COHAUSZ & FLORACK COHAUSZ & FLORACK. Patent- und Rechtsanwälte. Chemistry, Pharma & Life Sciences

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COHAUSZ & FLORACK Patent- und Rechtsanwälte Chemistry, Pharma & Life Sciences

Our Firm Intellectual property is a high-value asset as it provides a lead over one s competitors. It is therefore imperative that such assets be protected against any infringement by third parties. Only the protection of a technical invention or a trademark secures its value added. This is where COHAUSZ & FLORACK appears on stage. We see ourselves as legal management consultants for intellectual property issues and act as a strategic partner for our clients. Our most important task: We ensure the best possible protection of innovations and trademarks against imitation and use by competitors and we defend our clients against unjustified claims. Our firm Our services Our special expertise COHAUSZ & FLORACK at a Glance Partnership of 18 patent lawyers and three attorneys-at-law Currently around 100 employees, including patent lawyers in training and junior lawyers Industrial property rights (patents, utility models, trademarks, designs) and copyrights of any kind Related fields of law such as unfair competition Technology agreements Planning, applying for, protecting and managing extensive portfolios of industrial property rights for national and international clients Litigation, contractual issues, arbitration COHAUSZ & FLORACK is a partnership in which patent lawyers and attorneys-at-law specializing in different fields work together in an interdisciplinary manner. We provide high end advice to companies of all sizes in the areas of industrial property rights and copyrights and in related fields of law nationally and internationally. In advising our clients, we can rely on experience gained in more than half a century. Among other skills that distinguish us, we think not only in technical and legal categories, but also in an entrepreneurial and business context. We develop superior solutions for technical property rights, trademark rights and design protection by thinking things through to the end and always carving out the maximum protection to ensure the greatest possible freedom of action for our clients. For this reason, we are today among the most prestigious firms providing these services in Germany. We are known for our holistic approach and we cooperate closely with our clients decision makers to protect and promote their intellectual property. After decades in this field of expertise, we are recognized as advisors on all issues of patent and trademark law and are directly involved in our clients decision making processes. We are experts in handling patent applications for medium-sized and large industrial corporations. But our services go far beyond that. In addition to our extensive practice in prosecuting patent applications, we occupy a leading position in Germany in patent infringement proceedings. We draft and negotiate agreements for research and development and for the exploitation of rights. Whether we apply for patent, trademark or design rights, protect such rights or grant licenses to use them what always distinguishes us is our strategic thinking. We are attentive observers and advisors who view our clients interests as our own. In doing so, we often function like an outsourced IP-division. It is not least of all this approach to our consultancy work which has enabled us to maintain client relationships that hold for decades. Our history Partnership formed in Düsseldorf in 1954 by patent lawyers Werner Cohausz and Wilhelm Florack Initially heavy industry, railway and vehicle construction, agricultural and textile machinery Since the 70ies and 80ies also electrical engineering and chemistry, since the 90ies telecommunications and Life Sciences/biotechnology 2 Since 1997 also attorneys-at-law in addition to the patent lawyers 3

Our Specialization Chemistry, Pharma & Life Sciences If you understand nothing but chemistry, you cannot truly understand chemistry either, noted Georg Christoph Lichtenberg in his Sudelbücher. We do understand chemistry, but are not limited there. Instead, we combine our technical expertise in chemistry, pharmaceutical research and Life Sciences with our knowledge and skills in the area of patent law to provide effective advice and assistance to national and international clients on industrial property and other related legal issues. The beginnings of our practise in the field of Chemistry, Pharma and Life Sciences go back about two decades. Initially, in the time from 1990, we focused on pharmaceutical companies. Later, chemical clients followed from the paper, building materials and plant protection industries. A further technical focus of our work is on chemical processes, e.g. for the isolation and modification of organic base materials for synthesis. Parallel to the establishment of our firm in the field of chemical patents, COHAUSZ & FLORACK became active in obtaining patents for biotechnological inventions and genetic engineering processes. The lawyers in our Chemistry, Pharma and Life Sciences practise handle intellectual property rights in all fields of chemistry and Life Sciences, for example: pharma protein biochemistry molecular biology/genetic engineering immunology biotechnology organic and inorganic chemistry polymer chemistry Our special expertise comprises active pharmaceutical ingredients, medicinal substances and medical preparations (galenics), the synthesis of active substances (small molecules) or their production (biologics), diagnostics and screening methods as well as medical devices, therapeutic antibodies, enzymes/protein biochemistry, expression systems, DNA/RNA technologies, data carriers for digital print media (ink jet and thermal transfer printing) as well as biodegradable polymers. As lawyers we act in all fields of industrial property protection and represent clients before the European Patent Office, the German Patent and Trademark Office, the German Federal Patent Court, the Harmonization Office for the Internal Market, the World Intellectual Property Organization and, in patent and trademark infringement proceedings, before the competent courts of law. We advise and assist companies to obtain, enforce and defend their technical property rights (patents, utility models) and mark rights (trademarks, corporate name rights). In addition, we challenge industrial property rights wrongly granted to competitors. Together with our clients, we prepare customized solutions for even the most challenging problems. Overview over our Services preparing patent, trademark and design applications and prosecuting these up to their grant or registration conducting prior art searches to establish the protectability and legal validity of intellectual property rights freedom-to-operate analyses strategic advice, e.g. on the systematic buildup of a portfolio of intellectual property rights, concepts for company patent management or in due diligence proceedings defending our clients intellectual property rights in all judicial and official proceedings challenging competitors intellectual property rights in nullity, opposition and cancellation proceedings enforcing our clients intellectual property rights in litigation defending our clients in infringement proceedings monitoring intellectual property rights with a view to colliding rights and third-party infringements expert opinions on the infringement or legal validity of intellectual property rights advice on contractual matters such as licenses, R&D agreements and agreements on the co-existence of marks portfolio management to manage and maintain our clients intellectual property rights arbitration proceedings, alternative dispute resolution 4 5

