The Things They Told You They Would Never Patent: A Root Cause Analysis Peter T. DiMauro, #47,323 .

The Things They Told You They Would Never Patent: A

Root Cause Analysis

Peter T. DiMauro, #47,323

http://patentwatchproject.org

A Caution Before We Start...

•You would be advised to seek the counsel of an attorney in any matters involving intellectual property protection. This presentation has not been prepared by an attorney.

•IANAL-Y

A Thought from St.-Euxpery..

#1 It's been said that genes as they appear in nature would never be

patented.

Yet note US-6,294,662-B1, issued on 25 September 2001. Claims directly a molecule of messenger RNA, as found in a woman's body. Actual claims are as follows:

5. A 1.5 kb mRNA transcript encoding an isoform of ebaf.

6. A 2.5 kb mRNA transcript encoding an isoform of ebaf.

Fascinating facts:

Claim 5. A 1.5 kb mRNA transcript encoding an isoform of ebaf.

Claim 6. A 2.5 kb mRNA transcript encoding an isoform of ebaf.

In this case: (a) the nucleotide sequence of the mRNA transcript is admitted to be unknown; and (b) the amino acid sequence of the resulting protein which is encoded is also admitted to be unknown! This mRNA was detected in normal colon and ovarian tissue of a woman. While "useful" in the diagnosis of early adenocarcinomas in humans, it is neither isolated nor purified, but simply detected.

DNA Sequence on a floppy? Canadian Patent Application: CA 2218741

TITLE: "NUCLEOTIDE SEQUENCE OF THE HAEMOPHILUS INFLUENZAE RD GENOME, FRAGMENTSTHEREOF, AND USES THEREOF"

Inventor: VENTER, J. Craig (United States)

Owners : Johns Hopkins University; Human Genome Sciences, Inc.

What Is Claimed Is:

1. Computer readable medium having recorded thereon the nucleotide sequence depicted in SEQ ID NO:1, a representative fragment thereof or a nucleotide sequence at least 99.9% identical to the nucleotide sequence depicted in SEQ ID NO: 1.

#2 So, can't patent mere genetic info? That's what they say at least.

USPTO has strong stance against floppy disk patents with raw genomic information thereupon.

It would make the mere perception of genetic information in electronic form (e.g., opening a USPTO web page!) an act of infringement.

What couldn't happen, may have anyway:

United States Patent 6,183,121Title: "Hepatitis C virus helicase crystals and coordinates that define helicase binding pockets"

Inventors: Kim; Joseph L. et al.; Assignee: Vertex Pharmaceuticals Inc. (Cambridge, MA)

1. A computer for producing a three-dimensional representation of:

a. a molecule or molecular complex, wherein said molecule or molecular complex comprises a binding pocket defined by structure coordinates of NS3 amino acids Val232, Thr254, Gly255, Thr269, Gly271, Lys272, Ala275, Trp501 and Tyr502 according to FIG. 1; or

b. a homologue of said molecule or molecular complex, wherein said homologue comprises a binding pocket that has a root mean square deviation from the backbone atoms of said amino acids of not more than 1.5 .ANG., wherein said computer comprises:

(i) a computer-readable data storage medium comprising a data storage material encoded with computer-readable data, wherein said data comprises the structure coordinates of NS3 amino acids Val232, Thr254, Gly255, Thr269, Gly271, Lys272, Ala275, Trp501 and Tyr502 according to FIG. 1;

(ii) a working memory for storing instructions for processing said computer-readable data;

(iii) a central-processing unit coupled to said working memory and to said computer-readable data storage medium for processing said computer-machine readable data into said three-dimensional representation; and

(iv) a display coupled to said central-processing unit for displaying said three-dimensional representation.

#3 Well, at least people can't be patented... "We don't patent humans, that's our policy," said a

spokesman for the office. (Reuters Health, 17-May-02).

