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Expert patent advice from VIO Chemicals

Here, Dr Natasha Varvogli, intellectual property consultant, and Maria Andrielou, marketing & communication at VIO Chemicals, look at patents and their role in the pharma industry, asking the question whether they are complicating business or enhancing opportunities?

With pharma’s portfolio shifting substantially toward new product types and personalised treatments, process technology needs to overcome multiple challenges across the supply chain. Competition is fierce and the need for new and revolutionary solutions for drug development starts as early as the selection of the optimal route of synthesis and starting material, often calling for ‘out-of-the-box’ thinking.

Breakthrough solutions, as small as they may be, can drive your business forward. Nevertheless, if you have not considered the intellectual property (IP) landscape, then, you have only developed half a solution, which can drive your business right into the ground.

Stay a step ahead

Proper evaluation of the relevant IP landscape is crucial if you wish to be one step ahead of your competitors. In today’s era of abundant knowledge and technological advancements, where businesses grow across borders and continents, the intangible assets of human intellectuality cannot be underestimated.

Analysing the IP landscape will give you a competitive advantage to avoid roadblocks and see hidden opportunities. It will also draw your attention to issues that require frequent monitoring and, why not, lead to an unforeseeable opportunity for the near future, upon change of facts.

Just think of the multiple questions you are faced with when you are about to design, develop and manufacture a new product:

The breakdown before the breakthrough

In a hypothetical scenario you and your R&D team have come up with a solution for a manufacturing process, which is easier, cheaper or faster in a novel manner. Do you need a patent to employ it in your business? Does a patent give you the right to manufacture and/or sell your product?

What is a patent good for?

The short answer is: to prevent competition. A patent does not give you the right to commercialise your invention, but it will stop others from doing so. This is an intangible asset that can provide your business with a unique opportunity to grow.

What steps should you take to obtain a patent?

Seeking expert support is your only option. At first, the expert will perform a novelty search to ensure that what you are seeking protection for is indeed something new. Whether or not this can be regarded as an invention, depends on a number of factors determined by patent offices. Then the expert will guide you through all available options, analyse the cost, the markets you and your competitors are active in and the relevant timelines.

Why do you want an expert?

For many reasons. Firstly, a novelty search requires solid experience in process development to become effective. A single search is almost never enough and professional patent searchers perform in-depth bibliographical research in multiple databases, driven by multiple strategies.

Secondly, an expert can file a patent application in a proper manner. Preparing a patent application is a highly meticulous task. If it is not done properly from the beginning and the patent application goes public, there is no turning back, and filing another patent application for the same invention is not possible.

Thirdly, an expert understands the implications caused by the differences in procedural law across borders and can save you from embarrassing and irreversible situations. Every patent office operates and examines patents under its own rules.

Sailing in safe waters

Maybe your business is not driven by innovation and you are offering a well-established product. You still need to ensure that it is IP free in the place of manufacturing. And what about the manufacturing process itself or the starting materials?

A successful product or manufacturing process may be patent-protected by the same token it would make sense for you to own IP rights for something useful and innovative. Taking into account that a patent may last for 20 years, your business might relate to something well-established, but you may not be ‘off the hook’ for a critical time span of two to three years.

Launching a new product

The procedure by which your business activities are checked for possible infringement of IP rights is called ‘freedom-to-operate (FTO) search’. To perform an FTO search properly, one not only needs to know and understand patent language but must also be up-to-date with key patent issues across major markets.

Through this search, you can identify and retrieve patents or patent applications that are or could potentially become roadblocks in your commercial activities. The evaluation of the search results requires specialised knowledge to assess:

All those issues need to be considered by taking into account the technical language of the claims and any special rules that a specific country or region may enforce.

In or out of Europe?

Europe differs from other major markets in an important aspect: the European Patent Office. This common route chosen for commercial activities within the European territory has the task of issuing patents effective across the majority of the European countries, but it is not entitled to decide on the infringement of a patent. This is a matter resolved, for the moment, only within national jurisdictions.

If you manufacture and/or plan to commercialise your product outside Europe, you need to be extra cautious when you analyse the IP landscape and file a patent. Take the case of China: European firms have long complained that patents in China are often misused and enforcing their IP rights in the country stumbles upon local judicial protectionism and ill-fitting law enforcement rules. Despite efforts for progress and reform, you still need an expert to cope with China’s IPR regime, avoid future violation of your IP rights and get a fair share in China’s market and courts.

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