PATENTING GENES OR PATENTING LIFE?

Federico Simone

Are genes patentable? To this question the Federal Circuit responded in Amgen v.

Chugai, defining a gene as “a chemical compound, albeit a complex one, and it is well

established in our law that conception of a chemical compound requires that the inventor be able

to define it so as to distinguish it from other materials, and to describe how to obtain it.”1 Yet,

although the first gene was awarded patent protection in 1982, after almost three decades, the

debate regarding patenting genes is still continuing, and has, in fact, reached a new peak after a

federal judge of the United States District Court for the Southern District of New York, on

March 29, 2010, invalidated seven patents related to two human gene sequences, holding that the

patents involved a law of nature and were, therefore, improperly granted.2

This is the result of round one of a recent lawsuit filed to challenge the patentability of

genes.3 The American Civil Liberties Union (ACLU), together with cancer patients and other

organizations that include scientists, physicians, and activists filed suit in the District Court for

the Southern District of New York, against Myriad Genetics, the United States Patent and

Trademark Office (USPTO), and directors of the University of Utah Research Foundation.4

Petitioners sought invalidity or unenforceability of the patents over two breast cancer genes

(BRCA1 and BRCA2), and unconstitutionality of the PTO’s policies toward genetic patents.5

One of the main issues raised by the suit related to the high cost of the genetic tests

offered by Myriad, which has exclusive licenses over patents owned with its co-assignee, the

University of Utah Research Foundation, and developed the tests to assess a cancer risk profiling

for an individual at risk.6 By holding exclusive rights over these genes, Myriad has also control

over any related diagnostic tests and offers the only test available in the United States.

1
Consequently, the suit alleged that an individual at risk could not seek diagnostic test validation.7

Other issues in the suit involve the novelty requirement for patentability, subject matter

eligibility of products of nature or abstract ideas and, additionally, violation of first amendment

right to freedom of thought, obstruction of innovation by limiting or prohibiting access to gene

sequences, and related violation of Article I, Section 8, Clause 8 of the Constitution that requires

Congress to promote the progress of Science.8 Myriad intends to appeal the district court

decision to the United States Court of Appeals for the Federal Circuit,9 and many commentators

believe that the case will get its way up to the Supreme Court.10

This paper will discuss the novelty requirement for patentability and the subject matter

eligibility of genes. The issue presented before the court was “whether or not claims to isolated

DNA containing naturally-occurring sequences falls within the products of nature exception to

section 101.”11 Specifically, the district court considered whether the claimed compositions and

methods constitute statutory subject matter or fell under the judicially created products of nature

exception to patentable subject matter.”12

Patentability under section 101 requires determining (1) whether the claimed invention

possesses utility, and (2) whether the claimed invention constitutes statutory subject matter.13

First, the court defined the terms “DNA,” “isolated DNA,” and “BRAC1” and “BRAC2” and

concluded that DNA refers to the physical manifestation of the [deoxyribonucleic] acid, one that

may be ‘substantially separated from other cellular components which naturally accompany a

gene.’ “14 The term “isolated DNA” was defined by the court as “a segment of DNA nucleotides

existing separate from other cellular components normally associated with native DNA,

including proteins and other DNA sequences comprising the remainder of the genome, and

includes both DNA originating from a cell, as well as DNA synthesized through chemical or

2
heterologous biological means.”15 Finally, “BRAC1” and “BRAC2” refer to human genes,

normally integrated into chromosome 17 the first and into chromosome 13 the latter, some

alleles of which cause susceptibility to breast and ovarian cancer.”16

The Utility Requirement in the Chemical and Biotechnology Fields.

