Smith, Parsons & Summawww.smithparsons.com

AMP v. Myriad

As an introduction to Patent Law

© Philip Summa 2014

Introduction to Biotech

Dr. Todd SteckFebruary 19, 2014

Amp v. Myriad is a case decided by the US Supreme Court in June 2013. Because the subject matter is human genetics and because the decision arguably differs from long-standing aspects of US patent law, the case provides a worthwhile introduction to Patent Law and related legal issues.

http://kintalk.org/genetics-101/(Accessed February 12, 2014)

Mutations in the BRCA1 and BRCA2 genes have been discovered to dramatically increase an individual’s risk of developing breast and ovarian cancers.

Myriad found the exact location of the BRCA1 and BRCA2 genes, which allowed Myriad to determine their typical nucleotide sequence which enabled Myriad to better assess whether a patient has the mutation.

Myriad obtained a number of patents after this discovery . . . including a claim for the list of amino acids that the typical BRCA1 gene encodes. “1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”

US Patent No. 5747282

The second claim recites the sequence of cDNA that codes for the BRCA1 amino acids listed in claim 1.

“2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.”

Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes and synthetically create BRCA cDNA and exclude others from being able to make it.

Others began providing genetic testing based upon the Myriad discoveries, so Myriad filed patent infringement suits against other entities that performed BRCA testing, resulting in settlements in which the defendants agreed to cease all allegedly infringing activity and Myriad solidified its position as the only entity providing BRCA testing.Ostrer and others filed a lawsuit declaring that Myriad’s patents were invalid because they covered products of nature.

There are four (4) categories of patentable subject matter (§ 35 USC 101):

Processes Machines

Manufactures Compositions of Matter

“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. 101

There are three (3) exceptions (Case Law Precedent):

Laws of Nature

Physical Phenomena

Abstract Ideas

There are three (3) further requirements for patentability:

Novelty (§ 102)

Nonobviousness (§ 103)

A full and particular description (§ 112)

Novelty means “brand new.” Most typically, it means that the words of the claim recite something that, in total, cannot be found in any other single item. In the sciences, the relevant items are usually prior patents, published patent applications, and journal articles. Novelty is an objective standard.35 U.S.C. Section 102

Obviousness is a subjective standard based upon the knowledge of a hypothetical “person of ordinary skill in the art.”35 U.S.C. Section 103

Obvious?

© Gary Larson, The Far Side

The District Court ruled that Myriad’s patent claims were invalid because isolated DNA and cDNA were ineligible for patent protection as covering products of nature.

On appeal, the Federal Circuit ruled oppositely (“reversed”) on the grounds that isolating DNA or cDNA is an “inventive act.”

The Supreme Court began by bracketing the conceptual aspects:

We have “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” … Rather, “ ‘they are the basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection. (W)ithout this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” This would be at odds with the very point of patents, which exist to promote creation. (Products of nature are not created, and “ ‘manifestations ... of nature [are] free to all men and reserved exclusively to none’ ”).

Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 186 L. Ed. 2d 124 (2013)

(Versus:)

The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law.” As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” We must apply this well-established standard to determine whether Myriad's patents claim any “new and useful ... composition of matter,” § 101, or instead claim naturally occurring phenomena.

Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 186 L. Ed. 2d 124 (2013)

“It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.”

Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 186 L. Ed. 2d 124 (2013)

An intermediate reminder:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.”

The legal issue in chemistry terms: you need to cleave the gene from the DNA stand to isolate it. Does this create anything new in the patentable sense?

Problem for Myriad--the claims are written to cover information rather than chemical composition (“the claims undoubtedly focus on the genetic information encoded in the BRCA1 and BRCA2 genes”).

A molecule claim could be avoided by isolating a slightly different sequence; a result that wouldn’t help Myriad commercially.

cDNA is a different issue. Non-coding regions have been removed, and thus the sequence does not occur in nature. Therefore cDNA is patentable (unless it is identical to a natural short DNA that has no intervening introns).

“Final Answer”

“Genes and the information they encode are not patent eligible under Section 101 simply because they have been isolated from the surrounding genetic material.”

Thank you very much

© Philip Summa 2014

Smith, Parsons & Summawww.smithparsons.com