Biotechnological inventions and patents

Finland has had more than its fair share of biotechnological start-ups in recent years, but their success partly depends on their ability to protect their work in the midst of increasingly hazy EU patent laws. By Petri Eskola

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Biotechnological inventions have been subject to patenting for more than 100 years. In Finland, patent number three was granted in 1843 for a novel method of producing yeast cultures. Since then, there have been several patents for inventions that are biotechnological in their character.

But in recent decades, along with considerable improvements in scientific fields such as the human genome, opinions on patents for biotechnological inventions have become divided. It has especially been a hotly debated topic in Europe, not only during the lengthy preparation of the related European legislation, but also since the respective directive was enacted in 1998.

Finland was among the first member states of the EU to implement Directive 98/44/EC, on the legal protection of biotechnical inventions (Biotech Directive), in July 2000. At the same time, many of the amended provisions of the Patents Act were also adopted, following the wording of the Directive.

Prior to the implementation of the Patents Act, the provisions on patentable subject matter considered plants and animals to be not eligible for patenting. The patent practice in the field was, despite several patents granted over a lengthy period of time, rather limited. In practice, a much more important provision of the Patents Act was, until 1995, the statutory limitation that excluded product patents for pharmaceuticals. Only methods for manufacturing pharmaceutical products were patentable until that time. Upon joining the European Patent Organisation), this provision was amended by making pharmaceutical product patents possible.

Since the implementation of the Biotech Directive, the patentability of biotechnical inventions, as a point of departure, has been based on the same criteria as for inventions in any other field. However, there are specific limitations on the patentability of inventions in the field of biotechnology that derive directly from the provisions of the Directive.

Patents shall not be granted for plant or animal varieties. However, inventions that concern plants or animals are patentable, if the technical feasibility of the invention is not confined to a particular plant or animal variety.

The concept of plant variety within the meaning of the Patents Act is defined by Article 5 of Council Regulation (EC) No. 2100/94 on Community plant variety rights.

Furthermore, patents shall not be granted for essentially biological processes for the production of plants or animals. A process for the production of plants or animals shall be considered essentially biological, if it consists entirely of natural phenomena such as crossing or selection.

What is said above is without prejudice to the patentability of inventions that concern a microbiological or other technical process or a product obtained by means of such a process. Microbiological process means, according to the Patents Act, any process involving or performed upon or resulting in microbiological material.

Inventions shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Biological material that is isolated from its natural environment or produced by means of a technical process may be the subject of an invention, even if it previously occurred in nature. For the purposes of the Patents Act, biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

Historically, the Patents Act contained one important exclusion relevant in the field, namely the limitation of patents for methods aimed at treating humans or animals by surgery or therapy and diagnostic methods practised on humans or animals.

Biotechnology in Finland

During the 1990s, there was a remarkable investment boom in the biotechnological sector in Finland. With more than 115 biotechnology companies, Finland could be ranked among the top European countries with regard to the number of essentially biotechnological firms.

In the early 2000s, however, many of these promising firms ended up in a deadlock as the inventions they made and patented could not be successfully commercialised or when expected inventions never came to fruition.

Approximately half of the companies still in the business are concentrating on health products, such as pharmaceuticals. Generally speaking, the use of biotechnology in the pharmaceutical industry appears to be increasing.

Biotechnology and pharmaceutical industry

A well-known fact is that the pharmaceutical research process is particularly long and expensive. Therefore, the patent system plays an important role in the pharmaceutical industry. The relevance of the patent system is not only to protect inventions, but also, and no less importantly from the general point of view, to serve as a data bank for competitors.

According to some estimations, biotechnology is involved in every fourth new pharmaceutical molecule developed.

Finnish pharmaceutical companies are rather small compared to the steadily growing global giants. The trend towards globalisation and growth is noticeable within the industry. Mergers of the existing multinational entities have been abundant during recent years. The patent portfolio of a would-be partner becomes most diligently scrutinised in these processes and the relevance of the contents and legal protection of these is obvious.

The possibilities for smaller entities to survive in this tough environment lies in their inventiveness, and their duly protected intellectual property rights are of uttermost importance.

Petri Eskola is a partner at law firm Backström & Co. He can be contacted at: petri.eskola@backstrom.fi

Biography

Petri Eskola trained with the Helsinki District Court between 1996 and 1997, and was admitted to the Finnish Bar in 2001. He has experience in all intellectual property matters and advises clients on all related aspects, as well as major areas of business law. He joined Backström & Co in 1998, where he is now a partner.

The firm

Backström & Co Ltd, Attorneys-at-Law was established in 1993. The firm´s principle is to handle all commissions on a basis of personal responsibility. Backström & Co offers legal services in practically every area of business law. The firm´s core expertise is intellectual property and copyright law.

Backström & Co Ltd also offers services in general business law, especially contract, competition and corporate law. In addition, the firm handles civil litigations and arbitrations.

Over the years, Backström & Co has achieved a solid position as a frontranking law firm and has particularly gained recognition as an expert in intellectual property. The firm has been named in several international publications such as European Legal 500, Chambers and Partners and MIP as one of Finland’s leading firms in its special field.

Main areas of practice

Backström & Co offers legal services in all principal fields of business law. The firm’s essential field of proficiency and specialisation is intellectual property law, but they also have wide expertise in issues concerning commercial contracts, competition, consumer and company law. Backström & Co Ltd also have long-term experience in managing clients’ cases in general and special courts as well as in arbitration.

The firm is highly renowned for its skill and experience in issues regarding patents, utility models, trademarks, designs and copyright. Backström & Co Ltd offers related legal services in all fields of technology and trade and co-operate with leading patent offices and experts. In addition, the firm provides services in IP-related regulatory matters, and matters related to product liability advertising and consumer protection, confidentiality and trade secrets, franchising and merchandising, privacy and data protection.

Participation in numerous court cases in various fields of law has increased the experience of our lawyers and insight into the legal process.

Backström & Co Ltd´s profound proficiency in the dispute settlement process helps avoid unnecessary legal proceedings should a dispute occur. The experience allows the firm to provide successful services for its clients both in terms of avoiding disputes and of solving disputes by negotiation or in litigation.

International work

Backström & Co is a member of Eurojuris International, a leading network of small and medium-sized European law offices. Through the Eurojuris membership the firm is able to complement its individual assignments with first-rate, comprehensive local expertise in all the European Union countries and overall in more than 40 countries worldwide.

Backström & Co and its lawyers are members of several national and international organisations such as IBA, AIPPI, INTA, ECTA and EPLAW.

Clients

Backström & Co Ltd’s work is characterised by internationalisation: the main working language in the firm is English as a substantial amount of the clients are from abroad. In addition to English, other working languages are Finnish and Swedish.

Backström & Co has handled several litigations on behalf of large multinationals, and advised such clients on other legal matters. The firm has also advised specialised small and medium-size companies on various matters. A large part of the national clients are active on the international field.