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Biotechnology Patents: Disclosure Requirements
under 35 USC § 112University of Washington
School of LawGary M. Myles, Ph.D.
January 25, 2017(425) 466-8262
Copyright ©2017, Myles Intellectual Property Law
Topics Covered35 U.S.C. § 112
Enablement and Written Description• In Re Wright (Fed. Cir. 1993)• U. of California v. Eli Lilly (Fed. Cir. 1997)• Enzo v. Gen-Probe (Fed. Cir. 2002), Rader
Dissent• Chiron v. Genentech (Fed. Cir. 2004)• Rochester v. Searle (Fed. Cir. 2004)• Ariad v. Lilly (Fed. Cir. 2009), (Fed. Cir., en
banc, 2010)
• 35 U.S.C. § 101, Utility– Specific, Substantial, and Credible
• 35 U.S.C. § 112, Specification–Enablement–Written Description–Best Mode
The Statutory Patent Disclosure Requirements
PRE-AIA35 U.S.C. § 112, ¶ 1
The SPECIFICATION shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains … to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
POST-AIA35 U.S.C. § 112(a)
(a) In General.— The SPECIFICATION shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains … to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out [[his]] the invention.
Enablement – Basic ConceptsA patent application must provide
sufficient disclosure to enable a person skilled in the art to make and use the claimed invention
One skilled in the art would be enabled to practice the claimed invention if:• It would NOT require “undue
experimentation” to make and use the claimed invention
• The claims are NOT of “undue breadth” in view of the scope of the disclosure provided by the specification
Enablement – Basic Concepts In re Wands (Fed. Cir. 1988): “The key
word is ‘undue,’ not ‘experimentation’ ” Quoting In re Angstadt (CCPA 1976)• Quantity of experimentation• Amount of direction and guidance
provided• Presence or absence of working
examples• Nature of the invention• State of the prior art• Relative skill of those in the art• Predictability of the art• Breadth of the claims
The Problem of Enablement in Biotechnology
What is the scope of protection afforded by these claims?• A cDNA encoding Protein X, comprising the
nucleotide sequence of SEQ ID NO: 1. (wherein SEQ ID NO: 1 encodes full-length Protein X)
• A cDNA encoding Protein X, comprising a nucleotide sequence that is at least 70% identical to the nucleotide sequence of SEQ ID NO: 1.
How easy would it be for a third-party competitor to escape the literal scope of these claims by “designing around” with insubstantial nucleotide substitutions?
Degeneracy of the Genetic Code
T C A G
TTTT Phe (F)TTC " TTA Leu (L)TTG "
TCT Ser (S)TCC " TCA " TCG "
TAT Tyr (Y)TAC TAA Ter TAG Ter
TGT Cys (C)TGC TGA Ter TGG Trp (W)
CCTT Leu (L)CTC " CTA " CTG "
CCT Pro (P)CCC " CCA " CCG "
CAT His (H)CAC " CAA Gln (Q)CAG "
CGT Arg (R)CGC " CGA " CGG "
AATT Ile (I)ATC " ATA " ATG Met (M)
ACT Thr (T)ACC " ACA " ACG "
AAT Asn (N)AAC " AAA Lys (K)AAG "
AGT Ser (S)AGC " AGA Arg (R)AGG "
GGTT Val (V)GTC " GTA " GTG "
GCT Ala (A)GCC " GCA " GCG "
GAT Asp (D)GAC " GAA Glu (E)GAG "
GGT Gly (G)GGC " GGA " GGG "
Amgen v. Chugai (Fed. Cir. 1991)Teach how to make and use the claimed
invention such that it can be practiced by a person of skill in the art without undue experimentation• Disclosure that is commensurate in
scope with the breadth of the claims• Multiple working examples within the
claim scope• Teaching of how to test additional
undisclosed variants within the claim scope
Amgen v. Chugai (Fed. Cir. 1991)Make and Use Without Undue
Experimentation• Structural Limitations
−Provide algorithms for computing percent identity
−Describe conservative amino acid substitutions
• Functional Limitations−Disclose assay systems and
methodologies for confirming claimed functionality
In Re Wright (Fed. Cir. 1993)
Claim 11A live, non-pathogenic vaccine for a pathogenic RNA virus, comprising an immunologically effective amount of a viral antigenic, genomic expression having an antigenic determinant region of the RNA virus, but no pathogenic properties.
