Download Proposed U.S Patent Reform

RECENT CASES IN BIOTECH/PHARM/CHEM
&
2011 AMERICA INVENTS ACT
Korean Intellectual Property Office
October 19, 2011
Sunhee Lee, SUGHRUE MION PLLC
October 2011
2
Agenda

Recent Cases in Biotech/Pharm/Chem
 Ariad Pharm v. Eli Lilly – written description

Prometheus v. Mayo – statutory subject
matter

America Invents Act of 2011
3
October 2011
Written Description Requirement Under 35 USC 112, ¶ 1
• Written Description - Requires the
invention to be described in sufficient
detail that one skilled in the art can
conclude that the inventor had possession
of the claimed invention
• Enablement – Requires the specification to
teach one skilled in the art how to make
and use the invention, without undue
experimentation
4
October 2011
Written Description Requirement Under 35 USC 112, ¶ 1
• Breadth of Claims
• Representative Examples commensurate in
scope with claims
• At the time of invention (earliest effective
filing date)
5
October 2011
Ariad Pharmaceuticals, Inc. v. Eli Lilly
• 13 inventors, including David Baltimore, Philip Sharp,
and Thomas Maniatis
• Identification and characterization of the transcription
factor NF-kB
• Implicated in diseases and conditions ranging from sepsis,
cancer, and AIDS
• Patent at issue – US 6,410,516 – assigned on the face of
the patent to M.I.T., the Whitehead Institute, and
Harvard University
• Licensed to Ariad Pharmaceuticals
6
Ariad v. Lilly
Claim 80. A method for modifying effects of external
influences on a eukaryotic cell, which external influences
induce NF-κB-mediated intracellular signaling, the
method comprising altering NF-κB activity in the cells
such that NF-κB-mediated effects of external influences
are modified, wherein NF-κB activity in the cell is
reduced, wherein reducing NF-κB activity comprises
reducing binding of NF-κB to NF-κB recognition sites on
genes which are transcriptionally regulated by NF-κB.
October 2011
7
Ariad v. Lilly
Claim 144. A method for reducing bacterial
lipopolysaccharide-induced expression of cytokines in
mammalian cells, which method comprises reducing NFκB activity in the cells so as to reduce bacterial
lipopolysaccharide-induced expression of said cytokines
in the cells, wherein reducing NF-κB activity comprises
reducing binding of NF-κB to NF-κB recognition sites on
genes which are transcriptionally regulated by NF-κB.
October 2011
8
Ariad v. Lilly
• Written description must be determined as of
earliest effective filing date (here, April 12,
1989)
• Much of Ariad's evidence, however, was what
one of ordinary skill in the art knew in 1990
and 1991, and was thus legally irrelevant
October 2011
9
Ariad v. Lilly
October 2011
10
October 2011
Ariad v. Lilly
The specification states: classes of molecules that can reduce binding of
NF-κB to NF-κB recognition sites on genes which are transcriptionally
regulated by NF-κB :
1.Specific Inhibitors
2.Dominantly Interfering Molecules
3.Decoy molecules
Specific Inhibitors:
• Only one inhibitor provided, the naturally occurring IkB
• Figure 43 provided sequence of IkB
• However, Figure 43 not added until the 1991 application
11
Ariad v. Lilly
Decoy molecules:
• Designed to mimic the NF-kB binding site
• Court found that actual decoy molecules were adequately
described
• However, no description of a method of using these
molecules to reduce NF-kB activity
• Therefore, nothing more than a desired outcome
October 2011
12
Ariad v. Lilly
Dominantly Interfering Molecules:
• No examples provided
• Specification only states that they are theoretically
possible
• Irrelevant that others were practicing dominantly
interfering molecules after the 1989 application
October 2011
13
Ariad v. Lilly
Even with the November 1991 effective filing date, the
outcome would likely have been the same
• No working examples or even prophetic examples of
methods that reduce NF-kB activity
• No completed synthesis of any of the molecules
• Even with decoy molecules, there was no accompanying
description that they could be used to reduce NF-kB
activity
October 2011
14
October 2011
Ariad v. Lilly (En banc, Fed. Cir. 2010)
•
•
En banc decision to confirm that written description
requirement is a separate requirement from
enabling disclosure requirement
Claim – method for modifying effects of external
influences on a eukaryotic cell, … comprising
altering NF-kB activity, …, wherein reducing NF-kB
activity comprises reducing binding of NF-kB to NFkB recognition sites on genes.
•
•
•
No embodiments of a compound which reduces the
binding
Scare information in the art at the time of invention
Broad scope of claim
1515
October 2011
Statutory Subject Matter & Prometheus v. Mayo
Sughrue Mion PLLC
16
October 2011
Before Bilski
• Anything under the sun that is made by man
