were therefore wrong to not follow the lead of the EPO.

So essentially, HGS had good reason to believe that their technology would be useful for a few things related to inflamation, immunology and cancer and this, Lord Neuberger said, was good enough for them to patent it. Had they said it could be used to treat dandruff he might not have been so convinced!

What does this mean for UK bioscience?

The ability to patent discoveries reassures investors that they will get a return on their money. This ruling will make it easier to patent the products of biomedical research and should encourage investment in the area.

Gareth Williams, Partner at patent attorneys Marks & Clerk commented:

this sends a clear message to innovators hoping to operate in the UK market – the level of detail it is necessary to include in a patent application is now far clearer. We already knew that Europe accepts that “plausible” speculation is sufficient; now we know for sure that this is the case for the UK as well. This will be good news commercially speaking for HGS – which has a product on the market based on this patent – but also anyone else with patents based on similar ‘catch-all’ indications of use.

But many people disagree with patenting genes and proteins. A patent is meant to be for an invention or a technique, not a discovery. And many would argue that HGS only discovered Neutrokine-α and performed fairly standard molecular biology techniques (which were based on other people’s work) to isolate it and make antibodies against it. The equivalent, you might say, of typing the words of someone else’s book into your computer and printing it out again.

There is a fear that patents on genes will prevent other scientists working on those genes and stifle research. The Wellcome Trust quickly released their data into the public domain during the Human Genome Project to prevent others patenting the DNA sequences. In many cases companies have turned a blind eye to research that infringes their patent, but if that research results in a usable treatment – which is the aim of most medical research – then huge royalties could be payable to the patent-holding company. That could make drug development unfeasible for many medical research charities.

Most agree that patents are important to encourage innovation. But breakthroughs usually require the contributions of many different research groups. Restrictive patents, applied too early in the R&D process can threaten this process.

The legal profession will be figuring out the implications of this ruling for some time. Patents will continue to be challenged in the courts (at great expense) and some will undoubtedly be found to be invalid. This ruling just makes that outcome a little less likely.

Posted in: Policy