What is DNA? And what is a gene? DNA is a double helix consisting of antiparallel

strands in which the nucleotide units are linked by 5’-3’ phosphodiester bonds.17 DNA is also the

genetic material in all known organisms and many viruses.18 “The structure of DNA carries the

information needed to perpetuate its sequence.”19 Accordingly, DNA is a template that is

replicated into a copy of itself, necessary to perpetuate its information represented by its specific

nucleotide sequence.20 In addition, in order for its information to be expressed, its antisense

strand, i.e. the DNA sequence complementary to the RNA sequence, may be transcribed into a

single strand molecule of RNA identical in sequence with one of the strands of the duplex DNA,

which, in turn, may be translated into a polypeptide chain.21 A gene is “the segment of DNA

involved in producing a polypeptide chain; it includes regions preceding and following the

coding region (leader and trailer) as well as intervening sequences (introns) between individual

coding sequences.”22

The court characterized “DNA” and “isolated DNA” respectively as the physical

manifestation of DNA and as “a segment of DNA nucleotides” existing separate from the cell

and other proteins. To satisfy the utility requirement under section 101, the “DNA” or “isolated

DNA” must be related to a gene of which such DNA sequence represents a portion, and to its

function. Additionally, the Supreme Court in Brenner v. Manson set a heightened utility

standard, under section 101,23 for inventions in the chemical field.24 In Brenner, an inventor

3
isolated a steroid whose utility was not known at the time of filing, but argued that the steroid

possessed tumor-inhibiting effects in mice because an adjacent homologue of the steroid

exhibited such effects.25 However, in the chemical field, homologue compounds are not

presumed to have the same utility due the greater unpredictability in the chemical arts.26

Therefore, the Court rejected the argument and held that “[u]ntil he process claim has been

reduced to a production of a product shown to be useful, the metes and bounds of that monopoly

are not capable of precise delineation.”27

The same heightened utility standard applies to inventions in the biotechnological field.

In fact, DNA is a chemical compound and is subject to the requirements that apply in the

chemical field.28 The Federal Circuit in In re Fisher considered whether five “expressed sequence

tags” or “ESTs,” i.e. short nucleotide sequences that represent a fragment of a cDNA clone were

unpatentable for lack of utility under section 101.29 The court applied Brenner, which required

disclosing specific and substantial utility, and held that the claimed ESTs did not correlate to an

underlying gene function and, thus, failed “to meet the standard for utility intended by

Congress.”30

Therefore, to satisfy the utility requirement under section 101, the nucleotide sequence of

the genes patented by Myriad, must be correlated to an underlying gene function. Because the

nucleotide sequence of both BRCA1 and BRCA2 is known and it has been correlated to a known

gene function, at the time of filing, i.e. they act as tumor suppressor genes,31 the utility

requirement under section 101 is satisfied.

4
Genes Are Statutory Subject Matter.

The district court defined 35 U.S.C. § 101 and its scope,32 and cited Diamond v.

Chakrabarty, in which the issue was whether a microorganism that had been genetically

engineered to break down oil components in oil spills was patentable subject matter, under

section 101.33 The Supreme Court noted that “Congress plainly contemplated that the patent laws

would be given wide scope,”34 and that with the exclusion of laws of nature, physical

phenomena, and abstract ideas, anything under the sun is patentable.35 The Court distinguished

between “products of nature, whether living or not and “a nonnaturally occurring manufacture or

composition of matter – a product of human ingenuity ‘ having a distinctive name, character

[and] use,’ “and found that the human-made, genetically engineered microorganism claimed in

Chakrabarty, was the product of human ingenuity and research and was, therefore, patentable.”36

Then, the district court contrasted Chakrabarty with Funk Bros., where the Court found that a

mixture of several naturally occurring species of bacteria created by selecting strains that did not

inhibit each other, was unpatentable because the patent holder “did not create a state of inhibition

or of noninhibition in the bacteria. Their qualities are the work of nature.”37 Also, in Chakrabarty,

the Court stated that “the patentee has produced a new bacterium with markedly different

characteristics from any found in nature.”38 Additionally, the court discussed Am. Fruit Growers,

where the Court stated that an invention is required to have “a new or distinctive form, quality,

or property” from a product of nature.39 The court concluded that because patentable subject

matter must be markedly different from a product of nature the claimed isolated DNA was not

markedly different from native DNA and, therefore was not patentable under section 101.40

In Chakrabarty the Court gave broad scope to patent laws and noted that Congress

intended statutory subject matter to “include anything under the sun that is made by man.”41 The

5
Patent Act of 1952 awards a patent for “any new and useful . . . composition of matter,” but

nothing in the Act precludes the issuance of a patent “upon a ‘product of nature,’ when it is a

‘new and useful composition of matter,” if it further complies with the other conditions for

patentability.42 Accordingly, “the ‘matter’ of which patentable new and useful compositions are

composed necessarily includes naturally existing elements and materials.”43

One of the requirements for an invention to be patentable is that it must be a “manufacture,” i.e.

