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June 21, 20181
Priority under the Paris Convention:
Are National/Regional “Sonderwege”
Acceptable?
– The CRISPR/Cas 9 Case
Jay Erstling
June 14, 2018
PCT Inventors, applicants, and assignees.
How Are Questions of Internal & External Priority
Addressed under Paris and PCT?
What Freedom Do Designated States Have to Determine who is the
“Person Who Has Duly Filed an Application” to which Priority is Claimed?
Are Applicant-Inventors in a Provisional Application Only Applicants
with Respect to the Inventive Concepts to which they Contributed?
Did US Law Require the Omission of Applicants in a PCT Application
if They Did Not Contribute to the Subject Matter Claimed?
© 2018 Patterson Thuente Pedersen, P.A., some rights reserved - www.ptslaw.com
DISCLAIMER: This presentation and any information contained herein is intended for informational purposes only and should not be construed as legal
advice. Seek competent legal counsel for advice on any legal matter.
Priority under the Paris Convention:
Are National/Regional “Sonderwege” Acceptable? –
The CRISPR/Cas9 Case
Jay Erstling
11th Rhineland Biopatent Forum
Dusseldorf, 14 June 2018
My Response
Are national/regional “Sonderwege” available for determining the validity of
priority claims under the Paris Convention?
Sonderweg: A distinct (special) course of action followed by a nation
My initial response:
Yes, the Paris Convention gives member countries significant freedom
to determine the validity of priority claims
• Provided the “weg” chosen does not violate the Paris Convention
My more nuanced response:
A “Sonderweg” (if my understanding is correct) assumes that there is an
established “weg,” but a nation/region has chosen its own special
course
• Apart from certain basic requirements, the Convention does not
establish a “weg,” so there is nothing to be “sonder” about
3
My Response
But in any event –
The EPC and European case law are fully compatible with the Paris
Convention
• The case law and practice require identity of applicants for a valid
priority claim
– When there are joint applicants, the claim to priority is valid
only if each applicant of the priority application is an applicant
of the application claiming priority or a successor in title to
whom the right of priority has been transferred
US law concerning external priority (although maybe a little bit
“Sonder”), when interpreted properly, is also compatible with the Paris
Covention
4
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 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
5
Background
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
6
File History of P1 and P2
7
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.
8
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
9
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 invalidated any claim of priority
that Patentee may have had 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 was sure to fail for lack of novelty
because of important intervening prior art (including a publication by the
principal inventor)
10
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.
11
Legal Sources at Issue
Paris Convention
Article 4A(1)
Patent Cooperation Treaty (PCT)
Article 8
US Patent Act
35 USC § 119
European Patent Convention (EPC)
Article 87
12
Paris Convention
Establishes the right of priority
Article 4A(1)
• “Any person who has duly filed an application for a patent… or his
successor in title, shall enjoy, for the purpose of filing in the other
countries, a right of priority….”
Basic assumptions called into question during the opposition
• The right of priority arises solely from the act of filing an
application
• The right of priority is an independent right linked to the act of
filing an application
– It may be separately transferred
• The substantive validity of a priority claim is subject to the law of
the country in which the application claiming priority was filed
13
PCT
Article 8 – Claiming Priority
“(1) The international application may contain a declaration… claiming
the priority of one or more earlier applications filed in or for any country
party to the Paris Convention for the Protection of Industrial Property.
“(2)(a) Subject to the provisions of subparagraph (b), the conditions for,
and the effect of, any priority claim declared under paragraph (1) shall
be as provided in Article 4… of the Paris Convention for the Protection
of Industrial Property.
“(2)(b) The international application for which the priority of one or more
earlier applications filed in or for a Contracting State is claimed may
contain the designation of that State. Where, in the international
application, the priority of one or more national applications filed in or for
a designated State is claimed…, the conditions for, and the effect of, the
priority claim in that State shall be governed by the national law of that
State.”
14
PCT
Basic assumptions called into question during the opposition
To claim priority, a PCT application must be filed by the person(s) who
filed the earlier application or their successors in title.
