Nicole Ballew Chang, PhDLauren E. Schneider, Esq.

Christie Parker Hale nbc@cph.com1/30/2013

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Purpose of a Patent

Filing a Patent Application

Patent Prosecution (Examination)

America Invents Act (AIA)

Biotech Specifics:Patentability of DNAImportance of Written

Description © Christie, Parker & Hale, LLP

For Inventor/Applicant:

Exclude others

Extract a royalty

Add to capital of company

Enhance reputation of company

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U.S. Govt. Grants a Patent:

In exchange for up to 20 years of patent protection, invention is then dedicated to public.

Encourages innovation.

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TYPES OF PATENTS:

UTILITY— for inventions that perform useful functions. 20 years of protection after filing.

PLANT— for new strains of asexually reproducing plants. 20 years of protection after filing.

DESIGN– for a new design, used for visual ornamental characteristics. 14 years of protection from date of grant.

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PARTS OF A UTILITY PATENT APPLICATION:

WRITTEN DESCRIPTION: Background, Description, Examples.

DRAWINGS: Usually needed, but not required.

CLAIMS: Claims are what define “the invention.” Claims specifically define what the patent rights cover.

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Patent prosecution is the back and forth between the Applicant and the Patent Office which ultimately leads to the granting of a patent with claims that the Applicant and Patent Office agree on.

After the formal requirements are met, the patent application is examined by an Examiner at the Patent Office. After filing, it typically takes at least 1 year for examination to begin.

EXAMINATION:

Examiner reviews the claims of the patent application for:

Patentable Subject MatterNoveltyNon-obviousnessWritten DescriptionEnablement

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Non-Patentable Subject Matter—

One cannot obtain a patent on:

Laws of naturePhysical phenomenaAbstract ideasA natural product — even if it was

not previously identified

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NOVELTY:

Invention cannot already be publicly

known or publicly in use.

Invention cannot be previously described or published.

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NON-OBVIOUSNESS:

Invention cannot be obvious to those of “ordinary skill in the art.”

Invention cannot be taught or suggested by the prior art.

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WRITTEN DESCRIPTION:

Specification must contain a proper written description of the invention that describes the best mode known to Applicant for putting the claimed invention into practice.

This was clarified as distinct from enablement in Ariad v. Eli Lilly.

ENABLEMENT:

Specification must enable those of ordinary skill in the art to make and use the invention.

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From FIRST TO INVENT to FIRST TO FILECURRENT LAW

1) Filing within one year of publication2) Filing within one year of public use or offer

for sale (Grace Period)

NEW LAW (March 16, 2013)1) Prior to publication or filing BY ANOTHER.

2) Within one year of disclosure BY APPLICANT or one who derived invention from applicant (Personal Grace Period) U.S. only.

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Supplemental Examination ( September, 2012)Statutory provision to provide patentees with aMechanism to immunize a patent from allegations of

Inequitable conduct. Example—cited prior art.

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Post-Grant ReviewCongress just passed bill to ensure that the entire term

of issued patents will be available for a third-party challenge.

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Diamond v. Chakrabarty: the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability. The test is whether the living matter is the result of human intervention.

Invention claiming naturally occurring DNA (e.g. gene sequence) = not patentable.

Invention claiming “isolated DNA” = patentable

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Association for Molecular Pathology et al.

v.

USPTO, Myriad Genetics, Inc.,Directors of the University of Utah Research Foundation, andUSA as represented by Secretary of Health and Human Services

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Myriad Patents: Breast Cancer Genes: BRCA1 and BRCA2

ACLU, Plaintiff: The claims-in-suit directed to isolated DNA containing human BRCA1/2 gene sequences reflect the USPTO’s practice of granting patents on DNA sequences so long as those sequences are claimed in the form of “isolated DNA.”

This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a “lawyer’s trick” that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.

Patentability of DNA

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18© Christie, Parker & Hale, LLP

Patentability of DNAMay, 2009S. District of New York ruled that DNA and the method claimsof Myriad patents were unpatentable under 101. Myriad appealed.

July, 2011Federal Circuit reversed the decision with respect to thepatentability of DNA.

“The claimed isolated DNA molecules do notexist as in nature within a physical mixture to be purified.”

“If the law is to be changed, and DNA inventions excluded . . the decision must come not from the courts, but from Congress.”

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Patentability of DNA

December, 2011ACLU appealed to the Supreme Court.The Supreme Court remanded the case back to the FederalCircuit for reconsideration, but the Federal Circuit did not change its opinion.September, 2012ACLU petition the Supreme Court with respect to the Fed. Cir.Second decision.

November 30, 2012The Supreme Court agreed to hear the ACLU’s appeal of the Fed. Circuit’s ruling.

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WRITTEN DESCRIPTIONin view of ARIAD v. LILLY

David Baltimore et al. (Harvard, MIT, Whitehead Institute) filed a patent application on January 9, 1986 disclosing their discovery that NFκB is a regulator of gene expression in many, if not all, cell types.

NFκB is inactive when complexed with IκB in the cytosol. Upon signaling, IκB is “released” from NFκB, NFκB translocates into nucleus and upregulates gene expression.

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From this landmark discovery, 3 classes of molecules weredescribed as being capable of reducing NFκB activity: (i.e. molecules that “would bind”)

1. Specific inhibitors2. Dominantly interfering molecules3. Decoy molecules

Of the 3 classes, one single example was provided of a specific inhibitor— IκB (the naturally occurring inhibitor).

No other specific molecules were identified for reducing NFκB activity.

Ariad Patent Issued June 25, 2002.

WRITTEN DESCRIPTIONin view of ARIAD v. LILLY

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WRITTEN DESCRIPTIONin view of ARIAD v. LILLY

Claims 80 and 95 of Ariad patent read:

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April, 2003, Lilly’s (Evista) Patent Issued.Ariad sued Lilly asserting that Evista infringed their patent.Evista compound is a benzothiophene represented by Formula I below that inhibits NFkB.

WRITTEN DESCRIPTIONin view of ARIAD v. LILLY

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WRITTEN DESCRIPTIONin view of ARIAD v. LILLY

Result:Ariad claims were ruled invalid.Lilly’s Evista did not infringe.

Conclusions:

Inventor must be IN POSSESSION of the invention that is being

claimed.

One cannot claim a WISH.© Christie, Parker & Hale, LLP

Thank you.

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