“the production of articles for use from raw or prepared materials by giving to these materials

new forms, qualities, properties, or combinations, whether by hand or by machinery.”44

Therefore, “a new element discovered in the earth or a new plant found in the wild is not

patentable subject matter,” because these are “manifestations of . . . nature, free to all men and

reserved exclusively to none.”45 The Court observed that a claimed invention must have “a

distinctive name, character [and] use.”46

In Merck v. Olin, the Fourth Circuit noted that the ‘product of nature’ defense can be

separated into two doctrines:

“(1) [A] patent may not be granted upon an old product though it be derived from a new

source by a new and patentable process, and (2) that every step in the purification of a

product is not a patentable advance, except, perhaps, as to the process if the new product

differs from the old ‘merely in degree, and not in kind.’ “47

The Fourth Circuit contrasted American Wood Paper Co. v. Fibre Disintegrating Co.,48 in

which a patent covering cellulose obtained from wood products was held invalid because

cellulose obtained from other materials had been used for a long time to make paper, with

claimed B(12) active compositions that no one had produced before, that were previously

unidentified and unknown, and that had advantageous characteristics that could replace liver

6
products, and that, therefore, satisfied the first aspect of the defense.49

The second aspect of the defense was also satisfied because, although each slight step in

the purification of the B(12) compositions did not produce a new product, what was obtained in

the end was not only not in a salt form, which would account for a difference in degree but not in

kind, but the fact that, for the first time, it had been removed from other gland-tissue where it

was found, creating “a new thing commercially and therapeutically.”50 Yet, the court specified

that even if the product were merely extracted without change, still, “there is no rule that such

products are not patentable.51 To differ in kind, the product must have “a new utility in which

invention may rest.”52 Similarly, the active principle in natural fermentas of the claimed

compositions had great medicinal and commercial value, while the natural fermentas are

useless.53 Thus, the step from natural fermentas to products of great therapeutic and commercial

value “was not merely an advance in the degree of purity of a known product.”54 As an example,

a patent was issued for an alkaloid named cephalomannine, produced from the tissue of plants,

which was useful in causing remission of leukemic tumors in mice.55

Likewise, an isolated gene would satisfy the first defense if it had been previously

unidentified and unknown, and had advantageous characteristics. BRCA1 and BRCA2 clearly

satisfied the novelty requirement because they had been awarded a patent, and therefore, they

satisfied the novelty requirement, i.e. were unknown prior to their identification and isolation. In

addition, BRCA1 and BRCA2 genes can be used as diagnostic tools to detect carriers with

mutations.56 Further, BRCA1 could be potentially used as a predictive marker or response to

chemotherapy.57

The second aspect of the defense would also be satisfied because, similarly to the B(12)

compositions, for the first time the BRCA1 and BRCA2 genes had been removed from cells,

7
thus creating a new thing, both commercially and diagnostically. In fact, while a naturally

occurring gene present in a cell has no use, when it is isolated it becomes a powerful diagnostic,

and the step from naturally occurring genes to products of great diagnostic and commercial value

is not “merely an advance in the degree of purity of a known product.”58

Moreover, what distinguishes isolated genes BRCA1 and BRCA2 from isolated cellulose

in The Wood Paper Patent is that the claimed genes were previously unknown prior to their

isolation, while cellulose “had been produced and used in the manufacture of paper long before

