Insights

A Genus-Species Approach for Claiming Pharmaceutical Salts      Many drugs on the market today are formulated with active pharmaceutical ingredients in the form of salts rather than free acids or...

Solid Form Patents as Drug Substance Patents      In the pharmaceutical industry, it is well accepted that composition of matter patents are the most sought after and valuable patents for...

Cocrystals as drug substance not drug product - new opportunities      In 2013, FDA issued a final guidance called the "Regulatory Classification of Pharmaceutical Co-crystals."  In that guidance,...

Pharmaceutical products are typically dosed as solids, liquids (e.g., solutions) or gases. In gases and liquids, the molecules are tumbling; in solids, however, the molecules are essentially frozen...

Claimed inventions in issued patents must, of course, pass the statutorily required hurdles of novelty and non-obviousness. In the context of solid forms, there are particular nuances the...