USPTO Request for Comments on Enhancement in the Quality of Patents

In the December 9, 2009 issue of the Fed. Reg., the PTO requested public comments on a wide range of patent preparation and prosecution topics, from "Finding the Best Prior Art" to issuing and responding to first office actions and "proper use of interviews." (Request attached.) The PTO recently extended the response deadline from Feb. 8th until March 8th. Clearly, any currrent prep/pros attorney or agent could write a textbook on the five topics "in which the PTO is particularly interested" and you are encouraged to reply by email. So I spent some time on one of the topics (and tried to lobby for the return of Prosecution Specialists, at least to 1600). My comments are below. I hope you will take time to send in your thoughts. After all, they don't ask that often.
___________________________

Dear USPTO:

Following are my comments on Section V(5) -Proper Use of Interviews.

Examiners should be willing to, and encouraged, to grant interviews prior to a first action on the merits as well as after final rejection. Examiners should get credit for more than one interview per application.

Examiners should be responsive to requests that their Supervisor participate, and should be clear about whether or not such participation is required. Examiners should offer to reschedule interviews when a Supervisor unexpectedly cannot participate, with an appropriate amount of lead time.

Examiners or attorneys should be encouraged to propose amended, or even new, claims orally or in writing prior to the interview. If not presented at the interview itself, such claims would not become part of the record.

A more general suggestion: The USPTO should re-establish the position(s) of Prosecution Specialist(s) in the Pharma/Biotech art units (eg, 1600). These positons were once held by Richard Schwartz, Brian Stanton and Margaret Parr. The Specialists acted as ombudsmen for the applicants and attempted to mediate between Examiners and applicants, particularly in cases in which agreement could not be reached on focussed issues and/or the dispute appeared to turn on a particular point of law. The Specialists used to have real authority; they would review actions without identifying the particular application in question (eg,, so that the applicant would not suffer retaliation if the Specialist concluded that applicant's position was incorrect). If they felt that applicant's position was correct, they had the power to direct the Examiner to allow some or all of the claims, or at least could prevent the Examiner from filing an Answer if the claims went up on appeal. I worked effectively and regularly with Prosecution Specialists, until Brian Stanton left the Office and the program was, for all practical purposes, ended.

(This is a completely different approach than "second pair of eyes" review of Examiners' allowances, which applicants took no part in, and which encouraged Examiner's not to allow applications (for fear they would be found to have erred, and be penalized)).

Respectfully submitted,
Warren D. Woessner

12-09-09 Fed Reg - Request for Comments.pdf

BIO Joins Stakeholders in Expressing Concerns with Efforts to Restrict Gene Patenting

Today, the Secretary’s Advisory Committee on Genetics Health and Society (SACGHS), approved, with on dissent, a draft report which recommends legislative changes to the patent laws in regards to gene patents and recommends restrictions on licensing of federally funded research. The report will be forwarded with minor changes to the Secretary of Health and Human Services, Kathleen Sebelius. BIO spearheaded a sign-on letter urging the Secretary to reject the SACGHS’ recommendations and released the letter at an event at the National Press Club in Washington DC yesterday. Participating in the event yesterday were Jim Greenwood, President and CEO, BIO, former Senator Birch Bayh, Co-Author of the Bayh-Dole Act, Brian Stanton, Task Force Member, SACGHS, Jim Davis, General Counsel, Human Genome Sciences and Jon Soderstrom, Ph.D., Managing Director of Yale University’s Office of Cooperative Research. See below for links to the letter and a podcast of the event.

Press Release

Stakeholder letter to HHS Secretary

Podcast

BIO Joins Stakeholders in Expressing Concerns with Efforts to Restrict Gene Patenting Restrictions would threaten advances in public health and harm the national economy
For Immediate Release
2/5/2010

WASHINGTON, D.C. (Friday, February 05, 2010) - The Biotechnology Industry Organization (BIO) released today a letter to Health and Human Services Secretary Kathleen Sebelius regarding the potentially harmful recommendations of the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) in its Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.

BIO was joined on the letter by the Association of University Technology Managers (AUTM), Genetic Alliance, the Wisconsin Alumni Research Foundation (WARF), and more than 20 other stakeholders in urging Secretary Sebelius to reject the Committee’s recommendations and to ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved.

In the letter, the stakeholders stated, “We welcome efforts to improve patient access to genetic tests, and stand ready to work with you and other interested parties to do so. But we believe that the recommendations, if implemented, would unravel two sets of laws that are the foundation of life science innovation in this country – the patent system and the Bayh-Dole Act. This would do more harm to patients than good, by impairing the research, development and commercialization of the medicines and diagnostic tests of tomorrow.”

“By undermining the value of gene-based patents, these recommendations would chill future investment and innovation, and would undermine the investment-backed expectations of current patent owners and licensees,” stated BIO President and CEO Jim Greenwood. “The United States must preserve incentives for investment and innovation, particularly given the current state of the economy. It is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation.”

