Biotech Values

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From the FDA law blog: 2 interesting items, Dew

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House Passes Patent Settlement Legislation as Part of the War Funding Bill

Posted: 02 Jul 2010 01:45 AM PDT

By Kurt R. Karst –

Late Thursday, the U.S. House of Representatives passed a package of amendments (beginning on page 74) to the War Funding Bill (H.R. 4899) that included the “Preserve Access to Affordable Generics Act,” which is intended to curb patent settlement agreements (what opponents call “pay-for-delay” agreements). The amendment appears to be identical to an amendment Senators Herb Kohl (D-WI), Charles Grassley (R-IA), and Susan Collins (R-ME) introduced during the Senate’s consideration of the Tax Extenders Act (H.R. 4213) (see our previous post here).

The bill, which will have to be passed by the Senate, would amend the Federal Trade Commission (“FTC”) Act to permit the FTC to “initiate a proceeding to enforce the provisions of [new Sec. 28] against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product.” Such agreements, if challenged, would be presumptively anticompetitive and unlawful unless it can be demonstrated “by clear and convincing evidence that the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement.” In addition, “[e]ach person, partnership or corporation that violates or assists in the violation of [new Sec. 28] shall forfeit and pay to the United States a civil penalty of not more than 3 times the gross revenue of the NDA holder from sales of the drug product that is the subject of the patent infringement claim for the period of the violation, starting with the date of the agreement.”

The amendment was included in H.R. 4899 over the objection of some legislator who urged in a June 30, 2010 letter to House Appropriations Committee Chairman David Obey (D-WI) that the provision be eliminated. According to those legislators:

From a substantive standpoint, the legislative language will achieve exactly the opposite of its intent. The two primary provisions of the legislative language will, in concert, remove current incentives for generic drug companies to challenge drug patents. Consequently, generic drug companies will wait until new drug patents expire before they bring a generic product to market. Consumers will then wait, on average, 5 to 9 years for access to cheaper generic medicines and consumer benefit will arguably be diminished.

According to a Dow Jones report, the measure was strongly backed by both House Speaker Nancy Pelosi (D-CA) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA).

Supreme Court Decision on Bioengineered Alfalfa Stirs Action on the Hill

Posted: 01 Jul 2010 09:41 PM PDT

By Ricardo Carvajal –

The Supreme Court overturned a district court decision, affirmed by the 9th Circuit Court of Appeals, that enjoined the USDA Animal and Plant Health Inspection Service ("APHIS") from partially deregulating Roundup Ready Alfalfa ("RRA") and prohibited the planting of RRA until APHIIS completes an Environmental Impact Statement ("EIS") as required under the National Environmental Policy Act ("NEPA"). RRA is subject to regulation as a plant pest under the Plant Protection Act until APHIS decides that RRA does not present a plant pest risk and can be “deregulated.” To do so, APHIS is required under NEPA to prepare an EIS unless a less burdensome environmental assessment ("EA") reveals that deregulation would have no significant environmental impact.

APHIS’s decision to deregulate RRA on the basis of an EA was challenged by conventional alfalfa seed farms and some environmental groups on the ground that the EA did not adequately address the risks of gene transfer from RRA to conventional and organic alfalfa, or from RRA to weedy species, and that APHIS violated NEPA when it failed to conduct an EIS. The district court agreed and the Court of Appeals agreed. The Supreme Court did not address the merits of these issues, nor did it disturb the district court’s decision to vacate AHPIS’s deregulation of RRA. Rather, the Supreme Court held that the district court abused its discretion in the remedies that it crafted for APHIS’s violation, and remanded the case to the district court for further proceedings which could yet result in a complete or partial deregulation of RRA.

Although the fate of RRA remains uncertain, the Supreme Court decision stirred action on the Hill, where several bills that address different aspects of the controversy over development, marketing, and labeling of bioengineered foods were immediately introduced (H.R. 5577, The Genetically Engineered Food Right to Know Act; H.R. 5578, the Genetically Engineered Safety Act; and H.R. 5579, the Genetically Engineered Technology Farmer Protection Act.

The legal jousting over bioengineered crops is certain to intensify as developers seek to market and perhaps deregulate varieties that are bioengineered to produce substances used in the chemical and pharmaceutical industries. Those technological developments promise to accentuate the fault lines that have emerged between the biotechnology sector and those who seek to satisfy market demand for conventional and organic foods.

As for the FDA, this case serves as a reminder that NEPA, although perhaps a paper tiger, is not entirely toothless. Transgenic salmon, anyone?<<<