Ν E»S40FEflltl-EEBffiËËK INTELLECTUAL
PROPERTY
COURT EMPOWERS DRUG RESEARCH Ruling allows royalty-free drug development using patented materials
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N A UNANIMOUS DECISION LAST
week, the Supreme Court gave pharmaceutical and biotechnology companies wide latitude to use each other's patents without paying licensing fees for research related to developing new drugs. T h e decision means that drug companies could save millions in licensing costs when starting res e a r c h on n e w
GOVERNMENT
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compounds. It also means research t h a t might have gone overseas, where patent rules are often less restrictive, will likely remain in the U.S. Writing for the Court Justice Antonin Scalia found that "safeharbor" exemptions of existing law "extend to all uses of patented inventions that are reasonable to the development and submission ofany information under the Federal Food, Drug & Cosmetic Act." The ruling sets aside a lower court decision that ordered Germany's Merck to pay $6.4 million to Integra LifeSciences.
POLICY
HOUSE MAY ASK NIH TO LIMIT PUBCHEM House Appropriations subcommittee addresses NIH's chemical database
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HOUSE A P P R O P R I A T I O N S
subcommittee has added language aimed at the National Institutes of Health's PubChem chemical structure database to a report accompanying the Labor, Health & Human Services (HHS) & Education appropriations bill. PubChem—part of the agency's Roadmap for Medical Research—has raised concern among officials at the American Chemical Society, who argue that the new database replicates the society's existing Chemical Abstracts Service (CAS) Registry (C&EN, June 13, page 23). ACS, which publishes C&EN, is asking N I H 14
C & E N / J U N E 2 0 , 2005
to limit the scope of PubChem to include only compounds derived from research associated with the N I H Roadmap. The subcommittee, chaired by Rep. Ralph Régula (R-Ohio), added the language on how N I H should proceed with PubChem after receiving input from ACS as well as PubChem supporters. The full Appropriations Committee was marking up the HHS-related appropriations bill as C&EN went to press. According to draft language, N I H is asked to reevaluate its database: "The committee is concerned that N I H is replicating scientific information ser-
Merck and its partner Scripps Research Institute used Integra's patented RGB peptide sequence to develop a drug that halts tumor growth. The Supreme Court did not rule specifically on the issues between Merck and Integra and remanded the case to a lower court to allow Integra to argue its position under the Supreme Court's interpretation of the law Integra says the Court's exemption "does not globally embrace all experimental activity that at some point may lead to an FDA approval process" for specific new drug development. It contends that Merck started work with the RGB peptides as part of a basic research program for new drugs. For its part, Merck declares the ruling a "victory" for itself, for patients waiting for better treatments, and for the whole biotech and pharmaceutical industry.— MARC REISCH
vices that already exist in the private sector. In order to properly focus PubChem, the committee urges N I H to work with privatesector providers to avoid unnecessary duplication and competition with private-sector chemical databases." In a statement, ACS noted that it is pleased with the report language. ACS also recognized recent interactions with N I H Director Elias A. Zerhouni. "We appreciate Dr. Zerhouni's personal engagement in this issue and will continue to work diligently with N I H toward a collaborative model and solution that will best serve the scientific community" For its part, N I H said in a statement that it appreciates the House support ofits "ongoing effort to resolve concerns about any potential impact on privately run chemical databases," adding that " N I H continues to work with ACS and is optimistic that we can move forward together to resolve anyissues."-SUSAN MORRISSEY WWW.CEN-0NLINE.ORG
