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Patent Law Changes and Rulings: Impact on UNC Patent Applications. December 6, 2012 Steven J. Sarussi. Who’s involved. Supreme Court Ownership of federally funded inventions under the Bayh-Dole Act Court of Appeals for the Federal Circuit Induced infringement by joint actors

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Patent law changes and rulings impact on unc patent applications

Patent Law Changes and Rulings: Impact on UNC Patent Applications

December 6, 2012

Steven J. Sarussi


Who s involved

Who’s involved

  • Supreme Court

    • Ownership of federally funded inventions under the Bayh-Dole Act

    • Court of Appeals for the Federal Circuit

      • Induced infringement by joint actors

      • Inventorship

      • Standard for inequitable conduct

    • Both Supreme Court and Federal Circuit

      • Patent eligible subject matter under 35 U.S.C. § 101

    • Congress

      • America Invents Act

        • First to file provisions


Big changes

Big Changes??

YES/NO?


Patent law changes and rulings impact on unc patent applications

Quiz

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.

  • Patentable subject matter?


Patent law changes and rulings impact on unc patent applications

Quiz

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

  • Patentable subject matter?


Patent law changes and rulings impact on unc patent applications

Quiz

A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

  • Patentable subject matter?


Patent law changes and rulings impact on unc patent applications

Quiz

A method for screening potential cancer therapeutics which comprises: growing a trans-formed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeu-tic, growing said transformed eukaryotic host cell in the absence of said compound, determining the

  • Patentable subject matter?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Researcher signs agreement agreeing to assign rights in his inventions to University

  • Researcher later assigns his rights in Invention X to Company

  • Who owns the patents covering Invention X?

    • University? Company?

  • Does it matter if work resulting in Invention X was federally funded research under Bayh-Dole?

    • University? Company?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Is Bill’s invention patentable?

  • Under old law?

  • Under new law?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Who gets the patent?

  • Under old law?

  • Under new law?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Is the public use prior art?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Is the disclosure by Bill prior art to Amy?


Patent law changes and rulings impact on unc patent applications

Quiz

  • Is Amy’s publication prior art under new law against Bill’s application?

  • Is Bill’s application prior art against Amy under new law?


Patent eligible subject matter under 35 u s c 101

Patent eligible subject matter under 35 U.S.C. § 101


Mayo collaborative services v prometheus labs inc s ct 2012

Mayo Collaborative Services v. Prometheus Labs., Inc. (S.Ct., 2012)

  • Supreme Court

    • Method of administering drugs to a patient and determining the proper dosage is not patent eligible subject matter under § 101

    • Prometheus’s patents “involve well-understood, routine, conventional activity previously engaged in by researchers in the field.”

    • Patents cover laws of nature


Mayo collaborative services v prometheus labs inc s ct 20121

Mayo Collaborative Services v. Prometheus Labs., Inc. (S.Ct., 2012)

  • All steps considered together do not transform the claims to something other than laws of nature

  • Administering step: refers to doctors who treat patients with the drug

  • Wherein clause: alerts doctors to the laws of nature to consider during treatment

  • Determining step: doctors may use any laboratory process, even well-known methods, for assessing metabolite level in blood


Association for molecular pathology v uspto myriad fed cir 2012

Association for Molecular Pathology v. USPTO(“Myriad”, Fed. Cir. 2012)

  • Patent eligibility of isolated human DNA (BRCA) and diagnostic tests for mutations under § 101 in light of Prometheus

  • Disputed claims:

    • Composition claims for isolated DNA sequences (BRCA1 and BRCA2 genes)

    • Method claims for comparing and analyzing sequences

    • Method claim for screening cancer therapeutics with transformed cells


Association for molecular pathology v uspto myriad fed cir 20121

Association for Molecular Pathology v. USPTO (“Myriad”, Fed. Cir. 2012)

  • Eligibility of claims for human gene sequences:

  • Chakrabartycontrols, not Prometheus

  • “isolated DNA molecules are not found in nature” and “the product of human ingenuity”

  • Plaintiffs argued that isolated and natural DNA share the same sequence, and are not “markedly different”

  • CAFC reasoned that although isolated DNA are functionally similar to natural DNA, isolated DNA are structurally distinct


Association for molecular pathology v uspto myriad fed cir 20122

Association for Molecular Pathology v. USPTO (“Myriad”, Fed. Cir. 2012)

  • Eligibility of method claims:

    • method claims for analyzing/comparing DNA sequences ineligible because it is an “abstract mental process” [Prometheus controls]

    • method of screening potential cancer therapeutics using transformed cells are eligible subject matter because they “arose from human effort” [Chakrabartycontrols]


Association for molecular pathology v uspto myriad fed cir 20123

Association for Molecular Pathology v. USPTO (“Myriad”, Fed. Cir. 2012)

  • Congress should determine policy questions surrounding patenting biological molecules

  • PTO has issued 2,645 patents on “isolated DNA” over past 29 years

  • Addressed preemption issue of others experimenting with BRCAby noting that “patents are rarely enforced against scientific research, even during their terms”


Perkinelmer inc v intema ltd fed cir 2012

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • 1. A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome… comprising…:

    • measuring the level of at least one screening marker from a first trimester of pregnancy…

    • measuring the level of at least one second screening marker from a second trimester of pregnancy; and

    • determining the risk of Down's syndrome by comparing the measured levels of both the … first screening marker … and the …second screening marker … with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.