The determination of the validity of a priority claim takes place primarily
during the national or regional phase
• Responsibility of the designated office in accordance with its
national or regional (domestic) law
As a “special agreement” under Article 19 of the Paris Convention, PCT
provisions have to be consistent with the Paris Convention
15
US Law
35 USC § 119. Benefit of Earlier Filing Date; Right of Priority
“(a) An application for patent for an invention filed in this country by any
person who has, or whose legal representatives or assigns have,
previously regularly filed an application for a patent for the same
invention in a foreign country which affords similar privileges in the case
of applications filed in the United States or to citizens of the United
States… shall have the same effect as the same application would have
if filed in this country on the date on which the application for patent for
the same invention was first filed in such foreign country, if the
application in this country is filed within 12 months from the earliest date
on which such foreign application was filed. …”
• 35 USC § 119(a) codifies the Paris Convention right of priority
– External priority
– Establishes the right to claim priority to a prior application filed
in a foreign country
16
US Law
35 USC § 119. Benefit of Earlier Filing Date; Right of Priority
“(e)(1) An application for patent under section 111(a) or section 363
for an invention disclosed in a provisional application filed by an
inventor or inventors named in the provisional application, shall have
the same effect, as to such invention, as though filed on the date of
the provisional application…, if the application for patent is filed not
later than 12 months after the date on which the provisional
application was filed and if it contains or is amended to contain a
specific reference to the provisional application. …”
35 USC § 119(e) provides a right for a US application to claim
domestic benefit to a provisional application
An example of internal priority
17
EPC
Article 87. Priority right
“(1) Any person who has duly filed, in or for
• (a) any State party to the Paris Convention for the Protection of
Industrial Property or
• (b) any Member of the World Trade Organization
an application for a patent…, or his successor in title, shall enjoy, for the
purpose of filing a European patent application in respect of the same
invention, a right of priority during a period of twelve months from the
date of filing of the first application.”
• Follows the language of the Paris Convention
• The EPC forms a “complete, self-contained code of rules of law
on the subject of claiming priority”
– But as a “special agreement” under the Paris Convention (like
the PCT), its provisions have to be consistent with Paris
18
My Role in the Opposition
Expert for Opponent #1, 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 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
19
Questions that I Was Asked to Address
1. 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?
2. 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?
3. Under US law, are applicant inventors in a US provisional application
only applicants with respect to the inventive concepts to which they
contributed?
4. 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?
20
1. How Are Questions of Internal & External Priority
Addressed under Paris and PCT?
Under the Paris Convention
The Paris Convention is silent about internal priority
• Internal priority is relevant to US prosecution when a PCT
application enters US national phase
• But internal priority is irrelevant to prosecution in the EPO when
the priority claim is to a US application
The priority claims to P1 and P2 in the European regional phase were
external priority claims
• The Euro-PCT application claimed priority to applications filed in
another country
• Priority governed by Paris Convention Article 4A(1)
21
Internal & External Priority under PCT
The PCT recognizes both
PCT Article 8(2)(a): External priority
• The effect of the priority claim is governed in accordance with
Article 4 of the Paris Convention
– Article 8(2)(a) is the applicable provision concerning the
validity of the P1 and P2 priority claim
PCT Article 8(2)(b): Internal priority (domestic benefit)
• Where the PCT application claims the priority of an application
from a designated state, the effect of the priority claim in that
state is governed in accordance with that state’s national law
– Self-designation: Germany, Japan, Korea
– Provisional applications: US
22
External Priority under the Paris Convention
Right of priority is an independent right linked to the act of filing an
application
Paul Mathély: “The right of priority arises from the filing of a first
application…. As soon as it comes into existence, the right of priority
immediately becomes detached from the application which gave rise to
it. It then has an existence of its own.”
When an application claims priority, the substantive validity of the priority
claim is subject to the law of the country in which the application was filed
Paul Mathély: “When a corresponding application is filed with a claim to
priority, the right of priority will become a reality, but at that moment it
becomes an accessory of the application whose validity it sustains. And
since it is an accessory of the application, it will be submitted to the
same legal regime as that application.”
23
EPO Case Law is Consistent with the Paris Convention
European case law holds that the right of priority is a substantive property
right that is distinct from the property right in the first application.
As a result, the right of priority may be transferred even though the right
to the application is not
European commentators agree
“The applicant may transfer the right of priority to al successor in title,
independently of the right to the grant of the patent….” (D. Visser, The
Annotated European Patent Convention, 24th revised ed.)
“The right of priority may be transferred to a successor in title
independently of the transfer or non-transfer of the first application on
which it was based, and it can therefore remain with the original
application or be transferred to a third person. The right of priority
based on a first application can also be transferred independently for
one or more countries.” (G. Bodenhausen, Guide to the Application of
the Paris Convention)
24
2. What Freedom Do Designated States Have to
Determine who is the “Person Who Has Duly Filed an
Application” to which Priority is Claimed?
Once an application enters national/regional phase, domestic law governs
PCT Article 27(5) provides that “nothing in this Treaty and Regulations
is intended to be construed as prescribing anything that would limit the
freedom of each Contracting State to prescribe such substantive
conditions of patentability as it desires.”
