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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
AIPLA BIOTECHNOLOGY COMMITTEE
WEBINAR
Leslie McDonell
[email protected]
The contents of this presentation represent the views of this author and do not
represent the policies or viewpoints of Finnegan or its management
Future of 2nd Medical Use Claims
A method of treating disease X comprising
administering drug Y to a patient suffering from
disease X.
A method of treating a human having acquired
immunodeficiency syndrome comprising the oral
administration of an effective acquired
immunodeficiency syndrome treatment amount of
3'-azido-3'-deoxythymidine [AZT] to said human.
U.S. Patent No. 4,724,232
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What Is a Law of Nature?
“Prometheus’ patents set forth laws of nature -namely, relationships between concentrations of
certain metabolites in the blood and the likelihood
that a dosage of a thiopurine drug will prove
ineffective or cause harm. . . . While it takes a
human action (the administration of a thiopurine
drug) to trigger a manifestation of this relation in a
particular person, the relation itself exists in
principle apart from any human action.”
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Isn’t a 2nd Medical Use an “entirely natural process”?
• A method of treating disease X comprising
administering drug Y to a patient suffering from
disease X.
• effect of drug in body = entirely natural process?
• law of nature = relationship between the presence
of drug Y in the body and a reduction of the
symptoms of disease X?
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Personalized Medicine – has the bell tolled?
• methods involving novel dosage
• methods involving specific route of administration
– well-understood, routine, conventional activity?
• methods of diagnosing/treating disease by
correlating disease with the presence (or absence)
of a biomarker
• newly discovered marker vs. newly discovered
correlation between known marker and disease
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Tip of the Iceberg
Smartgene, Inc. v. Advanced Biological
Laboratories, SA, No. 08-00642, 2012 U.S. Dist.
LEXIS 44138 (D.D.C. March 30, 2012)
methods for computer-aided guidance for the
selection of a therapeutic treatment regimen
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Is There a Congressional Fix?
• Should or can Congress fix the ambiguities caused
by the Mayo decision?
• Is an amendment to the patent statutes necessary
or will future judicial interpretation make the correct
application of the Mayo decision more clear?
• Consider cases following:
– Seagate – no negative inference on willful infringement due to failure to
secure opinion of counsel
– Kingsdowne Therasense regarding definition of inequitable conduct
standards
– Ebay – standards for obtaining a preliminary injunction
– KSR, Bilski
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35 U.S.C. § 103(b)
• 35 U.S.C. 103 ( Conditions for patentability;
non-obvious subject matter.
(b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection,
a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious
under subsection (a) of this section shall be considered nonobvious if(A) claims to the process and the composition of matter are contained in either the same application for patent or in
separate applications having the same effective filing date; and
(B) the composition of matter, and the process at the time it was invented, were owned by the same person or
subject to an obligation of assignment to the same person.
(2) A patent issued on a process under paragraph (1)(A) shall also contain the claims to the composition of matter used in or made by that process, or
(B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other
patent, notwithstanding section 154.
(3) For purposes of paragraph (1), the term "biotechnological process" means(A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
(iii) express a specific physiological characteristic not naturally associated with said organism;
(B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
(C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of
subparagraphs (A) and (B).
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America Invents Act
• Section 33(a), 125 Stat. at 340
no patent may issue on a claim directed to or
encompassing a human organism
• Section 14(a), 125 Stat. at 327
any strategy for reducing, avoiding, or deferring tax
liability whether known or unknown at the time of the
invention or application for patent shall be deemed
insufficient to differentiate a claimed invention from the
prior art
99
Congress Has Implicitly Approved Diagnostic Methods
• Congress affirmatively considered certain
diagnostic method claims at Section § 27, (125
Stat. at 338-39)
• Congress required the Director of the USPTO to
“conduct a study on effective ways to provide
independent, confirming genetic diagnostic test
activity where gene patents and exclusive
licensing for primary genetic diagnostic tests exist”
AIA § 27(a), 125 Stat. at 338 (emphasis added)
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Is a Fix Necessary?
• Is an amendment to the patent statutes necessary
to protect diagnostics and personalized medicine?
• What type of amendment would be required?
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