UK: Patent Portfolios

Last Updated: 18 May 2018
Article by Isobel Finnie

Awareness of available IP options is key to building a robust and investable patent portfolio, which can drive R&D, thereby allowing for better drugs and diagnostics

At the core of any new pharmaceutical company – or the start of a new project for a more established pharma company – is an innovative piece of science that is believed to lead to new and beneficial healthcare products. It will take the combined efforts of a wide range of scientists, researchers, and clinical and regulatory experts to push these new healthcare products towards the market. Often, the innovation provides one or more new drug candidates, which the pharma company moves along the stages of R&D towards having a new blockbuster drug on the market or is aimed at earlier or better detection of disease and the research focuses on validating and refining the sensitivity and selectivity of the diagnostic tests.

To make spending time and money worthwhile when developing a new healthcare product, an exclusive market is needed, at least for a few years, during which the product can be sold at a price that enables re-couping the investment and making a profit. Therefore, aside from the underlying science and the company's key individuals, intellectual property (IP) – usually patents – protecting the innovation is needed.

An awareness of the importance of IP, the patenting process, its restrictions, and options – by those concerned at all stages of the product development and validation process – can help to ensure a stronger and more robust patent portfolio protecting that drug or diagnostic test.

Considering when one may be ready to file a new patent application is a balancing act between, on the one hand, making sure one files before any competitors working in the same space to get the earliest priority date, and, on the other hand, waiting until such a time when enough evidence is available to put into the new patent specification to show that the new healthcare product really works as claimed. Waiting too long means a competitor can get in before and take the lead or exclude the company from that technology space. However, filing too soon could mean not enough evidence exists to confirm that the new healthcare product actually works or does so for all of the applications claimed, which could be a problem.

Clearly, a patent application for a new drug is filed years before the clinical trials are performed, which is the true test of whether a drug works. Therefore, a key test is whether the new drug plausibly works and whether it does so in all of the ways claimed. What might be enough evidence depends on both the nature of the invention and the scope of claims to be pursued. As an example, this was one of the issues grappled with in the recent high-profile and on-going dispute between Actavis and Warner- Lambert relating to the drug pregabalin. The patent in question claimed treating neuropathic pain generally, which was construed to encompass all types of neuropathic pain. However, the patent specification was found to have evidence that only confirmed the usefulness of pregabalin for treating peripheral neuropathic pain and not central neuropathic pain, which was not evidence for treating (all types of) neuropathic pain.

Capturing Patentable Aspects

An initial patent filing is often focussed on a new chemical entity that shows to be a lead candidate. However, as the R&D process continues, other aspects can arise that are, in themselves, separately patentable.

Examples of such follow on aspects that can include modifications to the original lead candidate structure – ways in which challenges in formulation of a drug were overcome – or unusual modes of delivery. Understanding that each of these might warrant its own patent filing and should be documented and considered for IP protection can help build a layered and strong patent portfolio protecting that drug.

Patent Filing and Prosecution Strategies

A standard strategy is to file the first patent application wherever the inventors are based, followed within 12 months by a priority claiming international patent application, then wait until the end of the international phase before seeking patent protection in the countries/regions of interest. This standard strategy can provide what is required, but following this is not necessary if a better position can be achieved by doing something differently. Identifying the best strategy requires an awareness of what is helpful at separate stages for the business and an awareness of what is possible before different patent offices.

Some patent offices, such as the US Patent and Trademark Office, do very little with a new patent application within the first year of filing, while others offer more information. For example, the UK Intellectual Property Office (UKIPO) can provide a search and initial examination report well within the 12-month priority period. Analysis of this information can help shape subsequent patent prosecution strategy, such as modification of the claim structure or description of the application, giving some understanding of the likely final patent scope. Therefore, filing first or early with the UKIPO might be useful regardless of where inventors or a company is based. However, as a note of caution, taking into account any national patent laws dictating that inventions made in that country and/or by citizens with that nationality must be first filed with their national patent office or that a foreign filing licence is obtained is necessary. Since healthcare inventions often result from international collaboration, the interplay of these provisions needs to be built into the first filing decision.

Patentable Subject Matter Restrictions

Each jurisdiction has its own rules and restrictions on what is or is not patentable in the pharma and healthcare space. Since new pharma products are most often valuable to patients across the world, those making decisions about a patent portfolio must have a good understanding of these issues. A key message is that, regardless of the specific restrictions locally, they may not apply worldwide, and ways to navigate around them so that useful patent protection can be obtained will exist.

Patent Prosecution

How one wants to run patent prosecution depends on when granted patents are required, when a strong indication that patent protection will be obtained, and what the scope of that patent protection might be. If you need to maintain exclusivity by having or enforcing IP, then granted patents are key, and many patent offices offer mechanisms for accelerating patent prosecution. While the requirements, costs, and effectiveness of these different mechanisms vary, it could be valuable for core patents. Conversely, reasons can exist to want to slow down patent prosecution or delay certain stages, including insufficient information to make certain decisions or a need to defer certain costs. However, such delays mean third parties like potential investors do not have the comfort of knowing the technology is patented. For example, a good solution can involve blending together patent prosecution options to get rapid grant of a patent in one country – confirming patentability and achievable scope of protection, while the corresponding patents in other countries progress more slowly. Alternatively, an early official indication could be acquired from a patent office that the technology is patentable in the form of a positive opinion on an international patent application.

Most patent systems provide ways to file divisional applications or other types of continuing patent applications. These can be a helpful tool to seek patent protection that embraces other valuable scopes of patent protection, differing from that obtained in a first application in a family in a particular jurisdiction. Seeking protection that is closely focussed on a compound or close analogues in one application and then seeking protection more broadly for the underlying innovation in a separate divisional application is possible. This approach can provide another way to help build a layered and strong portfolio protecting a drug.

Extending Exclusivity

Supplementary protection certificates in Europe and patent term extensions in the US are examples of mechanisms within IP systems aimed at compensating a patent owner for the period of exclusivity (when the largest profits can be made) being eroded because regulatory requirements mean delays in bringing a product to market. Preparing the claim structure during patent prosecution to assist in applying for these extensions to the term of protection can be helpful in the long term.

Numerous options are available to a savvy patent strategist when building an effective patent portfolio. Creating an awareness of the options available within the world of IP can ensure that all individuals associated with the new healthcare product can assist in identifying new and protectable aspects and reduce the risk that such protectable aspects leak out unobserved and unprotected. Together, the resulting patent portfolio will be stronger and better able to offer the exclusivity needed to re-coup the investment and make a profit, which drives the R&D needed to generate new and better drugs and diagnostics for everyone.

Originally published by Innovations in Pharmaceutical Technology, April 2018.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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