• Substantive conditions = “the criteria of national law in respect of
prior art and other conditions of patentability”
– As opposed to the form and contents of the application
• The determination of the validity of a priority claim is substantive
– Especially where there is intervening art
25
States Have Significant Freedom
The determination of who is the person who has duly filed an application
from which Paris Convention priority is claimed is a matter of substantive
law
As such, countries have the right to make the determination
Different countries take different approaches and Paris and PCT
accommodate the differences
• Many follow EPO and require identity between the applicant for a
PCT application and the applicant or successor in title for the
application from which priority is claimed
– Provides degree of certainty and clarity, and is not unduly
burdensome
26
US Approach
US is somewhat of an outlier
Boston Scientific Scimed vs. Medtronic (Fed. Cir. 2007)
• A nexus must exist between the inventor and the foreign applicant
at the time the foreign application was filed
– The determination of whether a nexus exists is solely a
question of US law
27
Boston Scientific Scimed v. Medtronic
Question was whether a later US application was entitled to the benefit of
the filing dates of two earlier-filed EP applications, when the applicants of
the US application and the EP priority applications were not the same
Court held that the later US application filed by joint inventors was not
entitled to claim priority to two EP applications filed by a French
company because at the time the EP applications were filed, no legal
relationship existed between the French company and the inventors,
nor was the French company acting on behalf of the inventors
• Without a nexus, a priority claim in invalid
That the foreign application may have been filed in accordance with the
foreign country’s law “has no bearing here.”
• Foreign law is irrelevant to the determination of priority rights
under US law
28
Boston Scientific Scimed
The Boston Scientific case is consistent with other US cases that have
rejected attempts to impose US law on other jurisdictions
Voda v. Cordis (Fed. Cir. 2007)
• “The Paris Convention thus clearly expresses the independence
of each country’s sovereign patent systems and their systems for
adjudicating those patents. Nothing in the Paris Convention
contemplates nor allows one jurisdiction to adjudicate the patents
of another….”
• “As with the Paris Convention, the text of the PCT maintains the
independence of each country’s patents.”
29
Boston Scientific Scimed
And from the US Supreme Court
Microsoft Corp. v. AT&T, (Sup. Ct., 2007)
• “The presumption that United States law governs domestically but
does not rule the world applies with particular force in patent law.”
• “Our patent system makes no claim to extraterritorial effect; our
legislation d[oes] not, and [was] not intended to operate beyond
the limits of the United States, and we correspondingly reject the
claims of others to such control over our markets.”
• “[F]oreign law may embody different policy judgments about the
relative rights of inventors, competitors, and the public in patent
inventions.”
So (from a US perspective), countries can exercise freedom to determine
the validity of priority claims, and they should refrain from imposing their
approach on other countries
30
Choice of Law
A designated state/region is free to apply its own substantive law to
determine the validity of a priority claim
The Boston Scientific Scimed court got it right
Neither the Paris Convention nor the PCT provide any basis for
applying the substantive law of the priority country
Edwards Lifesciences AG vs. Cook Biotech Inc. (2009, Lord Justice
Kitchin)
Issue was whether a US provisional application could provide the basis
for a valid priority claim when not all the applicants or successors in title
were named in the application claiming priority
Justice Kitchin did not consider US law in holding that:
• Where the first-filed application contains multiple applicants, the
later filed application must be made by all of them, or by their
successors in title
31
3. Are Applicant-Inventors in a Provisional Application
Only Applicants with Respect to the Inventive Concepts
to which they Contributed?
Patentee argued that the failure to name priority applicants “has no
consequence for the validity of the priority claim to P1 and P2”
That applicants for a US provisional application are “only considered
applicants for those inventive concepts to which they have contributed”
Contrary to longstanding EPO case law
• Also contrary (in my opinion) to current US law
Problem with this argument is that Patentee incorrectly conflated the terms
“applicant” and “inventor”
Inventors’ rights are based on the contribution to the subject matter of
an application, but applicants’ rights stem from the application itself
P1 and P2 named individual applicants, without specifying any limits
based on inventorship contribution
32
Status of an Applicant under the AIA
The AIA changed the nature of an “applicant”
The status of an applicant is no longer restricted to inventors, and
“applicant” and “inventor” are not synonymous
• An applicant is defined with respect to the application as a whole
(not just to individual inventive concepts)
• As a result of the AIA, an “applicant” may be the “inventor,” “all of
the joint inventors,” “assignee,” “obligated assignee,” “person
applying for a patent,” or a “person who otherwise shows
sufficient proprietary interest” (37 CFR § 1.42)
References to “inventors” and “inventorship” concern only internal
priority claims to a US provisional application (35 USC § 119(e))
• The Paris Convention and 35 USC § 119(a) govern external
priority and make clear that each applicant has rights in the entire
application, including an independent right of priority
33
Nature of an Application
An application is a single application regardless of how many “independent
and distinct” inventions it discloses or claims
Any applicant named in a US application has rights in the whole
application
• “All parties having any portion of the ownership in the patent
property must act together as a composite entity in patent matters
before the Office” (MPEP § 301(IV))
34
Paris Convention Rejects Limiting Applicants by
Inventorship
The Paris Convention Diplomatic Conference considered and rejected the
idea of limiting applicants by inventorship.