A spokesman for the U.S. Patent and Trademark Office, said "Our policy has not changed. It is not changing. We do not patent claims drawn to humans." (Washington Post, 2002-05-16)

Looks like an animal patent...

And another ....

United States Patent 6,284,456

Jones , et al., September 4, 2001: “Transcriptional coactivator that interacts with Tat protein and regulates its binding to TAR RNA, methods for modulating Tat transactivation, and uses therefor”

8. A transgenic animal expressing at least one Tat-associating about 87 kDa and participates as a constituent of the TAK/TEFb complex, and wherein said polypeptide, or functional fragments thereof, wherein said polypeptide has a molecular weight of polypeptide modulates Tat transactivation by enhancing the affinity of the Tat protein for TAR RNA.

And maybe another .... United States Patent 6,211,429 Machaty , et al. April 3, 2001, “Complete oocyte activation using an oocyte-

modifying agent and a reducing agent” 20. A method for producing a cloned mammal, comprising: (a) isolating a membrane-bounded nucleus from a cell of said mammal; (b) removing the nuclear chromosomal material from an unfertilized recipient

mammalian oocyte, thereby preparing an enucleated recipient mammalian oocyte;

(c) introducing said membrane-bounded nucleus from said cell of said mammal into said enucleated recipient mammalian oocyte to form an oocyte containing said nucleus from said cell of said mammal;

(d) reprogramming the developmental cascade of events of said nucleus from said cell of said mammal;

(e) incubating said oocyte containing within its cytoplasm said nucleus of said cell from said mammal with an oocyte-modifying agent followed by a reducing agent, wherein said oocyte is incubating with said oocyte-modifying agent and said reducing agent, respectively, for a time and under conditions such that said oocyte is activated;

(f) culturing said activated oocyte of step (e) in vitro or in vivo; and (g) transferring said cultured, activated oocyte of step (f) to the oviduct or

uterus of a recipient maternal mammal to produce a cloned mammal.

And maybe even another ... United States Patent 6,376,743

Yanagimachi April 23, 2002, “Mammalian transgenesis by intracytoplasmic sperm injection”

1. A method for obtaining a transgenic embryo, comprising the steps of:

incubating a nucleic acid that is exogenous to the embryo with a membrane-disrupted sperm head or a demembranated sperm head for a period of time;

co-inserting the exogenous nucleic acid and sperm head into an unfertilized oocyte to form a transgenic fertilized oocyte; and

allowing the transgenic fertilized oocyte to develop into a transgenic embryo.

What about human gene therapy patents?

FTC thinks they are important for future of health care:

French Anderson received broad patent to ex-vivo gene therapy (genetic transformation of body cell), US 5,399,346:

1. A process for providing a human with a therapeutic protein comprising: introducing human cells into a human, said human cells having been treated in vitro to insert therein a DNA segment encoding a therapeutic protein said human cells expressing in vivo in said human a therapeutically effective amount of said therapeutic protein.

Assigned to GTI, later bought by Sandoz.

U.S. Federal Trade Commission, reviewing the proposed Sandoz-Ciba Geigy merger in 1996, demanded as condition for approving deal -rights to key GTI patents be licensed to rival companies. Sales of gene therapy drugs, FTC predicted, could reach $45 billion/yr by 2010.Today seems highly unrealistic.

#4. All those gene-therapy tranfected cells....They were at least transformed

human cells but only in cell culture, or outside the human body,

Right?

How do gene therapy patents relate to patents on people?

Sometimes the patient is the object of the patent claims!!!

Many claims have been issued on in vivo transformed human cells: heart muscle, hepatocytes, smooth muscle cells, etc.

Claims are sought and granted not just on viral vectors and gene therapy techniques, but also the "final product": human tissue.

Examples of transformed or transfected human cell patents

Claims to a transformed cell

Cell can be mammalian germ cell, in vivo or in vitro, human or nonhuman

Neither vector nor exogenous DNA named.

