PATENT DECISIONS
“THE FEDERAL CIRCUIT DECISION WAS BASED ON LONG-STANDING PRECEDENT AND WAS DRIVEN BY ITS GOAL OF ENSURING UNIFORM CLAIM CONSTRUCTION.”
individual polymer molecules that have varying molecular weights. Te meaning of the phrase ‘molecular weight’ was challenged by Sandoz as indefinite under 35 USC 112, paragraph 2, as the molecular weight of a compound can be determined by different approaches.
Tere are different ways to describe the resulting distribution of molecular weight values. One approach uses statistical measures, including the peak average molecular weight (Mp), number average molecular weight (Mn), and weight average molecular weight (Mw).
• Mp is the molecular weight of the most abundant molecule in the sample.
• Mn is the arithmetic mean, or the total mass of all the molecules in the sample divided by the total number of molecules.
• Mw is another average molecular weight measure that is calculated differently from Mp and Mn. In a typical polymer sample, Mp, Mn and Mw have different values.
Applications (ANDAs) to develop and market generic versions of Copaxone.
In response, Teva promptly sued Sandoz for patent
infringement, asserting nine patents
related to the manufacture and formulation of Copaxone. Te asserted patents included seven FDA Orange Book patents, one non-Orange Book patent expiring in May 2014, and one non-Orange Book patent expiring in September 2015.
In assessing whether there was infringement, the district court was required to interpret Teva’s patent claims and decide whether the
24 Life Sciences Intellectual Property Review
claims were sufficiently definite and, if so, what was the meaning and scope of those claims. Of particular interest in the Teva patent claims was the meaning of the phrase ‘molecular weight’.
Weighty matters
Te patents included claims reciting a product called copolymer-1 and claims reciting methods of making copolymer-1. Copolymer-1, in turn, consists of four different amino acids (alanine, glutamic acid, lysine and tyrosine) combined in a certain ratio to make a polypeptide product. A sample of polymeric material such as copolymer-1 typically consists of a mixture of
Volume 2, Issue 1
A third approach describes how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. For example, if 99% of the constituent molecules in a sample have molecular weights between 1 kilodalton (kDa) and 100 kDa, the sample may be described as having 99% of its mole fraction within the molecular weight range of 1 kDa to 100 kDa. Te patents at issue contained an ambiguity with regard to which of the three average molecular weight calculations was intended.
Sandoz argued that as a result of this ambiguity the term ‘molecular weight’ was indefinite—that is, not capable of construction, and that the lack of clarity rendered the claims invalid. Specifically, Sandoz argued that molecular weight can refer to different measures, including Mp, Mw and Mn. Terefore, the scope of
the claims can
vary significantly depending on the measure, according to Sandoz, and a skilled artisan cannot
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