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European Pharmaceutical Contractor

Added Protection

A patent protects the technical features of an invention and provides a monopoly in the territory where it has been granted. In most territories, the term of a patent is 20 years from the date of filing. They are intended to aid technological and scientific development, which is commercially and economically important. A patent can be exploited by the proprietor, licensed, mortgaged or sold – in short, having a patent could create a niche in the market and, potentially, bring in revenue.

To get a granted patent the invention must be novel, inventive and capable of industrial applicability. Novelty refers to whether the product has been publically disclosed in any way, by anyone, anywhere in the world; it must contain distinguishing features from what is already known. The product must also be inventive in a way which means it is not obviously based on existing goods or services. Being capable of industrial application means that the invention must be able to be manufactured or utilised in any kind of industry.

Excluded Subjects


There are some areas, such as business methods and mathematical formulae, which are not patentable and are considered to be excluded subject matter in the UK and Europe. However, it is possible to obtain protection for these in some territories. Computer-implemented inventions are complicated, as some are patentable and others are not. If it provides a technical function which solves a problem in a non-obvious and novel way then it is likely to be patentable. For these reasons, it is advisable to seek the opinion of a patent attorney as to whether your invention falls into one of the excluded categories in a particular territory.

In the UK

UK applications are processed by the Intellectual Property Office (IPO) which is tasked with checking the patentability of the invention and ensuring that the formal criteria have been met. To file an application, you must submit a patent specification and accompanying forms to the IPO. These include a description of what technical problem the invention solves and how it does so, as well as claims, an abstract and diagrams, if required.

The most important part of a patent specification is the set of claims which define the legal scope of the invention. The scope of the main claim will usually be broader than the commercial product, in an attempt to maximise the protection of the invention and prevent, or at least minimise, the ability for others to make minor modifications to the product in order to design around the wording of the claim. This makes claim-drafting an extremely important stage of the process, so seeking advice from a patent attorney is advisable. In the UK, the average cost of seeing a patent application through to grant is around £4,000.

With regard to pharmaceuticals, one can obtain patents for the products themselves, their method of manufacture, dosage regimens and their use in treating a medical condition – all of these can be covered in one application. Patents within the pharma industry are vital, as R&D departments spend a lot of money developing a drug; a patent will afford them the control to prevent others from exploiting their pharmaceutical or method of manufacture. Ideally, this can also allow them to exploit the pharmaceutical themselves, or license the patent or patent application in order to recoup some of their expenditure.

A supplementary protection certificate (SPC) can extend the life of a patent for a pharmaceutical product or ingredient by up to five years. This is extremely useful, as pharmaceuticals often become ready for market towards the end of a patent’s life. SPCs are viewed differently from country to country throughout Europe. In the UK, you can have one per patent, per product – whereas, in the Netherlands, you can only have one SPC per patent, irrespective of the number of products described within it. The application process begins once authorisation has been granted to place the product on the market.

Trademarks

The term ‘trademark’ is often used interchangeably with the word ‘brand’, although they are not exactly the same thing. A brand refers more to a marketing concept, some aspects of which are protected by trademark rights as a legal mechanism. A trademark, meanwhile, is a sign that distinguishes the products or services of one business from another, and helps consumers to make informed decisions. An example outside of pharma is the choice between Coca-Cola, or another cola producer, for instance. Trademarks are hugely valuable to any business, owing to the reputation they can build and the trust they engender with consumers.

To protect a trademark, you need to register it – either in the UK or at EU level, depending on where you wish to have security. Although it is possible to register a company or domain name, this does not provide a right to use said name – only trademark registration provides this, which is why it is so important.

A registered trademark gives an exclusive right to use the mark for the registered goods or services, in the territory where it is registered. This means that you can prohibit other businesses from using the same mark, or a similar one, for the same or similar goods and services. In the EU and the UK, this is based on a first-come, first-served system – unless there are special circumstances, rights in relation to a trademark go to the first to apply to register it, not the first to use it.

A mark can be a word (such as Ibuprofen), a logo, a combination of both, or a 3D shape. One of the main requirements for a trademark is that it must be distinctive to the goods or services applied for, and not descriptive of these, or any characteristics of them (such as the quality, quantity, purpose, value or geographical origin). Descriptive terms need to remain free for other traders to describe their own products. For example, Apple can be accepted for computers but not for fruits.

Prior to adopting a new mark, it is recommended that you undertake an availability search to make sure it is not already taken and you are not infringing an existing mark. It should also be noted that there is a requirement to use the mark within five years of registration or it can become vulnerable to cancellation.

Finally, in order to ensure proper use, consumers should be made fully aware of the trademark to prevent it from becoming generic. An example of this falling short is Aspirin, which lost its monopoly over its name through misuse.

Recent Challenges


The ever-topical argument from pharma companies is that they need patents to ensure they can recoup their costs and fund further research. Patents are vital in pharma as they can dissuade competitors from manufacturing products which have cost so much money to research, develop, trial and market. If it were not for the extensive research over many years and huge financial investments – which, at least in part, come from sales of patented products – these pharmaceuticals would not come to market.

This argument is met by opposition, as some say that life-saving medicines should be free for use by anyone, and that patents prevent this and push the cost of the drugs up, making them unaffordable for many.

At the same time, applications need to be carefully drafted to ensure they cover the commercial product, as well as any modifications which could be made as it is being developed and trialled. It is difficult to decide how early on in the research one should file a patent application. By filing early, applicants will be given an early filing date but, as the research has not yet been completed, all the information necessary to make the patent application satisfactorily detailed may not be ready. If filing takes place later in the process, once all the trial data is available, someone else may have already filed an application and be entitled to the protection. For this reason, it is important to devise a filing strategy with the support of a patent attorney.

Furthermore, it is possible to have a patent for the use of a known product in the treatment of a disease for which it has not previously been used. An example of this is Viagra®, which was originally used to treat high blood pressure in men, but now has a second medical use with which we are more familiar.

Pharma is a fast-paced industry; likewise is the world of intellectual property. Therefore, it is vital that companies not only understand the importance of intellectual property, but implement initiatives to help protect propriety inventions.

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About the authors

Victor Caddy is a Partner and Trade Mark Attorney Litigator at Wynne-Jones IP with over 20 years’ experience. He is an exam-qualified member of the Institute of Trade Mark Attorneys, and a member of the European Communities Trade Mark Association, the International Trademark Association and the brand owners’ association, Marques. Victor also serves on the ITMA Law and Practice Committee.

Lyndsey Lynch is a Patent Attorney at Wynne-Jones IP who handles a wide range of technology, including all aspects of chemistry, sensors, medical devices, semiconductors, life sciences, household appliances and defence. Lyndsey prosecutes patent applications before the UK and European Patent Offices, and has experience of applying for SPCs.
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Victor Caddy
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Lyndsey Lynch
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