In Re Wright (Fed. Cir. 1993)
One Working Example• A recombinant vaccine that confers
immunity in chickens against Prague Avian Sarcoma Virus (PrASV), which is an RNA virus that is a member of the Rous Associated Virus (RAV) family
In Re Wright (Fed. Cir. 1993)Federal Circuit
• “… claims are directed to vaccines, and methods of making and using these vaccines, which must by definition trigger an immunoprotective response in the host vaccinated; mere antigenic response is not enough”
In Re Wright (Fed. Cir. 1993)
Federal Circuit• “Wright has failed to establish by
evidence or arguments that, in February of 1983, a skilled scientist would have believed reasonably that Wright’s success with a particular strain of an avian RNA virus could be extrapolated with a reasonable expectation of success** to other avian RNA viruses.”
**QUERY: Is “reasonable expectation of success” a test for enablement?
Enablement
General Rules• Broad scope requires broad disclosure• Working examples not required• Not required to teach “and preferably
omits” what is well known in the art”(Hybritech v. Monoclonal Antibodies (Fed. Cir. 1986))
EnablementHistorically …
• Enablement was the most onerous disclosure requirement under 35 USC § 112, first paragraph
UCalifornia v. Eli Lilly (Fed. Cir. 1997)UC disclosed:
• Cloned a cDNA encoding rat insulin• Determined the rat cDNA nucleotide
sequence• Amino acid sequence of human insulin
protein• General method for obtaining the human
cDNA
UC v. Eli Lilly (Fed. Cir. 1997)
UC claimed:1. 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.5. A recombinant procaryotic microorganism modified so that it contains a nucleotide sequence having the structure of the reverse transcript of an mRNA of a human, which mRNA encodes insulin.
UC v. Lilly (Fed. Cir. 1997)District Court
• Held claims invalid under § 112, ¶ 1, because “the specification, although it provided an adequate written description of rat cDNA, did not provide an adequate written description of the cDNA required by the asserted claims.”
UC v. Lilly (Fed. Cir. 1997)Federal Circuit Upholds District Court
• Claim 1 invalid−A description of rat insulin cDNA is not a
description of the broad classes [genra] of vertebrate or mammalian insulin cDNA
−A description of a chemical genus ‘requires a precise definition, such as by structure, formula, [or] chemical name.’ Quoting, Fiers v. Revel 984 F.2d at 1171
• Claim 5 invalid−“whether or not [Example 6] provides an
enabling disclosure, it does not provide a written description of the cDNA encoding human insulin.”
UC v. Lilly (Fed. Cir. 1997)Written description becomes a super-
enablement requirement, which is separate and apart from the enablement requirement
Enzo v. Gen-Probe (Fed. Cir. 2002)
Rader dissent• UC v. Lilly (1997) was a “deviation from
30 years of precedent”• Fed. Cir., for the first time, “purported to
apply WD as a general disclosure doctrine in place of enablement, rather than as a priority doctrine.”
Enzo v. Gen-Probe (Fed. Cir. 2002)Rader Dissent
• History of the Written Description Requirement−“Written description” first appears in
Patent Act of 1793−Evans v. Eaton (1822), S. Ct.
construed description requirement to be an enablement requirement
−JEM AG Supply (2001), S. Ct. acknowledged only enablement as the disclosure quid pro quo of Patent Act
The Priority Claim35 U.S.C § 120. Benefit of Earlier Filing
Date in the United States• “An application for patent for an
invention disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States … shall have the same effect, as to such invention, as though filed on the date of the prior application.”
What Does 35 U.S.C. § 120 Mean?
