Patent strategies bring rewards

In the fast-moving area of biopharma research and development, efficient intellectual property strategies are becoming even more important as companies seek to protect their innovations at every stage of development. But what is best practice and what can biopharma companies learn from past successes and failures?

The biopharma industry is relatively new and to some extent the application of European Patent law in this important field of research and development, which attracts a high level of private sector investment, is still evolving. For this reason, it is particularly important for biopharma companies to stay abreast of legal developments so they can develop intellectual property strategies that allow them to exploit the full commercial value of their activities.

The nature of biopharma ‘products’ makes seeking patent protection more complex than in many other areas of scientific research. When seeking patent protection for a specific protein, for example, it may be difficult to predict what effects could be produced if minor modifications are made, such as altering one or more amino acids. Without undertaking extensive research prior to filing a patent application, it is possible that competitors could steal a march on the holders of the original patent by using a modified version of the protein that functions in substantially the same manner as the protein protected by the original patent.  In other words the competitors develop a modified version of the patented protein so that they can avoid infringing the patent.

The patent protection dilemma

The purpose of a patent is to protect commercially useful technology so it can deliver maximum value to the business that invented it.  Due to the fast-moving and competitive nature of biopharma research  there is an incentive for biopharma companies to file a patent application at the earliest opportunity. However, this may not always be the best strategy.

It may be best for the company to explore the full potential of the technology, for example, the gene sequence or the protein sequence that has been discovered, before filing for patent protection. In this way, it may be possible to demonstrate to the appropriate national patent office that patent protection should be obtained even when a significant number of modifications are made. This could extend the reach of the patent and make it more difficult for a competitor to develop a modified version without running the risk of a challenge for infringement.

This is not a strategy for the weak-hearted however, as clearly, for some companies, a delay in filing patent applications for a new technological development could leave it vulnerable at a time when competitors are working in the same field of research.

Herein lies the patent protection dilemma for the biopharma industry – whether to act early and risk only being able to obtain narrow protection, or to delay filing a patent application to allow time to gather further experimental data and to gain extended protection.

Benchmarking patent strategies

In order to decide on the best patent strategy to pursue, biopharma companies can look to past successes and failures.

In 1989, it was discovered that the antifungal agent rapamycin could be used as an immunosuppressive agent to prevent transplant rejection.  A patent application was filed by American Home Products covering the use of rapamycin and its derivatives for this purpose.  Subsequently, pharmaceutical company, Novartis, developed a rapamycin derivative (SDZ RAD) for use as an immunosuppressive agent and American Home Products sued them for patent infringement.  In 2005, the UK Court of Appeal found that American Home Products’ patent only covered the use of rapamycin and not its derivatives, essentially because no derivatives were described in the patent. Accordingly, Novartis’ use of the rapamycin derivative was not considered to be an infringement. 

What lessons can today’s biopharma industry take from this? The main message should be that it is usually best to wait until you have gathered a critical mass of experimental data before filing a patent application. Without this, there is a real risk that other companies could easily engineer around your patent and capitalise on all your hard work.

In the UK, a recent High Court case has further emphasised the need to accumulate experimental data. In the case Eli Lilly v Human Genome Sciences, the challenge brought against the patent-holder was successful and the court found that insufficient data had been provided about the function of the specific gene sequence, known as neutrokine alpha.

European patent law requires that a patent contains information that makes it ‘plausible’ to assume that a specific invention works as described. This recent High Court case effectively affirms this and sends a warning message to the biopharma industry about the hazards of filing for patent protection too early.

However, there is still a lack of clarity on this issue and in other recent patent challenges, where preliminary research data was provided, both the European Patent Office and the UK courts have ruled in favour of the patent-holder, saying that the company had provided sufficient information to demonstrate the ‘plausible’ function of the invention. As a result, biopharma companies should continue to tread with caution and take advice about the nature and extent of experimental data that is required in each case.

Extending patent protection

While the biopharma industry is still relatively up and coming, there is much that the industry can learn from the pharmaceutical industry with respect to extending the term of patent protection.

Recent changes in the law have made it easier for generics to come to market more quickly once a patent has expired and it is important that the biopharma industry plans ahead.

While patents have finite lives, it is possible to extend the patent protection that applies to individual drugs by seeking Supplementary Protection Certificates (SPCs). This kind of extension can only be given for a compound which has received regulatory approval and, if granted, can effectively extend the patent protection for up to five years, depending on the length of the delay that occurred when seeking regulatory approval for bringing the product to market in the first place.

Another way to extend the effective protection that applies to patented drugs is sometimes referred to as ‘ever-greening’. This is a strategy by which pharmaceutical companies attempt to extend their monopoly over patented products by, for example, reformulating the drug in a way that delivers an improvement. Such reformulations can achieve patent protection in their own right, lasting 20 years, but this doesn’t necessarily mean the reformulated drug will be a success when it comes to market.

Increasingly, independent advisory bodies are only recommending reformulated drugs to health service practitioners if the reformulated version demonstrates a significant improvement. In most cases, this means a health benefit, such as improved efficacy or reduced side effects. If pharmaceutical companies commit to bringing reformulated drugs to market, without demonstrating such improvements, they could well find that their investment is money wasted.

Summary

There is much that the biopharma industry can and should be doing to protect their innovations and to ensure that their investment in the research and development of new products is money well spent. In the fast-moving world of biopharma research, it is increasingly important to stay abreast of evolving legislation and learn from past experiences. Drawing on this knowledge, biopharma companies will be able to develop intellectual property strategies that deliver lasting value to the business.

Biographical note

Adrian Tombling is based in Withers & Rogers’ London office and has advised clients in the fields of biotechnology and pharmacology for over 14 years. He also serves on the Intellectual Property Committee of the UK Bioindustry Association.

By Adrian Tombling, patent attorney at Withers & Rogers LLP.