March 6, 2019
One active ingredient of a medicine may be included in tens or even hundreds of patents, so running the IP of a pharmaceutical company requires insight, experience, and strategic know-how. IP is one of the critical aspects in the success of a company in the pharmaceutical field, says Orion’s IP Director, Heidi Adler.
“A medicine is developed for as long as 15 years”
Competition is fierce in the pharmaceutical business. Everyone is constantly looking for new molecules based on which new innovative medicines can be developed. Patents in this field are particularly important so that original molecules could be protected at an early phase of development work to ensure exclusive rights and to safeguard the investments. Furthermore, the new drug development process of medicines is long, because testing the medicine requires clinical studies and heavy regulatory processes for the approval for a drug into marketing.
The marketing approval of a drug may be granted after 15 years from filing the first patent application of the original molecule. In such a case, there would be just 5 years left of the exclusive right at the time the medicine is offered for sale. In the pharmaceutical industry, the Supplementary Protection Certificate (SPC) system is in place, granting an additional protection period of five years, if certain prerequisites are met, in case it has taken a long time for the medicine to be introduced on the market. Through the extended exclusive right, this system allows the investment to be worthwhile and makes it possible for it to pay itself back.
“Many things can be patented”
An innovative active ingredient may be included in hundreds or patents, and drug dosage, among other things, may be patented. If a medicine has previously been administered twice a day, a new innovative coating may be developed, allowing a dose of one sustained-release pill once a day. Patents for medicinal substances are sought by both the originator and generic competitors bringing to market a competing product, which is based on the same medicinal substance. For example, docetaxel is an active ingredient in cytostatics, based on which a substantial number of medicinal products have been developed and most certainly will be developed – in an amount of tens of applications per year.
“Global portfolio covers different forms of protection”
In addition to patents, Orion’s IP portfolio consists of trademarks, domain names, and design rights. We are active in patenting, and were the second most active company registering Finnish trademarks in 2017 according to the statistics by the Finnish Patent and Registration Office. For example, we have design protection for the shape of a dosing apparatus of inhalable asthma medicines. Our IP utilization options further include licensing: if we do not ourselves use a molecule we have developed, we can license it for others to use. Similarly, we can in-license molecules or technologies others have developed, if we see potential in them and have the chance to further elaborate a promising development work.
“We do not infringe the rights of others”
Our IP portfolio is global and we have competitors all over the world. Our daily work includes oppositions, appeals, and disputes, which typically are taken through the various court instances and cases typically last until the end of protection period. During our history, we have fought for our innovative medicines in many locations such as United States, Japan, Finland, and Sweden. Disputes could arise when companies, which are bringing generic drugs into market, and by challenging our patents want to enter the marker sooner than would be allowed by the original patent protection period. We are fully prepared to protect our rights: for example, if someone were to use our trademark without a permission, we would intervene immediately. It is our own strong principle in our operations that we do not infringe the IP rights of others.
“Patent application writing skills is essential”
Orion invests a hundred million euros in R&D development annually, so we want to have exclusive rights of high-quality to our innovations. Our patents need to be strong enough so that we can successfully defend them to guarantee our exclusive rights. The patent applications must be written so that they will withstand courtroom hearings after, let’s say, 20 years. We are also continuously searching new digital tools and ways to manage the IP work more efficiently. According to my own philosophy of leadership, it is important that we do IP work together as a team in cooperation with the rest of the company organisation and with the external network. In an ideal case, the members of my team have their own individual strengths that support each other. In such a case we achieve more as a team than individuals could ever achieve as separate actors.
“Learning of new things is a key to success”
It was like coming home, when I started here in August, 2018 as the Director of Orion’s Intellectual Property Rights department. In this work I can utilise everything I have learned in the past: my studies at the chemistry department of the University of Helsinki and my long experience in tailoring corporate IP portfolios and strategies. The work with the highly skilled experts of our research and development unit and business people opens up interesting views in chemistry, pharmaceutical business and the IP sector. I am now involved in many new things and each day means learning.
“IP makes a company attractive”
I transferred to this job from Kolster where I managed the biotechnology and chemistry unit, and got great experience in strategic IP partnerships. I also had the chance to learn ways that companies apply when they develop and commercialise IP. The strategic development and management of a company’s IP portfolio is critically important from the point of view of the company’s business activities. A strategy should always be dynamic, and it need to be updated regularly to reflect with the ever-changing operational environment. Here at Orion, my work always has a link to the company strategy, and we make successful business operations possible by our own input. When IP is in shape, we are attractive as a company. I also participate in the IP work group of EFPIA (European Federation of Pharmaceutical Industries and Associations), which gives me more insights to my work and I can influence the IP development of the sector. We can make use of this information in our everyday work.