Tomos Shillingford has been Actavis' director of IP litigation since March 2012, using his considerable experience in international patent litigation to coordinate disputes across a range of jurisdictions.
Who’s Who Legal spoke with Shillingford about his role within Actavis, the company’s impressive growth in recent years, current developments in the pharmaceutical sector as well as the company’s interaction with the legal industry.
Actavis is a global pharmaceutical company which focuses on the development, manufacture and commercialisation of branded pharmaceuticals, medicines and biologic products. Since its establishment as a small drug development enterprise in 1984, Actavis has achieved impressive expansion as a result of strategic acquisitions and is now established as one of the world’s largest generic businesses, having also built a major portfolio of brand products in key categories including neuroscience, women’s health and urology and cardiovascular disease and infectious disease.
With global headquarters in Dublin and administrative headquarters in Parsippany-Troy Hills, New Jersey, the company has a commercial presence in over 100 countries and offers a portfolio of more than 1,000 products in a competitive pharmaceutical market. On 17 March 2015, the company completed its acquisition of Allergan in a cash and equity transaction valued at roughly US$70.5 billion, creating one of the fastest-growing and dynamic companies in global health care and providing a solid foundation for long-term growth in the industry.
Having previously acted as a senior patent counsel at Actavis, Tomos Shillingford has been the company’s director of IP litigation in the international markets since March 2012. In addition to his expertise as a corporate counsel, Tomos spent more than five years in private practice at Bird & Bird and Freehills.
I manage IP litigation for the group in the “international markets” (excluding the Americas). This is mainly patent litigation but of course also strays into other areas such as trade marks, copyright, rights of confidence, competition law and regulatory issues. There is a lot of variety in the role and given the diversity of substantive law and procedure around the world no two hours are ever the same, let alone days. I find it endlessly fascinating. I also have the honour of working with some brilliant and interesting people across the globe, both within Actavis and as our external counsel.
The ascent of Actavis has been remarkable. When I joined the legacy Actavis business around six years ago it was a medium-sized generics business, itself having conducted a string of acquisitions. I then moved to Watson three years ago, but was taken off gardening leave early when Watson immediately bought Actavis. Watson then renamed itself Actavis, which streamlined my CV nicely. The deals have continued unabated. The purchases of Warner Chilcott, Forest and now Allergan have jettisoned the new business into the top 10 pharma businesses in the world. We now have a diversified business in branded pharmaceutical products, generics, biosimilars and over-the-counter products. Our focus has recently been on closing the Allergan acquisition and successfully integrating two great companies in order to form a new type of pharma company with phenomenal growth rates.
I have around 70 active files at the moment with a huge number of multi-jurisdictional projects in the pipeline. While Actavis will respect valid IP rights, we are not shy in questioning those that we believe to be wrongly granted. Formulations and dosage regimens continue to be popular areas of dispute, but over the past few years the European Regulation relating to Supplementary Protection Certificates has spawned a large number of references to the European Court, including three that were initiated by Actavis. Unfortunately, it seems that the legislators had not foreseen many of the practical questions that would arise across the different types of medicinal product and in the cross-over between the regulatory and patent spheres.
Some companies use law firms to coordinate multi-jurisdictional proceedings and while I do this sometimes due to capacity issues our preference is to keep this in-house. This makes it much easier to align our various business functions (operations, regulatory, portfolio, launch management, etc) with the litigation strategy and timelines. The internal team also quickly accrues experience across the various jurisdictions that can assist in future strategy development and ensuring that parallel proceedings complement each other. This means that we have a high degree of interaction with law firms across Europe and the world. Selection of the best representation is an important function. There is no substitute for having watched counsel’s submissions first hand.
There is a lot of financial pressure on the industry at the moment. The difficult climate since 2008 has inevitably led to pricing pressures across Europe. This has combined with rising clinical and regulatory fees to squeeze cost structures in the pharma industry. Increased competition in the generics sector has led to consolidation and pressure to differentiate portfolios. Once polarised, the originator and generics sides of the industry have been coming together for some time but the above factors have accelerated this. Actavis is a case in point, representing a new hybrid model in the industry.
Our international IP litigation team is considerably smaller than most of our direct rivals. While there is some room for expansion, it is important to me that team structure is sustainable on a long-term basis. We have extremely high standards. We recently recruited a stellar senior associate from a top-tier niche London IP practice and will only consider similarly high-calibre candidates in the future. I think that you need to be resourceful and proactive to succeed in what is a very fast-moving environment. Indeed, this is certainly not a place for someone who doesn’t like change. As our role is often at the crossroads of many business functions there is a lot of travel and contact with people of all nationalities, so a gregarious nature is also helpful.
Some companies like to instruct the real “pitbull” style of litigator but that has never been the manner in which I have wanted to be represented at court. In my experience, feigned outrage and exaggeration, etc, are quite often counterproductive. I generally prefer counsel to exude “quiet authority”. I also find that the best IP litigators are those with the capacity for creativity and tend to have wider interests. They are quite often very interesting and engaging individuals.
I actually mapped out a career path when I was about 17 years old and have managed to follow it. At that age it is of course very difficult to know what you will find rewarding during your working life and I have been lucky to have enjoyed the journey. So my move in-house and into the pharma industry was pre-planned. I waited until I was senior enough and had sufficient experience to take on the challenge of the in-house role, which I believe requires the ability to work autonomously. When I joined Actavis I was promised a wild ride and that has certainly been delivered. The pace of the business is ferocious and the caseload is enormous so you need the ability to process information very quickly.
Actavis has been engaged with the UPC project for a number of years already and has carried out preliminary planning for the new system. While the goal is laudable there remain some very substantial issues that need to be resolved, in my view: not least how the law on infringement will develop under the UPC and how this will interact with the national laws of the member states. I think that we are still some way from the opening ceremony but in the meantime patent filing strategies should take the new system into account, including the transitional provisions which may be in force for a significant period of time.
I shamelessly love my job. Running trials on complex technical and legal issues and playing some part in the development of international patent law is very exciting. It is all the better to consider that at the end of the process patients will benefit from affordable, quality medicine that has a real impact on their lives. I am a great believer in the patent system and in research and development. There is balance in the system – it is just sometimes a question of finding it.