2009 BIOL503 Class 6, Part 1: Intellectual Property II: Subject Matter, Life forms; purified natural products

Intellectual Property II: Subject Matter CSUCI2009 BIOL503 K. Pessin

Intellectual Property II: Subject Matter Biological compositions and methods CSUCI2009 BIOL503 K. Pessin

Intellectual Property II

Subject Matter

Biological compositions and methods

Electronic, business methods, computer and software related

Utility requirement

“ Newness”

Novelty

Non-obviousness

Inventorship

Objective of this section

Understand subject matter than can be patented

Understand basics of patent laws for biological materials

Review specific case studies – proteins, DNA, stem cells, plants

Experience patent searching – stem cell example

Subject Matter

Utility

Novelty

Non-Obviousness

Intellectual Property II: Patents, Subject Matter

35 U.S.C. §101 Inventions patentable .

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter , . . . may obtain a patent therefor, . . ..

"Everything under the Sun. . .

made by Man”

http://cmex.ihmc.us/CMEX/data/images/Vik2ls.gif

Intellectual Property II, Patentable subject matter: Life forms

Generally

Purified Products of Nature

Proteins

Case study: Factor VIII case study

DNA, nucleic acids

Case study: Erythropoietin Case Study

Life forms

Microbial/Cellular

Chakrabarty case

Animals, Humans, Chimera, Synthetic

Stem cell patent search

Plants

Case study: Superior Seedless

Generally

Prometheus- personalized medicine case

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Unpatentable subject matter:

Laws of Nature

Abstract Ideas

Mathematical Algorithms

Mental Steps

Printed Matter

Other reasons for unpatentability. . .

Personalized medicine: testing a patient’s response to a drug as a natural phenomenon ?

Prometheus v. Mayo (S.D.Cal.2008) : Testing drug metabolite in patient to determine the correct dose for that patient is an unpatentable natural phenomenon.

Prometheus v. Mayo (S.D.Cal.2008 )U.S. Patent No. 6,355,623 claim 1: 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 8 x 108 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 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Personalized medicine - Natural phenomenon?

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature

Issue: Are purified products of nature patentable?

Answer: Yes.

Adrenaline case: Isolation of adrenaline free of source impurities created a product with new characteristics as compared to the impure product found in nature. Parke-Davis & Co. v. H.K. Mulford & Co., (2d Cir., 1912, Learned Hand )

Dr. Jokichi Takamine, inventor of first biotech blockbuster, Adrenalin (epinephrine)

Natural substances

Function may be identified in natural surroundings (e.g., willow bark)

Identify desired compound

Purify – transforms into material with new characteristics

Potency

Lack of problems of some sort

Example: Scripps v. Genentech, Factor VIII

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Testimony of Ryan White before the National Commission on AIDS March 3, 1988 Thank You Commissioners: My name is Ryan White. I am sixteen years old. I have Hemophilia, and I have AIDS. When I was three days old, the doctors told my parents I was a severe Hemophiliac, meaning my blood does not clot. Lucky for me, there was product just approved by the Food and Drug Administration. It was called Factorate, which contains the clotting agent found in blood. Ryan White 1971-1990

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Scripps v. Genentech : Scripps held a patent on “human” Factor VIII, and disclosed how to isolate it from human blood. Genentech: Made recombinant Factor VIII:C using human gene in eukaryotic cell culture. Issue: Is Scripps’ “human” Factor VIII:C pure enough to warrant a patent?

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature http://www.advate.com/evo_factor.html Hemophilia

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Factor VIII:C from pooled human blood donors: AIDS Recombinant VIII:C made in baby hamster kidney cells: No AIDS

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature In the 1980’s, a heat-treated version of pooled blood Factor VIII was introduced, presumably free of AIDS virus. But blood screening, and heat treating were not always done. http://www.thebody.com/cdc/news_updates_archive/2003/may22_03/hi ... article excerpted from AP 5/22/03

Scripps process: use anti-VIII:RP monoclonal to purify Factor VIII:C – claimed to be really super pure compared to the polyclonal purified

RP Factor VIII:C Anti VIII:RP antibody Polyclonal = prior art Monoclonal = patent

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature “ Discovery” in litigation means investigating facts using special rules for obtaining documents and testimony. Not all facts discovered will be admissible at trial. “ Smoking gun” refers to conclusive evidence of a party’s case (e.g., if the gun is still smoking, it was recently fired..) Notable deponents

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Scripps claimed “pure” Factor VIII:C in terms of activity or relative purity. Scripps told the patent examiner that their patent taught “essentially pure VIII:C”.

