“Patent linking” in the classic sense is thought of as linking the approval of a generic pharmaceutical to the patent status of the name brand drug
The Hatch-Waxman Act in the United States uses this classic approach in attempting to balance the rights of patentees with generic medicines and patients to provide a statutory framework intended to bring generic pharmaceuticals to market in a timely manner.
But, this is not the only approach. Europe, for example, focuses its efforts on data and marketing exclusivities to promote R&D as well as facilitate generic market entry, while India uses a hybrid approach without formal linking. Rather, India combines a developmental safety harbour with patent opposition practices to reduce evergreening.
The panel comprising comprising in-house IP counsel from an innovator drug company and independent IP practitioners from India, China, and the US, will provide an overview of each system and will discuss practice tips from each perspective as well as how to coordinate efforts between the jurisdictions when seeking to bring a generic to market.
MODERATOR: Branko Pejic - Greenblum & Bernstein (US)
Branko Pejic is a co-chair of the Greenblum & Bernstein litigation/trial practice group, and is a member of the firm’s start-up/acquisition group. Prior to joining G&B in 1999, he clerked for a US District Court Judge, and completed a mini-pupilage at Gray’s Inn, London, England. Branko litigates a wide spectrum of technologies on behalf of numerous foreign companies in disputes before the US Federal District and Appellate Courts and in contested proceedings before the US Patent and Trademark Office, advises in merger/acquisition transactions, and counsels clients on intellectual property matters including patent, licensing and monetisation strategies. He speaks on and has published articles on these issues as well US litigation practice and strategies, and currently serves as the Secretary of the US FICPI section.
Branko's primary focus is pharmaceutical/bio-tech, including Hatch-Waxman ANDA litigations, and high-tech technologies. He has represented both innovator and generic drug companies in litigations, including serving as lead trial and appellate counsel for generic manufacturers in several “blockbuster” drug litigations, as well as patentees and accused infringers in various other technologies, including medical devices. He additionally has served as lead IP counsel in due diligence and negotiations for multiple transactions to acquire/sell patents, business divisions and products as well in/out licensing of patent portfolios in the pharma/bio fields. Branko holds a B.S. in Chemical Engineering, a Juris Doctorate and an LL.M. in International and Comparative Law with a focus on Intellectual Property from Georgetown Law Center.
Daniel Alge - Sonn & Partner (AT)
Daniel Alge has been a partner at SONN since 1997 and is an authorised representative before the EPO, the Austrian Patent Office and the European Union Intellectual Property Office. He represents his clients in patent prosecution and enforcement of patents, mainly for pharma and biotech clients. He advises clients (ranging from universities and biotech start-ups to big international pharma firms) also in IP due diligence, patent and trademark valuation and employee’s inventions (service inventions).
In addition, Daniel Alge is an Expert Judge in patent litigation at the Vienna Commercial Court and the Austrian Supreme Court; he is President of the Austrian Chamber of Patent Attorneys, and the Austrian delegate of the International Federation of Intellectual Property Attorneys (FICPI) where he also acts as the president of the EU Working Group of FICPI.
Daniel Alge gained a doctorate in Chemistry (specialising in Biochemistry) at the Vienna University of Technology and then worked as a post-doc at the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany.
Juhua Luo - CCPIT Patent & Trademark Law Office (CN)
Juhua Luo's practice focuses mainly on patent drafting, prosecution, invalidation and litigation including patent linkage litigation. He has handled over a thousand patent filing and prosecuting cases and has successfully represented clients in many cases of patent reexamination, patent invalidation, patent linkage and patent-related administrative litigation.
He has extensive experience in patent appeals before Beijing No.1 Intermediate Court, Beijing Intellectual Property Court, Beijing High Court and Supreme Court. Juhua has also provided legal opinions which relate to the areas of patent infringement, validity of patents, granting prospects of patent applications and freedom to operate.
Juhua's subject matter expertise encompasses all fields of biotechnology and pharmaceuticals with emphasis on molecular biology, genetic engineering, immunology, plant sciences, microbiology, agricultural biology, biopharmaceuticals, regenerative medicine, food and small molecule drugs.
Dr Deepa K. Tiku - K&S Partners (IN)
Dr Deepa Kachroo Tiku is a partner at K&S Partners and based out of the Gurgaon (National Capital Region) office. Deepa is a registered Patent Agent with the Indian Patent Office and an attorney at law. She specialises in the area of Life Sciences, with an emphasis on patent drafting, prosecution and contentious practice, particularly biotechnology and pharmaceuticals as well as biomedical, nanotechnology, chemistry and polymer related inventions. Her practice also involves advising both domestic and international clients on Plant Variety Protection in India as well as the Biodiversity Act of India. Deepa also advises on enforcement of patents, freedom to operate, due diligence, technology transfer and licensing.
Deepa has been practicing in the field of patent law since 2004 with an added prior experience of few years of working in the industry as well as a researcher. She is a named inventor in total of 21 granted patents worldwide and has several publications and articles to her credit. Deepa offers a unique blend of science and law for handling and advising on complex life sciences patent matters in India.
Deepa is a regular speaker at various IP Fora and works on IP policy related issues as well. She serves as a member of the National Biotechnology Committee of CII, the premier Chamber of Commerce in India.