Beware genetic pollution!

#5 Well, at least when nonhuman animals get patented, they're genetically engineered... No, conventionally bred animals now

patented: 6,130,365 “Breeding lines of color-sexable

day-old chicks and methods for producing the same”

5,959,172 “Gender-specific fading down turkey breed”

#6. Well, at least the animals are bred, somehow....No, disfigured/surgically altered/infected animals are

patented, as long as the phenotypic change is permanent!

5,849,988 "Rat comprising straight filaments in its brain” Claim 1: A rat comprising straight filaments in its brain, wherein the rat is produced by injecting a sufficient amount of A68 protein to induce formation of said straight filaments.

Allergic beagle dog!!

Andersson , et al. September 3, 2002

Large animal model of invasive pulmonary aspergillosis in an immunocompromised host

1. A canine model for invasive pulmonary fungal infection in an immunocompromised host consisting essentially of a beagle dog being rendered profoundly immunocompromised comprising an invasive pulmonary fungal infection, wherein the fungus is a common species causing pulmonary fungal infection or an opportunistic pulmonary infectious fungus, wherein symptoms of pulmonary fungal infection are present.

#7. Well, at least the animals are changed in some way.... No, newly discovered species of animal has

been patented, as long as in “isolated form”. Think of claim to “Bird, when caged”

Raulston , et al. US-6,184,434 "Steinernema sp. nematode for suppression

of Helicoverpa zea and Spodoptera frugiperda”

Are unmodified parts of people patented? Frozen Umbilical Cord Blood patented, US-5,004,681. Original Claim 1.:A composition comprising: (a) a

plurality of viable human neonatal or fetal hematopoietic stem cells derived from the blood; and (b) cryopreservative. “Freezable Human Cord Blood”

Reexamined Claim 1: A cryopreserved therapeutic composition comprising viable human neonatal or fetal hematopoietic stem cells derived from the umbilical cord or placental blood of a single human collected at birth of said human, in which said cells are present in an amount sufficient to effect hematopoietic reconstitution of a human adult; and an amount of cryopreservative sufficient for cryopreservation of said cells”

“Like, frozen cord blood that really works, or something”

Is this a tempest in teapot?

No, live case and controversy!! Eight nonprofit and for-profit cord blood banks sued for patent infringement in Delaware District Court, 22 February 2002.

Pharmastem v. ViaCell et al., Case # 02-CV-148, now in preliminary motions before Judge Sleet.

Pragmatic Concerns About Gene Patents 1. Too far "upstream" 2. Confers control over mere "research tools" 3. Creates dangers of e.g. royalty stacking

Problem: Terms like "upstream" & "research tool" not cognizable in patent law

Solution:

Reinvigorate "Raw Material Doctrine"What is Raw Material Doctrine?

Did it Exist?

Is it same as "Product of Nature" (Justice Douglas) Doctrine?

In re McKee (1935 CCPA; 75 F2nd 991) Claimed: "A meat product having a surface

covering of a fell over a layer of fat, with pigment deposited in a plane below the fell at perforations therein according to chosen indicia" (Shank of meat with writing)

Held: Not patentable subject matter since "a carcass is not a manufacture".

In re John Wesley Marden (1931 CCPA; 47 F2nd 957) Claimed: "As a new article, ductile

uranium"; "Uranium in wire form". Held: "Uranium is a product of nature

and the appellant is not entitled to a patent on the same, or upon any of the inherent natural qualities of the metal"

In re Marden and Rich (1931 CCPA; 47 F2d 958) Claimed: "A pure ductile homogeneous

body of vanadium" Decision: "The quality of purity of

vanadium or its ductility is a quality of a natural product and as such is not patentable"

American Fruit Growers, Inc. Vs. Brogdex (Supreme Court 1931, 283 U.S. 1) Claimed: "Fresh citrus fruit of which the rind or skin

carries borax in amount that is very small but sufficient to render the fruit resistant to blue mode decay".