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature But, the inventors did not know the percent contaminants in their Factor VIII:C.

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Translation: About 50% fibronectin, 50% VIII:C

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature District court: “Scripps, your patent is no good because you lied to the patent office about how pure your Factor VIII:C was in order to get your patent.”

Federal Circuit: “Not so fast district court. The district court set the purity bar too high. The patent is valid because the Factor VIII:C taught is pure enough.”

Federal Circuit: “But…since recombinant Factor VIII:C is so much more active and pure than blood-derived Factor VIII:C, Genentech, you may have a non-infringement argument.”

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature http://library.corporate-ir.net/library/86/861/86121/items/320405/B00FD3E8-FD7C-4AC1-A4E6-A69942B888BF_BaxterJPMorgan2009.pdf NOTE: SEE FULL DOCUMENT INCLUDING SAFE HARBOR

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature This cartoon is fictional because a gene, unless specifically identified and isolated from the surrounding genome, is not patentable subject matter.

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature You can’t patent the DNA! That’s found in nature.

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Oh look! I have invented the gene encoding erythropoietin ‘cuz it’s in there somewhere! . NO. THIS IS NOT HOW PATENT LAW WORKS

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature DNA is patentable as a chemical compound , not a function.

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Entire human erythropoietin DNA sequence + plan to fish out the rest of the DNA Genetics Institute

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature Conception: I conceive of the gene encoding erythropoietin Reduction to practice: Now I have the entire DNA coding region! Simultaneous conception and reduction to practice .

A gene is a chemical compound, . . . . Conception does not occur unless one has a mental picture of the structure of the chemical. . . . It is not sufficient to define it solely by its principal biological property, e.g. , encoding human erythropoietin, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. We hold that when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e. , until after the gene has been isolated . Amgen v. Chugai (CAFC 1991)

Intellectual Property II: Patents, Subject Matter, Purified Products of Nature http://www.uspto.gov/web/offices/pac/mpep/documents/2400_2420.htm#sect2420

Quiz

Should genes, in purified form, where they have a known activity (and otherwise fulfilling patentability requirements), be patentable?

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Issue: Is genetically engineered bacteria patentable?

Decision: Yes. Living inventions modified by humans are patentable subject matter.

Diamond v. Chakrabarty, Supreme Court 1980

’ 80s

Test: Whether the living matter is the result of human intervention.

[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of . . . nature, free to all men and reserved exclusively to none." * * * [T]he production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery" [emphasis added] is a "manufacture" under 35 U.S.C. 101.

Diamond v. Chakrabarty (Supreme Court 1980)

Intellectual Property II: Patents, Subject Matter, Life Forms

While natural laws, physical phenomena, abstract ideas, or newly discovered minerals are not patentable, a live artificially-engineered microorganism is. The creation of a bacterium that is not found anywhere in nature, constitutes a patentable "manufacture" or "composition of matter" under Section 101. Moreover, the bacterium's man-made ability to break down crude oil makes it very useful.

Diamond v. Chakrabarty 447 U.S. 303 (1980)

Intellectual Property II: Patents, Subject Matter, Life Forms

Intellectual Property II: Patents, Subject Matter, Life Forms http://www.uspto.gov/web/offices/pac/mpep/documents/2400_2403.htm#sect2403

Intellectual Property II: Patents, Subject Matter, Organisms

Example of composition claims

DNA or RNAs

Peptides or proteins

“ Selective binding molecules”, e.g., antibodies, modified antibodies, peptibodies, etc.