• A useful, concrete, and tangible result was
persuasive, and little need to excuse data
gathering
• A price for a financial product, for example, is considered to be a concrete
useful and tangible result (see State Street Bank v. Signature Financial Group).
• Certainly no need to recite or assert a machine or
transformation
• Who could possibly think that detecting, assaying,
etc. could be done without a machine or
transformation?
October 2011
Sughrue Mion PLLC
17
The Bilski Test by CAFC: Machine or Transformation Test
2008, en banc
A claimed process is patentable under 35 U.S.C. § 101 if
§
(a) the process is tied to a particular
machine or apparatus,
or
(b) the process transforms a particular article into a
different state or thing
October 2011
Sughrue Mion PLLC
18
Supreme Court: The Bilski Test (2010)
Involvement of the machine or transformation must not be
insignificant, extra-solution activity, such as gathering data.
A claim simply to natural phenomena, mental processes,
and/or abstract ideas is not patentable.
In Bilski, Curt affirmed affirmed the rejection of an application for a patent on a method of hedging losses in one
segment of the energy industry by making investments in other segments of that industry, on the basis that the
abstract investment strategy set forth in the application was simply not patentable subject matter
Although the machine-or-transformation test is a “useful
and important clue,” it was not the sole test for
determining the patent eligibility of process claims.
Limited its holding to the invention at issue.
October 2011
Sughrue Mion PLLC
19
Prometheus v. Mayo
Patents 6,355,623 &6,680,302
A method of optimizing therapeutic efficacy for treatment of
an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject
having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject
having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol
per 8x108 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said
subject and
wherein the level of 6-thioguanine greater than about 400
pmol per 8x108 red blood cells indicates a need to decrease
the amount of said drug subsequently administered to said
subject.
19
October 2011
Sughrue Mion PLLC
20
Prometheus v. Mayo
2004 Prometheus sued Mayo for infringement
2008 District Court granted Mayo SJ motion of
Invalidity under 35 USC 101
- “the patents only claimed the correlations between
certain thiopurine drug metabolite levels and therapeutic
efficacy and toxicity.”
- “’administering’ and ‘determining’ steps are merely
neces-sary data-gathering steps for any use of the
correlations” and that “as construed, the the ‘warning’
step (i.e., the ‘wherein’ clause) is only a mental step.”
October 2011
Sughrue Mion PLLC
21
Prometheus v. Mayo
2009 CAFC reversed the DC decision and held that the
claims are valid (581 F.3d 1336) "administering" and
"determining" steps were transformative and not merely
data-gathering steps.”
2010 Supreme Court vacated CAFC decision and
remanded for further consideration in view of Bilski
(2010)
2010, Dec. CAFC re-affirmed validity of claims under
section 101 (628 F.3d 1347) CAFC.
October 2011
Sughrue Mion PLLC
22
Prometheus v. Mayo
• 2010, Dec. CAFC (628 F.3d 1347) decision:
• Both “administering” and “determining” steps The method
claims recited a patent-eligible application of naturally
occurring correlations between metabolite levels and
efficacy, i.e., the treatment of a specific disease by
administering specific drugs and measuring specific
metabolites. The method did not wholly preempt all uses of
the recited correlations. The methods were not "merely"
data-gathering steps or "insignificant extra-solution
activity," but rather were part of treatment regimes, and
therefore involved "a significant transformative element."
October 2011
Sughrue Mion PLLC
23
Prometheus v. Mayo – question presented for SC
• Whether 35 U.S.C. § 101 is satisfied by a patent
claim that covers observed correlations between
blood test results and patient health, so that the
claim effectively preempts all uses of the naturally
occurring correlations, simply because wellknown methods used to administer prescription
drugs and test blood may involve
“transformations” of body chemistry.
• Hearing scheduled on Dec. 7, 2011
October 2011
Sughrue Mion PLLC
24
Prometheus v. Mayo: Compare to Classen
A method of immunizing a mammal, including the
following steps:
1) screening information on immunization schedules
and the occurrence of chronic immune-mediated
disease,
2) comparing the results from different schedules and
identifying the lower risk schedule, and
[3) administering the vaccine on that lower risk
schedule.]
24
Sughrue Mion PLLC
THANK YOU
Sunhee (Sunny) Lee, partner
SUGHRUE MION PLCC
[email protected]