It faces the added difficulty of attempting to strike the appropriate balance between the sizeable investment required and achieving a sustainable monopoly regarding the benefits.
Elliott Davies, European Patent Attorney at Wynne Jones IP, advises on how inventors can protect their inventions and adapt them to ensure market exclusivity.
Prior art
Prior art is a term coined to describe anything that has been made publically available before a patent application is filed. Anything that has been placed in the public domain before patent application is filed, be it an oral disclosure, a presentation or even a magazine article, can be used to challenge the novelty and inventiveness of an invention. With regards to the pharmaceutical sector, a patent is increasingly vital to ensure that the owner of a revolutionary medical technique or medicine is granted market exclusivity. The sector has faced a financial crisis of sorts with the development of new drugs proving too costly a risk for the potential lack of future growth prospects and financial benefits.
Pharmaceutical companies are consistently under pressure to invest in and develop the latest drug discoveries and technology — at a large cost — while facing growing competition in the industry from aggressive competitors. A patent, however, sets out to protect various aspects of the developed technology. The patent itself enables the proprietor to prevent unauthorised use of the protected technology and therefore provides both a monopoly and a market niche for the individual or company.
This not only ensures commercial and product advancement for the patent proprietor, but also encourages continued growth in the industry as a whole. The patent safeguards the time and financial investment in the development of the product by enabling the proprietor to control the commercial exploitation of the product. The patent thus enables the proprietor to prevent third parties from exploiting their hard work. Those who seek to use the innovation must first seek permission from the inventor during the patent’s lifespan.
What can be patented?
Various patent applications can be submitted to ensure the advancement of techniques, technologies and medicines within the pharmaceutical industry. Patentable entities including the generic concept of a product, the technology utilised within a product and chemical advances are suitable to be protected. Other areas including compositions of matter, new chemical or biological entities, genetically engineered animals and plants, combinations and formulations are also suitable.
Processes for the preparation of compositions of matter, whether new or old, are also among pharmaceutical aspects that are worth protecting. Advanced manufacturing processes could significantly lower the cost of production. Devices that can enhance how a medicine is administered are also eligible for patentability. A potentially non-viable treatment could be turned into a reality thanks to the use of a physical device.
Screening libraries of compounds are also of great significance within the industry as they could identify new uses and therefore should be considered for patent protection. With the Internet now among the fastest way to grow and distribute a product, the pharmaceutical industry has to consider protecting its business methods. They will have to consistently evolve their methods to ensure they retain the monopoly on their invention and maximise commercial return. This also has the potential to take the product to a global market; however, methods, which have traditionally been granted only in America, are being considered as potential subject matter warranting protection in Europe and elsewhere. Patent monopolies are territorial and separate patents must be filed to protect rights in other countries. Treaties and pacts have been formed internationally; however, these only protect the property during the earlier stages of the application process.
How long does the patent remain in place?
A patent application will remain in force for up to 20 years, provided renewal fees are paid to the national patent offices. After 20 years, or if the renewal fees are not paid, then the patents will lapse and the technology will become freely available.
This significant period of time will enable the inventor to benefit from the full monopoly on their creation and also contributes to the progression and success of pharmaceutical companies. For two decades, inventors and creators can also recoup some of the substantial financial investment they have made in developing and researching innovative medical products and start to see profitability.
Case study: Alesi Surgical
When it came to developing their innovative product, Ultravision, a number of patent applications were filed to protect Alesi Surgical’s work. The new and innovative product clears surgical smoke from a surgeon’s view during laparoscopic surgery, and prevents its escape into the operating theatre. Ultravision is based on an electrostatic precipitation technique, which is unique to Alesi, and is highly effective at removing airborne particles.
As such, the company sought help to ensure their revolutionary product was protected and had commercial longevity. Patent protection will enable Alesi, like many other companies in the life sciences and technology sector, to create a commercial niche for Ultravision, which is useful when it comes to securing important funding for the company’s continuing research and development.
This is in addition to the principal, which enables Alesi to prevent unauthorised exploitation of the invention. Alesi is now safe in the knowledge that its new design developments were protected going forwards.
Overall benefits of patents
Patents can be highly beneficial to pharmaceutical companies to ensure the continued investment and development of vital drugs, techniques and methods … without fear of losing their monopoly in the future. Companies and individuals should ensure that they file a patent application as early as possible to ensure compounds and their methods are protected to support future progression. The pharmaceutical industry is now evolving and turning to patent attorneys to ensure the commercial longevity and protection of their valuable developments.