Decision: "Is an orange the rind of which has become impregnated with borax ... a 'manufacture', or

manufactured article, within the meaning of 31, Title 35, U.S. Code? ... This position, we think, is not tenable."

In re Ewald (1942 CCPA, 129 F2nd 340) Claimed: "A cored half pear having a

single, continuous groove of various longitudinal configuration ...."

Held: "A cored half pear is merely a cored half pear with the inedible portion thereby removed. It is, obviously, not a new and different article having a new name, character, or use... Claims 15 to 18, inclusive, do not define patentable subject matter" [Citing Brogdex, supra]

What happened to Raw Material Doctrine? Some say legislatively overruled by 1952

Patent Act.

Diamond v. Chakrabarty, 447 U.S. 303 (1980) .Mr. Chief Justice Burger:

"The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to 'include anything under the sun that is made by man.'

This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter."

Actual 1952 Committee Reports:

"[U]nder section 101 a person may have invented a machine or a manufacture, which may include anything under the sun that is made by man." Hearings on H.R. 3760 before Subcommittee No. 3 of the House Committee on the Judiciary, 82d Cong., 1st Sess., 37 (1951).

Translated: Any machine or manufacture may be patented!!

Existence of "Legislative History" Rebutted by.... Giles Rich!! In re Kirk and Petrow, UNITED STATES COURT OF CUSTOMS

AND PATENT APPEALS, 376 F.2d 936 (1967)

"The Supreme Court in Manson found 'no specific assistance in the legislative materials underlying 101,' which was a 1952 enactment. That is because the legislature was then taking no action with respect to that provision except to reenact it without change, wherefore the true 'legislative materials' necessarily consist only of its long history of construction and repeated reenactment without change, rather than some revisor's note or testimony at a hearing. It is history one must consider, rather than one's inner consciousness and preconceptions."

"It is true there are no legislative materials on 101 for the simple reason there was no discussion of this firmly fixed statute in the course of codifying it in 1952. There is no legislative history, therefore, to support a change from the historical construction."

Which Should Be Given More Weight?

A. Extrapolations of a Misquote of an Absent Legislative History Propounded by Special Interests... Or...

B. Judicial Precedent that chemical substances can, in certain cases not constitute Patentable Subject Matter? (i.e., McKee, Ewald, Marden, Brogdex, Funk Bros)

Who knows? Policy Decision.

How Can Judge Safely Find Raw Material Exception in 2002? Look to Statutory Construction: Section 101 As

Modified by Section 100(b)!

35 U.S.C. 101 Inventions patentable. (Four (4) Categories)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.

35 U.S.C. 100(b) Definitions.When used in this title unless the context otherwise indicates --- The term "process" means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

Five(5) categories!! Mysterious unpatentable "materials"!!

How Can Judge Safely Find Raw Material Exception in 2002? Look to Statutory Construction: Section

102(f)! 35 U.S.C. 102 Conditions for patentability:

A person shall be entitled to a patent unless -(f) he did not himself invent the subject matter sought to be patented.

Does not say subject matter was "invented by another person"; could have been invented by nature or nature's Deity.

Does not say subject matter was "stolen from another person". Don't read words into statute that aren't there.

Can create a "prior art" status for things occurring in nature. Combine with recent CAFC decision in Oddzon v. Just Toys, renders unpatentable any obvious modifications of naturally chemicals, e.g., cDNA of human polynucleotides.

Begs the question, though...

Are human embryonic stem cells raw materials?

Are genomic polynucleotide sequences raw materials?

Is whole human cord blood a raw material?

Policy Questions

Root Cause Analysis

Problem is not “poor examination quality” Biotech examiners in T.C. 1600 do fantastic

job of applying prior art printed publications to claims

Problem is expansionist mindset Blame Giles Rich First Victims of EverythingUnderTheSunStroke

Thank You Very Much!

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