Upjohn, J&J to pay P&G 7% of Motrin IB Sinus, Sine-Aid IB sales under jury decision.

MCNEIL, UPJOHN ORDERED TO PAY RICH-VICKS 7% ROYALTIES on "infringing sales" of Motrin IB Sinus and Sine-Aid IB under a May 10 decision resolving a patent infringement suit filed by Procter & Gamble's Richardson-Vicks unit Dec. 1, 1993. The jury found that Rich-Vicks' patent for "cough-cold mixtures comprising nonsteroidal anti-inflammatory drugs" containing 200 mg ibuprofen and 30 mg pseudoephedrine is valid and enforceable, and decided that Rich-Vicks is entitled to "a reasonable royalty rate" of 7% of the infringing products' sales from Dec. 1, 1993 to the present.

The amount of damages reportedly is $400,000 for both companies combined. The jury trial in the U.S. District Court for the District of Delaware began April 3.

Judge Sue Robinson has not yet ruled on Rich-Vicks' request for a permanent injunction that would prevent the sale of Sine-Aid IB and Motrin IB Sinus. A ruling is expected in the next few weeks.

Upjohn said it is appealing the case, and declared that Rich-Vicks' patent is "invalid" because "the benefits of using pain relievers with decongestants are obvious to all." Upjohn said it had attempted to arrange a licensing agreement with Rich-Vicks to settle the suit several times before the trial, but the attempts were fruitless. The cost of damages will not be a setback to the bottom line, Upjohn maintained, adding that the "young" product is not one of its top sellers.

McNeil commented that it is "disappointed" with the decision and is "evaluating" its options. Regarding a possible discontinuance of Sine-Aid IB, the firm said the product is "tiny" with "insignificant" sales.

Rich-Vicks had charged Upjohn and Johnson & Johnson's McNeil subsidiary with infringing U.S. Patent No. 4,552,899, which was filed in April 1984, and Re-examination Certificate No. B1-4,552,899 dated Oct. 20, 1992. The plaintiff had asserted that the infringement was willful and deliberate, entitling Rich-Vicks to treble damages and attorneys' fees. The judge decided that the infringement was not willful and thus Rich-Vicks was not awarded the additional damages.

The defendants had denied liability and counterclaimed for a declaratory judgment that the patent is "invalid, not infringed, and that intervening rights bar recovery." After a Feb. 27 hearing, the court denied an Upjohn and McNeil motion for summary judgment on the grounds that "the asserted claims of the patent are invalid because of prior work of doctors" and based on a previous invention by American Home Products.

The defendants had claimed that doctors generally knew that the combination of ibuprofen and pseudoephedrine at the dosage ranges in question were a useful treatment for colds and sinus headaches. Upjohn and McNeil maintained that doctors instructed their patients to take the two drugs in combination for colds and sinus headaches.

Rich-Vicks responded that the cases in which doctors prescribed the drugs in the specific ratios cited in the suit were accidental, and that some doctors did not favor the combination of the drugs in a single pill because they like having the freedom to tailor the doses to their specific patients. Rich-Vicks also alleged that some doctors did not believe the combination was beneficial because ibuprofen is known to cause congestion.

In the memorandum opinion denying the defendants' motion for summary judgment, the judge found that evidence submitted by Upjohn and McNeil would not permit the jury to find that the ibuprofen/pseudoephedrine combination be referred to as a "combinatory immixture" since the ingredients were in separate pills. "Because the court has interpreted `combinatory immixture' to exclude the two ingredients in separate pills, the court finds the prior work of the doctors does not render claims 36, 37, 47, and 48 of the `899 patent invalid," the document states.

The jury said "no" in response to the question "Do you find that defendants Upjohn and McNeil have proven by clear and convincing evidence that any of the claims 36, 37, 47, and 48 of plaintiff Richardson-Vicks' B1 `899 patent is invalid because the differences between the subject matter of the claims and the prior art as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made."

The argument centering around the American Home Products invention, which also did not yield a summary judgment for the defendants, was based on the allegation that AHP had a prior invention of the claimed compositions and methods.

Upjohn and McNeil had said that AHP conceived of the subject of the invention as early as October 1983 -- before Rich-Vicks filed its patent -- and was considering extending its Advil line with a product containing ibuprofen and a decongestant such as pseudoephedrine. The defendants further stated that AHP used the invention prior to the April 1984 filing date of the Rich-Vicks patent through December 1985, when clinical trials on the product were completed. AHP submitted an NDA to FDA for the product, which was approved in September 1989, and introduced CoAdvil and Dristan Sinus shortly afterward.

Rich-Vicks contended that one of the inventors listed in its patent conceived of the invention as early as May 3, 1983, prior to AHP's claimed conception date. Furthermore, Rich-Vicks argued, even if that inventor was not the first to invent the product, he was the first to reduce it to practice. Rich-Vicks added that AHP must have abandoned, suppressed or concealed the invention.

The jury answered "no" in response to the question: "Do you find that defendants Upjohn and McNeil have proven by clear and convincing evidence that American Home Products was the first to invent the subject matter of claims 36, 37, 47, and 48 of the B1 `899 patent and did not suppress or conceal the invention." The jury also decided that AHP reduced its invention to practice in August 1985 and did suppress or conceal the invention.

The jury also decided that Upjohn and McNeil failed to prove that Rich-Vicks "impermissibly broadened the physical and temporal scope" of the patent "with anti-competitive effect." Upjohn filed the counterclaim against Rich-Vicks Jan. 24, 1994.