1853, the year in which the Watt & Burgess patent was dated.”59 The issue in the Wood-Paper

case was not, as the court suggested, whether isolated and purified cellulose was not patentable

subject matter, but that it was not patentable because it was not a new invention, since “[p]aper-

pulp obtained from various vegetable substances was in common use before the original patent

was granted.”60 Accordingly, the Court considered immaterial that the manufacture might have

been the product of one or more different processes as long as that manufacture was already

known and in use.61 In fact, the Court noted that to be sustainable, a patent for a product must

claim a product, “namely, ‘a pulp suitable for the manufacture of paper, made from wood or

other vegetable substances,’ [that] was unknown prior to their alleged invention.”62 Thus,

because BRCA1 and BRCA2 were unknown prior to their isolation, similar to the B(12)

compositions in Merck, they would be patentable.63

The same reasoning applies to Cochrane v. Badische Anilin & Soda Fabrik,64 where the

Court did not reject a patent on an artificial version of a natural dye, called alizarine, because it

was not patentable subject to the ‘product of nature’ defense, but because “[i]t was an old

article,”65 and further because the claim was too broad.66

Moreover, are isolated genes nature’s handiwork or are they “made by man”?67 In

8
Chakrabarty, the Court held that a genetically engineered bacterium was patentee’s own

handiwork.68 The combination of the bacterium and the plasmids with which the bacterium was

engineered produced a new bacterium.69 However, an isolated gene, although derived from a

naturally occurring gene, is a synthetic product made by man. In fact, during the process of

isolating a gene, copies of the naturally occurring gene are degraded or eliminated and the

synthetic copies of that gene are further purified from proteins and other cellular components.

The technique utilized to amplify a DNA sequence is called “polymerase chain reaction,” in

which a template DNA fragment is undergoes a series of cycles, each doubling the number of

DNA copies present in the previous cycle, and involves the addition of synthetically produced

nucleotides to form a copy of a target DNA sequence by a purified DNA polymerase enzyme,

derived from thermophilic bacteria.70 The result is a DNA product that is identical to the template

DNA used, but that is otherwise a synthetic DNA made by man. The synthetically produced

DNA fragment is a perfect replica of its naturally occurring counterpart. Therefore, the naturally

occurring DNA sequences are not only isolated, but they are synthetically copied and amplified

and, therefore, the isolated sequence is human made based on the naturally occurring sequence.

Additionally, an isolated gene does not occur naturally since all naturally occurring genes are

integrated within the genome of a cell.71 For either a gene or for other chemical compounds,

whether insulin or B(12) compositions, the objective is to produce a composition of matter that

replicate every characteristics of their naturally occurring counterparts. Yet, although the

function of a specific DNA sequence is to code for a specific polypeptide,72 the use of an isolated

gene is different from the use of a naturally occurring gene in the cell. The use of the naturally

occurring gene within a cell relates to its specific function, which is provide the instruction for

making specific proteins to regulate metabolic pathways, or otherwise participate in the

9
regulation of the biology of the cell.73 Therefore, when a gene is isolated from a chromosome in a

cell, it cannot perform its natural function of regulating the cell metabolism. Genes are finely

regulated in order to perform their natural function.74 There are, in fact, many well-known DNA

sequences, occurring before and after the gene on the chromosome, that have the function to

regulate the specific gene activity.75 In addition, the function of a gene heavily depends on its

position on a chromosome and in the integrity of its sequence, such that a change in its position

on a chromosome or in its copy number, or in its sequence, are the cause for several diseases.76

In contrast, when a gene is isolated from a cell, it may be used as a tool for scientific

advancement, or for medical uses, either as a “probe,” or as a diagnostic tool.77 When isolated,

the gene may be either a copy of the genomic DNA or of the mRNA, in the form of a cDNA,

synthesized from the mRNA by reverse transcriptase.78 The genomic copy has the same

nucleotide sequence of the naturally occurring gene, but it possesses a specific utility that is not

present in the naturally occurring gene.79 In contrast, the cDNA is missing the intronic sequences

that are present within the genomic gene and, therefore, its sequence or structure, is “markedly

different” from the naturally occurring gene. The court presented two objections to this

observation,80 first, that the coding sequence of a native DNA is identical to the sequence of the

cDNA and, second, that many cDNA sequences, including the BRCA1 sequence, can be found

“in the human genome in the form of a naturally occurring pseudogene.”81 The first objection

does not consider that it is specifically the fact that a gene is isolated from the genome of the cell

that makes the gene patentable. Therefore, whether it is isolated from a continuous fragment or

from an interspersed sequence does not change the fact that, after its isolation, it is not present in

its native form, i.e. as being part of the genome of the cell. In either case the gene is isolated

from its surrounding material and can be used as a tool for medical diagnostics.

