Author Archives: Dr. Michael Wosnick

Elated Over US Supreme Court Decision Barring Human Gene Patenting? Umm…Not So Fast

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dnaTwo months ago, in these pages, I wrote an article entitled “Patent my jeans, NOT my genes”. This was written on the eve of the United States Supreme Court hearings about whether human genes should be entitled to patent protection. Despite being a holder of United States patents related to human genes myself, I was then, and remain today adamant that this practice is wrong and should be discontinued.

Yesterday, in a much anticipated ruling, the United States Supreme Court published its decision.

I was out and about all day yesterday so I missed the announcements about this decision. I became aware of the ruling late in the evening, and based on a couple of the initial news reports that I read I was thoroughly elated at the decision. This one, for example, entitled “Supreme Court rules human genes may not be patented” in the New York Times was typical of the initial reports. Although it is actually a balanced report, as befitting the New York Times, the tone of the headline and the text of the first paragraph had me, and no doubt others, drawing a more positive conclusion than perhaps was warranted by the actual ruling.

The first paragraph of the story reads:

“Human genes may not be patented, the Supreme Court ruled unanimously on Thursday. The decision is likely to reduce the cost of genetic testing for some health risks, and it may discourage investment in some forms of genetic research.”

Citing Justice Clarence Thomas who wrote for the Court:

“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

This would lead the reader to assume that the patenting of all human genes has now been struck down by the Supreme Court.

In fact, I was so happy about this decision, that I quickly e-mailed some friends and former colleagues about this, Tweeted about it, and I even posted on my Cancer Research 101 Facebook page how this landmark ruling took even me by surprise, by being a 9-0 unanimous decision. Even I was surprised at the unequivocal nature of the ruling (or so I then thought).

As often happens, things look a little bit different in the morning. I had the chance to read a bit more about this decision, and I went to the actual Supreme Court website and read the ASSOCIATION FOR MOLECULAR PATHOLOGY v.MYRIAD GENETICS, INC. (June 13, 2013) ruling for myself.

For those of you who, like me, perhaps jumped the gun a wee bit in thinking that a great victory has just been wrought, I unfortunately now have to say “not so fast”…

While it is true that the US Supreme Court said that the patenting of an isolated human gene should not be permitted, it also went on to say that a copy or cDNA version of the gene is indeed eligible for patent.

The following passage, taken directly from the ruling could not be clearer:

”For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring. We, therefore, affirm in part and reverse in part the decision of the United States Court of Appeals for the Federal Circuit.”

To me, despite the fact that the ruling was unanimous, this decision seems and feels more like a cop-out. Some may well applaud the compromise nature of this, and indeed for two months now many have been predicting exactly this outcome. Personally, however, I feel that this decision, when seen in the full light of day, actually is more defeat than victory for those of us that feel that patenting of human genes is just plain wrong on the face of it.

Now, after the initial reactions of victory for the “anti-patent” forces, we are seeing articles like this one that proclaim a “Partial victory for biotech sector after gene patent ruling”.

Myriad Genetics itself was even more upbeat, proclaiming in a press release that the “Supreme Court Upholds Myriad’s cDNA Patent Claims”. According to this press release from the company,

“following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”

This is not good news at all for all of the genetic testing advocates and breast cancer advocates in particular who felt that Myriad Genetics’ holding an essential monopoly on all testing of the BRCA1 and BRCA2 genes was simply wrong. It does not seem like this Supreme Court ruling is going to affect very much of Myriad’s business that is based on cDNA copies of the BRCA1 and BRCA2 genes that is the basis of their BRACAnalysis tests in the first place. It might well mean that other companies have an opening to be able to create (and commercialize) other tests for the BRCA1 and BRCA2 genes, as long as they are not based on the cDNA versions that Myriad has created. This might end up as good news if more competition is created because Myriad can no longer claim an absolute lock over anything and everything related to these breast cancer genes.

What does this ruling mean for the future? There are better experts out there who can answer that question, but it seems to me that this ruling is going to have very little impact in the future. Genome sequencing has progressed leaps and bounds since the days when isolated cDNA was used in the way that Myriad and others have done. So while this ruling may well protect a large number of patents that have already been issued concerning cDNA copies of human genes, the future of human genome sequencing and of genetic testing and treatments based on those sequences has long ago eclipsed the need for cDNA cloning for the most part. International accords of the type highlighted in this article are by far the way of the future as opposed to isolating cDNA and cloning of individual genes.

I still believe that the US Supreme Court has advocated a very important point of principle, namely that a naturally occurring gene is indeed a product of nature and cannot therefore  be patented. Whether that makes any real difference for the future as we use the technologies of today and tomorrow, remains to me a bit of a moot point.