A claim in a CON or CIP, which claims priority to a parent application, is valid under 35 U.S.C. § 112, ¶1 if the priority application: • Is enabling (make and use) of the claim• Provides written description
(possession) support for the claimSupports a policy of providing broad
protection for pioneering inventions
Historical Perspective onContinuation Practice
Pre-GATT• Before June 7, 1995, when US patent
term was 17 years from date of issue, continuations (CONs), and continuations-in-part (CIPs) attractive
• Submarine Patents−Inventor Lemelson−Policy/fairness concerns
17 YRS17 YRS
17 YRS
Post-GATT• Since June 8, 1995, US patent term is
20 years from date of first filing, making CONs and CIPs less attractive
20 YRS from 1st filed application
Historical Perspective onContinuation Practice
Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent App. Filed Discl. 1 MAbNo ChimericNo Humanized
May 1984First ChimericAntibody Publication
1985 CIP App. FiledDiscl. 6 MAbNo Chimeric No Humanized
1986 CIP App. FiledDiscl. 6 MAbNo ChimericNo Humanized
1995 CIPApp. FiledDiscl. 1 MAbChimeric & Humanized Ab Technology
May 1986First HumanizedAntibody Publication
Intervening Art1977First MonoclonalAntibody Publication
Chiron v. Genentech (Fed. Cir. 2004)
‘561 patent issues with claims directed to monoclonal antibodies that bind to HER-2 (an antigen associated with breast cancer)
Chiron sues Genentech for infringement over sales of Herceptin®, a humanized Ab that binds to HER-2
Chiron v. Genentech (Fed. Cir. 2004)
Chiron v. Genentech (Fed. Cir. 2004)
Claims construed to encompass chimeric and humanized antibodies to HER-2, in addition to the murine antibodies disclosed in the 1984, 1985, 1986, and 1995 applications
Parties stipulate that if Chiron is not entitled to a priority claim under 35 U.S.C § 120, the intervening art anticipates the ‘561 patent claims
Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent App. Filed Discl. 1 MAbNo ChimericNo Humanized(HELD: NO WD)
May 1984First ChimericAntibody Publication
1985 CIP App. FiledDiscl. 6 MAbNo Chimeric No Humanized(HELD: NON-ENABLED)
1986 CIP App. FiledDiscl. 6 MAbNo ChimericNo Humanized(HELD: NON-ENABLED)
1995 CIP (‘561 Patent) App. FiledDiscl. 1 MAbChimeric & Humanized Ab Technology(HELD: ANTICIPATED)
May 1986First HumanizedAntibody Publication
Chiron sues GenentechFor Infringement based on sale of Herceptin(Humanized Ab)
Intervening Art1977First MonoclonalAntibody Publication
Chiron v. Genentech (Fed. Cir. 2004)Fed. Cir.’s Reasoning
• The 1985 and 1986 applications do not enable the ‘561 patent claims because:−Chimeric Abs were “nascent technology
requiring a ‘specific and useful teaching.’ ”
−Undue experimentation required to make and use the claimed chimeric antibodies
−Enabling disclosure must be commensurate in scope with claims
◦Claim reads on chimeric and murine Abs, yet applications do not disclose chimeric Abs
Chiron v. Genentech (Fed. Cir. 2004)
Fed. Cir.’s Reasoning, cont.• The 1984 application does not provide
written description support for the ‘561 patent claims because:−No disclosure, hence possession, of chimeric
or humanized Ab technologies−Enablement requirement does not apply to
after-arising technologies
After-Arising Technologies: Lingering Questions Post-Chiron
OriginalApplication
Invalid
After-Arising Technology
CIP
Continuation
???
???
• Would the outcome in Chiron had been different if:
• The original application had matured into a patent?
• If the subsequent application had been a CON rather than a CIP?
