U.S. Patent Office Revises Guidelines After Drugmakers Complain

by jeeg 17. December 2014 23:55


After months of complaints from the pharmaceutical industry, the U.S. Patent and Trademark Office has issued revised guidelines for its examiners that should make it easier for drug makers and biotechs to obtain patents for their inventions.

In general, the new guidelines take what the agency calls an “integrated approach” for its examiners by addressing all types of claims and what a court might rule is not eligible for a patent.

The initial PTO guidelines were released last March in response to a pair of U.S. Supreme Court rulings that limited the extent to which natural products and processes can be patented by life sciences companies.

In one case involving Myriad Genetics MYGN +2.27% and breast cancer tests, the court ruled that isolated DNA cannot be patented. In the other, the court rejected an argument by Prometheus Laboratories that a test that relies on correlations between drug dosages and treatment are eligible for patents.

The guidelines were designed to help examiners evaluate patents related to natural products, but the effort caused a ruckus because the agency took a stance that industry complained was too restrictive and was prompting examiners to analyze whether an invention was eligible to be patented.

“The guidance went beyond what the Supreme Court was saying in those cases,” says Leanne Rakers, an attorney at the Harness Dickey law firm, who specializes in intellectual property issues.

In public comments, various industry trade groups expressed concerns that too many applications filed by drug makers and biotechs would be rejected. For instance, the Pharmaceutical Research and Manufacturers of America, the trade group for drug makers, wrote in one such letter posted on the PTO web site that “the guidance will add unnecessary uncertainty, cost and burden in their efforts to secure patent protection for new and improved therapies.”

In another comment posted last July, the International Biotechnology Associations wrote on behalf of industry trade groups from a dozen countries, complained that the guidelines “would establish peculiar disincentives for investment in R&D of entire categories of biotechnology.”

“Our member companies are already receiving rejections… for recombinant industrial enzymes, for pharmaceutical formulations having purified naturally-occurring substances as active ingredients, for methods of treatment using medicines molecules, for diagnostic laboratory procedures and other inventions that were neither considered nor discussed in the U.S. Supreme Court’s decisions.”

To what extent the guidelines issued last March resulted in greater rejections may be debatable. But an analysis conducted for the Harness Dickey law firm found that, after the March guidelines were issued, there was a statistically significant increase in the percentage of rejections – from approximately 8% to 13%. Of those, 266, or about 5%, expressly cited the March guidelines as a reason.

In any event, the agency acknowledged the outcry. In a blog post, Peggy Focarino, the USPTO Commissioner for Patents, wrote that “we carefully considered input from the public and our own patent examiners in addressing possible revisions to our guidance stemming from [the] Myriad and Mayo” cases.

In general, the guidelines take what the agency an “integrated approach” for its examiners by addressing all types of claims and what a court might rule is not eligible for a patent. As an example, a combination of two or more materials with different characteristics than what exists in nature may be eligible. This was unlikely to be considered eligible for a patent according to the March guidelines.

“The goal is to provide clarity as well as patent protections for natural-based products that are used by society,” says Rakers. “This new guidance will hopefully make it clearer for life sciences companies to know whether they might get rejected or accepted.”

Ed Silverman, Wall St Journal


Comments are closed
Log in