Category Archives Issue 445

The Federal Circuit Court of Appeals, in a divided ruling, has determined that Wrigley’s 2000 patent for menthol chewing gum was invalid because prior patents made Wrigley’s claimed invention obvious; thus, the court determined that Cadbury did not infringe Wrigley’s patent when it reformulated its chewing gum to include the compound claimed in Wrigley’s patent. Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, Nos. 2011-1140, -1150 (Fed. Cir., decided June 22, 2012). The court also determined that Wrigley did not infringe Cadbury’s 1989 patent for menthol chewing gum because the compound used by Wrigley is not the equivalent of the compound described in Cadbury’s patent. A dissenting judge argued that the majority applied the incorrect legal standard and improperly shifted the burden of proving the validity of Wrigley’s patent to Wrigley and erred in how it assessed the evidence of commercial success and copying by others in its determination…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) is seeking public comments on its proposal to establish a Proposition 65 maximum allowable dose level for sulfur dioxide of 220 micrograms per day. Comments should be submitted by August 20, 2012. Requests for a public hearing must be made no later than August 6. Sulfur dioxide preserves the color and flavor of dried, light-colored fruits, such as golden raisins and dried apricots, peaches, apples, pineapple, papaya, and mango, and acts as an antimicrobial agent. According to OEHHA’s draft interpretive guideline, a warning for exposure to sulfur dioxide from consumption of dried fruit is not required under Proposition 65 because reasonably anticipated rates of exposure “will be below the proposed Maximum Allowable Dose Level.” Sulfur dioxide was added to the list of chemicals known to the state to cause reproductive toxicity in July 2011; the particular type of toxicity found was…

After two years of deliberation, the Food Safety and Standards Authority of India (FSSAI) has reportedly agreed to issue draft regulations that would require energy drink manufacturers to rebrand their products as “caffeinated beverages.” Based on the findings of an expert panel convened to study caffeine and energy drink consumption in India, the draft regulations would apparently set an upper caffeine limit of 320 milligrams per liter or 320 parts per million (ppm) in caffeinated beverages, as well as prohibit any nutritive claims and the use of the word “energy” as a descriptor. FSSAI has also proposed that all energy drinks bear safety labels warning that such products (i) are “not recommended for children, pregnant or lactating women, persons sensitive to caffeine and sportspersons,” (ii) should not be consumed in excess of two cans per day, and (iii) contain a “high caffeine content.” “We had been considering the standards for…

The European Commission has apparently sent “a reasoned opinion” to 10 member states “that have failed to correctly implement Directive 1994/74EC which introduces a ban on the use of un-enriched cages for laying hens,” according to a June 21, 2012, EU press release. The Commission has given Belgium, Greece, Spain, France, Italy, Cyprus, Hungary, the Netherlands, Poland, and Portugal two months to ensure compliance with the directive before referral to the EU Court of Justice. These countries apparently still permit the use of “un-enriched cages” for laying hens “despite the ban which came into force in January 2012 for which they have had 12 years to prepare.” Under the directive, “all laying hens must be kept in ‘enriched cages’ with extra space to nest, scratch and roost,” or in systems with at least 750 square centimeters of cage area as well as “a nest-box, litter, perches and claw-shortening devices, allowing…

The Council of the European Union has issued a “One Health” perspective document recognizing that antimicrobial resistance (AMR) “is accelerated by excessive and inappropriate use of antimicrobial agents” and asking member states to “develop and implement national strategies or action plans for countering AMR.” According to the perspective document, which underlined the need for “an active holistic approach” to combating AMR, “some practices in human and in animal healthcare including the possible incentives deriving from the prescription and subsequent sale of antimicrobial agents may lead to inappropriate use and overuse of antimicrobial agents.” In particular, the Council has advocated restrictions on both the human and veterinary use of critically important microbials (CIAs) and newly developed microbials “with the aim in the future to reserve CIAs as much as possible for human use.” To this end, the Council has requested that member states curb the prophylactic use of all antimicrobials while…

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