PTO Proposed Rule Could Force Drug Firms To File More Patent Applications
Biotech and pharmaceutical companies may have to spend more time and money to patent their inventions under a new regulation proposed by the Patent and Trademark Office.
The PTO announced in an Aug. 10 Federal Register notice that it plans to revise the way patent applicants claim alternative compounds in their inventions. Under PTO's proposed rule each claim in a patent would be limited to a single invention and applicants who file a claim with alternative language would be encouraged to explain why the claim covers one invention.
"This will disproportionately affect the biotech and pharmaceutical industries because typically this type of alternative claim language is the standard, accepted way their inventions are claimed," said Jessica Wolff, a patent litigator at Heller Ehrman.
Wolff said the revision may ultimately mean a company has to file more applications to cover the same subject matter. And coupled with a proposed rule PTO published last year to limit the filing of continuing applications, she said it may encourage companies to file patents later in the research process.
Stephen Albainy-Jenei, a patent lawyer with Frost Brown Todd and editor of the Patent Baristas blog, said he is concerned that the PTO will require an applicant to state on the record whether the alternative compounds cited in the application are patentably distinct. In such a situation, he said, if prior art is found for one of the compounds then all of them will be knocked out.
If these elements are patentably distinct and a company has to file separate applications for each of them, Albainy-Jenei said the cost of patenting an invention could increase substantially. He noted that it can cost $10,000 to draft a biotech or pharmaceutical application and an additional $10,000 to $15,000 to prosecute it.
The new proposal is the latest effort by the PTO to reduce the burden on patent examiners by placing restrictions on what an inventor can submit to the agency. In January 2006 the patent office published a proposed rule on continuing applications - in which an applicant adds new claims or disclosures to a previous application. The agency also issued a separate proposed rule last year to have examiners initially look at a limited number of claims in an application. The Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America opposed both proposed regulations. The PTO is expected to issue final rules on continuing applications by September.
PTO's latest proposed rule focuses on a claim drafting technique in which a patent applicant cites multiple entities of a group as part of a claim. The patent office officially sanctioned the technique in 1924. Known as "Markush claims," they include the phrase "selected from the group consisting of" followed by a listing of specific equivalent members of the group.
For example, the PTO explained, if a claim to a chemical composition requires a particular alcohol, that alcohol could be defined under Markush language as "an alcohol selected from the group consisting of methanol, ethanol, and isopropanol."
The PTO said applicants sometimes use this format to claim multiple inventions or to recite hundreds, if not thousands, of alternative embodiments of a single invention in one claim.
"A single claim may continue for pages; even relatively short claims may encompass millions of species in the alternative," the agency stated. "Claims that recite alternatives, especially in the chemical and biotechnology arts, often describe alternatives which themselves have multiple, nested points of variation or other complex variations, or set forth alternatives that lack either a shared utility or a common structure."
The agency said its proposed rule is intended to enable patent examiners to process applications more quickly. Under the current procedures, the PTO said, examiners often have to do separate examination and patentability determinations for each alternative within the claim.
"Furthermore, the variety and frequency of alternatives recited in claims filed in applications pending before the office, driven in part by trends in emerging technologies, have exacerbated problems with pendency," the agency stated.
While claims that recite alternatives originated in the chemical arts, the PTO said they are now commonplace in all areas of technology.
PTO specifies that a claim using alternative language is limited to a single invention when "all of the species encompassed by the claim share a substantial feature essential for a community utility or all of the species are prima facie obvious over each other."
The PTO also proposes that if a single claim defines multiple independent and distinct inventions, the examiner may require the invention be restricted to one of the inventions before reviewing the application.
The PTO said it plans to encourage applicants who file a claim with alternative language to explain why the claim is directed at a single invention. If an examiner disagrees with the applicant, the official must explain why the applicant's argument is unconvincing and why the claim is not limited to one invention.
Wolff said it will be difficult for patent applicants to make this statement since it could be used against them in litigation to invalidate the claim or limit the construction or scope of the patent, or to provide a basis for a charge of inequitable conduct.
"Basically, the proposed rule is attempting to shift the burden onto the applicants to show why inventions should be considered not distinct," Wolff said.
The agency is seeking comments on the proposed rule by Oct. 9.
- Brenda Sandburg
This article is reprinted from "The Pink Sheet" – August 20, 2007
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