The letter is available at http://bio.org/ip/genepat/documents/SACGHSsign-onletter2-4-2010final_000.pdf.

SACGHS Final Report on Gene Patents - Taking a Machete to the IP Thicket

On September 17, 2009, the Secretary of HHS's Advisory Committee on Genetics, Health and Society (SACGHS) issued a Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. The 66 page report amounts to a wide-ranging attack on biotechnology patenting and licensing, even as it proclaims that it does not opine on "protein-based genetic tests or patent claims on isolated proteins." The report also tries to draw a line between its disapproval of patents on isolated genes or on simple tests based on gene-disease associations (read Myriad), and the development of test kits and multiplex tests, which it concedes may require patent protection for commercial development.

While beginning with the self-evident conclusions that professors like to conduct cutting edge research and publish the results (e.g., of gene-disease associations), the Committee goes on to conclude that clinical testing services rapidly arise, if there is physician interest (e.g., if someone will reimburse): "The case studies [of gene-disease associated testing] show that those researchers who did not pursue patenting were willing and able to invest in developing genetic tests soon after their discovery, despite the threat that 'free riders' could then offer competing test services." I bet they are, but they are not offering the test for free - they are charging for it, and trying to use their brand names to gather market share. The Committee found that cost and regulatory hurdles were much higher for companies attempting to develop test kits "than for testing services" and that patent protection "may be needed for companies to be willing to risk resources in satisfying the regulatory requirement." The Committee also only found that exclusive providers did not price-gouge, provide poor quality control, or otherwise limit patient access (but they might). However, this barely slowed the momentum of the report toward pushing gene and "simple association" patents off a legal cliff.

The next section is an investigation of how gene patents might inhibit "multiplex tests" (e.g., lymphoma-on-a-chip) or whole genome sequencing that could have been written by Affymetrix (a company who is specifically mentioned at least twice). It is beyond the scope of this post to begin to point out the legal errors or omissions in this section which focuses on how allegations of infringement of patents on single genes might block development in this area (something that does not appear to have occurred - I just read a paper on characterizing the genetic basis of malignant breast cancer that used a commercial chip that included over 50,000 gene probes).

Nonetheless, one of the Report's conclusions is that "claims upon the act of simply associating a genotype with a phenotype should not be patentable because they are claiming laws of nature that cannot be invented around." The Commission concedes that "[i]t would be up to the courts [to] decide what 'simply' means." That is, enough complexity in a test might render it patentable.

The Report then has a long section on the case law and PTO policy that has ended up with the PTO granting patents on purified and isolated naturally-occurring materials, particularly genes. The Report glosses over the value that patents have provided to society in making hard-to-obtain vitamins and hormones available to patients. The Report goes on to recognize (and approve) that In re Kubin has made it more difficult to patent genes (but manages to skip how In re Fisher effectively delivered millions of pages of Seq IDs and claims to ESTs and SNPs to the recycling bin). The Report ends with the hope that KSR and Kubin revived the "obvious to try" (to clone) standard so that existing patents on genes will be challenged.

While I was sure that the Commission was headed toward a recommendation that patents on isolated genes should be outlawed, after noting that such claims are allowable in one form or another worldwide, the Commission recommended enactment of statutory exemptions from liability for those infringing gene claims by developing and selling tests developed for patient care purposes (but wait, earlier the Commission recommended barring patenting such tests altogether), and enacting an exemption for liability for those using patented genes 'in the pursuit of research" (I thought we already had this exemption under common law - the Commission also misses the legal point that a patented test can be evaluated to see if it works without infringement). The Report closes with a bit of a whimper, by re-endorsing the NIH Best Practices for the Licensing of Genomic Inventions and the "Nine Points to Consider in Licensing University Technology" endorsed by AUTM. Finally, the Report recommends that the PTO establish a scientific advisory committee on genetic testing. "The Committee believes experts in the field could help USPTO in its development of guidelines on determinations of nonobviousness and subject matter eligibility in this field once pending court decisions such a Bilski v. Kappos are decided."

Oddly, my phone remains silent.

Hearings On SACGHS Report

Court Decision in China Recognizes Novelty in Dosage Limitations in Swiss-Form Claims

Peksung Intellectual Property Ltd sent an interesting article (link below) reporting that the Higher People's Court of Beijing held that both dosage form and dosage amount should be treated as limitations in Swiss-form claims. These "administration-related features" are often ignored by examiners in non-US jurisdictions as non-limiting. In issuing this judgment, the Higher Court apparently ignored the SIPO Guidelines for Examination. Although the ruling is non-precedential, it should provide the basis to appeal the rejection of second-generation Swiss-form claims, including claims under reexamination.

Patentability of medical use inventions.pdf