Our Expertise All theory is grey, and only the forest and experience are green, said the German forestry scientist Friedrich Wilhelm Pfeil. We do not know as much as he did about forests, but we can (also) back him up on the rest. We will therefore spotlight a few cases from our Chemistry, Pharma and Life Sciences practise beyond all theory. In a cross-border patent infringement case involving a protein-chemical process for the production of vaccines, COHAUSZ & FLORACK successfully defended the New York Blood Center in patent nullity proceedings in Germany, Austria, France and Switzerland against actions challenging its basic patents, for which licenses had been granted in more than 20 countries worldwide. Working together with a U.S. law firm, our client and other lawyers from Düsseldorf, we were able to settle the dispute with a financially attractive outcome for the New York Blood Center. COHAUSZ & FLORACK advised a leading U.S. pharmaceutical company on the market introduction of the blockbuster candidate Telaprevir (INCIVO ) in Europe, a novel protease inhibitor for the treatment of hepatitis C. Moreover, we not only assist and advise this company on the application proceedings before the European Patent Office, but also on the strategy to protect medical substances which are in the clinical trial process and/or are about to be introduced to the market. Our lawyers have extensive expertise in the protection of therapeutic peptides and organic-chemical active substances, as well as knowledge of the relevant case law of the Technical Boards of Appeal of the European Patent Office. Together with a reputed law firm from Düsseldorf, COHAUSZ & FLORACK was involved in patent infringement proceedings regarding the blockbuster drugs Omeprazol (Antra ) and Esomeprazol (Nexium ). A leading law firm from Düsseldorf specialized in patent infringement cases was assisted by us in patent infringement proceedings regarding the Taq-DNA-polymerase of a leading U.S. producer of enzymes. COHAUSZ & FLORACK secured the supplementary protection certificate (SPC) for the monoclonal antibody Tocilizumab in Germany, which is offered by Hoffmann-LaRoche under the trademark RoActemra for the treatment of rheumatoid arthritis. For the diagnostics division of a pharmaceutical company from the Rhine-Main area, COHAUSZ & FLORACK delivered an extensive legal opinion on the risk of marketing a diagnostic method using Taq-DNApolymerase in spite of existing competitors patents. COHAUSZ & FLORACK represent a multitude of innovative biotech companies. These include Kureha Chemical Industry, Meija Seika Pharma, BioGen IDEC, Phrixus Pharmaceuticals Inc, Aureogen Biosciences, Mucimed Inc, Pronai Therapeutics, Verstaron Corp. as well as various university and non-university research institutions. The leading developer and producer of hightech speciality papers in the world, e.g. for photo ink jet printing, has been advised and assisted by COHAUSZ & FLORACK on issues of industrial property protection for twenty years. We prepare patent applications, conduct opposition and arbitration proceedings and provide advice on licensing and research/cooperation agreements. COHAUSZ & FLORACK prepared numerous patent applications for polycarbonate glazing for one of the leading chemical companies in the world based in the Rhineland, Germany. We also successfully represented this company in a series of opposition proceedings before the European Patent Office against high-calibre competitors in the field of polymer compositions. Furthermore, with our freedom-to-operate statements for a plant to be built for the production of diesel fuel from crude oil and a plant to be built for the production of a certain type of fleece, we laid the foundation for a decision on each of these major investments. COHAUSZ & FLORACK conducts the patent application proceedings for an Australian company which develops a series of antibodies to be used for tumour therapy. Two of these antibodies are in the clinical trial process. To this end, COHAUSZ & FLORACK is constantly striving to obtain adequate protection before the background of the increasingly restrictive practise of the European Patent Office in granting patents for antibodies. 6 7