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 The second objection, in turn, does not consider that a pseudogene is an inactive version

“derived by mutation of an ancestral active gene,”82 and, therefore, is not functional due to

mutations, and cannot be translated into a functional protein. Thus, pseudogenes are “markedly

different” both structurally and functionally, from either the native or the isolated gene.83

Genes as Information

The court further objected that genes have a double nature, i.e. they are chemical

substances, and at the same time, they are physical carriers of information.84 Accordingly, the

court concludes that the importance of DNA’s nucleotide sequence overrides both its natural

function as well as its utility associated with DNA in its isolated form.”85 Therefore, because “the

information encoded by DNA reflects its primary biological function,” DNA “serves as the

physical embodiment of laws of nature,” i.e. constitutes an unpatentable product of nature.86

However, this objection fails to consider that the patents at issue are directed at isolated

DNA, not at a DNA sequence.87 There is a distinction between a law of nature and the object that

manifests that law of nature. The principle that a law of nature is unpatentable subject matter,

was expressed in Funk, “[h]e who discovers a hitherto unknown phenomenon of nature has no

claim to a monopoly of it which the law recognizes.”88 Such monopoly is created when someone

seeks patent protection of a law of nature, an abstract idea, or a natural phenomenon in the

abstract, with the result of pre-empting the use of a fundamental principle,89 rather than just a

particular application of that fundamental principle. Thus, a claim for a patent covering an

isolated DNA sequence would be a claim covering a natural law, i.e. a fundamental principle, if

its effect would be “to pre-empt substantially all uses of that fundamental principle.”90 In such

case, the claim would not be drawn to patentable subject matter.91 In contrast, a patent covering a

11
gene, like BRCA1 or BRCA2, does not pre-empt any use of genes as information, but it

specifically grants a monopoly only for the use of those specific genes covered by the patent.

Thus, despite the special role that genes have in carrying information, a patent covering such

genes is not a patent covering the principle of how such information is carried by genes, and

therefore, genes constitute patentable subject matter.

Patentability of the Method Claims.

Until the Supreme Court will decides Bilski, the “machine or transformation” test

remains the definitive test to determine whether a process claim recites a fundamental principle

and, therefore, substantially pre-empts all uses of that principle.92 Thus, a claimed process is

patentable under section 101 if (1) it is tied to a particular machine or apparatus; or (2) it

transforms a particular article into a different state or thing.93 Accordingly, claims will be found

valid if the claimed processes include the use of any machine, e.g. PCR machines,

electrophoretic apparatuses, microarrays, or other instruments commonly used for the

manipulation of nucleic acids, or the transformation of an article, e.g. a chemical transformation

of a physical object.94

The court rejected Claim 20 of the ‘282 patent directed at “ a method for screening

patential cancer therapeutics,” that involves growing cells carrying an altered BRCA1 gene in the

presence of compounds potentially useful in treating cancer, and determining whether the

compound is active in slowing rate of growth of the cells treated with compound versus

untreated cells.95 The reason given by the court for its rejection was that, although it recites

transformative steps, Claim 20 “in essence” and “when considered in its entirety,” compares cell

growth rates in order to conclude that a slower cell growth in the presence of a certain compound

12
is indicative of a cancer therapeutic, and, therefore, seeks to patent a basic scientific principle.96

However, this rejection fails to notice that Claim 20 is directed at identifying potential cancer

therapeutics useful to treat cells carrying an altered BRCA1 gene, and not only at comparing cell

growth rates in any test, whether patented or not, to determine whether cell growth rates reveal a

slower growth rate. In fact, such was the issue in Metabolite,97 where Claim 13 was directed at a

method for detecting a cobalamine deficiency by correlating an elevated level of homocysteine,

resulting from any medical test, with a deficiency of cobalamine. [FN] Id. The Court found that

