“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.
Rafał Witek - WTS Partners (PL)
Rafał Witek is a partner and co-founder of WTS Patent Attorneys, with a MSc in biotechnology, as well as a Polish and European patent attorney, UPC representative, specialising in the protection and commercialisation of inventions in the fields of biotechnology and pharmacy.
He obtained his degree in biotechnology from the Wrocław University of Technology in 1996. In 1996-97 he participated in a postgraduate studies on industrial property protection at Humboldt University in Berlin. In 2003 he obtained a Max-Planck Foundation scholarship for a research stay at the Max-Planck Institute of Industrial Property Protection and Tax Law in Munich. Rafał became a certified Polish patent attorney in 1999 and a European patent attorney in 2004.
He acquired his initial professional experience at the Office for Patent Protection of the Wrocław University of Technology (1997) and at the largest Polish office for industrial property protection (1998-2002), as a patent attorney responsible for biotechnological and pharmaceutical inventions.
As a co-founding partner of WTS Patent Attorneys, he has specialised in legal advice relating to the identification of and minimizing patent risks inherent in the market entry of pharmaceuticals. He has conducted many court processes before the Polish Patent Office and civil courts, in cases concerning patent invalidation as well as matters concerning their infringement.
Moreover, he is a consultant for the protection and commercialisation of intellectual property for many public and private scientific organisations in Poland. He advises and aids in the development of several biotechnological companies.
He was a co-author of the industrial property teaching course of the University of Warsaw. Rafał was the initiator of the Lower Silesia Patent Centre as well as the Mazovian Patent Centre (in collaboration with the FIRE foundation). Both these initiatives were financed by EU funds as well as the Foundation for Polish Science. The goal of these centres was to provide free legal aid to scientists interested in the commercialisation of their research. He was a consultant for the team designing the project “PATENT PLUS – support for patenting inventions” of the Polish Ministry of Science and Higher Education. He is also the author of many publications relating to this area, addressed to Polish scientists and entrepreneurs, as well as being a frequent speaker at conferences and seminars.
Rafał is a member of the Polish Chamber of Patent Attorneys, where he actively participates in the work of the Audit Committee, a member of the Institute of European Patent Attorneys, an associate member of the EPI Committee on Biotechnological inventions and a former President of the LES Poland. He is also a member of AIPPI, FICPI, UNION-IP and EPLIT.
He speaks German, English and Polish and has a basic understanding of Russian.
In 2021, Polish Prime Minister granted him the badge of honor “For the Merits in Inventiveness”.
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.