A proposed draft by the Belgian delegate would have created a link
between the right of priority and the right to the patent
• He argued that “C’est l’auteur d’une invention seul qui doit jouir
d’un droit de priorité,” and proposed:
– “L’auteur d’une invention,… qui aura, dans l’un des États
contractants, régulièrement déposé la demande de brevet,…
jouira pour effectuer le dépôt dans les autres États, d’un droit
de priorité”
The delegates rejected the inclusion of “l’auteur d’une invention”
because “ce n’est pas l’auteur seul qui a le droit de demander un brevet
d’invention”
35
Limiting Applicants by Inventorship Would be Unduly
Burdensome
From a practical/policy perspective
Limiting applicants by inventorship would require the designated office
to undertake an inventorship investigation under the law of the priority
country for every application claiming priority to a foreign country
The designated office would also have to reconsider the inventorship
determination whenever the applicant amended the claims
The argument falsely assumes that all offices would define inventorship
in the same way
• US and European practice often do not identify the same
“invention” in any particular patent application
– Due largely to the difference between restriction practice and
unity of invention
36
The Right of Priority Is Not Conditioned on an Inventor’s
Contribution
The right of external priority concerns only the filing of an application
Since the drafters rejected conditioning the right of priority on an
inventor’s contribution
• Attempting to link the two is arguably contrary to the Convention
– Although not necessarily for internal priority
Applicants who have filed a US provisional application, or their successors
in title, are applicants for the whole application under US law
And they hold priority rights in the whole application under the Paris
Convention
• Regardless of their particular contribution to any inventive
concept in the application.
37
4. Did US Law Require the Omission of Applicants in a
PCT Application if They Did Not Contribute to the
Subject Matter Claimed?
US law does not restrict who may be named as an applicant in a PCT
application
The PCT Request Form allows identification of inventors, identification
of applicants, and identification of inventor/applicants either on a
country-by-country basis or for all designated states.
• Any US-specific requirements for identifying inventors in an
international application only apply to the US designation, and
only during US national phase
– US internal priority provisions that are specific to US
applications do not restrict PCT filing practices merely
because an applicant is located in the US
• US law provides no basis for omitting as applicants in the PCT
application individuals who do not qualify as inventors
38
Overview of Arguments
The EP had 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)
39
Sonderwege?
The Paris Convention gives countries freedom
Is it a “Sonderweg” to take advantage of that freedom?
• Results in different requirements in different countries
– Is that too heavy a price to pay?
• Harmonization efforts have not focused on requirements for
claiming priority
– Should they?
G.H.C. Bodenhausen, Guide to the Application of the Paris Convention:
“All these common rules regarding the protection of industrial property
given in the Convention are of great importance. It should be noted,
nevertheless, that their scope is limited and they leave considerable
freedom to the member states to legislate on questions of industrial
property according to the interests or preferences.”
40
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
41
Lessons Learned – “Sonderwege” or Not
Procedure counts
Pay attention to chain of title
Seminal patent rights can be lost for what Broad has asserted was a
mere “technicality”
Remember that the Paris Convention gives countries considerable
leeway
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.
• In a crunch, name everyone and sort it out later
42
Postscript
Droplets, Inc. v. E*Trade Bank (Fed. Cir. 19 April 2018)
A US case involving internal priority (domestic benefit)
• Issue was the requirement for validly claiming priority
Court held that a priority claim must specifically include the entire chain
of priority
• Complex file history
– The application leading to the patent at issue was filed in 2009
and claimed priority to a patent filed in November 2003, which
itself claimed priority to a 1999 provisional application via a
separate patent filed in June 200. The patent also claimed
priority directly to the provisional application
• Because the patent did not contain a reference to each prior-filed
application, the priority claim was invalid and the patent failed for
obviousness
As a matter of public policy, the burden is on the patentee to show a
clear, unbroken chain of priority
43
Thank you!