Microorganisms newly isolated in pure form from a natural source or genetically engineered microorganisms

Transgenic or knock-out animals

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Intellectual Property II: Patents, Subject Matter, Humans 13 th Amendment to the US Constitution, abolishing property rights in humans Frank Leslie's Illustrated Newspaper, Cover, April 22, 1865, “President Lincoln Riding Through Richmond, April 4, 1865 ”

Intellectual Property II: Patents, Subject Matter, Humans

“If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102 , 103 , or 112 must also be made .”

http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2105.htm#sect2105 MPEP § 2105

Intellectual Property II: Patents, Subject Matter, Humans Patent office funding law: no money can be used for patents on humans

. . .Chakrabarty puts down the row over patents to what he calls the “mentality” in many developing countries “We never recognise product patents. We think this is how it is always going to be and that we can always copy innovations from industrialised countries,” said the scientist who was educated in the city of Kolkata. “We never send messages to young scientists that they can innovate.” “The US has attracted scientists from other countries because these countries cannot protect their patents.”... http:// www.panos.org.uk/newsfeatures/featureprintable.asp?id =1219

Dr Ananda Chakrabarty, 26 years later. (Currently associate professor of microbiology at the University of Illinois College of Medicine)

Intellectual Property II: Patents, Subject Matter, Animals

Nonnaturally occurring nonhuman multicellular living organisms, including animals are patentable subject matter.

E.g., Ex parte Allen , 2 USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), polyploid Pacific coast oyster

http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2105.htm#sect2105

Intellectual Property II: Patents, Subject Matter, Animals

Harvard Oncomouse

http://www.google.com/patents?vid=USPAT4736866&id=_q47AAAAEBAJ&printsec=abstract&zoom=4&dq=4,736,866#PRA2-PA8-IA1,M1

Intellectual Property II: Patents, Subject Matter, Part Humans

What about a human-zee?

http://www.pbs.org/newshour/bb/science/july-dec05/chimeras_newman-ext.html Stuart Newman, professor of cell biology and anatomy at New York Medical College, tried to patent a human-ape chimera as a way to draw attention to the practice of blending genes. The patent was denied, which was what they wanted, but it does not rule out other kinds of chimeras. + = ?

Intellectual Property II: Patents, Subject Matter, Part Humans Dr. Venter “ Synthetic Biology”

Intellectual Property II: Patents, Subject Matter, Part Humans

Example of composition claims

DNA , RNAs, vectors, antisense, analogs

Peptides or proteins, mimetics

“ Selective binding molecules”, e.g., antibodies, modified antibodies, peptibodies, etc.

Unicellular organisms, cell culture isolates or genetically modified;

Human stem cell cultures; human tissues;

Non-human genetically modified , e.g., transgenic, knockout, etc.

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Intellectual Property II: Patents, Subject Matter, Human Parts This cartoon could be true because manufactured body parts are patentable.

Intellectual Property II: Patents, Subject Matter, Cell cultures, tissues

Intellectual Property II: Patents, Subject Matter, Cell cultures, tissues http://www.uspto.gov/go/classification/uspc435/sched435.htm#C435S372000

366 Human

367 HeLa cell or derivative

368 Nervous system origin or derivative

369 Renal origin or derivative

370 Hepatic origin or derivative

371 Epithelial origin or derivative

372 Blood, lymphatic, or bone marrow origin or derivative

372.1 Myeloma origin or derivative

372.2 B-cell or derivative

372.3 T-cell or derivative

373 Method of co-culturing cells

374 Method of storing cells in a viable state

375 Method of regulating cell metabolism or physiology

376 Method of synchronizing cell division

377 Method of altering the differentiation state of the cell

378 Method of detaching cells, digesting tissue or establishing a primary culture

Intellectual Property II: Patents, Subject Matter, Cell cultures, tissues http://www.google.com/advanced_patent_search Osslund Amgen

Bio-Break

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

Intellectual Property II: Patents, Subject Matter, Plants

Plant Intellectual Property

US Patent and Trademark Office

Utility patents

Plant Patents

US Department of Agriculture

Plant Variety Protection

Case study: Superior Seedless® – the Prince of Grapes

Intellectual Property II: Patents, Subject Matter, Plants http://www.basf.com/group/corporate/en/function/conversions:/publish/content/news-and-media-relations/images/P101-e-First-ever_drought-tolerant_com_now_one_step_closer_to_farmers.pdf

