Patenting Protein Therapeutics: In the Shadow of Uncertainty 4th Protein Discovery and Therapeutics Global Technology Community презентация

Protein Therapeutics: In the Shadow of Uncertainty


4th Protein Discovery and Therapeutics
Global Technology Community

Baltimore, MD
October 25, 2013

Big Changes in Patent Law:
The America Invents Act (“AIA”)


Society of Women Engineers
Annual Conference 2013

Speaker:
Carla Todenhagen

to file
Other jurisdictions have a post-grant opposition system

Addresses concerns of many different groups
Provisions discussed over the course of five Congresses
Discussion in the courts and in industry on what needs to be addressed
Address significant backlog at the USPTO

improve patent quality and reduce backlog
Establish secure funding mechanism
Provide greater certainty for patent rights
Provide less costly, time-limited administrative alternatives to litigation

Invent”
Derivation proceedings replace interference proceedings
Inventor’s oath or declaration – easier for assignee to file
Supplemental Examination can be requested by patent owner
Post-grant review within 9 months of issuance
“Inter partes review” replaces “inter partes reexamination”
3rd party submission of prior art (pre-issuance)
Citation of prior art in a patent file (post-issuance)

encompassing a human organism” prohibited (methods of treatment OK)
New routes of expedited examination
Best mode no longer a defense to patent infringement
Establishment of micro-entities 75% reduction in fees
Heightened bar for granting inter partes reexamination (New “reasonable likelihood of success” standard)
Virtual marking changes
False marking changes
Prioritized examination established

entitled to patent
Prior art is established as of effective filing date
Date of invention is no longer relevant to prior art
E.g., can’t swear behind a reference published within a year before filing
Public use or sale of the invention in a foreign country is now prior art
Prior statute limited prior art to public use or sale in the U.S.
One-year grace now limited only to inventors that disclose “subject matter” before date of prior art.

red)
Patent or printed publication anywhere
In public use in US
In public use in foreign countries
On sale in US
On sale in foreign countries
Available to public in US (“known or used by others”)
Available to public in foreign countries
US patents and published applications as of EFD, including foreign priority dates

application, especially in fast-moving technologies, before preparing more detailed application.
Risk: Non-enabled disclosures not entitled to priority date. Balance filing with less enablement and risk that someone else beats you to USPTO.
Consider filing multiple applications directed to improvements or variations to protect against filing or disclosure by others.

to disclose invention:
One year grace period to file application.
This starts the clock. You have one year to file a patent application once you disclose.
More generous than Europe.

A third-party disclosure within one year of applicant’s filing date is NOT prior art if the inventor disclosed first.

SUBJECT MATTER A
Dec. 2014
(<1 year from A’s publication)

B publishes
SUBJECT MATTER A
Mar. 2014

B’s publication is NOT prior art to A
(But would be prior art to anyone else)

A as to SUBJECT MATTER X.
But SUBJECT MATTER Y is prior art. Claims to Y cannot be obtained.

A publishes
SUBJECT MATTER X
Jan. 2014

A files app for SUBJECT MATTER X + Y
Dec. 2014
(<1 year from A’s publication)

B publishes
SUBJECT MATTER X + Y
Mar. 2014

one-year grace period.
But what is a “disclosure” under new law?
No guidance in the AIA
Does a disclosure have to be enabling? Likely.
Does an offer for sale or public use without details of invention count?
If you want to rely on “disclosure” grace period
consider providing details of “subject matter” of invention

filing.
Loss of trade secret rights.
Unclear how “disclosures” will be treated by courts.
Gives competitors the chance to begin “improving” upon your ideas.
Can a competitor file on SUBJECT MATTER A+B if you disclose SUBJECT MATTER A?
Extra cost associated with proving first disclosure.

PROS?
Cheaper than filing a provisional or other patent application?
Ensures prior art effect as of publication.
Abandoned provisional applications don’t publish.
Prevents others from filing on the same invention while providing
the potential to file on the subject matter in the future.

First To File: Balancing Disclosure

of applicant's filing date is NOT prior art if:
the inventor already disclosed the invention prior to the third party disclosure.
derivation occurred.

obtained the subject matter disclosed directly or indirectly from the inventor” have a limited prior art effect.
A disclosure derived from the inventor is not available prior art for one year.
Patent applications or patents derived from the inventor are not available as prior art as of their “effective filing date” (only prior art as of their publication date).
How do you prove derivation?

exempt as prior art if common ownership or under joint research agreement
Old: only applies to obviousness rejections.
New: Expanded to cover novelty and obviousness rejections
New: Common ownership no longer required at time of invention, but must be in effect on or before the effective filing date.

at any time
Patent not invalid or unenforceable if a failure is remedied in this manner.
Oath needed before providing Notice of Allowance
No more Missing Parts for unexecuted declarations?
Separate oath or declaration no longer required.
declaration statement can be made in assignment documents.
declaration statements can be made before preparation of the application.

of today, the standard minimum fee, paid by large entities, when a new utility patent application is filed, is US$1,600.00. For the same application, a small entity pays only US$800.00. A qualifying micro-entity will pay, according to today's fee schedule, only US$400.00.

A micro entity is any applicant that:
Qualifies as a small entity
Has not been named as an inventor on more than 4 previously-filed applications.
Does not include foreign applications, provisionals, or international applications where basic national fee was not paid.
Applications from prior employment (which were assigned/under an obligation to assign) don’t count.
Did not, in calendar year before paying fee, have a gross income exceeding 3 times median household income for that preceding calendar year, as most recently reported by the Bureau of the Census. (Currently about $150k)
Not be under an obligation to assign, grant, or convey a license or other ownership to another entity that does not meet the same income requirements as the inventor.
U.S. Institutions of Higher Education also qualify as micro entities.

rejection or allowance) within a year
Utilities or plant applications only – not available for national stage application.
Request must be present at time of filing
4 independent claims and 30 total claims (subject to excess claims fees)
USPTO limit of 10,000 granted requests/year
Warning – application converted to regular application if:
Extension of time is filed
Amendment results in more than 4 independent or 30 total claims
RCE filed

application, patent, or printed publication
Concise statement of relevance and fee required
Timing restrictions

“information believed to be relevant to the patent.”
Inoculates patent against potential inequitable conduct.
Within 3 months of request, Director decides if a Substantial New Question of Patentability is raised.
A patent shall not be held unenforceable based on information considered in supplemental examination. But
Inapplicable to cure existing allegations
"If fraud on the Office is determined, disciplinary or criminal actions can be instituted.

than not” that at least one of the claims challenged is unpatentable
Challenge can be based on any ground for invalidity
Opportunity for petitioner to file written comments after petition
Inter Partes Reexamination becomes Inter Partes Review
Available after 9 months of grant
“reasonable likelihood that the requester would prevail”
Note: change in threshold is effective now for Inter Partes Reexamination
Challenge can be based only on patents and printed publications.

of $500/offense
For private suits
Must now show "competitive injury“
Damages limited to amount "adequate to compensate for the injury“
No violations for marking with an expired patent.

Virtual marking allowed
Provide Internet address where full listing provided