August 15-19, 2011 – Intellectual Property Law Summer School 2011 (IBC Legal) – Cambridge, UK

August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

September 6-7, 2011 – Pharmaceutical Law Academy (IBC Legal Conferences) – London, UK

September 8, 2011 – Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly (Strafford) – 1:00 – 2:30 PM (EDT)

September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

September 14-16, 2011 – 85th Annual Meeting (Intellectual Property Institute of Canada) – Chicago, IL

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) – Cape Town, South Africa

September 19-20, 2011 – Tech Transfer Summit Europe*** (Tech Transfer Summit Ltd.) – Paris, France

September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

September 21-22, 2011 – Forum on European Pharmaceutical Regulatory Law*** (C5) – Brussels, Belgium

September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NYNew York, NY

October 3-4, 2011 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – Bethesda, MD

October 4-5, 2011 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) –

October 5-6, 2011 – Biotech Patenting*** (C5) – London, UK

October 24-26, 2011 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, UK

October 25-26, 2011 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

***Patent Docs is a media partner of this conference or CLE

Tech Transfer Summit Ltd. will be holding the European and North American stops of its Tech Transfer Summit on September 19-20, 2011 in Paris, France and on October 3-4, 2011 at the National Institutes of Health (NIH) in Bethesda, MD.  The Summit focuses on dialogue, partnering, licensing and technology transfer between public sector research technology transfer offices and senior industry licensing and business development executives, and serves as an international think-tank for technology transfer professionals, researchers, business angels, Government funding bodies, venture capitalists, financiers and financial service providers, and the legal profession in the biotechnology and life sciences sectors.

A full program for the European and North American legs of the Tech Transfer Summit, including an agenda of each event's sessions and list of speakers can be obtained here (Europe) or here (North America).

The registration fee for the Tech Transfer Summit Europe is €499 (academia, start-up, and government rate) or €799 (industry, legal, financial, and advisory rate).  Details regarding registration for the European event can be found here.  The registration fee for the Tech Transfer Summit North America is $549 (academia, start-up, and government rate) or $899 (industry, legal, financial, and advisory rate).  Details regarding registration for the North American event can be found here.

Patent Docs is a partner of the Tech Transfer Summit.

International Quality & Productivity Center (IQPC) will be holding its 7th Annual Developing IP Strategies for Crystalline Forms conference from October 24-26, 2011 in London, UK.  The conference will allow attendees to:

• Receive clarification of the application submission criteria directly from the examiners;
• Make informed decisions before designing and drafting robust crystalline form patents;
• Understand the required levels of data disclosure;
• Save time and speed approval through successful examples of patent prosecution highways in practice;
• Understand and overcome the challenges of demonstrating true innovation in crystalline forms;
• Implement effective strategies to enforce and protect your polymorph patent;
• Discover strategies to defend against litigation and extend market exclusivity;
• Analyze the latest patent strategies, case laws, and judicial decisions to ensure a successful drafting and litigation strategy;
• Benchmark patent protection strategies with leading experts in the field; and
• Connect with colleagues and peers in dedicated interactive networking and discussion sessions.

In particular, the conference will offer presentations on the following topics:

• Drafting and designing a robust and meaningful crystalline form patent: The EPO perspective;
• USPTO: Your guide to examination of crystalline forms in the U.S. and the impact of these on your patent application;
• Are crystalline forms patentable in India?  Understanding what is and what isn't eligible for submission and approval;
• International panel discussion — chance to ask specific questions and get answers needed to ensure successful global crystalline form patent applications;
• Fast tracking your application using the patent prosecution highways and accelerated examination;
• Strategically strengthening your patent application;
• Understanding the value and reasons for patenting crystalline forms;
• Differentiating your polymorph from prior art: How do you demonstrate true innovation and prove novelty and inventive step?
• Computational prediction of crystal structures;
• Enforcing and protecting your polymorph patent;
• Understanding the Orange Book requirements to avoid litigation;
• Maximizing your patent lifecycle to extend market exclusivity;
• Breakout roundtable discussions: (a) supplementary protection certificates; (b) designing and drafting a robust patent application; and (c) preparing for litigation;
• Uncovering the available technologies to differentiate competitor samples from reference samples: Beyond x-ray diffraction;
• European judicial update;
• Update on the community/EU patent and unified litigation system;
• Unraveling multinational approaches to avoid exploitation: Strategies for obtaining a preliminary injunction; and
• Identifying and exploiting vulnerable patents: The generics perspective.

An additional pre-conference workshop will be offered on October 24, 2011.  The workshop will offer presentations on the following topics:

• Overview of current opportunities and requirements for SPC/PTE applications;
• SPCs at the interface between patent and pharmaceutical law;
• Extending patents via pediatric exclusivity in Europe and the U.S.; and
• SPC judicial case law update.

