New WG10 Brainstorming Groups on (1) The U.S. Patent System--Biopharma v. High-Tech & (2) The Unified Patent Court

Brainstorming Groups - Overview

(1) The Role of Patents in Biopharma v. High-Tech Industries: Can One Patent System Effectively Accommodate Both?

The brainstorming group will evaluate whether WG10 should create a drafting team to prepare a commentary on the following topic:

  • The high-tech and biopharma industries are two poles of the patent ecosystem. The arguments for and against the value of patent protection in each industry often diverge significantly. Some biopharma industry participants point to the need for patent protection to counterbalance costs associated with long product development lead time, a high and unpredictable failure rate, low barriers to entry when a product comes to market, and the need to facilitate competitive market entry after an appropriate period of exclusivity. Others cite increased cost and diminished access to lifesaving medicines as countervailing considerations.
  • In contrast, in the high-tech industry, critics of excessive patent protection note that high-tech industries operate in a world of much faster product development, significant non-patent barriers to entry, multi-feature products potentially covered by thousands of patents, and much greater risk than any given patent will be overvalued due to holdup effects. On the other side of the debate, other market participants identify a need to reward innovative approaches as well as incentives to share innovation with the public rather than maintain advances as trade secrets to justify strong patent protection. These disparate economic realities lead to very different views of what is good, and bad, in patent law. And in the context of standards-essential patents, the arguments on both sides take on additional complexity.
  • Recently, the two industries’ competing conceptions of the patent system have come to a head in the context of ongoing debate about the role of Section 101 in evaluating patent-eligibility. Many in the life sciences industry argue that the notion that pioneering advances in diagnostics and therapeutics should be ineligible for patent protection is both arbitrary and profoundly harmful to these industries. In the technology space, an equally vocal contingent points to the need to preserve Section 101 as a bulwark against vague, abstract, ambiguous patents that purport to cover mathematical algorithms and similar fundamental scientific tools used on a daily basis by software engineers and data scientists.
  • It has been a tenet of the patent system for as long as it has existed that one size does fit all: the same legal rules should apply regardless of technological field. And the only major industry-specific change to U.S. patent law—the Hatch-Waxman Act—has frequently been criticized as the cause of distortions that promote needless litigation and gaming of the system. But with major industries facing fundamentally different challenges and realities in product development and commercialization, is it time to reconsider whether one patent system can fully serve the needs of today's complex global economy? The goal of this Sedona commentary drafting team is to examine the practical reasons pushing the two industries toward different objectives, and to consider to what extent a single legal regime can work for both.
  • We will be looking for brainstorming group representation for at least some or all of the following categories of stakeholders:

               1. Biopharma

○  Pharmaceuticals - branded and generics 

○  Biologics - branded and biosimilar 

○  DNA sequencing 

○  Diagnostics  


               2. High-tech

○  SEP-holders and manufacturing companies 

○  Semiconductors 

○  Cybersecurity 

○  Finished product manufacturers 

○  Cloud service providers 

○  Telecom providers 

○  Software 

○  Computer gaming 

○  Cryptocurrency 


(2) Patent Litigation Best Practices in Europe before the Forthcoming Unified Patent Court

The brainstorming group will evaluate whether WG10 should create a drafting team to prepare a commentary on the following topic:

  • The Unified Patent Court system will be a completely new playing field for international patent litigation. The various courts scattered throughout Europe that are about to be established will decide infringement and validity of Unitary Patents and, during a transitional period, all other European Patents which have not been converted into Unitary Patents. The three main instruments setting up and defining the details of this new system―the Agreement on a Unified Patent Court, the Statute of the Unified Patent Court, and the Rules of Procedure of the Unified Patent Court―will likely have to be applied in the first "real" cases for the very first time starting in 2022 or 2023. Every aspect of patent litigation and civil procedure will be the subject of intense discussions in the first few years before there can be an established case law of any kind. This applies to venue selection, the languages used, the composition of the court, case management, including the choice to bifurcate infringement and validity or not, evidence taking, remedies and many more aspects. All stakeholders involved―patentees, defendants, practitioners and judges―will look for guidance in the relevant provisions, but also in the body of case law formed by national court practice and decisions. There will be a joint struggle to find the best way to litigate Unitary Patents before the new court, keeping in mind the potential competition from national courts for shorter, more effective and cheaper national procedures.
  • The Sedona Conference's Working Group 10 seeks representatives from the countries participating in the Unified Patent Court system to develop best practices.

Brainstorming Groups - Member Expectations

Brainstorming group members will be expected to actively participate in regularly scheduled phone conferences to brainstorm on work product ideas. Members will also be expected to participate in the drafting of a detailed outline that allows a subsequent drafting team to prepare work product consistent with standards of The Sedona Conference.

Brainstorming Groups - Selection

In order to apply for the brainstorming group(s), you must be a member of WG10. If you are interested in applying for the brainstorming group(s), but are not yet a member of WG10, please become a member by signing up for a Working Group Series (WGS) membership. Once a WGS member, one is eligible to take part in the activities of all Working Groups, including WG10. If you have any questions about how to sign up for a membership or encounter any difficulties while doing so, please contact our office at [email protected] or +1(602) 258-4910.

In order to be considered for the brainstorming group(s), please provide separate answers to each of the questions below, and submit to Jim Ko at [email protected] no later than COB EST on Thursday, October 14, 2021. Please be brief when answering the questions – no more than 50 words per answer to a question. When applying, please note which brainstorming group(s) you are applying for. If you are applying for both brainstorming groups, please be sure to answer the fourth question for each brainstorming group.

  • (1) What is your profession and expertise?
  • (2) How many years of experience do you have?
  • (3) What organization do you work for?
  • (4) What qualifications or experiences make you particularly qualified to serve on this brainstorming group, and why?

In addition to the above factors, we will consider the following factors in forming the brainstorming groups:

          (1) Balance:  As we work to achieve consensus-based documents, it is important that a wide range of perspectives and backgrounds are represented. Accordingly, in selecting brainstorming group members the Steering Committee will work to ensure these perspectives are fairly represented. Please keep in mind, however, we do not seek differing perspectives so that one may advocate on behalf of a particular perspective or constituency. We seek differing viewpoints, backgrounds and experiences in order to build a consensus-based document that is beneficial to all stakeholders.  

            (2) Diversity: Not simply the diversity of opinions on all sides of a particular position, but also the diversity of background and experience that shapes and influences the unique perspective of each member.

Announcement Date: 
Monday, October 4, 2021