At the BIO’s IPCC Conference today, attendees were treated to a look at pending cases that concern biotech.

John Dragseth, a Partner at Fish & Richardson, gave an overview of the Mayo v. Prometheus case after filing a Petition for a Writ of Certiorari with the Supreme Court just hours earlier.  The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a process for correlating the level of certain chemicals in a patient’s blood with the patient’s health.

Earlier, the Supreme Court granted certiorari in Laboratory Corp. of Am. Holdings v. Metabolite Labs but — despite being hit with 20 amicus briefs — the Supreme Court turned around and opted out of ruling on the case saying that it had “improvidently” agreed to hear the case in the first place and it dismissed the appeal. At that time, thousands of patents on medical tests and genes dodged a serious bullet since the Court could have deemed such tests “natural phenomena.”

Now, the Court may have another shot to clarify the situation in Mayo and the answer may hinge on preemption of natural phenomenon.  The question presented is as follows:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations

The Mayo case asks how a method can be patentable if anyone performing the test for other reasons can’t avoid infringing the claims if they do the test for any other reason but happen to “think” about the correlation knowing that it exists.

J. Michael Jakes, a Partner at Finnegan, gave an update on the Bilski v. Doll case as he prepares to argue the case before the U.S. Supreme Court.  The briefing is completed and argument is set for November 9.  The not so surprising note was that Bilski has garnered 65 amicus curiae briefs, which break down as 17 supporting the Federal Circuit decision, 22 against and 26 supporting neither.

Here, the questions presented are:

  1. Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”
  2. Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

Jakes pointed out that the Government-filed brief seems to want to resurrect the technological arts test by the CCPA, which was rejected by the CAFC in Bilski.  The examiner applied this test but it was overruled by the Board of Patent Appeals as not a proper test.  The technological arts test is problematic since technology is always evolving and not co-extensive with the test.

The problem of methods not tied to a specific machine or having a transformation is not solely related to business methods.  What about a method for seismic exploration?  In addition, the quality of the science is not a good measure of what is patentable.  While there are plenty of ridiculous business method patents, plenty of devices would meet the “not worthy” test, too.

See U.S. Pat. No. 5,443,036:

1. A method of inducing aerobic exercise in an unrestrained cat comprising the steps of:

(a) directing an intense coherent beam of invisible light produced by a hand-held laser apparatus to produce a bright highly-focused pattern of light at the intersection of the beam and an opaque surface, said pattern being of visual interest to a cat; and

(b) selectively redirecting said beam out of the cat’s immediate reach to induce said cat to run and chase said beam and pattern of light around an exercise area.

Is Bilski important?  Some estimates say as many as 200,000 patents could be invalidated if Bilski is held to strictly apply to all method patents.  In the end, it is doubtful that this will be the seminal case for biotech.  For that, we need a detailed court opinion on a solid diagnostic method patent.

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