Our Answers Biotechnology has been an important innovation driver for years. The most visible benefit is not least of all its contribution to the development of medicinal products and new diagnostic methods. As in the case of any other technical invention, patents play an important role also in biotechnology. Ralph Minderop and Arwed Burrichter explain the background and the approach adopted by COHAUSZ & FLORACK. Dr. Ralph Minderop, pharmacist, patent lawyer since 1989 and partner at COHAUSZ & FLORACK Why is patent protection important for biotechnological inventions? Minderop: A patent grants its holder a prohibitory right, subject to a time limit, for the inventor s innovative achievement. The patent is the crucial incentive for the investment in new products and their further development. Investors who put up money for expensive developments must be certain that they will gain a return on their investment in the form of an exclusive right of use, either through marketing the product directly or by granting licenses. Dr. Arwed Burrichter chemist, patent lawyer since 2000 and partner at COHAUSZ & FLORACK Burrichter: And it is precisely for this reason that it is important to prohibit the utilization of the invention for industrial and commercial purposes by third parties. Empirical studies show not least of all that the value added created by businesses today consists to a considerable extent of the development of products and services based primarily on knowledge. For many companies patents are the most important assets. Biotechnological inventions have for some years regularly constituted one of the ten biggest technical areas in patent applications to the European Patent Office. How can a patent law firm assist its clients in this regard? Burrichter: If the firm is good, it helps the inventor to define the protection as broadly as possible to avoid any circumvention. This is one of the neuralgic points. Already in the application, all of the essential features of the invention to be protected must be stated. Any subsequent extension is not possible. Minderop: For this reason the lawyers technical expertise plays a central role in the application process as it does in asserting and protecting the intellectual property rights. Why should a company invest in patents, also in view of its further development? Burrichter: Many small and medium-sized companies are financially hardly able to develop their inventions until they become marketable. Sooner or later they therefore need either a financially strong cooperation partner, a buyer, financial investor or licensee. Whatever the solution may be patents document the innovative strength and market orientation of a company and turn the result of research directly into a marketable asset. Patents are therefore an indispensable building block for the economic success of the company. What kind of business are your services especially suited for? Minderop: Basically all companies in the biotech industry can benefit from our spectrum of services. This begins with the start-ups. For them it is primarily the patent protection for a first product, i.e. the application, which is important, but also patent evaluations in view of venture capital financing. Medium-sized companies additionally need a professional partner to negotiate licensing agreements. This increasingly also concerns strategic advice, portfolio analyses and in case of a proposed cooperation or takeover the preparations for the due diligence. Patent mapping, i.e. the market and competition analyses, is also important in medium-sized and also large corporations. Burrichter: Apart from that, independently of the size of the company, the issue of infringements always becomes virulent once a product reaches the market. What can you offer smaller biotech companies which hesitate because of the costs to retain a reputed and large firm for its industrial property rights? Minderop: For these companies we have devised a kind of basic package. It comprises initial advice and we prepare a draft patent application and submit it to the patent office. All this for an attractive package price. 8 9

Why COHAUSZ & FLORACK? There are currently about 2,500 patent lawyers and about 160,000 attorneys-at-law in Germany. Naturally not all of them deal with industrial property protection. All the same: The choice is large. What speaks for COHAUSZ & FLORACK? We have many years of experience. Formed in the year 1954, COHAUSZ & FLORACK has decades of experience in matters of industrial property protection and copyrights and in the related fields of law, e.g. unfair competition. We have been helping our clients for over 55 years to draw the maximum benefit from industrial property rights not only through the possibility to prohibit the imitation or commercial use of the protected product or trademark by third parties, but also through advanced design and greater trademark value, granting licenses, and the advertising effect. Our know-how covers a wide range. COHAUSZ & FLORACK excels through special expertise in applying for, pursuing and managing extensive patent and trademark portfolios for national and international clients. This expertise goes hand in hand with our extensive experience in patent infringement litigation. We develop the maximum innovation and trademark protection. COHAUSZ & FLORACK stands for a quality difference. We extend the area of protection around an innovation or trademark to such an extent that they are fully shielded from imitation and thus from the cost-free takeover by a competitor. We regularly succeed in doing this even where others have given up. In this way, we give our clients the greatest possible freedom of action in using their inventions, trademarks, design or know-how. We are an interdisciplinary team. COHAUSZ & FLORACK is characterized by an interdisciplinary company culture marked by long-lasting client relationships. In our firm, patent lawyers from various disciplines or fields together with our attorneys-at-law develop pragmatic and user-oriented solutions. We stand by our clients throughout the world. COHAUSZ & FLORACK has its roots in Germany. Going far beyond the German market, we work together closely with lawyers in all relevant jurisdictions through a sophisticated network of foreign colleagues built up, fostered and maintained in decades throughout the world. We offer professional online-services. Whether it be online access for our clients to information in our data base regarding their intellectual property rights, a data room for the speedy and safe exchange of documents or a data base which provides a market overview over existing intellectual property rights - COHAUSZ & FLORACK provides professional online services for client communications and the management of patent and trademark portfolios. Seattle Los Angeles Mexico City Chicago Montreal Boston New York Bogota Lima Santiago de Chile Buenos Aires Rio de Janeiro Cape Town Cairo Moscow Ankara Tel Aviv Riad Mumbai New Delhi Bejing Seoul Singapore Tokyo Hong Kong Sydney 10 11

Patent- und Rechtsanwälte Partnerschaftsgesellschaft Bleichstraße 14 40211 Düsseldorf Germany Telephone: +49 211-90 49 0-0 Facsimile: +49 211-90 49 0-49 mail@cohausz-florack.de www.cohausz-florack.de