Andy Bentham, patent attorney and head of the Cambridge office of J A Kemp, offers some thoughts on current patenting issues for the biomedical sciences. 

The pace of change in biomedical research has surely never been greater. Life science innovation and intellectual property have always gone hand-in-hand but is the patent system keeping up?

In the antibody field, things have come a long way since Kohler and Milstein were advised not to patent ahead of publication of their seminal 1975 paper on monoclonal antibodies.

The last four decades have seen the patenting of innumerable developments around antibody production and diagnostics and the commercialisation of an increasing number of patented antibody drugs.

In the next couple of decades, we will also see new generations of drugs that are not ‘classical’ antibodies but rather smaller derivatives that are not only diverse and specific but also easier to deliver and manufacture. Even now, though, the field is sufficiently mature that the earliest commercially successful examples are starting to come off-patent and biosimilar ‘copies’ are becoming part of the landscape.

Litigation in this area has so far been mostly innovator-on-innovator as distinct from the innovator-generic struggles that characterise traditional pharma but this may now begin to change. 

Antibody therapeutics are revolutionary for patients with life-changing illnesses but there is reason for concern, too. In Europe at least, patenting is getting harder as the base of prior art grows, so it is not certain that every new drug will be patentable in the future, and the cost of the treatments is high so some public healthcare systems are reluctant to fund them.

If protection is harder to obtain and high-value sales harder to make, will the industry be sufficiently incentivised to develop new molecules that will in the end be dedicated to the public when patents expire? In the meantime, though, many excellent candidates are coming through both clinical trials and Patent Offices.

The patenting of research tools and discovery platforms is also of great importance. History shows it is rare to achieve true exclusivity for platform technologies, as broad patent claims are hard to obtain and new developments and design-arounds tend to erode the patentee’s position. But such technologies are nonetheless a key part of the IP ecosystem as many originate in academia and broad out-licensing enables universities to gain revenue through technology transfer.

The most important advances however tend not to have a smooth transition because of disputes over priority and/or ownership that are perhaps inevitable when blue-sky research carried out in collaborative environments suddenly acquires billion-dollar value.

In the last decade, there were battles regarding RNA interference and now there is an ever deeper dispute over CRISPR gene editing technology. For businesses seeking to access these advances, this is a problem because they may be willing to pay but it is not clear to whom to go for a licence. Perhaps in the future we will see more collaborative models and open licensing via the patent pools that are common in electronics, but perhaps not because the numbers of relevant patents will probably still be lower and the players fewer.

Lower-profile but no less important, there is also an upsurge in IP for medical devices. In 2015, more European patent applications were filed in the medical technology field than any other. There is a lot to commend patenting in this area as medical devices suffer fewer issues in patent prosecution than biological inventions and are good candidates for Patent Box tax relief.

In the developing field of digital health, little is yet clear about how the IP landscape will develop but it may be that software patent issues and the speed with which new innovations come to market and are superseded render patents less relevant than in traditional biomedical research. At a higher level, politics and IP often have an uneasy relationship and policy makers arguably listen too willingly to anti-IP lobbies. 

Diagnostics

This has led to negative developments in the USA, where recent Supreme Court case law has eroded and confused what inventions are patent-eligible there. This is particularly acute in diagnostics but may come to undermine other biomedical sectors too. 

Come 2017, we will see whether Congress, President Clinton, President Trump or the new Supreme Court Justice one of them will appoint will give priority to unlocking this. 

In Europe, basic patent-eligibility is not a major issue in biomedical science at present but a vote for the UK to leave the EU would damage and/or delay the forthcoming unitary patent system that will offer more cost-effective EU-wide coverage and enable centralised litigation. 

However, because it is not an EU instrument, the UK will remain a member of the existing European Patent Convention regardless, so much would continue as now even post-Brexit. 

Interesting times indeed: change is the only constant.