Transcript Slide 1

The Myth of
Industry
Differences
Robert A. Armitage
Eli Lilly and Company
1
The fundamental notion of
“industry differences” is
merely an artifact of a
patent system in need of
substantial reforms.
2
• What makes an invention patentable?
– Eligible subject matter.
– Practical utility.
– Possession-verifying written description.
– Commensurate enablement.
– Reasonable definiteness.
– Novelty (over express & inherent disclosures).
– Non-obviousness (to POSITA).
• The application of these criteria to any
particular technology is not self-evident.
3
• What makes any patent system work?
– Rigorous application of patentability rules.
– Consistent application of the rules.
– Highly predictable outcomes.
– Prompt examination of an inventor’s claims.
– Objective requirements for patentability.
– Patentability assessments dependent only on
publicly accessible information.
– Certainty in enforcement of valid IP rights.
• What “works” is not technology dependent.
4
• When does a patent system fail?
– Patentability rules not well developed.
– Patentability rules not consistently applied.
– Enforcement of valid patent rights is difficult.
– Testing of questionable patents is arduous.
– Patentability determinations are—
• Unpredictable – with prolonged uncertainty,
• Dependent upon non-public information, and
• Based on subjective elements.
• Common “fail” factors for all technologies.
5
• How do the criteria for “success” and
“failure” for patent systems differ by area
of technology?
– No evidence whatsoever that a “successful”
patent system for any one area of technology
would have different factors for success
compared to any other area of technology.
– Abundant evidence exists that some
technology areas are more failure-tolerant.
• Pharma/Bio tolerate more “false positives.”
6
• Differences among industry groups in their
focus on patent reform elements:
– Pharma-Bio: Reduce the number of “false
positives” by increasing “patent quality.”
– IT/Financial Services: Reduce the impact of
“false positives” through “civil justice” reforms.
• These agendas have elements that collide
and elements producing synergies.
– The rub resides in reducing remedies.
7
• What needs doing in all technology areas?
– National Academies recommendations:
• Eliminate subjective elements from patent
litigation.
• Eliminate non-public information in determining
patentability (first-inventor-to-file/best-mode).
• Institute “open review” of issued patents.
• Provide PTO with adequate resources.
– Goal: Pick up any patent, read it, reference
only publicly accessible information, and be
able to determine its validity with finality.
8
• Case Study: Biotechnology Patenting
– What is required for possession-verifying
“written description”? Enablement? Utility?
• U. of California v. Lilly, 119 F.3d 1559 (Fed. Cir.
1997) – Human insulin gene written description.
• Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir.
2004) – antibodies decision contradicts U.C. v.
Lilly.
• In re Fisher, 421 F3d 1365 (Fed. Cir. 2005) – EST
utility finally addressed.
– Do we yet know how to apply the basic rules
of patentability to biotechnology inventions?
9
• U.C. v. Lilly barred patenting all vertebrate
genes:
– “A recombinant plasmid replicable in procaryotic host
containing within its nucleotide sequence a
subsequence having the structure of the reverse
transcript of an mRNA of a vertebrate, which mRNA
encodes insulin.”
• Noelle v. Lederman has dicta that permits
patenting all mc antibodies to an known antigen:
– “A monoclonal antibody, which specifically binds and
forms a complex with the 5c8 antigen located on the
surface of activated T cells and thereby inhibits T cell
activation of B cells … .”
10
• U. of Rochester v. G.D. Searle & Co., 375 F.3d
1303 (Fed. Cir. 2004), dissenting (J. Newman):
“The issue of whether patent law contains a separate written
description requirement has percolated through various panels
of this court, on a variety of facts. The differences of opinion
among the judges of the Federal Circuit, are, in microcosm, the
‘percolation’ that scholars feared would be lost by a national
court at the circuit level. Percolation is the great justifier of
conflict among the regional circuits. In the words of the Supreme
Court:
We have in many instances recognized that when frontier legal
problems are presented, periods of “percolation” in, and diverse
opinions from, state and federal appellate courts may yield a better
informed and more enduring final pronouncement by this Court.
Arizona v. Evans, 514 U.S. 1, 24 n.1 (1995).
“This question has percolated enough; it is ripe for en banc
resolution.”
11
• What was the Rochester decision about?
– “1. A method for selectively inhibiting [COX-2]
activity in a human host, comprising
administering a non-steroidal compound that
selectively inhibits activity of the [COX-2] gene
product to a human host in need of such
treatment.”
– Plain English: “Having found a COX-2 gene,
we hereby patent the use of anything and
everything that can block its activity.”
12
• In re Nuijten – What is patent eligible?
– “A signal with embedded supplemental data,
the signal being encoded in accordance with
a given encoding process and selected
samples of the signal representing the
supplemental data, and at least one of the
samples preceding the selected samples is
different from the sample corresponding to the
given encoding process.”
• What is this “invention” all about?
13
• Is the following signal patent-eligible?
– “He said to his friend, ‘If the British march
By land or sea from the town to-night,
Hang a lantern aloft in the belfry arch
Of the North Church tower as a signal light, One if by land, and two if by sea;
And I on the opposite shore will be,
Ready to ride and spread the alarm
Through every Middlesex village and farm,
For the country folk to be up and to arm.’”
– H. W. Longfellow, noted American inventor?
14
• Why apply unitary patentability principles
to diverse technology areas?
– Cross-pollination effect – ideas from one
technology area inform application to others.
– Acceleration effect – “chemical” patent law
accelerates “biotechnology” patent law
development, et cetera.
– Ultimate “litigation reform” is only issuing
patents in rigorous compliance with welldeveloped patentability criteria.
15
• Conclusions:
– Application of patentability criteria to emerging
technology areas is unacceptably slow.
– The prolonged uncertainty generated bedevils
all fields of technology equally.
– Comprehensive patent law reforms are
needed to accelerate development of a deep
understanding of patentability requirements.
– The fundamental notion of “industry
differences” is merely an artifact of a patent
system in need of substantial reforms.
16