Jay Erstling | erstling@ptslaw.com | +1 612.349.5771
44

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Priority under the Paris Convention: Are National/Regional "Sonderwege" Acceptable? - The CRISPR/Cas 9 Case

  • 1. June 21, 20181 Priority under the Paris Convention: Are National/Regional “Sonderwege” Acceptable? – The CRISPR/Cas 9 Case Jay Erstling June 14, 2018 PCT Inventors, applicants, and assignees. How Are Questions of Internal & External Priority Addressed under Paris and PCT? What Freedom Do Designated States Have to Determine who is the “Person Who Has Duly Filed an Application” to which Priority is Claimed? Are Applicant-Inventors in a Provisional Application Only Applicants with Respect to the Inventive Concepts to which they Contributed? Did US Law Require the Omission of Applicants in a PCT Application if They Did Not Contribute to the Subject Matter Claimed?
  • 2. © 2018 Patterson Thuente Pedersen, P.A., some rights reserved - www.ptslaw.com DISCLAIMER: This presentation and any information contained herein is intended for informational purposes only and should not be construed as legal advice. Seek competent legal counsel for advice on any legal matter. Priority under the Paris Convention: Are National/Regional “Sonderwege” Acceptable? – The CRISPR/Cas9 Case Jay Erstling 11th Rhineland Biopatent Forum Dusseldorf, 14 June 2018
  • 3. My Response Are national/regional “Sonderwege” available for determining the validity of priority claims under the Paris Convention? Sonderweg: A distinct (special) course of action followed by a nation My initial response: Yes, the Paris Convention gives member countries significant freedom to determine the validity of priority claims • Provided the “weg” chosen does not violate the Paris Convention My more nuanced response: A “Sonderweg” (if my understanding is correct) assumes that there is an established “weg,” but a nation/region has chosen its own special course • Apart from certain basic requirements, the Convention does not establish a “weg,” so there is nothing to be “sonder” about 3
  • 4. My Response But in any event – The EPC and European case law are fully compatible with the Paris Convention • The case law and practice require identity of applicants for a valid priority claim – When there are joint applicants, the claim to priority is valid only if each applicant of the priority application is an applicant of the application claiming priority or a successor in title to whom the right of priority has been transferred US law concerning external priority (although maybe a little bit “Sonder”), when interpreted properly, is also compatible with the Paris Covention 4
  • 5. 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 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 5
  • 6. Background 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 6
  • 7. File History of P1 and P2 7
  • 8. 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. 8
  • 9. 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 9
  • 10. 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 invalidated any claim of priority that Patentee may have had 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 was sure to fail for lack of novelty because of important intervening prior art (including a publication by the principal inventor) 10
  • 11. 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. 11
  • 12. Legal Sources at Issue Paris Convention Article 4A(1) Patent Cooperation Treaty (PCT) Article 8 US Patent Act 35 USC § 119 European Patent Convention (EPC) Article 87 12
  • 13. Paris Convention Establishes the right of priority Article 4A(1) • “Any person who has duly filed an application for a patent… or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority….” Basic assumptions called into question during the opposition • The right of priority arises solely from the act of filing an application • The right of priority is an independent right linked to the act of filing an application – It may be separately transferred • The substantive validity of a priority claim is subject to the law of the country in which the application claiming priority was filed 13
  • 14. PCT Article 8 – Claiming Priority “(1) The international application may contain a declaration… claiming the priority of one or more earlier applications filed in or for any country party to the Paris Convention for the Protection of Industrial Property. “(2)(a) Subject to the provisions of subparagraph (b), the conditions for, and the effect of, any priority claim declared under paragraph (1) shall be as provided in Article 4… of the Paris Convention for the Protection of Industrial Property. “(2)(b) The international application for which the priority of one or more earlier applications filed in or for a Contracting State is claimed may contain the designation of that State. Where, in the international application, the priority of one or more national applications filed in or for a designated State is claimed…, the conditions for, and the effect of, the priority claim in that State shall be governed by the national law of that State.” 14
  • 15. PCT Basic assumptions called into question during the opposition To claim priority, a PCT application must be filed by the person(s) who filed the earlier application or their successors in title. The determination of the validity of a priority claim takes place primarily during the national or regional phase • Responsibility of the designated office in accordance with its national or regional (domestic) law As a “special agreement” under Article 19 of the Paris Convention, PCT provisions have to be consistent with the Paris Convention 15
