Apotex USA, Inc. v. Merck & Co., Inc

Brief Fact Summary.

Apotex (Plaintiff) sued Merck (Defendant) claiming infringement of its patent.  Defendant argued they had invented the product in this case before Plaintiff did, and Plaintiff’s patent was therefore invalid.

Synopsis of Rule of Law.

A patent will not be valid if another party invents the product at issue within the United States before the patent holder and if that party does not abandon, suppress, or hide the invention.

Facts.

Plaintiff has two patents that related to a process for making enalapril sodium, which is used to treat high blood pressure.  Defendant has manufactured and sold enalapril sodium under the trademark Vasotec since 1983.  Defendant owns patents that cover the enalapril sodium compound but does not own a patent covering its manufacturing process.  Defendant disclosed the ingredients it used in its manufacturing of Vasotec in a Canadian product monograph in 1992, of which 30,000 copies were distributed.  Defendant also disclosed the ingredients used in manufacturing its enalapril sodium product in a French dictionary which was sold in various foreign countries.  Defendant sued Plaintiff in 1991 in Canada for infringement of Defendant’s patent covering the enalapril sodium compound.  A demonstration of Defendant’s process of manufacturing Vasotec was performed during the trial.  Within days, one of Plaintiff’s employees had the idea for the patented product at issue.  Plaintiff then sued Defendant claiming that Defendant infringed on its patents for enalapril sodium.  Defendant claimed that the patents were invalid.  Cross-motions for summary judgment were filed.  Plaintiff’s motion for summary judgment on infringement was granted by the district court, and so was Defendant’s motion for summary judgment that the patent was invalid.  Plaintiff appealed.

Issue.

Are the patents invalid because Defendant (1) invented the enalapril sodium process within the United States before Plaintiff and (2) did not abandon, suppress, or hide that invention?

Held.

(Lourie, J.)  Yes.  The patents are invalid because the enalapril sodium process was invented by Defendant within the United States before Plaintiff, and the invention was not abandoned, suppressed, or hidden.  It is agreed that Defendant invented the process before Plaintiff and that Defendant did not abandon its process of manufacturing Vasotec.  Defendant also did not hide or suppress the process.  This case involves a type of alleged concealment which is a legal inference of suppression or concealment claiming an unreasonable delay in filing a patent application.  Without a satisfactory explanation for the delay, a prior invention will be found suppressed or concealed if steps are not taken to make the invention publicly known within a reasonable amount of time after completion.  Congress did make it clear that the product had to be made in the United States, but the statutory language and legislative history does not require that suppression or concealment occur in this country.  In addition, since Defendant has established priority of invention, the burden is on Plaintiff to produce evidence showing that Defendant suppressed or concealed the invention.  Defendant then bears the ultimate burden of persuasion and must disprove any alleged suppression or concealment with clear and convincing evidence to the contrary.  In this case, Plaintiff has produced enough evidence to create a genuine issue of material fact as to whether Defendant suppressed or concealed its process of manufacturing enalapril sodium tablets.  Defendant failed to make its invention publicly known.  Defendant perfected its process and began to use the process commercially to manufacture Vasotec no later than 1983 but did not make the invention publicly known until 1988 when it published the ingredients in the French dictionary.  A delay of five years suggests that Defendant suppressed or concealed its invention.  To disprove that inference, Defendant showed clear and convincing evidence that it resumed activity and made the benefits of the invention known to the public before Plaintiff’s entry into the field, and therefore Defendant did not suppress or conceal the invention.  Following the period of suppression or concealment, Defendant made the invention publicly known before Plaintiff entered the field in 1994 by Defendant’s disclosures in the French dictionary, monographs, and trial testimony.  In addition, statements by the Plaintiff’s own employee in his deposition for the case and the employee’s statement of facts in the Canadian trial regarding the composition of the Vasotec tablets and the starting ingredients, along with various disclosures by Plaintiff, prove that Defendant made its invention publicly known.  Affirmed.

Discussion.

Diligence does not play a role in determining suppression or concealment.