patent eligibility and engineered natural...
TRANSCRIPT
Patent Eligibility and Engineered Natural
ProductsOvercoming 101 Challenges, Leveraging Options to Obtain IP Protection
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TUESDAY, JANUARY 15, 2019
Presenting a live 90-minute webinar with interactive Q&A
Virginia L. Carron, Partner, Finnegan Henderson Farabow Garrett & Dunner, Atlanta
Jessica L.A. Marks, Attorney, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va.
Erin M. Sommers, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Patent Eligibility and
Engineered Natural Products
Implications from Myriad Genetics and
Seqenom
66
Engineered Natural Products
Impossible Burger, Beyond Meat, Just Inc.
(formerly Hampton Inc.)
Plant-based meat market to reach $5B by
2020 MarketsandMarkets
Dairy alternatives expected to make up 40%
of the ‘milk’ market by 2021 Innova Market Insights
• In 2017, milk alternative sales were
up 3.1% while cow’s milk sales were
down 5% Nielsen
Dairy alternative market projected to be
$19.5B by 2020 MarketsandMarkets
77
Engineered Natural Products
Vegan Leathers:
• Made from pineapples, mushrooms,
kombucha
Faux leather market predicted to reach $85B
by 2020 Grand View Research, Inc.
Indoor agriculture:
Vertical farming projected to
be $13B by 2024Global Market Insights, Inc.
88
Investment in Sustainable Technologies
99
Top Food Patent Applicants - 2016
1010
Statutory Definition of Patent—35 U.S.C. Sec. 101
• Whoever invents or discovers any new and useful
process, machine, manufacture, or composition
of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title.
1111
Claim Types
• Whoever invents or discovers any new and useful
process, machine, manufacture, or composition
of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title.
1212
Historic Case Law
– Ex parte Latimer
• 1889 Dec. Comm‘r Pat. 123 (1889)
• Not patent eligible
• Natural products are “common stock”
– Parke-Davis & Co. v. H.K. Mulford Co.
• 189 F. 95 (C.C.S.D.N.Y. 1911)
• Judge Learned Hand
• Patent eligible
• Extraordinary utility of isolated and purified
product overcame the exclusion
• Isolated and Purified Exception
1313
Historic Case Law
• Made by Man or Nature?
– Funk Brothers Seed Co. v. Kalo Inoculant Co.
• 333 U.S. 127, 130 (1948)
• Not patent eligible
• “[W]ork of nature”; no species acquired a different property or
use
1414
Historic Case Law
• Made by Man or Nature?
– Diamond v. Chakrabarty
• 447 U.S. 303 (1980)
• Patent eligible
• “[A]nything under the sun that is made by man”
1515
Myriad
• Ass’n for Molecular Pathology v. Myriad
Genetics Inc.
– 569 U.S. 576 (2013)
– An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ ID NO:2. (Isolated gene)
– The isolated DNA of claim 1, wherein said DNA has the
nucleotide sequence set forth in SEQ ID NO:1. (cDNA)
1616
Myriad
• Ass’n for Molecular Pathology v. Myriad
Genetics Inc.
– 569 U.S. 576 (2013)
– An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ ID NO:2. (Isolated gene)
• Not patent eligible
– The isolated DNA of claim 1, wherein said DNA has the
nucleotide sequence set forth in SEQ ID NO:1. (cDNA)
• Eligible
1717
Post-Myriad Cases
• In re: BRCA1- and BRCA2- Based Hereditary
Cancer Test Patent Litigation
– 774 F.3d 755, 760 (Fed. Cir. 2014)
– Not Patent Eligible
– DNA primers were “structurally identical to the ends of
DNA strands found in nature”
1818
Post-Myriad Cases
• Exergen Corp. v. Kaz USA, Inc.
– 725 F. App'x 959 (Fed. Cir. 2018)
– Patent Eligible
– “[T]he patent is directed to the measurement of a natural
phenomenon (core body temperature). Even if the
concept of such measurement is directed to a natural
phenomenon and is abstract at step one, the
measurement method here was not conventional,
routine, and well-understood.”
