Patent LawProf. Merges

Section 101

8.24.09

Logistics

• Course web page: http://www.law.berkeley.edu/9236.htm

• Syllabus on bSpace

Main Themes

• Living Subject matter

• Gene Patents

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/antithesisThe 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

Jokichi Takamine

Jokichi TakamineJokichi Takamine was born on November 3, 1854 in

Takaoka, Japan. He attended schools in Osaka, Kyoto, and Tokyo, graduating from the college of science and engineering at the University of Tokyo in 1879. That year the Japanese government selected Takamine as one of 12 scholars to pursue graduate studies in Scotland at Glasgow University and at Anderson College. He returned to Japan in 1883 and joined the department of agriculture and commerce.

In 1884 Takamine made his first trip to the United States where he met his future wife, Caroline Field Hitch. The family moved to Japan, and continued to work for the department of agriculture and commerce as chief of the division of chemistry until 1887. At that time he formed his own company, the Tokyo Artificial Fertilizer Company, where he later isolated a starch-digesting enzyme, Takadiastase, from a fungus.

In 1894 Takamine moved permanently to United States, settling in New York City. He opened his own private laboratory but allowed Parke, Davis & Company to produce Takadiastase commercially. In 1901 he isolated and purified the hormone adrenalin in his laboratory, becoming the first person to accomplish this for a glandular hormone. --- Am Chem Soc’y, J. Chem Ed Online

Takamine: The Legend

Takamine’s patents

• ‘176 Product patent–Why was this valuable?–Why not a process patent (see

Chakrabarty)

• See p. 107

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

• See p. 107

Takamine’s patents (cont’d)

• ‘177 Patent– “Salt” (acid) form of isolated hormone– Why not at issue here?

• Why claim it?

• How could it have been valid?– Prior art

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. 108

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. 108

Hand’s Pragmatism

• “Practical differences”

Vs.

• “Scholastic distinctions”

-- p. 108

Two additional points

• Evidence of patentability: Takamine’s product displaced the prior products

• “I cannot stop without calling attention to the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these . . . .” -- p. 109

Critiques

“Reinventing the double Helix: a novel and nonobvious reconceptualization of the biotechnology patent”

• 55 Stanford Law Review 303 (2002); Demaine, Linda J.; Fellmeth, Aaron Xavier

Demaine and Fellmeth (cont’d)

Science, Vol 300, Issue 5624, 1375-1376 , 30 May 2003

The challenge is to craft a test to distinguish products of nature from patentable inventions. A parsimonious solution is a variant of the "substantial transformation test“ (STT) used in customs law, in which a product is considered to have undergone a substantial transformation when it has a "new and distinct name, character, or use.“ Because name is highly mutable, the real focus of the test is a change of character or use.

Commentary• Eileen M. Kane, Splitting the Gene: DNA Patents and the

Genetic Code, 71 Tenn. L. Rev. 707, 707 (2004)

By scientific and historical criteria, the genetic code can be characterized as a law of nature and as an essential component of the public domain in molecular biology. The Article concludes that the patenting of genes results in constructive preemption of the genetic code, a result that is contrary to the Supreme Court‘s [rulings].

Association for Molecular Pathology v. United States PTO

(The “Myriad” Case)2010 U.S. Dist. LEXIS 35418 (Apr. 5, 2010)

BRCA-1

Gene Expression Protein

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.

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

• Rejects Learned Hand analysis in Parke-Davis

• Statement re: 101 was dicta there

HoldingIn 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.

Lab Corp of America v. Metabolite Labs, Inc.

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. 58-65.

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.

Proceedings belowThe jury found that LabCorp breached its

license agreement with Metabolite, that LabCorp willfully infringed the ’658 patent, and that the claims at issue are not invalid. The jury assessed damages against LabCorp of $3,652,724.61 for breach of contract and $1,019,365.01 for infringement. . . . In light of the finding of willfulness, the district court doubled the jury’s infringement award to $2,038,730.02.

“The correlating step is a simple conclusion that a cobalamin/folate deficiency exists vel non based on the assaying step.” – 370 F.3d at 1367.

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

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. 58-65.

Back to claim 13

• because the natural relationship between homocysteine and vitamin deficiency was now well known, such “correlating” would occur automatically in the mind of any competent physician . . .

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. 105