  • 16. US Law 35 USC § 119. Benefit of Earlier Filing Date; Right of Priority “(a) An application for patent for an invention filed in this country by any person who has, or whose legal representatives or assigns have, previously regularly filed an application for a patent for the same invention in a foreign country which affords similar privileges in the case of applications filed in the United States or to citizens of the United States… shall have the same effect as the same application would have if filed in this country on the date on which the application for patent for the same invention was first filed in such foreign country, if the application in this country is filed within 12 months from the earliest date on which such foreign application was filed. …” • 35 USC § 119(a) codifies the Paris Convention right of priority – External priority – Establishes the right to claim priority to a prior application filed in a foreign country 16
  • 17. US Law 35 USC § 119. Benefit of Earlier Filing Date; Right of Priority “(e)(1) An application for patent under section 111(a) or section 363 for an invention disclosed in a provisional application filed by an inventor or inventors named in the provisional application, shall have the same effect, as to such invention, as though filed on the date of the provisional application…, if the application for patent is filed not later than 12 months after the date on which the provisional application was filed and if it contains or is amended to contain a specific reference to the provisional application. …” 35 USC § 119(e) provides a right for a US application to claim domestic benefit to a provisional application An example of internal priority 17
  • 18. EPC Article 87. Priority right “(1) Any person who has duly filed, in or for • (a) any State party to the Paris Convention for the Protection of Industrial Property or • (b) any Member of the World Trade Organization an application for a patent…, or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.” • Follows the language of the Paris Convention • The EPC forms a “complete, self-contained code of rules of law on the subject of claiming priority” – But as a “special agreement” under the Paris Convention (like the PCT), its provisions have to be consistent with Paris 18
  • 19. My Role in the Opposition Expert for Opponent #1, 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 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 19
  • 20. Questions that I Was Asked to Address 1. 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? 2. 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? 3. Under US law, are applicant inventors in a US provisional application only applicants with respect to the inventive concepts to which they contributed? 4. 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? 20
  • 21. 1. How Are Questions of Internal & External Priority Addressed under Paris and PCT? Under the Paris Convention The Paris Convention is silent about internal priority • Internal priority is relevant to US prosecution when a PCT application enters US national phase • But internal priority is irrelevant to prosecution in the EPO when the priority claim is to a US application The priority claims to P1 and P2 in the European regional phase were external priority claims • The Euro-PCT application claimed priority to applications filed in another country • Priority governed by Paris Convention Article 4A(1) 21
  • 22. Internal & External Priority under PCT The PCT recognizes both PCT Article 8(2)(a): External priority • The effect of the priority claim is governed in accordance with Article 4 of the Paris Convention – Article 8(2)(a) is the applicable provision concerning the validity of the P1 and P2 priority claim PCT Article 8(2)(b): Internal priority (domestic benefit) • Where the PCT application claims the priority of an application from a designated state, the effect of the priority claim in that state is governed in accordance with that state’s national law – Self-designation: Germany, Japan, Korea – Provisional applications: US 22
  • 23. External Priority under the Paris Convention Right of priority is an independent right linked to the act of filing an application Paul Mathély: “The right of priority arises from the filing of a first application…. As soon as it comes into existence, the right of priority immediately becomes detached from the application which gave rise to it. It then has an existence of its own.” When an application claims priority, the substantive validity of the priority claim is subject to the law of the country in which the application was filed Paul Mathély: “When a corresponding application is filed with a claim to priority, the right of priority will become a reality, but at that moment it becomes an accessory of the application whose validity it sustains. And since it is an accessory of the application, it will be submitted to the same legal regime as that application.” 23
  • 24. EPO Case Law is Consistent with the Paris Convention European case law holds that the right of priority is a substantive property right that is distinct from the property right in the first application. As a result, the right of priority may be transferred even though the right to the application is not European commentators agree “The applicant may transfer the right of priority to al successor in title, independently of the right to the grant of the patent….” (D. Visser, The Annotated European Patent Convention, 24th revised ed.) “The right of priority may be transferred to a successor in title independently of the transfer or non-transfer of the first application on which it was based, and it can therefore remain with the original application or be transferred to a third person. The right of priority based on a first application can also be transferred independently for one or more countries.” (G. Bodenhausen, Guide to the Application of the Paris Convention) 24