Perkinelmer inc v intema ltd fed cir 20121

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • District Court

    • Denied PerkinElmer's motion for summary judgment of patent ineligibility under § 101

    • Concluded that the claims were directed to a data-gathering method comprising measuring steps that satisfied the machine-or-transformation test

      • “the process of gathering data by taking blood samples and measuring ultrasounds is manifestly statutory subject matter. . . .”


Perkinelmer inc v intema ltd fed cir 20122

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Federal Circuit Reverses

    • “Laws of nature, natural phenomena, and abstract ideas are not patentable.”

      • These exceptions make mental processes ineligible for patenting

    • But, all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”


Perkinelmer inc v intema ltd fed cir 20123

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Federal Circuit Reverses

    • "The key distinction … is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter." 

    • Patentable process claims “must contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”


Perkinelmer inc v intema ltd fed cir 20124

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Federal Circuit’s analysis

    • Claims recite a mental process of comparing data to determine a risk level

      • Data are gathered in the first trimester of pregnancy

      • Data are gathered in the second trimester of pregnancy

      • Those data are compared to known statistical information.

    • No action beyond the comparison is required.


Perkinelmer inc v intema ltd fed cir 20125

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Federal Circuit’s analysis

    • That an increased risk of fetal Down’s syndrome produces certain analytical results is a natural process

      • “an eternal truth that ‘exists in principle apart from any human action.’ ”

    • Thus, claims recite mental processes and natural laws

      • So, do they add enough to the ineligible subject matter to direct the claims to applications of those concepts” We think not.


Perkinelmer inc v intema ltd fed cir 20126

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Federal Circuit’s analysis

    • Because the claims recite mental processes and natural laws:

    • Do they add enough to the ineligible subject matter to direct the claims to applications of those concepts?

    • Do they possess or require an inventive concept?

    • Court: “No”


Perkinelmer inc v intema ltd fed cir 20127

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Inventive concept?

  • Measuring steps: No

    • Merely tell the users of the process to measure the screening markers through whatever known method they wish.

      • “The individual measurements are obtained through known methods”

      • “Tell the user to engage in well understood, routine, conventional activity previously engaged in by scientists who work in the field.”


Perkinelmer inc v intema ltd fed cir 20128

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • Inventive concept?

  • Determining step: No

    • Requires ineligible mental step of “comparing”

    • Statistical information mentioned in the determining step?

    • “Well-understood, conventional information.

      • “[T]he necessary statistical distribution parameters … are known, being derivable from observed distributions …”.

      • Statistical calculation: also known and conventional


Perkinelmer inc v intema ltd fed cir 20129

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

  • “Inventive concept”

    • A hint?

    • “It is the ‘two data points are better than one’ concept which is the focus of the claims; that concept simply does not depend on the method by which the data points are obtained.”


Diagnostic method claims

Diagnostic method claims

  • Recommendations

    • Identify “natural laws” and “products of nature”

    • Need more than “measuring” and “correlating”

    • Claim strategies

      • Narrow, specific, encompassing particular assay and detection steps

      • Add some (any) patentable feature other than the naturally occurring correlation between a marker and disease

        • Novel transformative step, machine, composition, etc.

      • Isolated DNA molecules


Back to the supremes

Back to the Supremes

Myriad questions presented to Supremes

  • Are human genes patentable?

  • Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs?

  • Did the court of appeals err in adopting an inflexible rule that parties who have been deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with a lawsuit?


Ownership of federally funded inventions under the bayh dole act

Ownership of federally funded inventions under the Bayh-Dole Act


Board of trustees of the leland stanford junior university v roche molecular systems inc 2011

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)

  • Employee of Stanford University developed a method for quantifying amounts of HIV in blood in collaboration with Cetus, a research company

  • Researcher “agreed to assign” the rights to his inventions to Stanford University, but also assigned his rights to Cetus

  • Roche acquired Cetus’s rights

  • Stanford sued Roche, claiming Stanford had superior rights under the Bayh-Dole Act because the research was federally funded

  • Roche claimed co-ownership of the HIV kit based on the assignment to Cetus


Board of trustees of the leland stanford junior university v roche molecular systems inc 20111

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)

  • Universities do not automatically own the rights to inventions conceived with federal funds

    • Rights do not “vest” with government contractor under Bayh-Dole

  • Reasoning: Bayh-Dole Act § 201(a) permits government contractors to “elect to retain title to any subject invention.”

