Patent Opposition and Disputes. CRISPR/Cas9

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The CRISPR/Cas9 Patent Dispute in
the EPO
Jay Erstling
10th Global Intellectual Property Convention
Bangalore, January 2018

2. Background
Patent at issue was EP 2,771,468 (“Engineering of Systems, Methods and
Optimized Guide Compositions for Sequence Manipulation”)
Applicants: Broad Institute, MIT, Harvard
• Issued as European Patent No. 2771468 on 11 February 2015
Resulted from a European patent application that was a PCT regional
phase application
• PCT/US2013/074819
– Filed on 12 December 2013
PCT application claimed priority to 12 US provisional applications
• First two provisional application (P1 and P2) were filed on 12
December 2012 and 2 January 2013
The grant of the patent was opposed by 9 opponents
The large number is testament to the importance of the patent to the
CRISPR landscape
May 30, 20182

3. File History of P1 and P2
May 30, 20183

4. P1 and P2 Inventors and Assignees
At the time P1 and P2 were filed, each named Zhang, Cong, Habib and
Marraffini as inventors. Later, inventors Cox, Hsu, Lin and Ran were
added.
Zhang, Habib and Lin assigned P1 and P2 to The Broad Institute, Inc. Cox
assigned P1 and P2 to the Massachusetts Institute of Technology.
Marraffini assigned P1 and P2 to Rockefeller University. Cong, Hsu and
Ran assigned P1 and P2 to the President and Fellows of Harvard
College.
May 30, 20184

5. PCT Inventors, Applicants and Assignees
When the PCT application was filed, it named Zhang, Cong, Hsu and Ran
as inventors and applicants, and The Broad Institute, Inc., Massachusetts
Institute of Technology, and President and Fellows of Harvard College as
applicants.
Though Habib, Lin and Cox were not named as inventors, their rights were
transferred to The Broad Institute, Inc. (Habib and Lin) and the
Massachusetts Institute of Technology (Cox), both of which were named
as applicants.
Neither Marraffini (as an inventor or applicant) nor Rockefeller University
(as an applicant) was named on the PCT application or the later EP
regional phase application, nor were any rights in the invention(s) or of
priority in P1 or P2 transferred by either Marraffini or Rockefeller University
to any of the inventors or applicants named on the PCT application and the
EP regional phase application
May 30, 20185

6. Issue in the opposition
Whether the failure of Patentee to name Marraffini or Rockefeller
University as an applicant in the PCT application or to obtain assignments
from Marraffini or Rockefeller University of their rights of priority in P1 and
P2 prior to the filing of the PCT application invalidates any claim of priority
that Patentee may have to P1 or P2 in the EP patent.
Whether the EP requirement for identity between the applicants for a
EP application and the applicants for an earlier application from which
priority is claimed (or their successors in title) should apply in this case
Without a valid priority claim, the patent would fail for lack of novelty
because of important intervening prior art (including a publication by the
principal inventor)
Outcome is likely to apply to other related patents
May 30, 20186

7. EPO Oppositions
Opposition to a European may be filed by anyone.
Opposition must be filed within nine months of the publication of the
patent grant.
• The procedure may involve multiple opponents.
Opposition can only be based on three grounds specified in Article 100
of the EPC
• that the subject-matter of the patent is not patentable for lack of
novelty, inventive step, industrial applicability, or lack of
patentable subject matter
• that the invention is not disclosed clearly and completely enough
for a person skilled in the art to carry it out
• that the patent's subject-matter extends beyond the content of the
application as filed.
May 30, 20187

8. My Role in the Opposition
I was an expert for Opponent #1 and was charged with commenting on the
validity of the priority claims to P1 and P2
My opinion was that the failure of the lack of identity (clear chain of title)
between the European and PCT application resulting from the failure to
name or obtain assignments from M and RU invalidated the priority
claims
Patentee’s argument was (basically) that M was not an inventor of the
inventions embodied in the PCT application and therefore there was no
obligation to name him or obtain an assignment
Relevant sources of law: Paris Convention, PCT, European Patent
Convention, and US law
May 30, 20188

9. Specific Questions that I Addressed
The US Patent Act provides for both internal and external priority. How are
questions of internal and external priority addressed by the Paris
Convention and PCT?
Do states designated in a PCT application have some freedom to
determine who is the “person who has duly filed an application” to which
priority is claimed?
Under US law, are applicant inventors in a US provisional application only
applicants with respect to the inventive concepts to which they
contributed?
Did US law and USPTO rules require the omission of individuals as
applicants in the PCT application if they did not contribute to the subject
matter claimed?
May 30, 20189

10. Overview of Arguments
The EP has the right to require complete identity between applicants
Supported by the Paris Convention (Art. 4)
• Right of priority is an independent right linked to the act of filing
an application
• When an application claims a right of priority, the substantive
validity of the priority claim is subject to the law of the country in
which the application was filed
Supported by the PCT (Art. 8)
• Under PCT, the validity of a priority claim is determined by the
designated state in accordance with the Paris Convention
Supported by US law
• Distinguishes between internal and external priority
• Rejects extraterritorial application of US patent law
• Distinguishes between inventors (rights only in their inventive
concepts) and applicants (rights in the whole application)
May 30, 201810

11. Outcome of the Opposition
Opposition hearing took place on 16-17 October 2018
On 17 October, the EPO revoked the CRISPR patent
Priority claim invalidated
• European law applies
• Patentee was not a valid successor in title
• Priority claim invalid since neither M nor R had assigned their
rights to claim priority
Broad has announced its intention to appeal to the EPO Technical Board
of Appeal
May 30, 201811

12. Lessons Learned
Procedure counts
Pay attention to chain of title
Seminal patent rights can be lost for what Broad has asserted was a
mere “technicality”
When filing in Europe (and elsewhere)
Make sure that the applicants named in the application are the same as
the applicants named in the earlier application to which priority is
claimed, unless a valid succession of title has occurred during the
priority year.
May 30, 201812

13. Questions?
[Presenter name] | [Phone] | [Email]
May 30, 201813