Claim 13 simply instructed “the user to (1) obtain test results and (2) think about them” and,

therefore, did not entail a physical transformation of matter.98 The Federal Circuit in Bilski noted

that a claim directed at a non-transformative process, encompassing purely mental processes,

were not patent-eligible subject matter.99 In contrast, Claim 20 is directed at screenings of drugs

for cancer therapy where cells carrying a mutant BRCA1 allele are used as a model system to

test for therapeutic substances.100 Thus, in Claim 20, the transformative step is represented by the

growth of cells, which may be negatively be affected by the presence of a compound, causing

alterations in the cell growth and cell death rate, and therefore the claimed process covers patent-

eligible subject matter. The court’s observation that the transformative step is present only if a

test compound affects a change in cell growth does not consider that the test is designed to

screen for new drugs and that, implicitly, some compounds will have a greater effect on growth,

while others will have a lesser effect. To conclude that a claim is invalid because some

compounds may not have a relevant effect on growth, and, therefore, the test is not

transformative, undercuts the whole principle on which the test is based, i.e. to screen for

effective drugs, and not to simply compare growth rates.

13
Invalidity of the Composition Claims

A claim directed at analyzing the sequence of a BRCA1 gene from a human sample to

detect a germline alteration might not, as the court noted, involve any physical transformation,

because the claimed methods are directed only at mental processes.101 Although the purpose of

such a claim may be directed at detecting germline alterations in a BRCA1 gene, the language of

the claim limits the method to the comparison of two nucleotide sequences to determine whether

alterations are present.102 Therefore, the claimed process may not, in fact, cover patent-eligible

subject matter.

It should be noted that extreme caution must be exercised during the process of claim

drafting. Yet, would Claim 1 of the ‘999 patent be valid if it included the hybridization step of a

BRCA1 gene probe present in dependent claim 3,103 or would the physical step inclusion be

considered merely insignificant extra-solution activity?104 The claim might include the required

transformative step occurring as a result of DNA hybridization, i.e. the change into a different

state of the DNA molecules involved in the hybridization.

In Flook, the claim at issue was directed to using a mathematical formula to calculate an

“alarm limit,” i.e. a value indicating an abnormal condition during catalytic conversion

processes.105 The Court rejected the claim (1) because the use of the formula was not limited to

any specific chemical reaction, nor was it tied to any machine or apparatus, and (2) because to

include in the patent application a step showing that the formula could be applied to an existing

machine, or a particular transformation of a specific article, constituted mere “insignificant pot-

solution activity.”106 Therefore, mere field-of-use limitations, introduced in an attempt to limit

the use of a formula to a particular technological environment, would be insufficient to render an

otherwise ineligible process claim patent-eligible.107 In fact, “[a] competent draftsman could

14
attach some form of post-solution activity to almost any mathematical formula.”108 In contrast,

the Court, in Diehr, stated that “when a claim containing a mathematical formula implements or

applies that formula in a structure or process which when considered as a whole, is performing a

function which the patent laws were designed to protect, then the claim satisfies the requirements

of [section] 101.”109 Additionally, the Federal Circuit noted that the Court’s reasoning would be

equally applicable to any “insignificant extra solution” activity, regardless of where it is

introduced in the claimed process.110

However, a modified Claim 1 of the ‘999, directed to “a method for detecting a germline

alteration in BRCA1, said alteration selected from the group consisting of the alterations set forth

in Tables 12A in a human which comprises hybridizing a BRCA1 gene probe which specifically

hybridizes to nucleic acids containing at least one of said alterations and not the wild-type

BRCA1 sequences and detecting the presence of a hybridization product, wherein the presence

of such product indicates the presence of such alteration in said gene and therefore the presence

of said germline alteration in said sample” would likely be considered patent-eligible because the

hybridization step is central to the claim and it would not be considered “insignificant extra-

solution” activity.111 Therefore, this example suggests that if the claims found invalid by the

court had been drafted less broadly, they would have likely passed muster.