    • Does not state that inventors are “deprived of their interest in federally funded inventions”

    • The Act “simply assures contractors that they may keep title to whatever it is they already have’”


Board of trustees of the leland stanford junior university v roche molecular systems inc 20112

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)

  • Federal Circuit interpretation of the licensing agreement language:

    • Stanford agreement: used the words “agree to assign”

      • promise to assign rights in the future

    • Cetusagreement: used the words “do hereby assign”

      • automatic transfer of rights once the invention was created


Board of trustees of the leland stanford junior university v roche molecular systems inc 20113

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)

  • Recommendations

    • Technology transfer department

      • Aware of all communications between inventors and third parties

      • Develop/approve collaborations

      • Review/approve agreements

        • Assignments or other conveyances!

        • Assignment of (potential) inventions: early

        • Record


Induced infringement by joint actors

Induced infringement by joint actors


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 2012

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • The court addressed the issue of joint infringement of method patents under 35 U.S.C. § 271(b)

    • Induced infringement § 271(b): “when a single actor induces another actor to commit all the elements of infringement, the first actor is liable”

    • Direct infringement § 271(a): “when a single actor commits all the elements of infringement


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20121

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • Akamai

    • Method patent for efficient delivery of web content, including:

      • Placing some content on servers, and

      • Modifying content provider’s web pages

    • Limelight directly performed step 1, but instructed its customers to perform step 2

    • Limelight found not liable by D.Ct. for induced infringement because customers performed one of the steps


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20122

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • McKesson

    • Method patent covering electronic communication between healthcare providers and patients

    • Epic licensed software to healthcare companies

    • The steps of the patent were performed in part by patients and in part by healthcare providers – none of the steps were performed by Epic

    • Found not liable by D.Ct. for induced infringement


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20123

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • Problem: induced infringement liability arises only if the “inducement give[s] rise to direct infringement” and “direct infringement must be committed by a single actor” BMC Resources, Inc. v. Paymentech, L.P. (Fed. Cir. 2007)

    • Requirement of direction and/or control by inducer


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20124

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • Issue: whether a person may be liable for induced infringement if:

    • The person performed some steps of a claimed method and induced other parties to commit the remaining steps (Akamai); or

    • The person induced others to jointly perform all the steps of the claimed method, but no single person performed all of the steps (Mckesson)

  • Finding: Yes


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20125

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • To prove

    • Knowledge of patent

    • Actions that induce performance of claimed method steps

    • Steps were performed

  • All steps need not be performed by same parties


Akamai tech inc v limelight networks and mckesson tech inc v limelight networks fed cir 20126

Akamai Tech., Inc. v. Limelight Networks and McKesson Tech., Inc. v. Limelight Networks(Fed. Cir. 2012)

  • Recommendations

    • Although easier to prove induced infringement, still important to consider claim drafting strategies for method claims

      • How invention is to be used

      • Who will use it

      • What is sold

      • What is used

      • Where will it be used

      • What activities will infringe (or which will not)


Inventorship

Inventorship


Falana v kent state university fed cir 2012

Falana v. Kent State University(Fed. Cir. 2012)

  • Falana, a post-doc at Kent State University, developed the synthesis protocol to produce a previously unknown compound (Compound 7)

  • Collaborators synthesized Compound 9, a more desirable chemical of the same genus as Compound 7, using Falana’s protocol

  • Collaborators filed a patent claiming Compound 9, and disclosed Falana’s protocol and Compound 7 in the specification

  • Falana was not listed as an inventor and filed a § 256 action to correct the inventorship of the patent


Falana v kent state university fed cir 20121

Falana v. Kent State University(Fed. Cir. 2012)

  • Joint inventorship is a question of who conceived the subject matter of the disputed claims

    • Conception of chemical compounds: requires 1) knowledge of structure; and 2) synthesis method

  • Falana’s contribution was more than an exercise of ordinary skill, and deserved inventorship 

  • Holding:“a putative inventor who envisioned the structure of a novel genus of chemical compounds and contributes the method of making that genus contributes to the conception of that genus.”


Falana v kent state university fed cir 20122

Falana v. Kent State University(Fed. Cir. 2012)

  • Recommendations

    • Inventorship determination

    • Consider co-authors listed on publications


Standard for inequitable conduct

Standard for inequitable conduct


Therasense inc v becton dickinson and co fed cir 2011

Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2011)

  • Infringement lawsuit for patent on disposable blood glucose strips

  • District court found one of Abbott’s patents unenforceable for inequitable conduct

  • Abbott failed to disclose to the PTO contradictory arguments it made to the EPO during prosecution of the European counterpart


Therasense inc v becton dickinson and co fed cir 20111

Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2011)

  • Heightened standard for Inequitable Conduct:

    • Intent: Accused infringer must prove by clear and convincing evidence that the patentee had specific intent to deceive the PTO

      • Applicant knew of the reference;

      • Applicant knew the reference was material; and

      • Made a deliberate decision to withhold it


Therasense inc v becton dickinson and co fed cir 20112

Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2011)

  • “But for” materiality: “[w]hen an applicant fails to disclose prior art to the PTO, the prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.”