Bottom line for me, as the holder of patents on human genes that were derived from cDNA, that means that my patents are still protected by this ruling.

In one of those sad ironies, I wish it were not so…

 

 

 

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Good News, Bad News: Dr. Ralph Meyer is Moving

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Ralph MeyerThis past Thursday the Hamilton (Ontario) newspaper, The Hamilton Spectator, published a small article in its “Local News” section that said Cancer researcher Ralph Meyer appointed to head Juravinski Hospital. This may have gone unnoticed by most, and likely under-appreciated even by many who read it.

But this is a BIG news story for Canada’ s entire cancer research community and especially for clinical oncologists and clinical trials researchers all over the country, and even beyond our borders.

Since 2007 Dr. Ralph Meyer has been the Director of the NCIC Clinical Trials Group (NCIC CTG). The NCIC CTG is a “cooperative oncology group which carries out clinical trials in cancer therapy, supportive care and prevention across Canada and internationally”.

The NCIC CTG  is one of the national programs and networks of the Canadian Cancer Society Research Institute (CCSRI), and is supported by a major grant (the largest single grant the  CCSRI awards) from the Canadian Cancer Society (CCS). The CCS through the (then) National Cancer Institute of Canada (NCIC) established the group in 1980 and has been supporting it continuously since then. Even though the NCIC officially amalgamated with the CCS in 2009, the CTG still bears the NCIC name since it has achieved a stellar international brand among clinical oncologists worldwide and the CCS did not wish to disrupt that brand recognition at the time of the amalgamation.

Ralph Meyer assumed the role of Director, NCIC CTG in April, 2007. I was privileged to be the Co-Chair of the Queen’s University Search Committee that identified and recruited Dr. Meyer to that post. He holds the Edith and Carla Eisenhauer Chair in Clinical Cancer Research and is Professor in the Departments of Oncology, Medicine and Community Health and Epidemiology at Queen’s University. He is a hematologist by training and his own research interests are in the hematologic malignancies and in the generation of clinical trial evidence for use in health care policies.

The irony of sorts is that CCS and NCIC “lured” Dr. Meyer away from McMaster University in Hamilton where he had been the Director of Division of Hematology and Professor in the Department of Medicine, and Head, Hematology Malignancy Program at the Juravinski Cancer Centre. And now, as the Hamilton Spectator has proclaimed  “Hamilton has lured one of Canada’s leading experts on cancer research from Queen’s University to head Juravinski Hospital and Cancer Centre.” They could have said “lured back”. I guess what goes around comes around….

Effective in Mid-August, Ralph will become President of the Juravinski Hospital and Cancer Centre, as well as as a regional Vice-President of Cancer Care Ontario.

I have known Ralph personally for probably 20 years or so. He was a member of, and then Chair, of grant peer review committees when I was at the NCIC, and we worked closely together after we recruited him to head the NCIC CTG. He brought huge insights, integrity, wisdom and a fairly unflappable personality to the CTG, and indeed the organization has gone through some major restructuring over the last years under his leadership and mentorship.

But beyond all of his professional credentials and accomplishments which are legion and impressive, Ralph is also one of the most “decent” men I know. His integrity is unrivalled, and the care and interest he takes in his colleagues is remarkable. I have a genuine fondness for Ralph the person just as much as I have a huge respect and admiration for Ralph the cancer researcher and clinical trials specialist.

As one example, Ralph called me on the phone a week or so ago to tell me the news personally. Even though I am fully retired and have no official connection with the CTG anymore, he did not want me to read about the move in a press release or in a newspaper article. He wanted to tell me personally and to make sure I wasn’t “blind-sided” by this. Given all of the (no doubt) millions of things he had to do, I was touched that he still included me in that close circle who he felt  should get an advance notice. He certainly did not have to do that. But that’s Ralph’s style.

I know that Ralph’s roots are in the Hamilton region and he has family still in that area, so to him this is a bit like “coming home”. I know he is excited and at the same time nervous about the move and his new role.

He ought not to be. I know him and I know that the Juravinski will be thrilled with him as their new leader, just as much as we who know him have been thrilled with his skillful leadership of the CTG these past years.

This is a perfect example of the Juravinski Hospital’s gain being the CTG’s loss. I most certainly wish Ralph much happiness and every possible success in his new role and know he will succeed.

But I am also very sorry to see him go from the leadership post at the NCIC CTG. His contributions to both the organization and conduct of truly practice-changing cancer clinical trials in this county and internationally have been exemplary, and his shoes will be large and difficult ones to fill.

Good Luck Ralph!