  • 25. 2. What Freedom Do Designated States Have to Determine who is the “Person Who Has Duly Filed an Application” to which Priority is Claimed? Once an application enters national/regional phase, domestic law governs PCT Article 27(5) provides that “nothing in this Treaty and Regulations is intended to be construed as prescribing anything that would limit the freedom of each Contracting State to prescribe such substantive conditions of patentability as it desires.” • Substantive conditions = “the criteria of national law in respect of prior art and other conditions of patentability” – As opposed to the form and contents of the application • The determination of the validity of a priority claim is substantive – Especially where there is intervening art 25
  • 26. States Have Significant Freedom The determination of who is the person who has duly filed an application from which Paris Convention priority is claimed is a matter of substantive law As such, countries have the right to make the determination Different countries take different approaches and Paris and PCT accommodate the differences • Many follow EPO and require identity between the applicant for a PCT application and the applicant or successor in title for the application from which priority is claimed – Provides degree of certainty and clarity, and is not unduly burdensome 26
  • 27. US Approach US is somewhat of an outlier Boston Scientific Scimed vs. Medtronic (Fed. Cir. 2007) • A nexus must exist between the inventor and the foreign applicant at the time the foreign application was filed – The determination of whether a nexus exists is solely a question of US law 27
  • 28. Boston Scientific Scimed v. Medtronic Question was whether a later US application was entitled to the benefit of the filing dates of two earlier-filed EP applications, when the applicants of the US application and the EP priority applications were not the same Court held that the later US application filed by joint inventors was not entitled to claim priority to two EP applications filed by a French company because at the time the EP applications were filed, no legal relationship existed between the French company and the inventors, nor was the French company acting on behalf of the inventors • Without a nexus, a priority claim in invalid That the foreign application may have been filed in accordance with the foreign country’s law “has no bearing here.” • Foreign law is irrelevant to the determination of priority rights under US law 28
  • 29. Boston Scientific Scimed The Boston Scientific case is consistent with other US cases that have rejected attempts to impose US law on other jurisdictions Voda v. Cordis (Fed. Cir. 2007) • “The Paris Convention thus clearly expresses the independence of each country’s sovereign patent systems and their systems for adjudicating those patents. Nothing in the Paris Convention contemplates nor allows one jurisdiction to adjudicate the patents of another….” • “As with the Paris Convention, the text of the PCT maintains the independence of each country’s patents.” 29
  • 30. Boston Scientific Scimed And from the US Supreme Court Microsoft Corp. v. AT&T, (Sup. Ct., 2007) • “The presumption that United States law governs domestically but does not rule the world applies with particular force in patent law.” • “Our patent system makes no claim to extraterritorial effect; our legislation d[oes] not, and [was] not intended to operate beyond the limits of the United States, and we correspondingly reject the claims of others to such control over our markets.” • “[F]oreign law may embody different policy judgments about the relative rights of inventors, competitors, and the public in patent inventions.” So (from a US perspective), countries can exercise freedom to determine the validity of priority claims, and they should refrain from imposing their approach on other countries 30
  • 31. Choice of Law A designated state/region is free to apply its own substantive law to determine the validity of a priority claim The Boston Scientific Scimed court got it right Neither the Paris Convention nor the PCT provide any basis for applying the substantive law of the priority country Edwards Lifesciences AG vs. Cook Biotech Inc. (2009, Lord Justice Kitchin) Issue was whether a US provisional application could provide the basis for a valid priority claim when not all the applicants or successors in title were named in the application claiming priority Justice Kitchin did not consider US law in holding that: • Where the first-filed application contains multiple applicants, the later filed application must be made by all of them, or by their successors in title 31
  • 32. 3. Are Applicant-Inventors in a Provisional Application Only Applicants with Respect to the Inventive Concepts to which they Contributed? Patentee argued that the failure to name priority applicants “has no consequence for the validity of the priority claim to P1 and P2” That applicants for a US provisional application are “only considered applicants for those inventive concepts to which they have contributed” Contrary to longstanding EPO case law • Also contrary (in my opinion) to current US law Problem with this argument is that Patentee incorrectly conflated the terms “applicant” and “inventor” Inventors’ rights are based on the contribution to the subject matter of an application, but applicants’ rights stem from the application itself P1 and P2 named individual applicants, without specifying any limits based on inventorship contribution 32
  • 33. Status of an Applicant under the AIA The AIA changed the nature of an “applicant” The status of an applicant is no longer restricted to inventors, and “applicant” and “inventor” are not synonymous • An applicant is defined with respect to the application as a whole (not just to individual inventive concepts) • As a result of the AIA, an “applicant” may be the “inventor,” “all of the joint inventors,” “assignee,” “obligated assignee,” “person applying for a patent,” or a “person who otherwise shows sufficient proprietary interest” (37 CFR § 1.42) References to “inventors” and “inventorship” concern only internal priority claims to a US provisional application (35 USC § 119(e)) • The Paris Convention and 35 USC § 119(a) govern external priority and make clear that each applicant has rights in the entire application, including an independent right of priority 33