  • No sliding-scale: weak showing of intent + strong showing of materiality ≠ inequitable conduct

    • Intent and materiality analysis must be done separately


Therasense inc v becton dickinson and co fed cir 20113

Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2011)

  • Recommendations

    • Disclose if question of materiality

    • Record reason for not disclosing

    • Advise against “smoking gun” communications


The leahy smith america invents act

The Leahy-SmithAmerica Invents Act


Patent law reform statutes

Patent Law “Reform” Statutes

  • On Congress’ menu for years

  • Numerous (fizzled) efforts to date:

    • Berman/Boucher H.R. 5299 in 2004

    • Evolving versions of H.R. 2795 in 2005

    • Hatch and Leahy S. 3818, the “Patent Reform Act of 2006”

    • “Patent Reform Act of 2007 (S. 1145 and H.R. 1908)

    • “Patent Reform Act of 2009 (S. 515 and H.R. 1260)


Why success in 2011

Why success in 2011?

  • Patent Law Reform was high on Congressional agenda

    • A desire to legislate

    • Bipartisan

    • Patent law reform is linked with job creation

  • Harmonization with foreign patent laws


  • Leahy smith america invents act

    Leahy-SmithAmerica Invents Act

    • IP QUOTES

      • “Through patent reform, we can cut the red tape that stops too many inventors and entrepreneurs from quickly turning new ideas into thriving businesses—which holds our whole economy back.” (President Barack Obama, August 2, 2011, as quoted by the National Journal)


    Leahy smith america invents act1

    Leahy-SmithAmerica Invents Act

    • IP QUOTES

      • “Patent reform is about jobs…”

      • “This bill will ensure that newly-issued patents will be strong, high-quality patents that have gone through rigorous review”

      • “Reform will go a long way toward eliminating lawsuit abuse” (U.S. Congressman Mike Pence, (R) Indiana, Congressional Record, June 23, 2011)


    Leahy smith america invents act2

    Leahy-SmithAmerica Invents Act

    • IP QUOTES

      • "There will be heightened uncertainty for the rest of the decade," said Paul Michel, a retired judge of the U.S. Court of Appeals for the Federal Circuit, in evaluating the provisions of the new legislation. "The bill makes fundamental changes, and many sections are poorly written and ambiguous."


    Leahy smith america invents act3

    Leahy-SmithAmerica Invents Act

    • The Act in many people’s eyes


    Leahy smith america invents act4

    Leahy-SmithAmerica Invents Act

    • 37 Sections

    • General Topics

      • PTO Fees & Funding

      • Substantive Patent Law

      • PTO Practice & Operations

      • Post-Grant PTO Proceedings

      • Litigation

      • Special Interest Legislation

      • Studies


    Leahy smith america invents act5

    Leahy-SmithAmerica Invents Act

    Substantive Patent Law

    • Change from a first to invent system to a first inventor to file system

    • Prior art exceptions

    • A broadened scope of patent-defeating prior art

    • Broadened Prior User Rights provisions


    Leahy smith america invents act6

    Leahy-SmithAmerica Invents Act

    • March 16, 2013 (18 months from enactment)

    • “First inventor to file” replaces “First to invent” system

      • Priority based on application filing dates


    Leahy smith america invents act7

    Leahy-SmithAmerica Invents Act

    • The First Inventor to File System

      • The Act omits interference and prior art provisions of current law, relating to an invention previously made by another inventor

        • Patent interferences abolished, with transition provisions

        • Derivation proceedings available before the renamed Patent Trial and Appeal Board


    Leahy smith america invents act8

    Leahy-SmithAmerica Invents Act

    • The First Inventor to File System

      • Race to the Patent Office

      • Two paths

        • File first (assuming nobody makes a public disclosure of the invention before you file the application)

        • Be first to publicly disclose the invention and then file within one year (assuming nobody files an application on the invention before your public disclosure

          • CAREFUL, CAREFUL, CAREFUL!!!


    Leahy smith america invents act9

    Leahy-SmithAmerica Invents Act

    • Whoever files a patent application first will be entitled to a patent over another inventor who later files an application on the same invention, regardless of who was first to make the invention.

      • This applies to the situation where multiple inventors independently invent the same invention.

    • Eliminates patent interferences and court determinations

      • Less uncertainty


    Leahy smith america invents act10

    Leahy-SmithAmerica Invents Act

    • No concerns with conception, diligence, reduction to practice, abandonment, suppression, and concealment

    • But: also eliminates the ability of an inventor to swear his invention behind a prior art reference with an effective date no more than one year earlier

      • The invention date simply has no significance under the AIA


    Leahy smith america invents act11

    Leahy-SmithAmerica Invents Act

    • Old §102

    • A person shall be entitled to a patent unless—

      • (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

      • (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or


    Leahy smith america invents act12

    Leahy-SmithAmerica Invents Act

    • Old §102

    • A person shall be entitled to a patent unless—

      • (c) he has abandoned the invention, or

      • (d) the invention was first patented or caused to be patented, or was the subject of an inventor‘s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor‘s certificate filed more than twelve months before filing of the application in the United States,


    Leahy smith america invents act13

    Leahy-SmithAmerica Invents Act

    • Old §102

    • A person shall be entitled to a patent unless—

      • (e) the invention was described in — (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or


    Leahy smith america invents act14

    Leahy-SmithAmerica Invents Act

    • Old §102

    • A person shall be entitled to a patent unless—

      • (f) he did not himself invent the subject matter sought to be patented, or

      • (g)(1) during the course of an interference conducted under section 135 or section 291, another inventor …establishes, …, that before such person’s invention thereof the invention was made by such other inventor …, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of….


