In a previous post, I wrote about a patent infringement suit between Danish biopharm rivals Novozymes and Danisco, which are both active in developing enzymes used in production of biofuels.
In the suit, Novozymes has accused Danisco of infringing U.S. Patent No. 7,713,723 (’723 Patent) by selling alpha amylase enzymes including Danisco’s GC358 product. See the complaint here: novozymes_complaint.pdf.
The ’723 Patent is entitled “Alpha amylase mutants with altered properties” and relates to variants of certain alpha amylases that exhibit altered stability under high temperatures, low pH and other conditions. The patented variants can be used for starch conversion in ethanol production.
Last month Judge Barbara B. Crabb of the U.S. District Court for the Western District of Wisconsin denied Danisco’s motion for summary judgment of invalidity of the ’723 Patent.
In the Opinion (Novozymes-Order), Judge Crabb rejected Danisco’s argument that the patent is invalid for insufficient written description.
A U.S. patent must have an adequate written description to be valid. This means the patent’s specification (which includes the description and figures, but not the claims) must convey to a person skilled in the relevant technical field that the inventor actually invented and “had possession” of the claimed invention.
Danisco argued that the ’723 Patent – directed to a substitution of an amino acid at position 239 in the alpha-amylase protein – was inadequate because the written description lists position 239 as one of 33 possible positions for an “alteration” and lists a substitution as just one possible type of alteration.
According to Danisco, that extensive variability means the ’723 Patent identifies 8.589 x 1042 possibilities for experimentation to arrive at the claimed invention.
Despite “doubts” about the adequacy of the written description, Judge Crabb concluded that Danisco did not meet its burden of proving invalidity as a matter of law.
The opinion notes that Novozymes put forth expert testimony and other evidence sufficient to create an issue of fact as to whether a person of skill in the art would interpret the specification of the ’723 Patent as disclosing that substitutions at each of the 33 positions would lead to improved stability of the alpha amylase.
The decision was a close one for Judge Crabb, who stated in the opinion ”[i]t is not without hesitation that I am denying defendants’ motion.” This will be an interesting case to watch, and one that could go down to the wire.
Eric Lane is a patent attorney at Luce, Forward, Hamilton & Scripps in San Diego and the author of Green Patent Blog. Mr. Lane can be reached at elane@luce.com.