CellPro, a biotechnology company in Seattle, Washington, developed an extraordinary device. (1) Its Ceprate system separates stem cells from blood and enables the reintroduction of healthy stem cells into patients who have undergone debilitating radiation treatment. (2) This device was so effective that it cured CellPro's own CEO, Rick Murdock, of his deadly form of cancer. (3) The Food and Drug Administration (FDA) approved CellPro's Ceprate system for sale in the United States, (4) but it is not on the market. (5)
The Ceprate system is not for sale because the United States District Court for the District of Delaware found that CellPro willfully infringed four patents in the creation of the Ceprate device. (6) Those four patents were initially found to be invalid in a jury trial. (7) However, the district court overturned the jury's decision by granting the patents, assignees and licensees, motion for judgment as a matter of law ("JMOL") using de novo review. (8) After its own de novo claim construction, the district court remanded the case to another jury. (9) That jury trial found CellPro had willfully infringed the patents. (10) That decision was upheld on appeal (11) and as a result CellPro dissolved, along with its Ceprate system. (12) This cancer-curing device was shelved. (13)
Rick Murdock comments on his experience with CellPro, Ceprate, and the district court in his book, Patient Number One. (14) He describes the entire process as "a sham, a kangaroo court ... about as real as pro wrestling." (15) Rightfully upset, Murdock was on the losing side of the case that destroyed the very technology that saved his life. (16) Stem cells continue to help biomedical research gain significant ground in the fight against cancer and other life-threatening diseases. (17) Yet the rush by scientists to patent their discoveries creates tension between open scientific research, and exclusivity and profit protection. This tension is all the more evident when life-saving technology is at stake because it is difficult to morally justify restricting technology that could eradicate debilitating diseases for the sake of exclusive intellectual property rights. Is Murdock right? Was his experience with the justice system a sham? Is the district court's review of jury verdicts too powerful? Maybe Markman (18) has changed the patent review system too much.
The opinion in Markman anticipated the possibility of "certainty in claim construction ... early settlements, reduced litigation costs, and increased judicial efficiency." (19) In practice however, it has had the opposite effect. (20) The Federal Circuit now reverses approximately forty percent of the claim constructions it reviews on appeal. (21) Litigation is not reduced as anticipated, since "[p]arties are much less willing to settle knowing that there exists a forty percent chance that the Federal Circuit will reverse the claim construction and remand the case for trial under a new construction." (22) If reality after Markman is a system fraught with uncertainty and added expense, (23) one cannot help but agree with Murdock. After all, the patent system was created to "promote the progress of science and useful arts" by protecting rights of inventors. (24) Congress created the United States Court of Appeals for the Federal Circuit as a court with exclusive jurisdiction over patent-related appeals. (25) Congress hoped to avoid forum shopping and create certainty in patent cases. (26) Further adding to the confusion is that the United States Constitution protects the right to a trial by jury. (27) Unless Congress takes the Federal Circuit one step further by creating an even more highly-specialized patent court system, a jury should be allowed to continue its fact-finding function in patent claim construction without the threat of de novo review by the Federal Circuit.
II. PATENT PROTECTION AND BIOMEDICAL …