Patent Law Practice Center

Bilski v. Kappos: Summary And Implications

 

Written by Andrea M. Augustine (Partner at Foley & Lardner LLP and faculty member for the upcoming PLI Patent Litigation program) and Kevin J. Malaney (Associate at Foley & Lardner LLP)

On June 28, 2010, the U.S. Supreme Court issued its much anticipated opinion in Bilski v. Kappos.  In Bilski, the Court affirmed the judgment of the Court of Appeals for the Federal Circuit, In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), that the claims in question did not qualify for patent protection.  In doing so, the Court unanimously rejected the Federal Circuit’s determination that the “machine-or-transformation” test was the exclusive test for “process” patent eligibility.  But instead of establishing what test should be applied in future cases, the Court left this question open and simply relied on previous Supreme Court case law and the Patent Act to hold Applicants’ claims ineligible for patent protection.  Despite the uncertainty regarding the appropriate test, Bilski does provides some guidance as to what “process” claims are eligible for patent protection.  Because of the open questions that remain, future cases will be closely watched and studied for clarification and application of the Court’s holdings.  In the meantime, observers, advocates, and pundits will review the fine details and history of In re Bilski in search of guidance on the future of business method patents and patent applications. (more…)

Post-Bilski: “Patent Strategy for Personalized Medicine”

Today’s guest post comes from Michael J. Shuster, Ph.D. (a partner in Fenwick & West’s Intellectual Property group and co-chair of  the lifes sciences group) and Pauline Farmer-Koppenol (associate in Fenwick & West’s intellectual property group).

Protecting inventions in personalized medicine with patents is essential to making the investment in research and development of those inventions worthwhile.  Absent meaningful patent protection, however, companies will be less likely to pursue such innovation since there is nothing to prevent competitors from free-riding on the back of the many hours and millions of dollars expended by the innovator company.

Personalized medicine diagnostics can produce meaningful improvements in patient outcome and medical economics.  Diagnostic innovations developed by University of California Professors Dan Pinkel and Joe Gray allowed for the first time sensitive and accurate measures of gene amplifications in breast cancer patient biopsies. This allows physicians to determine whether Herceptin® (trastuzumab) treatment is likely to improve the patient’s outcome because only tumors with the amplification respond to Herceptin®.  Pinkel and Gray’s remarkable invention was exclusively licensed to Abbot Laboratories which devoted years of effort and millions of dollars to bring this innovation to market.  Considering the cost of a full course of treatment with Herceptin®, approximately $70,000, the development of the HER2/neu amplification diagnostic test is valuable not only in minimizing the use of an expensive treatment for patients for whom it is unlikely to provide benefit, but it also helps patients by not wasting valuable time pursuing a treatment that is unlikely to be beneficial. (more…)

USPTO Interim Bilski Guidelines: David Luettgen of Foley & Lardner Weighs In

While the Supreme Court’s Bilski v. Kappos decision answered some questions regarding patent eligibility under 35 U.S.C. 101, much remains unclear.  Last week, the USPTO attempted to clear up some of the uncertainty for the patent examiners when it published it’s Interim Guidance for Determining Subject Matter Eligibility for Process Claims (See Patent Office Releases Interim Bilski Guidelines ).  I had an opportunity to discuss the Interim Bilski Guidelines with David Luettgen, partner at Foley & Lardner LLP.

Here is what he had to say…..

Me:  Most agree that the Bilski decision left a lot of uncertainty.  Do you think the USPTO’s interim guidelines help clear up some of that uncertainty? Are the guidelines a step in the right direction?

DL:  The guidelines are helpful in that they present the PTO’s view of everything we know about subject matter eligibility from Bilski and other cases.  However, the PTO cannot create certainty where none really exists.  There are just a lot of things we do not know right now.  It will take some Federal Circuit cases before we get that certainty, for example, in the areas of computer-implemented inventions and medical diagnostic methods. (more…)

Patent Office Releases Interim Bilski Guidelines

Written by Gene Quinn (of IPWatchdog.com and Patent Center Contributor)

This morning the United States Patent and Trademark Office published Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos. The Interim Bilski Guidance is effective July 27, 2010, and applies to all applications filed before, on or after the effective date. Most noteworthy is that the Patent Office is encouraging examiners to issue 101 rejection in only “extreme cases” and allow patentability to be decided by sections 102, 103 and 112.

These interim guidelines build upon the memo sent to the examining corps the day the Supreme Court issued its decision in Bilski v. Kappos, and is intended for use by Office personnel when determining subject matter eligibility under 35 U.S.C. 101. According to the Federal Register Notice, this guidance supersedes previous guidance on subject matter eligibility that conflicts with the Interim Bilski Guidance.

Significantly, the guidelines explain:

Therefore, examiners should avoid focusing on issues of patent eligibility under Sec. 101 to the detriment of considering an application for compliance with the requirements of Sec. Sec. 102, 103, and 112, and should avoid treating an application solely on the basis of patent eligibility under Sec. 101 except in the most extreme cases.

This should be music to the ears of the patent bar and applicants who were previously stopped dead in their tracks by a seemingly insurmountable 101 rejection. (more…)

Bilski Aftermath: Will Europe’s “Technical Effect” Test Become the Law in the U.S.?

Robert Hulse, of Fenwick & West LLP, Practice Center Contributor and PLI Faculty member, discusses what the future may look like for business method patents:

I think most patent practitioners and applicants who have been following this case believe that we dodged a bullet, as the Court’s decision was about as good as could have been expected.  The Court removed the Federal Circuit’s overly rigid application of the machine-or-transformation (MOT) test as the sole test for patent eligible-subject matter, but it retained the test as a useful indication of whether a claim meets the subject matter requirement.  (In this respect, the Bilski decision is much like the Court’s decision in KSR a few years ago, where the court kept the teaching-suggestion-motivation (TSM) test, but held that it was just one of many useful ways to evaluate a claim for its compliance with the nonobviousness requirement.)  The benefit to applicants is that we can continue to rely on compliance with the MOT test by reciting a machine or transformation, subject to the “post solution activity” and “meaningful limits” considerations, while not being completely constrained by that test.

The Court also declined to exclude business methods from patent-eligible subject matter, although four justices (including Stevens, who is leaving the Court) would have done so.  This means that companies who innovate to create new ways of conducting business can continue to protect their inventions.  Excluding business methods for patent-eligible subject matter would have created more problems than it solved, not the least of which would have been how to define a “business method.” (more…)