Patent Law Prof. Merges Section 101: Issues in the Life Sciences

Main Themes Living Subject matter Gene Patents

Historical progression 1.Chakrabarty – on the cusp of “classical genetic engineering” 2.Rediscovering Parke-Davis – Learned Hand’s 1911 decision on the “adrenalin patent” – p Supreme Court “dodges” Metabolite: 2006

Today’s controversy Ass’n Molecular Pathology – the “Myriad” gene patent case Fed Cir. Opinion 2011 – motion to rehear, rehear en banc, then cert. petition?

Chakrabarty: Questions 1. Why are “discovered” things not patentable? 2. Why are newly discovered laws of nature not patentable?

Chakrabarty (cont’d) 3. Why isn’t Chakrabarty’s invention just a newly discovered law of nature? 4. Why don’t the Plant Patent Act and the PVPA show that Congress assumed living things to be unpatentable?

Chakrabarty (cont’d) 5. Why is this decision so important if Chakrabarty could have obtained process claims anyway?

6. Would a cloned human be patentable under this decision? How broad is this holding?

Page 72 “Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”

Thesis/antithesis 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.” S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952) casebook p. 70

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. Likewise, Einstein could not patent his celebrated law that 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.”

“Purified and isolated” claims – § 101 Issues – Practical advantages Natural substance patents

Parke-Davis v. Mulford 1911 District Court case Centered on a patent for purified adrenalin Patented by Jokichi Takamine

Jokichi Takamine

Takamine: The Legend

Takamine’s patents ‘176 Product patent – Why was this valuable? – Why not a process patent (see Chakrabarty) See p. 164

What is the value of a product patent? Mulford used a different process to precipitate out the final adrenaline product Might not have infringed a detailed process patent if Takamine had claimed narrowly

Judge Hand’s Decision

Hand’s decision “While it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically.” -- p. 168

Everyone, not already saturated with scholastic distinctions, would recognize that Takamine’s crystals were not merely the old dried glands in a purer state, nor would his opinion change if he learned that the crystals were obtained from the glands by a process of eliminating the inactive organic substances. The line between different substances and degrees of the same substance is to be drawn rather from the common usages of men than from nice considerations of dialectic. -- P. 166

Lab Corp of America v. Metabolite Labs, Inc. Supreme Court 2006 No official opinion – cert dismissed Grant of cert., dissent from dismissal: signals from the Court?

Metabolite v. Lab Corp. Am. 13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate. ’658 patent, col. 11, ll

The ’658 patent claims methods for detecting cobalamin or folate deficiency. Cobalamin and folate are both B vitamins, commonly known as B12 and folic acid, respectively. A deficiency in these vitamins can cause serious illnesses in humans, including vascular disease, cognitive dysfunction, birth defects and cancer. If detected early enough, however, vitamin supplements readily treat the deficiency.

Because these B vitamins assist in metabolizing the amino acid homocysteine, scientists directly or indirectly assay homocysteine to screen for cobalamin and folate deficiency.

Supreme Court Drafted its own cert question: “First, measure the level of the relevant amino acids using any device, whether the device is, or is not, patented; second, notice whether the amino acid level is elevated and, if so, conclude that a vitam in B deficiency exists. Is the patent invalid because one cannot patent “laws of nature, natural phenomena, and abstract ideas”?

Official disposition Writ of certiorari dismissed as improvidently granted.

Breyer et al. dissent “laws of nature, natural phenomena, and abstract ideas” excluded from § 101 “[T]he reason for the exclusion is that sometimes too much patent protection can impede rather than “promote the Progress of Science and useful Arts”.... Casebook p. 100

But one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable “natural phenomenon,” and I can find nothing in claim 13 that adds anything more of significance casebook p. 132

Myriad The gene The patent The controversy

BRCA-1

Gene Expression  Protein

Relying on a large set of DNA samples from families with inherited breast and ovarian cancers, the inventors correlated the occurrence of cancer in individual family members with the inheritance of certain marker DNA sequences. This allowed the inventors to identify, or “map,” the physical location of the BRCA genes within the human genome and to isolate the BRCA genes and determine their exact nucleotide sequences. This in turn allowed Myriad to provide BRCA diagnostic testing services to women. – p. 8

Myriad The isolated DNA sequence can be used in genetic testing to determine whether a person carries certain alleles of the BRCA 1 or 2 gene and is thus at higher risk for breast or ovarian cancer.

Claim 1 of U.S. Pat. No. 5,747,282 (issued 1998) 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.

Association for Molecular Pathology v. United States PTO (The “Myriad” Case) 2010 U.S. Dist. LEXIS (Apr. 5, 2010)

Myriad – district court Rejects Learned Hand analysis in Parke-Davis Statement re: 101 was dicta there

Holding In light of DNA's unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA. "markedly different." This conclusion is driven by the overriding importance of DNA's nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its “isolated” form.

. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

Am. Fruit Growers (1931) Manufacture implies a change, but every change is not manufacture, and yet every change in an article is the result of treatment, labor, and manipulation. But something more is necessary.... There must be transformation; a new and different article must emerge having a distinctive name, character, or use.

Myriad in the Federal Circuit [A]lthough the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. – p. 10

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. [Patentable:]…. compositions that human intervention has given “markedly different,” or “distinctive,” characteristics. – p. 11

Fed Cir Strategy Point out the significance of the isolation Chromosomes: 80 million – 110 million base pairs Genes: 80,000 bp Coding region: 10,200 bp

Distinguishing Parke-Davis Purified vs. merely isolated: [I]n nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

Dissent: Judge Bryson No to long DNA sequences

P. 14 It is also important to dispute the dissent’s analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.