Conclusion

In conclusion, genes are patentable subject matter because, despite their intrinsic

quality of carrying genetic information, they are chemical compounds, subject to the same

requirements imposed to the chemical arts by section 101. Claims directed at DNA sequences

15
satisfy the utility and the “product of nature” requirements, whether they cover genomic

sequences or cDNAs, and claims directed at processes may be patent-eligible, unless they are

construed too broadly, just like in other areas of invention. Patents serve a fundamental role in

promoting the Progress of Sciences and useful arts,112 and in allowing companies to invest huge

sums of money to find new products. It is auspicable that the reviewing courts will reverse the

decision of the Southern District of New York and hold that genes are patentable subject matter.

However, even if the reviewing courts were to find otherwise, inventors will find new

applications in the biotechnological field that satisfy the requirements of section 101.

16
1
See Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206 (1991).
2
John Schwartz and Andrew Pollack, Judge Invalidates Human Gene Patent, The New York Times
(2010), available at http://www.nytimes.com/2010/03/30/business/30gene.html (last visited May 9,
2010).
3
See Ass’n for Molecular Pathology v. U.S. PTO, Cancer Detection Gene Can’t Be Patented, Suit
Says, 16 No. 3 ANIPLR 2, 1 (2009).
4
Scott Rylan Powell, Gerry J. Elman, Takes on Patent Office & Myriad Genetics, GEN, March 1,
2010, available at http://www.genengnews.com/articles/chitem.aspx?aid=3201 (last visited May 9,
2010).
5
See 28 Biotechnology L. Rep. 514.
6
See http://www.myriadtests.com/index.php?page_id=159 (last visited May 9, 2010).
7
See E. Richard Gold and Julia Carbone, Myriad Genetics In the Eye of the Policy Storm 10 (2008),
available at http://ssrn.com/abstract=1260098 (last visited May 9, 2010).
8
See Katherine Drabiak-Syed, Commercialization and Gene Patenting, PredictER Law and Policy
Update, Indiana University Center for Bioethics, (2009), available at http://bioethics.iu.edu/body.cfm?
id=112&fr=true (last visited May 9, 2010).
9
See GenomeWeb, Federal Court Rules that Myriad’s BRCA patents are invalid; Deems ‘Isolated
DNA’ Unpatentable, March 30, 2010, available at http://www.genomeweb.com/dxpgx/federal-court-
rules-myriads-brca-patents-are-invalid-deems-isolated-dna-unpatent (last visited May 9, 2010).
10
See Top 5 Reasons the Myriad Genetics ACLU Patent Ruling Is Not a Big Deal, April 1, 2010,
available at http://crossborderbiotech.ca/2010/04/01/top-5-reasons-the-myriad-genetics-alcu-patent-
ruling-is-not-a-big-deal/ (last visited May 9, 2010).
11
See Ass’n for Molecular Pathology v. USPTO, 2010 WL 1233416, at *35 (S.D.N.Y.).
12
Id.
13
Id. at 35.
14
Id. at 31.
15
Id. at 32.
16
Id.
17
BENJAMIN LEWIN, GENES VI 94, Oxford University Press (1997).
18
Id. at 76.
19
Id. at 83.
20
Id. at 153.
21
Id.
22
Id. at 1224.
23
35 U.S.C. § 101.
24
See Brenner v. Manson, 383, U.S. 519, 530 (1966).
25
Id. at 533.
26
Id. at 532.
27
Id. at 534.
28
See, Chugai, supra note 2.
29
See In re Fisher, 421 F.3d 1365, 1367 (2005).
30
Id. at 1374.
31
See S.J. Boulton, Tumour Suppressor Proteins, BIOCHEMICAL SOCIETY TRANSACTIONS,
Volume 34, part 5, (2006).
32
Id. at 33.
33
Diamond v. Chakrabarty, 447 U.S. 303, 308-09 (1980).
