Magazine article Drug Topics

Generic, Brand Firms Battle across Atlantic on Patents

Magazine article Drug Topics

Generic, Brand Firms Battle across Atlantic on Patents

Article excerpt

On both sides of the Atlantic, the generic drug industry is under siege. It has been rebuffed in efforts to gain a place on an international advisory committee where brandname companies discuss pharmaceutical patent and trade issues with U.S. and European government officials.

On Capitol Hill, a new plan is being floated by the innovator firms to pay the federal government a 3% royalty on certain drugs, commit themselves to additional research, and receive a guarantee of 10 years without generic competition. The generic industry also expects there will be attempts to slip through patent extensions for a handful of brand-name drugs before Congress adjourns. In addition, legislation that would overhaul the Food & Drug Administration could for the first time grant exclusivity to new antibiotics.

"There's a big strategy here to attack the generic industry, to go after additional patent time," Robert Milanese, president of the National Association of Pharmaceutical Manufacturers, maintained. Milanese, who represents one of three generic trade associations, said that "by cleverly attacking the patent issue, by challenging generics at every step along the way," the brand-name industry frequently succeeds in keeping monopolies even after patents expire.

Patents are not the only monopoly vexing the generic industry; the composition of an obscure panel known as the Transatlantic Business Dialogue is, too. Initiated by the Commerce Department and the European Union, TABD consists of U.S. and European industry and government officials. Its purpose is to recommend ways to lower traditional trade barriers and create a "New Transatlantic Marketplace" based on a regulatory principle of "approved once, accepted everywhere."

The pharmaceutical subcommittee last November urged repeal of the Bolar Amendment, a U.S. law considered by foes and friends to be the cornerstone of the generic industry. In addition, the subcommittee recommended that European governments not enact anything similar. The amendment overturned a court decision and allowed generic firms to begin research and development on a brand-name product well before the end of its patent life. Advance approval can be sought from the FDA so that a generic can be shipped to pharmacies on the day the patent expires.

"Any modification or repeal of the Bolar Amendment, as contemplated by the TABD, would not only have a devastating effect on the U.S. generic pharmaceutical industry but would also deprive the American people and the U.S. government of the fiscal benefit of pharmaceutical competition during the de facto extended patent protection period," said Chris Sizemore, executive director of the National Pharmaceutical Alliance. Sizemore last month urged the FDA to garner generic industry representation on TABD or refrain from participation.

But later, the European and U.S. generic Rx makers received word not to pack their bags for the next TABD meeting. Greg Perry, executive director of the European Generic Medicines Association, said he had been "informed by TABD's EU coordinator that a specific decision had been taken not to allow representatives from the generic pharmaceutical industry to participate in any Issue Group or to be invited to the TABD meeting in Rome."

Perry demanded that "any statements made by the TABD in relation to either pharmaceutical or patent issues should be ignored by the EC Commission and its American counterpart, as they have been discussed and formulated behind closed doors and with the active prevention of any participation from interests with a different view. …

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