    Leahy smith america invents act15

    Leahy-SmithAmerica Invents Act

    • New §102

      (a) What is prior art

      • public disclosures

      • patent filing disclosures

        (b) Exceptions

        (c) Joint Research Agreement situations

        (d) Effective prior art date for patents and published applications


    Leahy smith america invents act16

    Leahy-SmithAmerica Invents Act

    • 35 U.S.C. §102 Conditions for patentability; novelty

      (a) A person shall be entitled to a patent unless –

      (1)The claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention, or

      (2)The claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.


    Leahy smith america invents act17

    Leahy-SmithAmerica Invents Act

    • New 102(a) compared to current §102(b)

      35 U.S.C. 102 Conditions for patentability; novelty

      (a) A person shall be entitled to a patent unless –

      (1) the claimed invention was patented, ordescribed in a printed publication,in this or a foreign country or in public use,oron sale in this country, or otherwise available to the public more than one year prior to the date of the application for patent in the United Statesbefore the effective filing date of the claimed invention, or


    Leahy smith america invents act18

    Leahy-SmithAmerica Invents Act


    Leahy smith america invents act19

    Leahy-SmithAmerica Invents Act

    • Prior Art

      • Prior use and on sale activities:

        • No longer would be limited to “in this country”; and

        • “On sale” would still include offers for commercial sale (literally broader than many other countries’ prior art laws), and

        • Will applicants’ and third party offers, sales and uses, which do not reveal the claimed invention, be considered prior art?

          • Unclear


    Leahy smith america invents act20

    Leahy-SmithAmerica Invents Act

    • Prior Art

      • The basic novelty provision: Section 102(a)(1)

        • “A person shall be entitled to a patent unless--(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention”


    Leahy smith america invents act21

    Leahy-SmithAmerica Invents Act

    • Prior Art

      • “otherwise available…”

        • ???

      • Legislative history suggests the AIA was intended to overrule Metallizing Engineering

      • Apparently meant to

        • clarify the broad scope of relevant prior art

        • emphasize the fact that it must be publicly accessible


    Leahy smith america invents act22

    Leahy-SmithAmerica Invents Act

    • Prior Art

      • “otherwise available…”

        • Places a public availability standard on the definition of all prior standard.

      • Example

        • Quses secret process X to make product Y (cannot reverse engineer)

        • Sells Y for 15 years

        • Files patent application on process X.


    Leahy smith america invents act23

    Leahy-SmithAmerica Invents Act

    • 35 U.S.C. 102 Conditions for patentability; novelty

      (a) A person shall be entitled to a patent unless…

      (2) The claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.


    Leahy smith america invents act24

    Leahy-SmithAmerica Invents Act

    §102(d) PATENTS AND PUBLISHED APPLICATIONS EFFECTIVE AS PRIOR ART. –For purposes of determining whether a [U.S.] patent or application . . . Is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the patent or application –

    –(1) if . . . (2) does not apply, as of the actual filing date of the patent or the application . . .; or

    –(2) if the patent or application for patent is entitled to claim a right of priority. . . or the benefit of an earlier filing date . . ., based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter.


    Leahy smith america invents act25

    Leahy-SmithAmerica Invents Act

    • What?

      • Expanded scope of prior art

        • U.S. patents and published patent applications of other persons “effectively filed before the effective filing date of the claimed invention” will be included in the prior art.

        • “Effectively filed” includes foreign priority dates

        • The priority date will be the effective date for both novelty and obviousness

          • More broad than in many other countries


    Leahy smith america invents act26

    Leahy-SmithAmerica Invents Act

    • Deemed published means

      • §374. Publication of International Application

      • The publication under the treaty defined in section 351(a) of this title, of an international application designating the United States shall be deemed a publication under section 122(b), except as provided in sections 102(e) and 154(d) of this title.


