Here's yet another write up of the Celebrex patent decision, this time from the Boston Globe. I included it because it references the analogous cases filed by Pfizer and Ariad:
RULING HITS WIDE BIOTECH PATENT RIGHTS
Author(s): Naomi Aoki, Globe Staff Date: March 6, 2003 Page: E1 Section: Business
A federal judge yesterday ruled that a patent laying claim to drugs blocking an enzyme known as Cox-2 involved in pain and inflammation is invalid, dismissing the University of Rochester's lawsuit against Pharmacia Corp. and Pfizer Inc. over their arthritis drug Celebrex.
The decision questions the validity of a growing number of similarly broad patents that cover methods of treating disease by regulating a gene, protein or biological pathway. At stake is billions of dollars for makers of blockbusters like Celebrex and universities and rivals asserting rights to a portion of those profits. In an opinion issued yesterday, US District Judge David G. Larimer wrote that the University of Rochester patent outlines "a wish or plan or a first step" for discovering a drug that selectively inhibits Cox-2 with the aim of treating inflammation. But, he wrote, it does not give enough information to enable another researcher to achieve that aim, a requirement of patent law.
"The decision strikes at the core of basic research," said Gerald P. Dodson, the attorney representing the University of Rochester. "It's the universities who do basic research that identify methods of treatment. From our viewpoint, this patent provides a blueprint."
Dodson said the university will appeal the decision.
In June, Cambridge's Ariad Pharmaceuticals Inc. filed a similar suit against Eli Lilly & Co., alleging that two of the pharmaceutical giant's drugs infringe its patent covering a way of treating disease by regulating a family of molecules known as NF-kB. Analysts predict the drugs, Lilly's osteoporosis medication Evista and its sepsis therapy Xigris, will reach $1 billion in annual sales. A judge is considering a motion to dismiss the case.
In October, New York-based Pfizer won a patent covering impotence treatments that block the action of an enzyme known as PDE5, the biological mechanism by which its top-selling Viagra works. On the day it received the patent, Pfizer filed suits against Bayer AG and its partner Glaxo SmithKline and Icos Corp. and its partner Eli Lilly to block the rivals from bringing to market impotence treatments that work much like Viagra.
Such sweeping claims are becoming increasingly common in the pharmaceutical field, but attorneys say they raise some nettlesome issues. Patents are meant to spur scientific advance by making public key discoveries. But if a party can lay claim to a significant piece of the biological landscape and any drug that treads upon it without actually discovering a drug, some question whether society loses more than it gains.
The law allows anyone who invents or discovers "a new and useful process, machine, manufacture, or composition of matter" to get a patent. The discovery can not be obvious to those who are trained in the field, and it must be sufficiently detailed as to allow others schooled in that field to reconstruct the invention.
Describing the importance of blocking a biological cascade of events in treating disease and methods of doing so in lab experiments is a major scientific contribution. But defendants in these cases claim it is a far cry from discovering and developing a drug that acts on the biological pathway to effectively treat disease. Legal scholars are split on whether the discovery is sufficient to merit a patent that lays claim to any treatment acting on the pathway.
Dodson argues that the patents protect the basic research done primarily by universities. Once a scientist shows that blocking a certain protein is useful in treating a disease, drug makers need only screen their libraries of compounds to identify a potentially lucrative drug. Without these patents, universities would reap none of the rewards while industry would stand to gain millions, potentially even billions of dollars.
Medically, the implications could be vast. A single pathway may be involved in a number of diseases, and a patent on it could be used to block research that could result in a variety of treatments. Even if the patent holder didn't aim to block competition, some fear the very existence of such patents would discourage others from working on the pathway out of fear of litigation. And since the way many drugs work remains a mystery, there is no guarantee that drugs on the market aren't already doing what is covered by a newly issued patent.
"If it becomes clear that the method covered by the patent was already in practice, then the patent becomes invalid," said Kathleen Madden Williams, cochairwoman of the patent practice at Palmer & Dodge LLP. "So these patents have the potential to be tremendously valuable, but they live under a cloud."
Naomi Aoki can be reached at naoki@globe.com. |