1919
Post-Myriad PTAB Decisions
• Ex parte Sheau Yu Hsu
– 2016 WL 7474845 (PTAB Dec. 19, 2016)
– Not patent eligible
– “[N]either naturally occurring compositions of matter, nor
synthetically created compositions that are structurally
identical to the naturally occurring compositions, are
patent eligible.”
2020
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Federal Register, Vol. 79, No. 241, Dec. 16, 2014
2121
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Three-step analysis
• Step 1
• Step 2A
• Step 2B
2222
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Step 1
2323
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Step 2A
2424
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Step 2B
2525
Post-Myriad PTO Guidance
• PTO 2014 Guidance
– Option for Streamlined Analysis
• for a claim that “clearly does not seek to tie up any judicial
exception such that others cannot practice it”
– Examples:
• “an artificial hip prosthesis coated with a naturally occurring
mineral”
• claims that “merely include ancillary nature-based components,”
such as “a cellphone with an electrical contact made of gold.”
2626
Post-Myriad PTO Guidance
1. Gunpowder and Fireworks
2. Pomelo Juice
3. Amazonic Acid, Pharmaceutical
Compositions, & Methods of
Treatment
4. Purified Proteins
5. Genetically Modified Bacterium
6. Bacterial Mixtures
7. Nucleic Acids
8. Antibodies
9. Cells
10. Food
https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-
based_products.pdf
2727
Post-Myriad PTO Guidance
1. Gunpowder and Fireworks
Gunpowder comprising: an intimate finely-ground mixture of 75%
potassium nitrate, 15% charcoal and 10% sulfur.
A fountain-style firework comprising: (a) a sparking composition, (b)
calcium chloride, (c) the gunpowder of claim 1, (d) a cardboard
body having a first compartment containing the sparking
composition and the calcium chloride and a second compartment
containing the gunpowder, and (e) a plastic ignition fuse having one
end extending into the second compartment and the other end
extending out of the cardboard body.
2828
Post-Myriad PTO Guidance
2. Pomelo Juice
A method comprising providing a pomelo fruit.
A beverage composition comprising pomelo juice and an effective
amount of an added preservative.
2929
Post-Myriad PTO Guidance
10. Food
A kit for preparing goat milk yogurt comprising: Streptococcus
thermophilus and Lactobacillus alexandrinus.
A yogurt starter culture comprising: goat milk mixed with Streptococcus
thermophilus and Lactobacillus alexandrinus.
3030
Post-Myriad PTO Guidance
28. Vaccines
29. Diagnosing and Treating Julitis
30. Dietary Sweeteners
31. Screening For Gene Alterations
32. Paper-Making Machine
33. Hydrolysis of Fat
https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf
3131
Post-Myriad PTO Guidance
28. Vaccines
A vaccine comprising live attenuated Pigeon flu virus.
A vaccine comprising inactivated Pigeon flu virus.
A vaccine comprising Peptide F; and a pharmaceutically acceptable carrier.
A vaccine comprising Peptide F; and a pharmaceutically acceptable carrier
selected from the group consisting of a cream, emulsion, gel, liposome,
nanoparticle, or ointment.
A vaccine comprising Peptide F; and an immuno-effective amount of an
aluminum salt adjuvant.
A vaccine comprising Peptide F; an immuno-effective amount of an
aluminum salt adjuvant; and a pharmaceutically acceptable carrier.
A vaccine delivery device comprising a microneedle array that is coated
with a vaccine comprising Peptide F.comprising inactivated Pigeon flu
virus.
3232
Post-Myriad PTO Guidance
30. Dietary Sweeteners
A dietary sweetener comprising texiol; and water.
A dietary sweetener comprising 1-5 percent texiol; and at least 90
percent water.
A dietary sweetener comprising 1-5 percent texiol; at least 90 percent
water; and 1-2 percent Compound N.
A dietary sweetener comprising 5 percent texiol; water, fruit juice, or a
combination of water and fruit juice; and sufficient amounts of pectin to
provide a solid gel.
