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Title: Presented by: David Rook

1
Lessons from Stanford v. Roche

2
Lessons from Stanford v. Roche

3
1. Background of Dispute

Holodniy and two other Stanford researchers
engaged in research to quantify HIV and correlate
the measurements to therapeutic effectiveness of
antiretroviral drugs using PCR techniques.
1988 - Holodniy signs onto Stanfords IP policy,
which states I agree to assign right, title,
and interest in inventions...
1989 Holodniy goes to Cetus (later Roche) to
learn polymerase chain reaction (PCR)
techniques. Holodniy signs a Visitors
Confidentiality Agreement with Cetus that hereby
assigns to Cetus, my right title, and interest
in inventions...

4
Background of Dispute (cont.)

This research results in three patented methods
not on PCR per se.
1991 - Roche purchases Cetus.
2000-2004 - Stanford attempts to negotiate an
exclusive license of the patents to Roche.

5
Background of Dispute (cont.)2005 - Stanford
Files Patent Infringement Suit

6
2. Federal Circuit Decision

Note not an en banc decision.
A. The Parties Patent Rights
Roche precluded by CA statute of limitations from
obtaining a judgment of ownership.
But, Roche can assert affirmative defense that
Stanford does not own patents no standing.

7
B. Chain of Title

Federal Circuit law resolves the question of
whether contractual language effects a present
assignment of patent rights, or an agreement to
assign rights in the future.
Agree to assign means a mere promise to assign
rights in the future, not an immediate transfer
of expectant interests. That is, a subsequent
written instrument is required.
Do hereby assign means a present assignment of
future invention.

8
B. Chain of title (cont.)Competing Agreements

Once the invention is made and application for
patent is filed legal title to the rights
would be in the assignee by operation of law.
Assignor-inventor would have nothing remaining
to assign.

9
C. Additional Arguments

Stanford bona fide purchaser per 35 USC 261?
Stanford argues they were a subsequent to Cetus
(Roche) good faith purchaser when Holodniy
assigned to Stanford.
On the facts, Court says no. Stanford had notice
of Holodniys work with Cetus (Roche) even if
Stanford lacked specific notice of the Cetus
(Roche) agreement.
Holodniys Cetus (Roche) assignment in breach of
Stanford agreement creates cause of action
against Holodniy not Cetus (Roche).

10
C. Additional Arguments (cont.)

Bayh-Dole Act negates Holodniy assignment to
Cetus?
On the facts, Court says No.
Court agrees - Stanford had right of second
refusal after Government refrained from exercise
of rights.
But Act did not automatically void Holodniys
assignment to Cetus.
Continuing We see no reason why the Act
voids prior contractual transfers of right.

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D. Stanford Lacks Standing

Standing to sue party has sufficient stake in
order to bring suit.
Stanford cannot establish ownership of
Holodniys interest and lacks standing to assert
its claims of infringement against Roche.

12
3. Stanford Petitioning for Rehearing En Banc

Katharine Ku, Director of Office of Technology
Licensing at Stanford, informed us that they are
petitioning for rehearing en banc by the Federal
Circuit.
Arguments
Permissive will assign language in Stanfords
IP policy is due to Bayh-Dole, i.e., cannot take
title until know government is not interested.
Patents cover quantifying HIV and correlating the
measurements to therapeutic effectiveness of
antiretroviral drugs using PCR techniques. Not,
PCR techiques per se - too tenuous a relationship
with matter learned at Cetus (Roche).

13
4. University Perspective

If university prefers an agreement to assign
future inventions, i.e., believe Bayh-Dole
requires it
Where possible, consider strengthening policing
of inventor activities with other entities and/or
strengthening IP policy and agreements.
Where possible, consider increasing inventor
obligations to inform the university.
Where possible, consider establishing first right
of refusal for all inventions.

14
4. University Perspective (cont.)

(Cont.)
Consider requiring inventors to disclose
university IP policy and agreements to any
third-party involved in research.
Consider requiring inventors to submit all other
agreements before executing, if manpower allows.

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4. University Perspective (cont.)

B. If consistent with philosophy and IP policy of
the university, IP policy and/or inventor
agreements may have a present assignment of
future inventions subject to Bayh-Dole
provisions.
Query What if Stanford had a present assignment
of future inventions in its agreement?

16
4. University Perspective (cont.)

C. Review Third Party Agreements
Material Transfer Agreements should clearly state
ownership rights. Customize standard MTAs?
Require third-parties (that university
collaborates with) to submit all documents to
university for review including but not limited
to any documents to be signed by inventors.
When university not directly involved, but
third-party is known place 3rd party on notice
of ownership/assignment rights, requirements of
the third-party, and requirements of the
inventor.
Seek to establish uniform agreements.

17
5. Inventor Perspective

Be aware of obligations to school in employee
agreement and IP policy.
Do not sign any documents without universitys
review and/or approval in accordance with the IP
policy.
You risk personal responsibility if you sign
these documents!

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6. Questions