Pill splitting raises issues of safety and patent coverage; cases upholding single-use limitations might prevent dividing doses, either by commercial outfits or by individuals

Article Abstract:

Safety and patent coverage issues raised by pill splitting are discussed, as is the single-use restriction which may restrain the many health maintenance organizations using this practice because it would make the pill splitters guilty of direct infringement. The Federal Circuit has approved the single-use restriction for medical devices, but courts have yet to rule on such a restriction for drugs.

Pharmaceutical industry, Dosage and administration, Drug administration and dosage

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Clinical trials may bar drug's patent protection; courts rely on a variety of policy factors to determine if such testing is 'public use.'(Pharmaceuticals)

Article Abstract:

Issues are discussed regarding the different policy factors used by the courts to determine if the use of drugs in clinical trials qualifies as public use such as to make the drugs worthy of patent protection. Patentability will not be jeopardized if the patent application is filed before beginning the clinical trial.

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Split trials skirt privilege dilemma; accused infringers can avert harsh choice between privilege waiver and negative inference

Article Abstract:

Reasons for the trend to order bifurcation in Abbreviated New Drug Application (ANDA) cases is discussed. In ANDA cases evidentiary overlap between liability and wilfulness issues is unlikely and bifurcation also discourages potential prejudice.

Generic Drugs, Confidential communications, Attorney-client privilege, Drug approval

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