    Leahy smith america invents act27

    Leahy-SmithAmerica Invents Act

    • What is the prior art date


    Leahy smith america invents act28

    Leahy-SmithAmerica Invents Act

    • What is the prior art date


    Leahy smith america invents act29

    Leahy-SmithAmerica Invents Act

    • Impact of new §102(d)

      • Some claims patentable in EPO not possible in United States

        • Claims may be obvious in US that are not in EPO

      • More translations necessary

      • Granted patents subject to validity attack in court on issues not discoverable by USPTO (e.g. prior use or sale in foreign country)


    Leahy smith america invents act30

    Leahy-SmithAmerica Invents Act

    • Exceptions for Applicants

      • Personal Grace Period

    • Exceptions from Prior Art

      • Applicant’s own “disclosures” within 1 year before the “effective filing date” (first priority date) of a U.S. application

        • Includes Applicants’ own publications

        • Grace period extends to cases claiming foreign priority


    Leahy smith america invents act31

    Leahy-SmithAmerica Invents Act

    35 U.S.C.§102(b)(1)

    (b) EXCEPTIONS. –

    (1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION. –A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if –


    Leahy smith america invents act32

    Leahy-SmithAmerica Invents Act

    §102(b)(1) (cont’d) –two exceptions

    (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (disclosure is inventor‘s own work); or

    (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (“first to publish” provision).

    The public disclosure represents the inventors own work.

    --a personal exception--

    (the existing U.S. grace period)

    A subsequent disclosure by anyone else is not prior art with respect to subject matter in an inventor’s earlier public disclosure.

    This is the “first to publish” system.


    Leahy smith america invents act33

    Leahy-SmithAmerica Invents Act

    • 35 U.S.C. §102(b)(1)

      • Essentially defines what is not prior art under §102(a)(1).

      • Inventor has one year grace period for inventor‘s own disclosures (or disclosures obtained from the inventor).

      • §102(b)(1)(B) allows inventor to avoid independent 3rd party disclosures by disclosing the invention with an earlier date.

        • BUT, inventor‘s benefit is limited to identical disclosure

          • So that independent 3rd party could damage inventor with obvious variation.


    Leahy smith america invents act34

    Leahy-SmithAmerica Invents Act

    • 102(b)(1)

      • Obvious variation disclosed by third party

        • A discloses X

        • B reads A’s disclosure of X and discloses expanded X + Y

        • A then files patent application claiming X

        • If X is obvious in view of X + Y, then A‘s patent application is not patentable


    Leahy smith america invents act35

    Leahy-SmithAmerica Invents Act

    • 102(b)(1)

      • Personal Grace Period

        • Is a public use or “on sale” activity a “disclosure” for grace period purposes?

        • Act is not clear


    Leahy smith america invents act36

    Leahy-SmithAmerica Invents Act

    35 U.S.C. §102(b)(2)

    (2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS – A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if –

    • Defines three exceptions to disclosure in a patent disclosure being prior art


    Leahy smith america invents act37

    Leahy-SmithAmerica Invents Act

    • three exceptions

    • (A) the subject matter disclosed was obtained directly or indirectly from the inventor or joint inventor

    The inventors own work

    (§102(b)(2)(A))


    Leahy smith america invents act38

    Leahy-SmithAmerica Invents Act

    • three exceptions

    • (B) The subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (―first to publish‖ provision);

    Earlier patent filings of others to the extent of inventors public disclosures that precede those patent filings

    (§102(b)(2)(B))


    Leahy smith america invents act39

    Leahy-SmithAmerica Invents Act

    • three exceptions

    • (C) The subject matter disclosed and the claimed invention, not later than the effective date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person (common ownership).

    The inventor’s co-workers and research collaborators patent filings

    (§102(b)(2)(C))


    Leahy smith america invents act40

    Leahy-SmithAmerica Invents Act

    • AIA did not create a “first to publish” system

      • Rely on Grace Period to your peril!

    • Best strategy is to obtain an early filing date (and not rely on grace period).

    • Grace period protection is only available for the identical scope of the inventor‘s early public disclosure

      • 3rd party can disclose obvious variants that might defeat later patent application filing by inventor.

    • And patent rights around the world are lost by publishing prior to filing.


    Leahy smith america invents act41

    Leahy-SmithAmerica Invents Act

    Strategy/Actions

    • More important to get earliest filing date to avoid expanded prior art

      • Speed up in-house invention disclosure and preparation process

      • Serial filing of provisionals to secure early dates for subject matter.

    • Prior art/validity searches will must consider new areas of potential prior art.

    • Need to consider “new” prior art for in-licensed technology (university technology in particular)


    Leahy smith america invents act42

    Leahy-SmithAmerica Invents Act

    • Joint Research Agreements/New §102(c)

    • §102(c) defines common ownership to qualify for prior art exception under 102(b)(2)(C)

      • 3 requirements

        • Claimed invention resulted from JRA activities.

        • Patent application amended to name JRA parties.

        • JRA in effect on or before effective filing date


    Leahy smith america invents act43

    Leahy-SmithAmerica Invents Act

    • Joint Research Agreements

      • Company A invents M

      • Company B (having some collaboration with Company A) invents broader genus LMN.

      • Company B and Company A sign JRA before filing patent application claiming LMN

        • Company A invention M is not prior art.


