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Forget the political opposition to gene patenting. The biggest threat to the biotech industry may be from the PTO itself.

By Thomas J. Kowalski

Strategic Insights 
· Genes & Liens 
· After the Gene Rush
· Patently More Difficult
· Navigating Gene Patent Minefields
· Are Gene Patents in the Public Interest?
Nov. 12, 2002 | Many patent applications for nucleic acid molecules involve claims to the gene itself, probes, or primers for isolating the gene. Or they may involve products encoded by the gene (such as proteins), as well as uses of the gene, the probes or primers, and the proteins. Often these claims are subject to "restriction" — the U.S. Patent and Trademark Office (PTO) requires that each type of claim involving one or more inventions be pursued on additional applications. These "continuation" or "divisional" patent applications reference the earlier applications.

Furthermore, patent examiners don't usually grant the breadth sought by the applicant as to each of these types of claims. So patent applicants have developed the practice of "baby steps" — accepting narrower claims that the examiner will allow in a first application, and then refiling a continuation application on broader subject matter. This results in the patent applicant having one or more patents, which, while varying in scope, may be claiming obvious variants of each other.

Thus one discovery — a gene, the protein it expresses, and the uses for them — can give rise to many patents.

The law allows this "baby-steps" approach, and so far the costs to patent applicants for using this strategy have been manageable. But the PTO has recently proposed new, higher fees for patent services, which, if approved by Congress, would significantly raise the costs of patent application and maintenance. These higher fees would in effect penalize patent applicants for filing continuation or divisional applications, particularly for independent claims. The fees would increase exponentially — literally — for each independent claim.

To illustrate how substantial the costs may be under the PTO's proposed exponential fee calculation system, consider the following examples:

  1. The proposed filing fee for an application — under 50 pages — having three independent claims and 47 dependent claims would be over $15,000 (currently the fee for the same application is about $5,200), with that proposed fee rising to over $70,000 for an application under 50 pages having 20 independent claims. The cost would skyrocket to more than $58 million for an application under 50 pages having 50 independent claims.
  2. The proposed "transitional fee" for an obviousness-type double-patenting rejection (which can arise from the baby-steps approach) with regard to one other pending application or patent is $10,680. That fee would rise to $13,350 when the rejection involves two other pending applications or patents, and to $16,690 when three other pending applications or patents are rejected.
  3. The proposed transitional fee for an application that contains a reference to three earlier filed applications (such as a series of continuations) is $1,000; this rises to $2,000 when the reference is to four earlier filed applications; to $4,000 when five earlier filed applications are referenced; and to $8,000 for six.

The PTO is striking back at the baby-steps method of applying for patents, sparking significant opposition. Opponents argue that the PTO's proposed fees fail to appreciate how a single discovery, such as a gene, the protein encoded by the gene, and uses thereof, can give rise to many patents. There are several legitimate reasons for this multiple-patent effect, including the written-description and enablement requirements of the patent statute, the realities of dealing with the PTO, and business strategy.

Biotech companies and organizations should closely watch how Congress addresses the PTO's proposals. Higher fees are likely to inhibit the willingness and ability of applicants to seek the broadest protection possible for inventions. Indeed, the new fee structure may well stymie the preparation and filing of patent applications arising from gene discoveries.

In a nutshell, if Congress approves the fees proposed by the PTO (a definitive ruling was still pending at press time), then our elected representatives will be living up to the old adage, "If the opposite of pro is con, then the opposite of progress is Congress!"

Back to Navigating Gene Patent Minefields 

Thomas J. Kowalski is a partner in the national intellectual property law firm of Frommer Lawrence & Haug LLP in New York. He may be reached at tkowalski@flhlaw.com. 





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