Hyatt v. Kappos: The En Banc Decision Makes Section 145 Actions More Attractive

Clement S. RobertsThe following post comes from Clement S. Roberts (Partner at Durie Tangri and Practice Center Contributor).

Two weeks ago, the Federal Circuit handed down an en banc decision in Hyatt v. Kappos overruling a panel decision and substantially changing the rules for admitting evidence in a §145 action.  Although the decision has not attracted much attention, Hyatt may make §145 actions substantially more attractive and meaningfully alter the strategic landscape for those applicants who wish to pursue their claims beyond a BPAI rejection.

After an applicant’s claims are rejected by the BPAI, the applicant has two basic options—either appeal the  decision to the Federal Circuit, or bring an action in district court under 35 U.S.C. §145.  If the applicant elects to appeal the decision to the Federal Circuit, the appeal is heard on the administrative record created by the PTO and pursuant to the substantial deference standard normal in judicial review of expert administrative proceedings.  In a §145 proceeding, however, some new issues can be raised and (prior to Hyatt) some new evidence could be submitted to the district court. (more…)

New BPAI Appeal Rules Proposed

The following post comes from Scott A. McKeown, partner at Oblon Spivak, Practice Center Contributor and writer for Patents Post Grant.

Rules for Ex Parte Appeals to be Simplified

In recent years, the USPTO has advanced significant changes to the rules of practice for ex parte appeals to the Board of Patent Appeals & Interferences (BPAI). (previously proposed appeal rules). The past proposal was not exactly greeted with enthusiasm by stakeholders. In response, today’s Federal register includes a new, and much improved, ex parte appeals rule package. (here)

The new proposal, consistent with the spirit of Director Kappos’ administration to date, advances a refreshing change of pace. Previously the Office proposed increased formality and bureaucratic hurdles seemingly geared toward making USPTO appeal practice more burdensome and expensive to Applicants. The new rules, like many of the proposals of the Kappos regime, advance common sense solutions designed to simplify appeal. Yet, one of the proposed revisions could be used to frustrate the statutorily mandated special dispatch to be accorded ex parte patent reexaminations. (more…)

Federal Circuit: Foreign Application Not Priority in Interference When it Only “Envisions” Invention

Written by Gene Quinn (of IPWatchdog and Practice Center Contributor)

Last week the United States Court of Appeals for the Federal Circuit issued a ruling in Goeddel v. Sugano, which might be one of a dying breed should patent reform actually pass.  The case dealt with an appeal from an interference proceeding where the Board awarded priority based on a Japanese application.  The Federal Circuit, per Judge Newman, explained that it was inappropriate to say that the Japanese application demonstrated a constructive reduction to practice because the application merely would allow the skilled reader to “envision” the invention covered in the interference count.  If patent reform passes (and yes that could really happen) cases like Goeddel would become a thing of the past, although priority determinations like this one in Goeddel will certainly not go away.

Goeddel was a consolidated appeal from two decisions of the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office in two related patent interference priority contests between the party Haruo Sugano, Masami Muramatsu, and Tadatsugu Taniguchi (together “Sugano”) and the party David V. Goeddel and Roberto Crea (together “Goeddel”).  The Board held that Sugano is entitled to the benefit of the filing date of its initial Japanese application, and awarded Sugano priority as to the counts of both interferences. (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…)

BILSKI: Where Do We Go From Here?

The following guest post comes from  Kenneth Nigon, Practice Manager for the Patent Preparation and Prosecution Group at RatnerPrestia and PLI Faculty member.

On Tuesday, July 27, the USPTO published its Interim Guidance for Determining Subject Matter Eligibility for Process Claims in view of Bilski v. Kappos (“Interim Bilski Guidance”).  This Guidance supplements the Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101 (“Interim Instructions”), published on August 24, 2009 and the memorandum to the Patent Examining Corps on the Supreme Court Decision in Bilski v Kappos published on June 28, 2010 (“Bilski Memorandum”).

The Bilski Memorandum instructs the examiners to reject method claims that do not meet the requirements of the Machine or Transformation (MoT) test formulated by the Federal Circuit in In re Bilski 545 F.3d 943 (Fed. Cir. 2008).  The Interim Bilski Guidance modifies these instructions to require examiners to apply a balancing test which weighs factors both in favor of and opposed to patent eligibility and directs examiners to consider all requirements for patentability in the interest of compact prosecution.

The factors weighing in favor of eligibility of a claim include that it:

  • passes the MoT test,
  • is directed toward the application of a law of nature and
  • is more than a mere statement of a concept. (more…)