    Aia section 3 n 1

    AIA: Section 3(n)(1)

    • …(n) EFFECTIVE DATE.—

      • (1) IN GENERAL.—Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, and shall apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—

      • (A) a claim to a claimed invention that has an effective filing date as defined in section 100(i) of title 35, USC, that is on or after the effective date described in this paragraph; or

      • (B) a specific reference under section 120, 121, or 365(c) of title 35, United States Code, to any patent or application that contains or contained at any time such a claim.


    Aia section 3 n 11

    AIA: Section 3(n)(1)

    • Effective Date Complexity and Confusion (§ 3(n)(1))

      These provisions will apply to any application or patent issuing thereon that contains or contained at any time:

    • a claim to a claimed invention that has an effective filing date that is on or after March 16, 2013, or

    • a specific reference under §§ 120, 121, or 365(c) (continuation, divisional, international, or national stage) to any patent or application that contains or contained at any time such a claim


    Aia section 3 n 12

    AIA: Section 3(n)(1)

    • Effective Date Complexity and Confusion (§ 3(n)(1))

      • Once under new law, no swearing behind etc.

      • Raises transition issues


    Aia section 3 n 13

    AIA: Section 3(n)(1)

    • Which Law for Your Application?

      • Depends on the effective filing date and support for the claims in the application

      • New law will apply to any application “that contains or contained at any time” a claim with an “effective filing date” after March 16, 2013

    March 16, 2013

    File Provisional

    Application

    File Non-provisional

    Application adding disclosure, examples, and claims


    Aia section 3 n 14

    AIA: Section 3(n)(1)

    • Applications forever infected by claim with post March 16, 2013 effective date

      New subject matter/claim situation


    Aia section 3 n 15

    AIA: Section 3(n)(1)

    • That “contains or contained at any time”

      No new matter added in non-provisional


    Aia section 3 n 16

    AIA: Section 3(n)(1)

    Transition Issues

    • Avoid mixing pre-AIA and post-AIA (Mar. 16th 2013 priority) claims in one application!

      • “Mixing” brings in prior art from both pre-AIA and post-AIA

      • Subject to pre-AIA §102(g) prior inventions and cannot prove earlier date of invention to remove prior art under pre-AIA §102(a) or §102(e)

      • Subject to all post-AIA prior art (expanded)


    Aia section 3 n 17

    AIA: Section 3(n)(1)

    Transition Issues

    • If pre-AIA and post-AIA claims are necessary, keep the claims in separate applications

      • File first US application with only pre-AIA claims

      • Then file separate application with only post-AIA claims


    Aia section 3 n 18

    AIA: Section 3(n)(1)

    Transition Issues

    • Preserving First to Invent

      • File non-provisional applications early –before March 16, 2013

        • New disclosure, examples, and claims


    Aia section 3 n 19

    AIA: Section 3(n)(1)

    Transition Issues

    • Preserving First to Invent

      • Add new matter (disclosure, examples, claims) in CIP applications

      • File continuations before 16-March-2013 for pending important applications

      • Avoid mixing claims having different priority dates during the transition time


    Aia section 3 n 110

    AIA: Section 3(n)(1)

    Transition Issues

    • Preserving First to Invent

    March 16, 2013

    File CIP

    File Provisional

    Application

    File Non-provisional

    Application (no new disclosure)


    Aia section 3 n 111

    AIA: Section 3(n)(1)

    Transition Issues

    • Preserving First to Invent

      • Advance prosecution to obtain allowable subject matter in most important cases

      • Use Patent Prosecution Highway

      • Use Prioritized Examination ($4,800 Fee)

      • Secure narrower claims now

    • File continuations


    Leahy smith america invents act44

    Leahy-SmithAmerica Invents Act

    Impact

    • May put pressure on those with limited patent budgets

    • Little or no change to large company strategies

      • Already had international focus

    • Need to consider the timing of their patent filings

    • Heightened diligence to analyze priority rights when in-licensing


    Leahy smith america invents act45

    Leahy-SmithAmerica Invents Act

    • Derivation Proceedings (§ 135)

      • Someone derives invention from first-to-disclose inventor and files first

        • Must prove derivation

          • Timing

          • Cost

          • Complexity


    Leahy smith america invents act46

    Leahy-SmithAmerica Invents Act

    • Other changes

      • Prior User Rights

      • Prioritized Examination

      • Opinions of Counsel

      • Special Interest Provisions

      • New Post Grant Proceedings


    Leahy smith america invents act47

    Leahy-SmithAmerica Invents Act

    • Prior User Rights

      • The prior user defense would be expanded to cover commercial use of the subject matter of a patent in the United States

        • But: this defense will not apply where the subject matter of the patent was developed pursuant to a federal government funding agreement, or by a nonprofit institution of higher education or an affiliated technology transfer organization that did not receive private funding in support of that development.


    Leahy smith america invents act48

    Leahy-SmithAmerica Invents Act

    • Prior User Rights

      • Provides trade secret owners and other alleged infringers with the “prior user defense” against patent infringement claims for all inventions if the trade secret owner or other accused infringer can demonstrate internal commercial use (or other commercial uses) of the subject matter at issue in the patent infringement claim at least one year prior to the effective filing date of the claimed invention.


