Life sciences

The life sciences industry lives through an unprecedented era of change. Recent discoveries have led to exciting new cures for life threatening diseases in a range of fields such as oncology and neurology. Pharmaceutical firms also increasingly focus on rare diseases that had been neglected but are now tackled with breakthrough treatments.

At the same time, the industry is under significant pressure because the commercially successful products that catered for more common diseases and helped millions of patients have now lost patent protection or are about to do so. The resulting financial strains are exacerbated by the tightening of public purses around the globe. Furthermore, bringing a pharmaceutical product to market is becoming ever more difficult because of the increasing demands of regulators. These economic and social developments go hand in hand with a web of rules at the international, regional and national levels that have grown considerably in complexity.

Offering a full range of services in the life sciences field, including advice on regulatory, advertising, intellectual property and antitrust matters as well as representation and advocacy before various judicial and administrative bodies and industry boards, Van Bael & Bellis' lawyers have an in-depth understanding of the latest developments in the pharmaceutical and biotechnological fields, as well as in the neighbouring fields of medical devices, cosmetics and food supplements.

Van Bael & Bellis is active in both the European and Belgian life science arenas. It is, moreover, able to give pan-European advice under the various sets of local rules by relying on both in house lawyers of diverse nationalities and a network of specialist corresponding firms.

Regulatory

The firm has been very active in pricing and reimbursement matters dispensing advice, drafting position papers, creating strategies for dealing with governmental authorities and preparing for litigation as a fall-back option if other strategies were to fail.

Van Bael & Bellis also often advises on clinical trials, drafting all related documentation (such as Clinical Trial Agreements) and dealing with a variety of issues such as privacy, clinical research organizations, patient injury resulting from a clinical trial, insurance, etc.

It also deals with delicate regulatory issues and has addressed questions involving pharmacovigilance, product liability, orphan medicines, parallel trade, product liability and data protection. The firm recently prevailed in litigation against a parallel trader in generic products which had sought to register one of its products in reliance on the marketing authorisation ("MA") of the pioneering product in the import market rather than on the MA of the generic equivalent in that market.

Marketing and Advertising

The firm has an established marketing and advertising practice that is rooted in first-hand knowledge of the day-to-day activities of the commercial arms of pharmaceutical, biotechnological and medical device organizations. Van Bael & Bellis reviews marketing schemes and promotional tools such as detail aids, leave-behinds, support materials and conferences, medical surveys, sponsoring activities in favour of health professionals, hospitals and patient organizations, and Internet-based information carriers. The firm also provides in-house training to clients on these matters. Moreover, it engages in litigation on behalf of firms which challenge the marketing practices of rivals or find themselves at the receiving end of legal challenges.

The firm has acted as co-counsel for one of the largest pharmaceutical companies in the world in complex patent litigation against generic competitors and is making preparations for similar litigation. It also defended valuable biotechnological patents in complex "torpedo" litigation. Moreover, Van Bael & Bellis often counsels on SPC patent-extension issues. The firm also has hands-on experience in dealing with counterfeit trade both under the pertinent EU Regulation and in a Belgian setting. It uses the full panoply of rules available, including patent law, trademark law, data exclusivity rules and the regulatory framework governing medicines, medical devices, cosmetics etc.

Van Bael & Bellis is in a unique position to combine its pre-eminent competition practice with its broad experience in the life sciences field to offer the client a premium service in what often amounts to complex matters. The firm thus has repeatedly counselled in the area of parallel trade including registration and repackaging issues and allocation systems pre and post Bayer (Adalat). Similarly, it has given advice on parallel import issues arising from the enlargement of the EU in 2004. More recently, it has been very active in helping firms manage supply levels and was successful in proceedings before the Belgian competition authorities.

Van Bael & Bellis has drafted and reviewed co-marketing and co-promotion relationships, joint R&D projects and multi-faceted licensing agreements involving a major biotechnological patent portfolio.

The firm has also dealt with the antitrust aspects of dual pricing systems and various discount schemes and it has carried out European and national merger control filings.

It also assisted several clients in the framework of the EU pharmaceutical sector inquiry and is now dealing with the aftermath of that inquiry.

The firm's litigation practice in the life-sciences field is extremely diverse both in the number of jurisdictions used and the range of issues handled. For example, the firm has acted for major pharmaceutical companies in reimbursement matters (before the Belgian civil and administrative courts), issues of generic competition, questions of misleading and disparaging advertising, complex patent litigation and litigation in the framework of co-promotion agreements.

The firm is very active in a number of fora including Belgian civil, administrative and commercial courts, industry boards and antitrust authorities.

Moreover, its experience in dealing with the different directorates general of the European Commission on healthcare issues is difficult to match. By way of illustration, Van Bael & Bellis successfully concluded administrative proceedings before DG Competition involving charges against its client of abuse of patent rights and excessive pricing on a matter crucial to public health throughout the EU. It is also active in dealing with the fall-out of the pharmaceutical sector inquiry.