The agenda for the Developing IP Strategies for Crystalline Forms conference can be found here (Day 1), here (Day 2), and here (pre-conference workshops). A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

Pricing for the conference and workshops can be found here.  Those registering by September 9, 2011 will receive a discount of between £100 and £250 off the registration fee, and those registering for the conference and workshop by September 30, 2011 will receive a discount of £150 off the registration fee.  Those interested in registering for the conference can do so here.

Patent Docs is a media partner of the Developing IP Strategies for Crystalline Forms conference.

American Conference Institute (ACI) will be holding its FDA Boot Camp Devices Edition conference on October 25-26, 2011 in Chicago, IL.  ACI faculty will help attendees:

• Master the basics of the application and approval processes, including 510(k) clearance and PMAs;
• Navigate the complexities of device regulations;
• Comprehend the structure of the FDA and the roles of the three major agency centers:  CDER, CBER, and CDRH;
• Develop a practical working knowledge of clinical trials and IDEs;
• Learn how devices are classified, monitored, and regulated;
• Recognize the pivotal role of labeling and learn how to avoid misbranding and off label promotion;
• See the importance of cGMPs and QSRs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, product withdrawals, and recalls.

In particular, ACI's faculty will offer presentations on the following topics:

• The basics: Understanding and working with the FDA — jurisdiction, functions, organization, and operations;
• Overview of device regulation;
• Understanding clinical trials and the investigational device exemption (IDE);
• Navigating the 510(k) clearance process;
• Comprehending the premarket approval process (PMA);
• Complying with general post-market controls;
• Understanding FDA enforcement tools, policies, practices, and trends;
• Labeling and promotion;
• Medical device reporting;
• Guidance for navigating recalls and withdrawals; and
• Quality system regulation.

A pre-conference training session on the "Fundamentals of FDA Regulatory Law," will be offered on October 24, 2011 from 1:00 – 5:00 pm.  The workshop will provide a basic overview of FDA regulations and will prepare attendees for the in-depth discussions that will take place throughout the conference.

Two concurrent post-conference master classes will be offered from 2:00 – 5:00 pm on October 26, 2011.  The first master class, entitled "Staying Ahead of the Curve: FDA's Regulation of In Vitro Diagnostics and Laboratory Developed Tests," will provide an in-depth overview of the FDA regulatory structure governing IVDs, and the coming changes that will regulate LDTs.  The second master class, entitled "Software as a Medical Device: Understanding the Nuances of FDA Regulation," will address issues that are encountered when dealing with software classified as medical devices.

A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $2,295 (conference alone), $2,895 (conference and training session or conference and one master class), or $3,295 (conference, training session, and one master class).  Those registering by August 25, 2011 will receive a $300 discount and those registering by September 22, 2011 will receive a $200 discount.  In addition, Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's FDA Boot Camp Devices Edition conference.

C5 will be holding its 2nd Annual Forum on European Pharmaceutical Regulatory Law on September 21-22, 2011 in Brussels, Belgium.  The conference will provide attendees with practical and strategic guidance on the most current regulatory developments impacting on the pharma sector, including presentations on the following topics:

• Interpreting the pharmacovigilance rules and the impact on reporting obligations;
• Reviewing pharma regulatory requirements and the interaction with competition law;
• The inclusion of environmental aspects into the EU legislation on good manufacturing practice (GMP);
• Obtaining and maintaining an effective pricing and reimbursement structure;
• The evolution of regulation and the drug approval system in the 21st century;
• The do's and don'ts in multi-jurisdiction clinical trials: Where are we and where are we going?
• Adopting an effective product labeling model to combat anti-counterfeiting;
• Implementation of the UK bribery act and how pharma company practices will need to change;
• The rise in social media: Balancing information to patients and advertising to ensure compliance;
• Avoiding product liability litigation by reviewing global labeling practices;
• The current U.S. approval process in light of recent regulatory and legislative developments;
• Overcoming obstacles to ehealth and personalized medicine;
• Successfully obtaining SPCs and extensions of regulatory data protection: Extending market exclusivity (panel session);
• Guidance on the regulations applicable to advanced therapy medicinal products; and
• Privilege and discovery in pharma litigation.

A post-conference workshop on "Adopting Effective Risk Management Strategies to Avoid Product Liability Claims," will be offered from 9:00 am to 12:30 pm on September 23, 2011.  The workshop will provide in-depth guidance on devising strategic risk management plans to ensure that internal processes and drug standards comply with drug safety requirements across Europe and the U.S., and equip attendees with the practical and strategic tools needed to obtain sustainable market access in Europe and the U.S. to avoid costly product liability claims.

The agenda for the European Pharmaceutical Regulatory Law Boot Camp can be found here.  A complete brochure for this conference, including an agenda, description of the sessions, list of speakers, and registration form can be downloaded link.

The registration fee for this conference is €1899 (conference alone) or €2398 (conference and workshop).  Patent Docs readers who reference the discount code "PD 200" will receive €200 off the current price tier when registering.  Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, or by faxing a registration form to +44 20 7878 6885.

Patent Docs is a media partner of ACI's Forum on European Pharmaceutical Regulatory Law.