Intellectual Property II: Patents, Subject Matter, Plants Capturing the Benefits of Genetically Modified Organisms for the Poor, World Development Report 2008: Agriculture for Development http://econ.worldbank.org/WBSITE/EXTERNAL/EXTDEC/EXTRESEARCH/EXTWDRS/EXTWDR2008/0,,contentMDK:21498673~pagePK:64167689~piPK:64167673~theSitePK:2795143,00.html Africa: GMO crops not adopted due to regulatory policy

Plant Intellectual Property

Utility patents

Plant Patents

Utility patents – Regular patent

Genetically modified plants, plant materials, cell culture, anatomical parts, products produced

Plant Patents – Asexually reproduced (except tubers)

Stable, distinct, propagated

Can be found in wild if propagated

Junius G. Groves; Potato King , Edwardsville, Kans. (c1907) If I were still alive, I would get a utility patent on aspects of my potatoes, but not a plant patent because potatoes are tuberous http://www.google.com/url?q=http://www.blackpast.org/%3Fq%3Daaw/groves-junius-george-1859-1925&ei=fi-WSd-QF4nYsAOdroCPAQ&sa=X&oi=spellmeleon_result&resnum=2&ct=result&cd=1&usg=AFQjCNEObHk54KVspBaCMm-Gkj220TsSJg

Intellectual Property II: Patents, Subject Matter, Plants, Plant patents

Anyone who has invented or discovered and asexually reproduced any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber-propagated plant or a plant found in an uncultivated state. 35 USC §161

Asexually propagated plants: Tissue culture, rooting of cuttings, by layering, budding, grafting, inarching, etc.; no seeds

No tuber-propagated plants: "tuber" defined narrowly as a short, thickened portion of an underground branch, e.g., . Irish potato and the Jerusalem artichoke

Application similar to utility patent;

Term: 20 years from filing (oversimplified)

http://www.uspto.gov/web/offices/pac/plant/index.html#1

Intellectual Property II: Patents, Subject Matter, Plants, Plant patents http://www.uspto.gov/web/offices/pac/plant/index.html

Intellectual Property II: Patents, Subject Matter, Plants, Plant patents

How to protect plants?

Utility patents

Plant Patents

Plant Variety Protection Act

Plant Variety Protection Office (a division of the United States Department of Agriculture)

7 U.S.C. §§ 2321-2582

Sexually reproduced or tuberous

New, distinct, uniform, stable

20 years new variety; 25 years tree or vine

No “brown bagging” or “seed piracy”

International Union for the Protection of New Varieties of Plants (UPOV)

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection http://www.ams.usda.gov/SCIENCE/PVPO/PVPO_Act/PVPA2005.pdf http://www.ams.usda.gov/SCIENCE/PVPO/PVPO_Act/PVPA.htm

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection

How to protect plants?

Utility patents

Plant Patents

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection The Prince of Grapes: “Sugarone” , the grape formerly known as Superior Seedless® variety

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection Plant patent expired 1989, grapes should be available for the public to propagate

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection Superior Seedless? Grapes for illustration only

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection Agricultural Marketing Offensive: How to identify grape if varietal name is trademarked?

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection How to identify grape if varietal name is trademarked? Easy - Change the name to one no one knows. . .

