Patenting Diagnostic Tests Post-Myriad and Post-Prometheus

• Author: Elizabeth Rodriguez - Sean Solberg
• Pages: 81-100

Warren D. Woessner1 and Robin A. Chadwick2

University life sciences and biotech discoveries have traditionally been the most valuable

in terms of their potential to generate license income. Increasingly, however, the path to

patenting these technologies has grown complex, discouraging, and expensive. The con-

troversy about what is patent-eligible subject matter is one such complexity that must be

understood by technology transfer ofces, since an invention deemed patent-ineligible will

not be further examined by the U.S. Patent and Trademark Ofce (USPTO).

Section 101 of the Patent Act

3

states that the following categories of invention are eligi-

ble for patent protection, so long as the other standards of patentability are met: processes,

machines, manufactures, and compositions of matter, as well as improvements thereof.

In 1980, the Supreme Court ruled that a man-made microorganism was also eligible for

patent protection under § 101,4 reafrming at the same time that no patents should be

granted on laws of nature, physical phenomena, and abstract ideas. Instead, the Court

emphasized that patent-eligible inventions must be generated by human ingenuity. Apart

1. See Woessners ’Patents4Life blog at www .patents4life .com for further discussion of these and other bio-

technology issues.

2. Warren D. Woessner and Robin A. Chadwick are patent attorneys at Schwegman, Lundberg & Woessner,

PA, headquartered in Minneapolis, Minnesota. This chapter reects the personal views and thoughts of Woess-

ner and Chadwick which are not to be construed as representing in any way the views, opinions, or practices

of Schwegman, Lundberg & Woessner, PA, or any of its clients. The content is solely for purposes of discussion

and illustration and is not to be considered legal advice.

3. 35 U.S.C. § 101.

4. Diamond v. Chakrabarty, 447 U.S. 303 (1980).

81

Chapter 4

Patenting Diagnostic Tests Post-

Myriad and Post-Prometheus

Useful Applications of Natural Products

or Patent-Ineligible Natural Laws?

from its decision in 2001 that plants were also eligible for patenting,5 the Supreme Court

has not again addressed whether living organisms, or their natural components, were

patent-eligible until 2012.

Although the courts have grappled for years with the “abstractness” of software claims,

in 2010 through 2013, the courts turned their attention to life sciences patents, nding

that some diagnostic claims were patent-ineligible as abstract ideas,6 while others were

patent-ineligible for patenting as embracing natural phenomena.7 Shortly after the Bilski

decision8 held that claims to a method of hedging commodity risk were patent-ineligible

under § 101 as an attempt to patent an abstract idea, the Supreme Court granted certiorari

and remanded the Classen case

9

involving an appeal of claims to immunization sched-

ules and then decided two biotech/pharma cases, the Prometheus case10 in 2012 and the

Myriad case11 in 2013. The application of the Supreme Court’s Prometheus decision by

the Federal Circuit to the prenatal testing claims in the PerkinElmer case

12

and the Fed-

eral Circuit’s own rejection of the Myriad diagnostic claims suggest that claims directed

to the use of biomarkers in personalized medicine have increasingly become vulnerable

to attack by litigants as not constituting patent-eligible inventions. The USPTO has now

also entered the arena with their memorandum outlining the patent eligibility of natural

products, natural phenomena, and laws of nature.13

This chapter discusses and reects on what the courts and the USPTO have said illus-

trating the recent evolution of biotechnology-related court decisions on patent eligibility

and comments on the problems faced by early-stage technologies such as those developed

by universities. A table is provided at the end of the chapter showing the language of vari-

ous biotech patent claims and how the courts have ruled.

5. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124 (2001).

6. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Ofce, 702 F. Supp. 2d 181 (S.D.N.Y. Mar. 29,

2010); Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,689 F.3d 1303 (Fed. Cir. 2011).

7. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. ___, 132 S. Ct. 1289, 182 L. Ed. 321.(2012).

8. Bilski v. Kappos, 561 U.S., 130 S. Ct. 3218, 177 L. Ed 2d 792 (hereinafter, the Bilski case).

9. Classen Immunotherapies, Inc. v. Biogen IDEC, 130 S. Ct. 3541 (2010) (remanded); Classen Immunothera-

pies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011); GlaxoSmithKline v. Classen Immunotherapies, Inc.,

133 S. Ct. 973 (2013) (cert. denied).

10. Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010); Mayo Collaborative

Servs. v. Prometheus Labs., Inc., 566 U.S. ___, 132 S. Ct. 1289, 182 L. Ed. 2d 321 (2012).

11. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Ofce, 702 F. Supp. 2d 181; Ass’n for Molecu-

lar Pathology v. Myriad Genetics, Inc., 689 F.3d 1303; Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,

133 S. Ct. 2107 (2013).

12. PerkinElmer, Inc. v. Intema, Ltd., 496 F. App’x 65, 73 (Fed. Cir. 2012) (non-precedential). Intema led a

petition for certiorari with the Supreme Court, which has been denied.

13. Memorandum from Andrew H. Hirscheld, Deputy Comm’r, U.S. Patent & Trademark Ofce, to Patent

Examining Corps (Mar. 4, 2014), available at http:// www .uspto .gov /patents /law /exam /myriad-mayo _guidance .pdf.

WARREN D. WOESSNER AND ROBIN A. CHADWICK82