Drug Development: To Sue or Not to sue?

Guest blog written by Dr Nicholas Jones, partner and patent attorney at Withers & Rogers LLP.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world.

By the time clinical trials get underway, pharmaceutical companies will have already invested large sums of money in research and development activities, just to get to this point. The final stage required to obtain market approval is often a large, double-blind trial involving the use of a comparator drug, where the efficacy of the new drug is pitched against an existing one that is already in use. At this stage, when the new drug comes head to head with a current treatment, and when publicity surrounding the new drug reaches another level altogether, the risk of being sued for patent infringement may be greatest.

If a patent-infringement action arises, for example because the new drug is alleged to fall within the scope of another company’s patent, the patent holder could seek to slap a temporary injunction on the new drug, ultimately seeking to block its passage to market. Sometimes the patent holder will be the manufacturer of the comparator, but not always. If the infringement action was successful, then significant costs and delay would be incurred and the financial implications could be devastating for the company that has invested so much time and money in getting so far. If the injunction was upheld, the only realistic course of action would be to wait until the other company’s patent protection expires before restarting the trial and attempting to bring the new product to market again, which would of course eat into its profit potential in the meantime.

At a lower and earlier level in drug research and development, scientists are often unaware of the risks involved in carrying out experiments that involve the use of third party drugs, or drugs covered by third party patents. It is rare for a pharmaceutical company to initiate this kind of legal action. But it does happen.

Most pharmaceutical and chemical companies will recall the case of ‘rapamycin’, an antifungal and immunosuppressant drug, which was owned by American Home Products (now part of Pfizer). Novartis developed an analogue of rapamycin and sought to carry out clinical trials of its analogue. American Home Products sued Novartis for alleged patent infringement prior to the analogue’s market entry and the case reached appeal stage in the UK before being rejected.

In a slightly different setting, field trials conducted by Stauffer Chemical prior to the introduction of its version of the herbicide, glyphosate, were blocked in 1985 by an infringement action based on a patent belonging to Monsanto. Such trials, aimed at demonstrating product efficacy to a regulatory body, were considered not to benefit from the ‘experimental use’ exemption to patent infringement.

Seeking to remove this risk, Science Minister David Willetts, is proposing to introduce an amendment to the UK Patents Act 1977, which will exempt clinical and field trials of innovative drugs from patent infringement actions. Backed by an existing EU Directive, which was applied in a restricted manner in the UK a few years ago, this broader exemption already applies in a number of EU member states, such as Germany, Italy and France. There are plans to implement it in the broader form in the UK in October 2013.

Most intellectual property experts believe that current UK patent law in this area is perhaps out of step. An EU Directive known as the ‘Bolar provision’ was passed in 2008 and was implemented into national law in each member state. This Directive provides that trials necessary to get approval of a medicine should be exempt from patent infringement actions. Under the narrowest interpretation of the Directive, this could mean that only clinical trials conducted to support market approval of a ‘generic’ product would be exempt from infringement, and this interpretation was adopted in the UK.

In terms of the planned amendment to the legislation, research scientists in the pharmaceutical and chemical sectors will be hoping that the extent of the exemption is made as clear as possible. They may also be hoping that the amendment will allow patented drugs to be used more freely in the laboratory, for example when setting controls to measure against. This could be a very positive move that would benefit smaller research institutions in the drug discovery arena as well as those involved in early stage research.

Patent laws in other parts of the world pose less risk to pharmaceutical research and development activity than those that currently apply in the UK. In Germany, for example, the EU Bolar provision was implemented in the broader form from day one.

Whatever the position internationally, the fact is that pharma companies and scientists undertaking drug research work in the UK may currently be doing so at some level of infringement risk. Urgent action is needed to address this issue to protect the commercial interests of companies that are investing time and money in the development of new medicines. This will also ensure that research scientists and companies involved in clinical trials in the UK can operate on a level playing field with those in other parts of the world.

Dr Nicholas Jones is a partner and patent attorney at Withers & Rogers LLP, specialising in pharmaceutical research and development. He is a member of the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry.