This is the Title of the Presentation

Data/Working Examples: Role in
Acquiring and Protecting a Patent
Tina Williams McKeon
April 12, 2012
Basics of patentability
Basics of patent process
Data in the various stages of the patent process
Preparing the patent application
Prosecuting the patent application
Litigating about the patent application
Basics of Patentability
Sufficient Disclosure
Written Description
Best Mode
Stages of the Patent Process
US Supreme Court
Federal Circuit
US District Court
Patent Acquisition
Proceedings (Reexam,
Post-Grant Review)
Patent Application
Role of Data in the Patent Process - Overview
Step 1: Data in preparation of the patent application
Working examples
Prophetic examples
US versus EP and JP
Relevant in the decision of when to file
Influenced by shift to first-to-file
Role of Data in the Patent Process - Overview
Step 2: Data provided during patent prosecution
Proof of enablement
Proof of non-obviousness (e.g., surprising and unexpected
Role of Data in the Patent Process – Overview
Step 3: Data provided during litigation (context: invalidity
of granted patent)
Proof of enablement
Proof of secondary factors of nonobviousness (e.g., surprising
and unexpected results)
Step 1: Filing the Application with Data
Examples (supposedly first included in a patent that
issued in 1839)
Working examples – result of actual research (past tense)
Prophetic example – proposed (present or future tense)
Correlative examples
Animal data for human treatment
In vitro proof of in vivo method
Data in the Patent Application (continued)
Purpose of Data/Working Examples
How to make and/or use the invention without undue
One of the “Wands” factors - presence or absence of working
Data in the Patent Application (continued)
Proof of non-obviousness
Negative data
Surprising or unexpected results
Substantiate a genus
Disclosure of best mode
Avoid inequitable conduct
Negative results
Data in Patent Application (continued)
Examples NOT required (or are they?)
Particularly common in biotech and chemistry applications
because of unpredictability
Amgen v. Chugai (Fed. Cir. 1991) – must make and use
enough sequences to justify the breadth of the claim (EPO –
provided only a limited number of DNA sequences)
In re Wright (Fed. Cir. 1993) – Skilled artisan would be
unable to carry out the steps required to full scope (vaccine)
to any RNA virus in any animal
Data in Patent Application (continued)
Broader claims/ complex inventions may need more
Examples not necessarily limiting (Or are they?)
Contrast with EP
Step 2: Filing Data During Patent Prosecution
Lack of enablement
Application as filed must enable one of skill in the art to make
and use the invention – post filing data can be used to support
an assertion of enablement (In re Brana)
Declaration (37 CFR §1.132)
Generally examiner should not use post-filing data references
to show patent is not enabling – unless later reference provides
evidence of what one skilled in the art would have known on or
before the filing date (In re Wright (Fed. Cir. 1993 – reference
showed unpredictability of viruses)
Data Provided During Patent Prosecution
Proof of surprising and unexpected results
Negative data during experimentation
Duty of disclosure
Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc. (Fed.
Cir. 2003)
Negative data included in publication that served as basis
for patent application but that published after filing
Failure to provide during prosecution was inequitable
Step 3: Data Provided During Litigation (Janssen
v. Teva)
Proof of enablement based on post-filing data
Janssen v. Teva (Fed. Cir. 2009)
Factual background
Invention - Reminyl use for treatment of Alzheimers Disease
Inventor saw a paper related to use of drug as an antidote for
a powerful drug relaxant
Inventor recognized cause of action may be useful in AD
Drug unavailable in US for testing until post-issuance
Commercial success
Data Provided During Litigation (Janssen v. Teva)
Specification -1 page
No experimental data
Summarized 6 articles related to administration of Reminyl
to animals or human (not for AD treatment)
Described an animal model of AD
Treating and diagnosing AD and other dementias by
administering Reminyl or its salt
Data Provided During Litigation (Janssen v. Teva)
Obviousness rejection – Response that animal experiments
No enablement rejection
District Court
Held non-obvious but invalid for lack of enablement because no
utility demonstrated (“[S]ince plaintiffs rely exclusively on the
prior art to establish enablement, the court agrees with
defendants that the . . . patent cannot be both non-obvious and
Data Provided During Litigation (Janssen v. Teva)
Tests can be conducted by third party
Human trials not needed
In vitro tests can be enough
Test results after issuance cannot be used to establish
Data Provided During Litigation (Genetics Institute
v. Novartis Vaccines and Diagnostics)
Proof of surprising and unexpected results
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics,
Inc (Fed Cir. 2011)
Factual basis
Invention related to a truncated form of a blood clotting
factor and use in treatment of hemophilia
Factor VIII
2332 amino acid residues and 6 domains
Binds von Willibrand factor- prevents
degradation (Not known at time of filing)
GI was first to file
Data Provided During Litigation (Genetics Institute
v. Novartis Vaccines and Diagnostics) (continued)
Factual background (continued)
Genetics Institute
Claims to DNA encoding truncated Factor VIII, genetically
engineered cell that made truncated Factor VIII, method of making
truncated Factor VIII, Factor VIII protein (permit but does not
require deletion of domain that binds vWF)
Received 3.5 years of patent term extension (based on FDA
approval process)
Claims to DNA encoding truncated Factor VIII that retains a
portion of the domain that binds vWF
Filed about 9 months after GI priority date
Data Provided During Litigation (Genetics Institute
v. Novartis Vaccines and Diagnostics) (continued)
Procedural status
Genetics Institute sued Novartis in district court to determine
priority of invention (Interfering patents)
Novartis moved to dismiss asserting (in part) no interference
exists because the Novartis claims are directed to a truncated
Factor VIII that retains the von Willibrand binding portion
District court granted Novartis’s motion to dismiss
GI appealed – DC erred in finding no interference in fact
Data Provided During Litigation (Genetics Institute
v. Novartis Vaccines and Diagnostics) (continued)
Legal analysis
Does an interference in fact exist?
Same or substantially the same subject matter
GI asserted
Novartis’s claims obvious because their deletion narrower than GI
Novartis truncations based on known cleavage points
Court erred by relying on post-filing evidence showing unexpected
results (domain binds vWF- not appreciated at the time of filing)
Data Provided During Litigation (Genetics Institute
v. Novartis Vaccines and Diagnostics) (continued)
The structure of a compound and its properties are inseparable
Every property of a claimed compound need not be fully recognized as of filing
Evidence of unexpected properties developed after patent grant can be
considered in obviousness analysis
Should not look at a feature no one appreciated at time of filing to establish
non-obviousness – Hindsight
Data Provided During Litigation (continued)
Evidence of enablement should be provided in the application
or during prosecution (may NOT be sufficient if first submitted in
Evidence of unexpected results even if not appreciated at the
time of filing or even during prosecution may be sufficient
evidence of non-obviousness if first submitted during litigation
Some resistance by courts - seem more reluctant to accept
post-filing data – watch for tension in future cases
Take-home Messages
In unpredictable arts, provide working examples in application
(consider delayed filing – consider upcoming first-to-file standard)
Human tests best but not required
Animal tests acceptable if accepted animal model
In vitro tests acceptable if reasonable correlation
Include negative data in application (with explanation?) or in IDS
If no working examples in application, provide enabling data during
prosecution (even if no enablement rejection!)
If evidence of unexpected results, watch out for tension in court and
potential shift in court’s position – file evidence during prosecution
even if no obviousness rejection!
Tina Williams McKeon
McKeon Meunier Carlin &
404-645-7701 (office)
[email protected]

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