34
Id. at 303.
35
Id. at 309.
36
Id. at 313.
37
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 128-31 (1948).
38
See Ass’n for Molecular Pathology, 2010 WL 1233416 *at 37.
39
See Am. Fruit Growers, Inc. v. Brodgex Co., 283 U.S. 1, 11 (1931).
40
See Ass’n for Molecular Pathology, 2010 WL 123416, at *39.
41
See Chakrabarty, supra note 34, at 309.
42
See Merck v. Olin, 253 F.2d 156, 161 (1958).
43
Id. at 162.
44
Id. at 308.
45
Id. at 309.
46
Id. at 309-10.
47
See Merck, supra note 43, at 162.
48
See American Wood Paper Co. v. Fibre Disintegrating Co. 90 U.S. 566 (1874).
49
See Merck, supra note 43, at 162.
50
Id. at 163.
51
Id.
52
Id.
53
Id. at 164.
54
Id.
55
See U.S. Patent No. 4,206,221 (filed Jan 3, 1979).
56
See for example, Elena A. Takano, et al., Rapid Detection of Carriers with BRCA1 and BRCA2
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http://www.biomedcentral.com/1471-2407/8/59 (last visited May 9, 2010).
57
See Colin R. James, et al., BRCA1, a Potential Predictive Biomarker in the Treatment of Breast
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http://theoncologist.alphamedpress.org/cgi/content/full/12/2/142 (last visited May 9, 2010).
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See Merck, supra note 43, at 164.
59
See supra note 49, at 594.
60
Id. at 593.
61
Id. at 595.
62
Id. at 594.
63
See Merck, supra note 43, at 162.
64
See Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884).
65
Id.
66
Id. at 312.
67
See Chakrabarty, supra note 34, at 310.
68
Id. at 310.
69
Id.
70
Id. at 635.
71
LEWIN, supra note 18, at 654-55.
72
NEIL A. CAMPBELL, et al., BIOLOGY 296, 5th Ed., Benjamin Cummings, (1999).
73
Id. at 294-96.
74
LEWIN, supra note 18, at 847.
75
Id. at 848.
76
CAMPBELL, supra note 73, at 358.
77
See for example, Ansgar Gerhardus, et al., Diagnostic Accuracy of Methods for the Detection of
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78
LEWIN, supra note 18, at 631-36.
79
See Merck, supra note 43, at 164.
80
See Ass’n for Molecular Pathology, supra note 41, at *43.
81
Id.
82
LEWIN, supra note 18, at 1233.
83
Id. at 703.
84
See Ass’n for Molecular Pathology, supra note 41, at *41.
85
Id. at *42.
86
Id.
87
See U.S. Patent No. 5,747,282 (filed June 7, 1995), in which claim 1 recites, “[a]n isolated DNA
sequence coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth
in SEQ ID NO:2.
88
See Funk Bros. Seed Co. v. Kalo Co., 333 U.S. at 130.
89
See In re Bilski, 545 F.3d 943, 953 (2008).
90
Id.
91
Id.
92
Id. at 954.
93
Id.
94
Id. at 962.
95
See ‘282 Patent, supra note 88, at col. 156, l. 15-26.
96
See Ass’n for Molecular Pathology, supra note 41, at 50.
97
See Lab. Corp. of America Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 129 (2006).
98
Id. at 135-36.
99
Id. at 965-66.
100
See ‘282 Patent, supra note 88, at col. 31, 46-53 and col. 34, l. 65-67.
101
See Ass’n for Molecular Pathology, supra note 41, at 46-48.
102
Id. at 48.
103
See U.S. Patent No. 5,709,999 (filed June 7, 1995), at col. 161, l. 28-36.
104
See Ass’n for Molecular Pathology, supra note 41, at 46.
105
See Parker v. Flook, 437 U.S. 584, 584 (1978).
106
See Bilski, supra note, at 955-58.
107
Id. at 957.
108
Id.
109
Id. at 956.
110
Id.
111
See ‘999 Patent, supra note 104, at col. 161, l. 17-36.
112
See U.S. CONST, art. I, § 8, cl. 8.