Nice article by the Patent Doc blog again.
The author, Kevin Noonan, argues (persuasivley for my money) that Myriad should drop its challenge before the Supreme Court as to whether genes should be patentable or not -- for the good of biotech generally. The crux of the argument is as follows:
- The original gene patents are about 30 years old and were meant to protect therapeutic molecules like tPa or EPO. These type of patents are fading fast.
Most new patent applications for genes were filed in or aroudn 2000 as a result of the Human Genome Project and these are limited in several important ways.
- The applicant had to provide a utlity for the genes on the filing date to be patent eligible, not just file on the sequence
- Second, much of the HG sequence was published very soon after its discovery thereby akng it part of the prior art landscape
- Since most of these were filed in the 2000 time frame, they only have life until about 2020. Thus it is a self-liquidating problem if it indeed is a problem to begin with.
Noonan argues that Myriad shoudl drop its case before the Supreme Court. They have other patents to protect their business. Even if they didn't, they have 15 years of business experience and a proprietary database that is more valuable to them than the patents and ensures their market position fo rthis tye of diagnostic testing. Plus, modern methods don't rely on isolation and sequencing of a gene anyway so aren't important. The Myriad gene patent doens't block anyone from doing research in the area either.
Bottom line: there is no compelling legal reason that we need this ruling. And Myriad doesn't have any compelling business reason either. Their other patent suite protects them. So, Noonan argues that Myriad grant the plaintiff, Harry Ostrer a convenant not to sue. This renders the case moot and the Supremes will not hear nor rule on the issue. No ruling on the patent eligibility of isolated DNA from other species (which may have importance in fields like agriculture or biofuels) or other "products of nature" that may provide the basis for biologic and other types of drugs will be protected.
The only reason that Myriad would proceed now woudl be to gratify its own ego. That could cause more damage than its worth. Food for thought.
Posted by Bruce Lehr Jan 25th 2013.