Prior Art
U. of Rochester v. Searle (Fed. Cir. 2004)
Rochester Discloses• COX-2 gene and protein• COX-2 is expressed in response to
inflammatory stimuli and is associated with arthritis
• Screening of compounds to see if they are capable of selectively inhibiting COX-2
• No actual disclosure of any COX-2 inhibitors
U. of Rochester v. Searle (Fed. Cir. 2004)
Rochester claims• Methods 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
Searle sued for sale of COX-2 inhibitors Celebrex® and Bextra®, marketed for treatment of inflammation
U. of Rochester v. Searle (Fed. Cir. 2004)
U. of Rochester v. Searle (Fed. Cir. 2004)
Fed. Cir. upholds invalidity of claims for lack of written description.• “[T]he ‘850 patent does not disclose
any compounds that can be used in its claimed methods. The claimed methods thus cannot be practiced based on the patent’s specification, even considering the knowledge of one skilled in the art.”
Ariad v. Lilly (Fed. Cir. 2009)Ariad Claims:
95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.
Ariad v. Lilly (Fed. Cir. 2009)Ariad Disclosed:
• Three classes of molecules (by function, not structure)−Specific Inhibitors−Dominantly interfering molecules−Decoy molecules
Ariad v. Lilly (Fed. Cir. 2009)District Court
• Held claims infringed and not invalid for anticipation, lack of enablement, and lack of written description
Ariad v. Lilly (Fed. Cir. 2009)Federal Circuit
• “Regardless of whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods. … the specification suggests only the use of the three classes of molecules*** to achieve NF-κB reduction.”
*** The three classes of molecules include−Specific Inhibitors−Dominantly interfering molecules−Decoy molecules
Ariad v. Lilly (Fed. Cir. 2009)Federal Circuit
“Thus, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity.” Citing, Capon v. Eshhar (Fed. Cir. 2005)
Ariad v. Lilly (Fed. Cir. 2009)Federal Circuit
“A vague functional description and an invitation for further research does not constitute written disclosure of a specific inhibitor.
* * *written description requires more than a ‘mere wish or plan for obtaining the claimed chemical invention.’ ” UC v. Eli Lilly
Ariad v. Lilly (Fed. Cir. 2009) Federal Circuit
• Judge Linn’s Concurrance“I write separately to emphasize … my
belief that our engrafting of a separate written description requirement onto 35 USC 112, paragraph 1 is misguided.
* * *[S]ection 112, paragraph 1 requires no more of the specification than a disclosure that is sufficient to enable a person having ordinary skill in the art to make and use the invention.”
Ariad v. Lilly (Fed. Cir. 2009)Ariad appeals to Federal Circuit for en banc
review• Whether 35 U.S.C. § 112, ¶ 1, contains a
written description requirement separate from an enablement requirement
• If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
On August 21, 2009, Federal Circuit grants en banc review, vacating the court’s April 3, 2009 opinion
Ariad v. Lilly (Fed. Cir. 2010) (en banc)
Federal Circuit• Opinion joined by every member of the
Court except Linn and Rader• Reaffirms that there is a separate
written description and enablement requirement under 35 USC § 112, first paragraph
Ariad v. Lilly (Fed. Cir. 2010) (en banc)
A separate written description requirement “plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented**, and thus cannot be described.”
Ariad v. Lilly (Fed. Cir. 2010) (en banc)
And “particularly for the biological arts,” having a separate written description requirement “ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function.”
Ariad v. Lilly (Fed. Cir. 2010) (en banc)
“Generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus clamed.”
Ariad v. Lilly (Fed. Cir. 2010) (en banc)
“A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”
In Summary … 35 U.S.C. § 112 (a) -- Specification
• Enablement−Teach one skilled in the art−Make and use the claimed invention−Without undue experimentation−Disclose nascent technology
• Written Description−Demonstrate Applicant’s possession of the
claimed invention−Provide disclosure of structure, formula,
chemical name, or physical properties
Practice TipDisclosure of Single Embodiments is
Risky
Claim Construction
35 U.S.C. § 112 (a)
OK if construed reads on:· Your commercial product· Competitor’s commercial product
“Invalid”
Practice TipDisclose Multiple Embodiments
Claim Construction
35 U.S.C. § 112 (a)
“Not Invalid”
Practice TipDraft Nested Claims from Broad to
Narrow
1. Broad Independent Claim
2. Narrow Dependent Claim
3. Still Narrower Dependent Claim
4. Narrowest “Picture” Claim