Patent Law Practice Center

The Clones War: Chapter Two – Myriad Files Their Brief on Appeal

The following guest post was written by Birch, Stewart, Kolasch & Birch Partner Mark J. Nuell, Ph.D.

Myriad Genetics has filed their brief in their appeal of the decision in Assoc. of Med. Pathology et al. v. Myriad Genetics et al. This case is one having effect on patent-eligibility of claims directed to purified natural products and to sequence-based diagnostic methods.  Myriad’s brief is a paper of advocacy, and it is persuasive of an asserted lack of jurisdiction.  Thus, the Federal Circuit might not even reach the questions of patentability of isolated DNA and of nucleic acid (sequence)-based diagnostic methods.  But, should the Federal Circuit choose to consider those questions, it appears that claims to “isolated DNA” meet the standard for patent-eligibility.  Despite their arguments to the contrary, some of Myriad’s diagnostic method claims are likely to fail to meet the standard, as falling within the scope of abstract ideas or laws of nature.  The other method claims that are challenged, although they can be interpreted to include a “transformative” step and so include a strong clue in favor of patent-eligibility under Bilski v. Kappos, might be deemed ineligible for patent protection because the “transformative” steps represent mere data-gathering steps. (more…)

Bilski’s Impact on Finance Industry Patents

The following was written by Dale Lazar (Partner at DLA Piper and one of our newest Practice Center Contributor’s)  and Jim Heintz (Partner at DLA Piper).

When the Supreme Court announced it would hear the Bilski case, many speculated that the Court would use the opportunity to declare an end to patents on business methods. This did not happen. However, the Court did find that Bilski’s claims to a method for hedging risk were not the kind of invention for which a patent should be granted.

What does this mean for other finance industry patents and patent applications? Certain types of business method patents may be safe for now – but warning signs point to hazards down the road.

Most would agree that the claims of Bilski’s patent application are directed toward a business method. Two aspects of the Supreme Court’s Bilski decision are particularly important to the issue of whether finance industry inventions can be protected by patents: (1) business methods are not categorically excluded from patent protection; but (2) Bilski’s claims to methods for hedging risk are unpatentable because they claim an “abstract idea.” (more…)

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…)