A dietary sweetener comprising granular particles of texiol having a
particle diameter of X10 of 80 microns and X90 of 300 microns.
A dietary sweetener comprising texiol in a controlled release formulation.
3333
Post-Myriad Cases
• Vanda Pharm. Inc. v. West-Ward Pharm. Int'l
Ltd.
– 887 F.3d 1117 (Fed. Cir. 2018)
– Patent Eligible
– Method of treating patient suffering from schizophrenia
based on genetic testing
3434
Post-Myriad PTO Guidance
• Vanda Memorandum– www.uspto.gov/sites/default/files/documents/memo-vanda-
20180607.PDF
• Addresses the limited question of how to evaluate the patent eligibility
of "method of treatment claims" in light of the Federal Circuit decision in
Vanda
(1) "method of treatment" claims that practically apply natural relationships
should be considered patent eligible under Step 2A of the USPTO's
subject matter eligibility guidance; and
(2) it is not necessary for "method of treatment" claims that practically apply
natural relationships to include nonroutine or unconventional steps to be
considered patent eligible under 35 U.S.C. § 101.
3535
Post-Myriad Cases
• Berkheimer v. HP Inc.
– 881 F.3d 1360 (Fed. Cir. 2018)
– Some claims ineligible; Remanded for other claims
– Whether a claim element or combination of elements
would have been well-understood, routine, and
conventional to a skilled artisan in the relevant field at a
particular point in time is a question of fact
3636
Post-Myriad PTO Guidance
• Berkheimer Memorandum– www.uspto.gov/sites/default/files/documents/memo-berkheimer-
20180419.PDF
• Examiner must expressly support a rejection in writing with:
– A citation to an express statement in the specification or to a statement made by an
applicant during prosecution that demonstrates the well-understood, routine,
conventional nature of the additional element(s).
– A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II)
as noting the well-understood, routine, conventional nature of the additional
element(s).
– A citation to a publication that demonstrates the well-understood, routine,
conventional nature of the additional element(s).
– A statement that the examiner is taking official notice of the well-understood, routine,
conventional nature of the additional element(s).
3737
Post-Myriad Claims
3838
Post-Myriad Claims
3939
Post-Myriad Claims
4040
Post-Myriad Claims
4141
Post-Myriad Claims
4242
Post-Myriad Claims
4343
Post-Myriad Claims
4444
Post-Myriad Claims
4545
Post-Myriad Claims
4646
The Future of § 101
• New USPTO Guidance
– Federal Register, 50 Vol. 84, No. 4, January 7, 2019
– “[A]pplies to all applications, and to all patents resulting
from applications, filed before, on, or after January 7,
2019”
– Written comments due March 8, 2019
– https://www.federalregister.gov/documents/2019/01/07/2018-
28282/2019-revised-patent-subject-matter-eligibility-guidance
4747
The Future of § 101
• New USPTO Guidance
– Abstract Ideas:
• (a) Mathematical concepts
• (b) Certain methods of organizing human activity
• (c) Mental processes
– Revised Step 2A:
• (1) Whether the claim recites a judicial exception; and
• (2) Whether a recited judicial exception is integrated into a
practical application.
4848
The Future of § 101
• New Legislation
– December 2018 – Closed-door Senate meeting
– https://www.law360.com/articles/1112205/sens-appear-keen-on-
drafting-new-patent-eligibility-law
4949
Best Practices
• Product Claims
• Other Claim Types
• Arguments to Consider
5050
Thank You!
Virginia L. Carron
Jessica L.A. Marks
Erin M. Sommers
5151
Disclaimer
These materials are public information and have been prepared solely
for educational purposes to contribute to the understanding of American
intellectual property law. These materials reflect only the personal
views of the authors and are not individualized legal advice. It is
understood that each case is fact-specific, and that the appropriate
solution in any case will vary. Therefore, these materials may or may
not be relevant to any particular situation. Thus, the authors and
Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. cannot be
bound either philosophically or as representatives of their various
present and future clients to the comments expressed in these
materials. The presentation of these materials does not establish any
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