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SMi presents their workshop for the Biosimilars USA conference, on dealing with Life Science patents in the Biosimilar Space. We will discuss trends for life science patents (including both small molecule and biologics) at the PTAB with respect to Inter Partes Review and Post Grant Review including a review of pertinent case law, strategies for writing petitions and responding to petitions as well as tips for handling depositions and oral hearings.

<p>Patents and patent approval is particularly relevant for the biosimilars industry, as many patents filed and approved for leading drugs are nearing their expiration. After the Supreme Court&rsquo;s decision in Oil States confirmed the Constitutionality of IPRs and PGRs, we can only expect the increasing use of these challenges in the life sciences to continue. IP practitioners need to be prepared for how to prepare to protect their IP assets as well as how to challenge IP assets that may impact their future products.</p>

Workshop LEADER

keynote-img

Ha Kung Wong

Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO

Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics and chemistry. Cases Ha Kung has litigated include those related to siRNA, proton pump inhibitors, anti-epileptic drugs, anti-tussives and other pharmaceuticals. Mr. Wong also has extensive experience with inter partes review (IPR), post grant review (PGR), intellectual property counseling, pre-suit investigations, licensing and due diligence.

Mr. Wong is the recipient of the 2017 ILO Client Choice Individual Award for Intellectual Property in New York. He is currently the Chair of the Recruiting Committee, serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a "Furthered 40" by Lawline for his contributions. He is also an Advisory Board Member for The Center for Biosimilars.

Ha Kung was named to The National Law Journal's 2017 inaugural list of Elite Boutique Trailblazers.

Workshop programme

13:30 Registration & Coffee

14:00 Workshop leaders introduction

Ha Kung Wong

Ha Kung Wong, Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO
View Bio

John Kirkland

John Kirkland, Director, Alkermes, Inc.
View Bio

14:10 Primer on Inter Partes Review and Post Grant Review

14:30 The Impact of Oil States and SAS Supreme Court Decisions

15:00 Networking Break

15:20 Life Science Patent Trends at the PTAB

15:40 Tips for IPR & PGR Trials

16:45 Workshop Exercise regarding PTAB Proceedings

17:30 Final Discussion and Close of Workshop

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FEATURED SPEAKERS

John Kirkland

John Kirkland

Director, Alkermes, Inc.

Ha Kung Wong

Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO
Ha Kung Wong

Ha Kung Wong practices general intellectual property law with an emphasis on complex patent and trade secret litigation in pharmaceuticals, biologics and chemistry. Cases Ha Kung has litigated include those related to siRNA, proton pump inhibitors, anti-epileptic drugs, anti-tussives and other pharmaceuticals. Mr. Wong also has extensive experience with inter partes review (IPR), post grant review (PGR), intellectual property counseling, pre-suit investigations, licensing and due diligence.

Mr. Wong is the recipient of the 2017 ILO Client Choice Individual Award for Intellectual Property in New York. He is currently the Chair of the Recruiting Committee, serves as faculty for NITA (the National Institute of Trial Advocacy) and Lawline, and has been named a "Furthered 40" by Lawline for his contributions. He is also an Advisory Board Member for The Center for Biosimilars.

Ha Kung was named to The National Law Journal's 2017 inaugural list of Elite Boutique Trailblazers.

John Kirkland

Director, Alkermes, Inc.
John Kirkland

John Kirkland is a Director of Intellectual Property at Alkermes, Inc., a global biopharmaceutical company focused on the development of innovative treatments for central nervous system (CNS) disorders. He is responsible for managing all aspects of the IP portfolio related to litigation. Before moving to Alkermes, he was Counsel at Fitzpatrick, Cella, Harper & Scinto, where he focused his legal practice on intellectual property strategy, patent litigation, including Hatch-Waxman litigation and post-grant proceedings. He received his B.A. in Biochemistry and Molecular Biology from Rutgers College and his J.D. from Cardozo Law

VENUE

Renaissance Woodbridge Hotel

515 US Highway 1 South, Iselin, New Jersey, USA

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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