  • 34. Nature of an Application An application is a single application regardless of how many “independent and distinct” inventions it discloses or claims Any applicant named in a US application has rights in the whole application • “All parties having any portion of the ownership in the patent property must act together as a composite entity in patent matters before the Office” (MPEP § 301(IV)) 34
  • 35. Paris Convention Rejects Limiting Applicants by Inventorship The Paris Convention Diplomatic Conference considered and rejected the idea of limiting applicants by inventorship. A proposed draft by the Belgian delegate would have created a link between the right of priority and the right to the patent • He argued that “C’est l’auteur d’une invention seul qui doit jouir d’un droit de priorité,” and proposed: – “L’auteur d’une invention,… qui aura, dans l’un des États contractants, régulièrement déposé la demande de brevet,… jouira pour effectuer le dépôt dans les autres États, d’un droit de priorité” The delegates rejected the inclusion of “l’auteur d’une invention” because “ce n’est pas l’auteur seul qui a le droit de demander un brevet d’invention” 35
  • 36. Limiting Applicants by Inventorship Would be Unduly Burdensome From a practical/policy perspective Limiting applicants by inventorship would require the designated office to undertake an inventorship investigation under the law of the priority country for every application claiming priority to a foreign country The designated office would also have to reconsider the inventorship determination whenever the applicant amended the claims The argument falsely assumes that all offices would define inventorship in the same way • US and European practice often do not identify the same “invention” in any particular patent application – Due largely to the difference between restriction practice and unity of invention 36
  • 37. The Right of Priority Is Not Conditioned on an Inventor’s Contribution The right of external priority concerns only the filing of an application Since the drafters rejected conditioning the right of priority on an inventor’s contribution • Attempting to link the two is arguably contrary to the Convention – Although not necessarily for internal priority Applicants who have filed a US provisional application, or their successors in title, are applicants for the whole application under US law And they hold priority rights in the whole application under the Paris Convention • Regardless of their particular contribution to any inventive concept in the application. 37
  • 38. 4. Did US Law Require the Omission of Applicants in a PCT Application if They Did Not Contribute to the Subject Matter Claimed? US law does not restrict who may be named as an applicant in a PCT application The PCT Request Form allows identification of inventors, identification of applicants, and identification of inventor/applicants either on a country-by-country basis or for all designated states. • Any US-specific requirements for identifying inventors in an international application only apply to the US designation, and only during US national phase – US internal priority provisions that are specific to US applications do not restrict PCT filing practices merely because an applicant is located in the US • US law provides no basis for omitting as applicants in the PCT application individuals who do not qualify as inventors 38
  • 39. Overview of Arguments The EP had 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) 39
  • 40. Sonderwege? The Paris Convention gives countries freedom Is it a “Sonderweg” to take advantage of that freedom? • Results in different requirements in different countries – Is that too heavy a price to pay? • Harmonization efforts have not focused on requirements for claiming priority – Should they? G.H.C. Bodenhausen, Guide to the Application of the Paris Convention: “All these common rules regarding the protection of industrial property given in the Convention are of great importance. It should be noted, nevertheless, that their scope is limited and they leave considerable freedom to the member states to legislate on questions of industrial property according to the interests or preferences.” 40
  • 41. 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 41
  • 42. Lessons Learned – “Sonderwege” or Not Procedure counts Pay attention to chain of title Seminal patent rights can be lost for what Broad has asserted was a mere “technicality” Remember that the Paris Convention gives countries considerable leeway 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. • In a crunch, name everyone and sort it out later 42
  • 43. Postscript Droplets, Inc. v. E*Trade Bank (Fed. Cir. 19 April 2018) A US case involving internal priority (domestic benefit) • Issue was the requirement for validly claiming priority Court held that a priority claim must specifically include the entire chain of priority • Complex file history – The application leading to the patent at issue was filed in 2009 and claimed priority to a patent filed in November 2003, which itself claimed priority to a 1999 provisional application via a separate patent filed in June 200. The patent also claimed priority directly to the provisional application • Because the patent did not contain a reference to each prior-filed application, the priority claim was invalid and the patent failed for obviousness As a matter of public policy, the burden is on the patentee to show a clear, unbroken chain of priority 43
  • 44. Thank you! Jay Erstling | erstling@ptslaw.com | +1 612.349.5771 44