Significant U.S. Casesin 2010

Brian R. Dorn, Ph.D.

November 4, 2010

Cases

1. Bilski v. Kappos2. Ariad v. Eli Lilly & Co.

3. ACLU v. USPTO (“Myriad”)

4. Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd.

Bilski v. Kappos561 U.S. ___ (2010)

• Machine or Transformation (MoT) test is a good test but not the only test

• A claimed process is patentable under 35 U.S.C. § 101 if (a) the process is tied to a particular machine or apparatus, or (b) the process transforms a particular article into a different state or thing

Bilski

• Not patentable subject matters– Abstract ideas

– Natural phenomenon

– Laws of Nature

• Involvement of the machine or transformation must not be insignificant, extra-solution activity, such as gathering data (CAFC)

Bilski

• MoT test may not apply to “advanced diagnostic medicine [sic] techniques” being part of the “information age”

• To be further elucidated in Prometheus and Classen

Prometheus

Patentable Transformation (CAFC):1. A method of optimizing therapeutic efficacy for treatmentof an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Classen

Not patentable subject matter (CAFC):1. A method of determining whether animmunization schedule affects the incidence orseverity of a chronic immune-mediated disorder in atreatment group of mammals, relative to a controlgroup of mammals, which comprises immunizingmammals in the treatment group of mammals withone or more doses of one or more immunogens,according to said immunization schedule, andcomparing the incidence, prevalence, frequency orseverity of said chronic immune-mediated disorderor the level of a marker of such a disorder, in the treatment group, with that in the control group.

Assoc. Mol. Pathol. v. USPTO

702 F.Supp.2d 181 (SDNY, 2010)• The “Myriad Case”• Potential seismic shift in the biotech

industry• Decision granting Plaintiffs’ motion

on Summary Judgment that the claims to isolated DNA sequences coding for BRCA1/BRCA2 polypeptides are invalid because the subject matter of the claims is not patentable subject matter because the claims cover natural products or abstract mental processes

The Myriad Case ‘282 & ‘492 patents

• Claim 1:An isolated DNA molecule coding for the [BRCA1/BRCA2] polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2

• SEQ ID NO:2 is the BRCA1/BRCA2 polypeptide

The Myriad Case

• Markedly Different Test—derived from Chakrabarty

• Does purification/isolation of a natural product render the product patentable?

• Is isolated DNA markedly different than DNA found in nature?

The Myriad Case

• Judge Sweet characterizes DNA as “physical embodiment of information”; ignores physical/chemical differences

• Finds that “none of the structural and functional differences…render the claimed DNA markedly different”

Ariad Pharm., Inc. v. Eli Lilly & Co.(Fed. Cir. 2010) (en banc)

• Reaffirmed that the Written Description requirement is separate from the enablement requirement

• Also reaffirmed the “possession” standard

Ariad

• Constructive RTP that ID’s claimed subject matter is sufficient; Actual RTP is not necessary

• Sufficient examples demonstrating common features to members of the genus

Daiichi Sankyo Co. v. Matrix Labs. Ltd.Fed. Cir. 2010

CAFC affirmed that olmesartanmedoxomil (Benicar) is notobvious over lead compoundssuch as losartan

Daiichi Sankyo v. Matrix

Lead Compound

• Known prior art compound• Closest prior art compound• Most structurally similar prior

art compound• Most active prior art

compound• Most promising prior art

compound to modify• Most preferred prior art

compound

Daiichi Sankyo v. Matrix

Proof of obviousness based on structuralsimilarity requires clear and convincingevidence that a medicinal chemist ofordinary skill would have been motivatedto select and then to modify a prior artcompound (e.g., a lead compound) toarrive at a claimed compound would havesimilar or improved properties comparedwith the old.”

Daiichi Sankyo v. Matrix

“proving a reason to select acompound as a lead compounddepends on more than just structuralsimilarity, but also knowledge in theart of the functional properties andlimitations of the prior artcompounds. Potent and promisingactivity in the prior art trumps merestructural relationships.”

Daiichi Sankyo v. Matrix

“While the lead compound analysis must,in keeping with KSR, not rigidly focus onthe selection of a single, best leadcompound, the analysis still requires thechallenger to demonstrate by clear andconvincing evidence that one of ordinaryskill in the art would have had a reason toselect a proposed lead compound orcompounds over other compounds in theprior art.”

Thank you!

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