    Leahy smith america invents act49

    Leahy-SmithAmerica Invents Act

    • Prior User Rights

      • AIA establishes prior user rights as a defense

      • Right is personal, transferred only as part of good faith assignment of entire business

      • Commercial use one year prior to patent filing or public disclosure that is exception to 102(b)

        • Includes internal commercial use

      • Clear and convincing evidence standard


    Leahy smith america invents act50

    Leahy-SmithAmerica Invents Act

    • Prior User Rights

      • Company A invents “X” decides not to seek patent protection for “X” and instead elects to protect the invention as a trade secret.

      • Independently, Company B invents “X” but Company B elects to file and prosecute a patent application resulting in a patent for “X.”

    • Consider trade secret protection


    Leahy smith america invents act51

    Leahy-SmithAmerica Invents Act

    Prioritized examination:

    • Covers all patent applications and technologies

      • Requirements:

      • $4,800 fee for filing request for prioritized examination of non-provisional application

        • Does not include filing, search, examination fees, excess claims and pages fees, processing and publication fees

        • Fee reduced 50% for small entities

      • Application limited to 4 independent claims or 30 total claims

      • Limited to 10,000 requests per fiscal year


    Leahy smith america invents act52

    Leahy-SmithAmerica Invents Act

    • Lack of opinion of counsel cannot be used as evidence of willfulness or inducement

    • Stronger than existing case law (i.e., no adverse inference)

    • Extends to inducement as well


    Leahy smith america invents act53

    Leahy-SmithAmerica Invents Act

    • Special Interest Provisions

      • Priority examination for technologies important to the national economy or competitiveness

      • Pro bono program to assist financially under-resourced independent inventors and small businesses

      • Transitional program for covered business method patents

      • Certain tax strategies within the prior art


    Leahy smith america invents act54

    Leahy-SmithAmerica Invents Act

    • Post Grant Proceedings

    • Bottom Line

      • PTO and courts have more bullets to refuse/invalidate patents

      • More options to contest patents

      • Not clear whether public use falls within grace period

      • New category of prior art “otherwise available to the public” undefined

      • New challenge provisions are costly


    Leahy smith america invents act55

    Leahy-SmithAmerica Invents Act

    • Bottom Line

      • Impact on

        • Quality

        • Trolls

        • Easier to challenge

        • Large damage awards

        • Business methods patents

        • PTO speed/efficiency


    Leahy smith america invents act56

    Leahy-SmithAmerica Invents Act

    • Take-aways

      • Be much more aware of competitor activities

        • Commercialization

        • Patent

      • Early filing more important

        • Plan as early as possible

        • (Multiple) provisional applications

      • First-to-file may have little impact on companies that have taken a global approach to patenting


    Leahy smith america invents act57

    Leahy-SmithAmerica Invents Act

    • Take-aways

      • Pay attention to disclosures, public use, and offers for sale

      • Universities must watch publications more closely

      • Consider trade secrets

      • Consider “Pro bono” program


    Leahy smith america invents act58

    Leahy-SmithAmerica Invents Act

    • Notebooks

      • Continue to be relevant

      • Valuable history of work and activities

      • Potential evidence in derivation proceedings

      • Potential evidence in prior commercial use defense

      • Corroboration (co-signature) not necessarily needed, but strengthens evidentiary proof


    Answers

    Answers

    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.

    • Patentable subject matter?

    No


    Answers1

    Answers

    An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

    • Patentable subject matter?

    Yes

    But Stay Tuned


    Answers2

    Answers

    A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

    • Patentable subject matter?

    No


    Answers3

    Answers

    A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

    • Patentable subject matter?

    Yes


    Answers4

    Answers

    • Researcher signs agreement agreeing to assign rights in his inventions to University

    • Researcher later assigns his rights in Invention X to Company

    • Who owns the patents covering Invention X?

      • University? Company?

    • Does it matter if work resulting in Invention X was federally funded research under Bayh-Dole?

    Company owns invention

    Federal funding does not change answer


    Answers5

    Answers

    • Is Bill’s invention patentable?

    • Under old law?

    • Under new law?

    Amy’s sale is not prior art because not in U.S.

    Amy’s sale is now prior art


    Answers6

    Answers

    • Who gets the patent?

    • Under old law?

    • Under new law?

    First to invent: Amy can win

    First inventor to file: Bill wins


    Answers7

    Answers

    • Is the public use prior art?

    No, because public use was less than one year from filing


    Answers8

    Answers

    • Is the disclosure by Bill prior art to Amy?

    No. §102(b)(1)(B)

    Provided Bill’s disclosure is identical


    Answers9

    Answers

    • Is Amy’s publication prior art under new law against Bill’s application?

    • Is Bill’s application prior art against Amy under new law?

    Yes, under § 102(a)(1)

    No, not if identical to Amy’s disclosure (§ 102(b)(1)(B))


    The end

    The End

    Thank you

    Steven J. Sarussi

    (312) 913-2136

    [email protected]


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