WASHINGTON _ The U.S. Patent and Trademark Office (PTO)will release a new draft examining guidelines for biotechnologypatents today in an effort to clarify its standards for the "practicalutility" of biotechnology inventions.

The new guidelines will instruct examiners to accept anyscientifically plausible evidence, including in vitro and animal data,in support of claims of utility in humans for biotechnology products.

In recent years, the PTO biotechnology patent examiners haveincreasingly required human clinical trial data in support of utilityclaims, an evidentiary threshold that is higher than U.S. patent lawdictates, according to experts. Industry representatives, patentattorneys and the Biotechnology Trade Organization (BIO)persuaded PTO Commissioner and Assistant Secretary of CommerceBruce Lehman that the practice was unfair and unwarranted during a12-hour hearing in San Diego last October.

Under the new guidelines, "if an applicant presents a scientificallyplausible use for the claimed invention, it will be sufficient to satisfythe utility requirement," explained Lehman. "We will not imposeunrealistic and unattainable evidentiary requirements, like successfulhuman clinical trials, on patent applicants." The PTO will acceptpublic comment on the draft guidelines through Feb. 24, 1995 andexpects to finalize the guidelines sometime in early March.

Lehman also said that, once implemented, the new guidelines willinsure that if a utility rejection is appropriate, it will be made andreviewed according to "consistent and correct legal standards." Thenew guidelines will be accompanied by a new training program forPTO patent examiners and their supervisors and the appointment ofat least two "biotechnology practice specialists" and one qualityassurance expert to review biotechnology patent applications.

A total of more than 40 attorneys, biotechnology CEOs, venturecapitalists, academic researchers and patient advocacy groupstestified on a range of patent issues during the October meeting inSan Diego. In addition, BIO presented Lehman with a 224-pagereport covering the gamut of intellectual property protection issuesas they relate to the biotechnology industry.

BIO, which has pushed for a change in policy on the utility standardsince early this year, praised Lehman for acting swiftly andforcefully on the issue. "This administration and this commissionerhave demonstrated, in real terms, their understanding of theproblems that an entrepreneurial industry faces," said ChuckLudlam, BIO's vice president of government relations.

Patentable inventions must meet three main criteria:operability/enablement (i.e., the application must adequately teachhow to make and use the invention), non-obviousness, and practicalutility. According to attorney Lisa Raines, vice president ofgovernment relations at Genzyme Corp., the utility requirement hastraditionally been "the easiest to meet."

Examiners Adopted Onerous Stance

However, the 170 biotechnology patent examiners at the PTO (55percent of whom hold PhDs) have apparently grown increasinglyskeptical in recent years of claims of human utility. Group 1800, asthey are known within the PTO, has thus evolved toward adopting arigorous and, to industry, onerous stance on biotechnology patents.Even the National Institutes of Health, which seeks patents forcountless biomedical inventions each year, has complained to thePTO about its utility standards.

"They were making the patent office into a second FDA," Rainestold BioWorld. "All that a patent application must do is to showevidence that the invention could work. Leave it up to the FDA andthe marketplace to decide whether it does work."

According to the BIO report, case law in the field clearly establishesa low evidentiary threshold for meeting the utility requirement.Although legal standards established by the federal courts governingutility (35 U.S. Code Section 101) are clear, the report asserts thatthe PTO has misapplied the law.

Stephen Bent, chair of the biotechnology practice group at theWashington law offices of Foley & Lardner, told BioWorld that hisfirm's clients _ which include between 120 and 150 biotechnologycompanies _ view the PTO's practice of demanding clinical trialdata in support of utility as a major obstacle to doing business."When the prospects for your patent portfolio are thrown intodisarray and confusion, it hampers your ability to develop a businessplan," said Bent.

Examiners Will Have To Buy In

Changing the attitudes and practices of biotechnology patentexaminers may not be a simple matter of publishing guidelines in theFederal Register, Bent cautioned. "Examiners will have to buy intothese guidelines before it means anything," he noted. "Trying toimplement change in a large bureaucracy is always an up-hill battle."

Another challenge facing the PTO may be budgetary in nature.Although the office receives no federal funding per se _ it subsistsentirely upon the fees it collects from applicants _ it may still besubject to head count reductions as mandated by Congress. Inaddition, Congress actually withholds money that the PTO hascollected each year (it held onto about $30 million last year, forexample), making budgeting a tricky task.

Bent worries that the PTO reform and training initiatives could losesteam without money. "The PTO has only static resources to throwinto this fray," he said. Group 1800 currently reviews between12,000 to 15,000 patent applications per year.

To further complicate the scenario, the General Agreement on Tariffand Trade (GATT) will force the PTO to decrease its averagependency period (the amount of time a patent application ispending). Starting on June 8, 1995, patents will be good for 20 yearsafter the filing date (with some complicated exceptions due to"grandfathering" clauses), rather than 17 years after the issuancedate, as U.S. practice has always had it. As a result, the PTO will beunder intense pressure to issue patents in a timely fashion.

"The pressure on examiners generally, and on biotechnologyexaminers particularly, will ramp up considerably under GATT,"said Bent. "After June 8, everybody's ox gets gored by delays in thepatent process. On one hand, the PTO has budget-cutters potentiallyslicing their staff, while on the other hand, they face new demandsfor faster turn-around time. There's bound to be some kind ofcrunch." n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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