Welcome to the Autumn edition of Inside Life Sciences.
In this release, we focus on one of the most important, but hugely under-reported issues facing life sciences companies: data theft, with my colleague Rhymal Persad reporting on a matter we managed for one of my clients, a long established and successful originator pharmaceutical and biotechnology company.
In a small, but significant number of cases, a departing employee copies and takes commercially sensitive and valuable information with them as they leave. This will, of course, usually be detected and Rhymal's article is a great summary of the legal actions and remedies that are available. That these remedies can include the ability to search the employee's home may come as a surprise to many, but this is a product of the secrecy surrounding the investigations - the necessary orders are usually obtained without notice to the employee - and the confidentiality of the settlements that are eventually reached. The objective of the article is to make life sciences companies more alive to the dangers, and also to the extent of the available remedies.
Of course, prevention is better than cure. But, data theft can go undetected, and the security processes and procedures that can all but eliminate this risk may fall short. Given the sensitivity and value of the information in question, this is surprising, particularly given that the necessary security measures are often inexpensive to implement. If this article makes you do nothing else, I hope it makes you speak to your IT team to ensure that your existing security system and processes are fit for purpose.
We also discuss in this edition two extremely significant decisions in the pharmaceutical patent space: (1) the Supreme Court decision in Warner-Lambert v Actavis relating to issues of sufficiency and plausibility, and infringement, of second medical use patents (we are advising Dr Reddy's, one of the generic manufacturers which wishes to launch its generic product for the non-patented treatments) and (2) the decision invalidating Gilead's SPC for Truvada (where we advised Lupin, one of the claimants seeking invalidation).
Medical Cannabis
Following on from our lead article in the last edition, most readers will be aware that, on 1 November, the new regime for medical cannabis became law in the UK. It will now be legal for doctors to prescribe medical cannabis but there are a number of controls and restrictions.
First, medical cannabis can only be prescribed by specialists, meaning that consultants, and access to them, is much more limited than general practitioners who cannot prescribe it.
Second, medical cannabis can be prescribed only if there is an "exceptional clinical need". How each consultant interprets this remains to be seen, but the intention is that doctors should not prescribe medical cannabis unless established treatments have not proved to be effective in a particular case.
Finally, consultants will have a wide discretion on what products they prescribe. Provided they are manufactured, the delivery system is up to the doctor. However, clinicians will not be permitted to prescribe the smoking of the cannabis product.
The new law has met resistance from doctors, particularly those specialising in pain relief, and the debate over the overall efficacy and long term safety profile of medical cannabis continues.
Commentary
The development in the law is in many ways positive. In particular, the legal availability of cannabis-developed medications – which may contain tetrahydrocannabinol (THC) to enhance the reported efficacy of the medicine for certain illnesses such as drug-resilient childhood epilepsy – is to be welcomed.
However, the implementation leaves much to be desired. There is an effective, and evidently deliberate, "choke" on the access to medical cannabis by those who may feel that it would help their condition by limiting it to prescription by consultants and for exceptional clinical need. Also, it is quite clear that many consultants are concerned about or are against medical cannabis. This is evidenced by a letter from consultants specialising in pain relief for The Times on 26 October objecting to the "premature" mandate to prescribe cannabis for pain relief. The recommendations from the Royal College of Physicians are also very cautious. Given that there has been no training or directions given to discussions this is not surprising.
While the caution of the Government is understandable, there is an argument that this does not reflect the new reality. Following the announcement by the Chief Medical Officer that there was evidence of the therapeutic benefit of medical cannabis, it is believed that the sales of (at least) CBD oil have risen sharply. If people are unable to get access to medical cannabis, the speculation must be that they will look to self-medicate by obtaining products from unregulated sources of which there are many - with unproven manufacturing standards and formulation. It will be difficult for many to see this aspect as a positive outcome.
While no further changes in the law are expected in the short term, it will be interesting to see how the landscape develops.