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection Use agriculture marketing laws! Say no one can import under a wrong name, and the correct name is trademarked! http://www.eulaw.soton.ac.uk/europriv/Munoz_Proceedings_23_02.htm

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection http://www.actahort.org/members/showpdf?booknrarnr=546_4

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection http://www.dur.ac.uk/resources/deli/annuallecture/2002_DELI_Lecture.pdf Example of EU "private attorney general" equivalent

Intellectual Property II: Patents, Subject Matter, Plants, Plant Variety Protection Superior Seedless- the "Prince" of Grapes

Quiz

Patentable? Yes or no

Novel isolated genes with known function

Novel isolate of naturally occurring marine bacteria purified from culture of seawater microbes

Known yeast cells with new DNA genetically modified with new DNA

Human stem cells with novel DNA (satisfying all other criteria for patentability)

Active ingredient identified and purified from folk remedy spices

A genetically modified potato

Lightening Round

Generally

Proteins

DNA, nucleic acids

Life forms

Microbial/Cellular

Chakrabarty case

Plants

END Intellectual Property II, Patentable Subject Matter: Biological compositions and methods CSUCI 2009 BIOL503 K. Pessin Next: Intellectual Property II, Patentable Subject Matter, Electronics

General Patent Examination Links

USPTO Manual of Patent Examining Procedures

USPTO Examination Guidelines and Examiner Training Materials

USPTO Patent Search Landing Page

Google Patents Advanced Search Interface

USPTO Classification 435, Chemistry and Molecular Biology

Search Links

United States Patent Office: Patent classification system

Drug, Bio-Affecting, and Body Treating Compositions: Class 424

Drug, Bio-Affecting, and Body Treating Compositions: Class 514 (subclass of 424)

Medical or Lab Equipment: D24

Molecular Biology and Microbiology: 435

Multicellular Living Organisms and Unmodified Parts Thereof and Related: 800

Organic Compounds and Derivatives: 532-570

Peptide or Protein Sequence: 930

Plant: PLT

Surgery: 600-607

Patent Links - International Patent Offices

jpo.go.jp

justice.gov.il

patentsoffice.ie

patentoffice.nic …

sipo.gov.cn

ieeepi.org

dpma.de

eapo.org

espace.com

wipo.int

patent.gov.uk

iponz.govt.nz

basmp.gov.ba

patentamt.at

ipaustralia.gov .…

impi.gob.mx

inpi.gov.br

bpo.bg

depatisnet.dpma .

Resources

World Intellectual Property Organization, Life Sciences Resources

US National Center for Biotechnology Information

Resources

Non-Government Organizations and Industry Watchdogs

AgBioWorld

Center for Science in the Public Interest

GeneWatch

Greenpeace - Genetic Engineering

Resources

Biotech patent law blogs (no particular order)

Orange Book Blog

Patent Docs

Patently Biotech Blog (Biotechnology Industry Organization sponsored)

Stem Cell Patents.com

Patent Baristas

Holman’s Biotech IP Law Blog

Plant Material

IMPORTATION OF SMALL LOTS OF SEED WITHOUT PHYTOSANITARY CERTIFICATES USDA/APHIS Federal Register: click HERE

CROP COMMERCIALIZATION AND DEREGULATION RESOURCES ( Information Systems for Biotechnology - Virginia Tech)

Petitions of Nonregulated Status Granted by APHIS Search USDA Petitions of Nonregulated Status of GM Crops U.S. Database of Completed Regulatory Agency Reviews Commercialized Crops Worldwide

FIELD TEST RESOURCES ( Information Systems for Biotechnology - Virginia Tech)

USDA field tests of GM crops US EPA notifications 1998-present US EPA notifications 1987-1997 US FDA List of consultations Field tests worldwide

INTELLECTUAL PROPERTY PROTECTION

USDA/Plant Variety Protection Office Find out if a variety of seed is still protected: www.ars-grin.gov/cgi-bin/npgs/html/pvplist.pl

OTHER REGULATORY RESOURCES ( Information Systems for Biotechnology - Virginia Tech)

USDA regulatory overview General information on the regulatory process USDA documents US Environmental Protection Agency (EPA) documents US Food and Drug Administration (FDA) documents

PLANT VARIETY PROTECTION

USDA/Plant Variety Protection Office

STATE SEED REGULATIONS

http://www.amseed.org/member_SeedRegs.asp American Seed Trade Association creates first comprehensive Guide to State Seed Regulations (01/07)

CALIFORNIA What the small-time sellers of seed need to know before they sell seed in California by John Heaton, Senior Agricultural Biologist, California Department of Food and Agriculture , Nursery, Seed & Cotton Program