Tuesday, May 9, 2017

Harvard, Matt Shair being sued by former postdoc

For soon, but for now, a few sentences from the report from Chemical and Engineering News (article by Marc S. Reisch):
A former Harvard University postdoctoral researcher has sued the university for his share of $20 million that Merck & Co. paid Harvard in 2016 to license preclinical compounds to treat leukemia. At the time, the license fee was called the largest ever for a technology developed at Harvard. 
The researcher, Alexander Arefolov, worked in the lab of Harvard chemist Matthew Shair between 2011 and 2015. He claims that he was intentionally left off a patent covering the compounds, which are derivatives of cortistatin A. 
The patent, which Harvard applied for in 2016, names five scientists, including Shair, as inventors. It details steps to synthesize derivatives of cortistatin A, a complex, difficult-to-isolate natural product from sea sponges...
NB the lawsuit is being filed by the same lawyer that filed suit (and reached a settlement) in the Charest case.

UPDATE 1: According to the Boston Globe:
Arefolov is seeking about $1 million, plus a pro-rated share of future royalties that could be paid by Merck if a drug based on the Harvard technology is approved, according to his attorney, Brian D. O’Reilly.
UPDATE 2: I contacted Dr. Arefolov's lawyer (Brian O'Reilly) and he provided the lawsuit and related documents. (Google Drive link) Things that I found interesting:

Here are the basic facts, as laid out by Dr. Arefolov:
29. Between 2006 and 2011, Dr. Arefolov and Dr. Shair worked together at Makoto Life Sciences, a biotechnology startup. Dr. Arefolov was a research scientist and Dr. Shair was a Scientific Advisory Board member at the company. During that time, Dr. Arefolov and Dr. Shair worked closely together.
30. In July 2011, Professor Shair invited Dr. Arefolov to accept a visiting scientist position at Harvard.
31. Over the next three months, Dr. Arefolov worked on the Cortistatin A Project. During that time, he made an important breakthrough that had beguiled previous lab members.
32. Seeing Dr. Arefolov’s contribution to the Cortistatin A Project, in October 2011, Dr. Shair offered Dr. Arefolov a position as a post-doctorial scientist to continue his work on the project.
33. Dr. Arefolov accepted the position and continued to work on the project until April 2015.
34. The pay for post-doctorial scientist was substantially less than many industry positions. Part of the allure of taking a position as a post-doctorial scientist in Dr. Shair’s laboratory was the hope that he would receive patent royalties from his work.
35. Dr. Shair repeatedly assured Dr. Arefolov that his work on the Cortistatin A Project was valuable and that he would ensure that Harvard would recognize Dr. Arefolov’s contributions if they were successful in securing a patent and any patent royalties.
39. During the four years Dr. Arefolov worked in Dr. Shair’s lab he worked long hours and dedicated his work exclusively to the Cortistatin A Project. Central to the Cortistatin A Project was the effort to investigate, create, and test new Cortistatin A analogs. Dr. Arefolov’s worked extensively on the investigation and creation of Cortistatin analogs.
 And the important bits about money:
62. In multiple conversations with Dr. Shair, Dr. Arefolov inquired about possible patent royalties he could receive from his work on the Cortistatin A Project. Dr. Shair reassured Dr. Arefolov that Harvard would recognize his work. Dr. Shair understood that it was unlikely Dr. Arefolov would agree to a reduced share of the royalties in order to increase Dr. Shair’s share of the royalties.
63. In fact, it was that very reliance on future royalties that Dr. Shair used to convince Dr. Arefolov to stay on as post-doctorial scientist. On multiple occasions, Dr. Shair made statements such as “Alex, the inventors at Harvard University receive 35% of any license fee, if the project is successful – you will receive your fair share.”
I think we should take a moment here and note this story is told from the point of view of the plaintiff, and so Harvard and Professor Shair are going to have a different story.

That said, it's clear to me that Dr. Arefolov was convinced to leave his previous position at a small company in order to work with Professor Shair on the cortistatin project. If you go through the complaint, it sounds like Dr. Arefolov is hanging his hat on that he should have been a co-inventor because he suggested the making of analogs that made it into one of the patent applications. Assuming (a big assumption) that Dr. Arefolov was a co-inventor, it seems very reasonable for him to want relief for being left off the patent and for the 4 years he was convinced to work as a postdoc.

The thing that the documents do not answer is this: why is Dr. Arefolov no longer working for Professor Shair? Who are the other inventors that were put on the relevant patents and patent applications? What share did they get? (UPDATE 3: see below) 

It will be interesting to see what happens next, especially since Dr. Arefolov (and, I presume, Mr. O'Reilly) are also claiming that Professor Shair should have been acting in his role as a fiduciary for Dr. Arefolov. As long time readers of the blog may know, Mark Charest (and Mr. O'Reilly) did not succeed in this claim against Professor Andy Myers of Harvard. 

I look forward to hearing the facts behind this case; until then, students who have made big, commercialize-able discoveries in the laboratory, might want to find out what your university's IP policy is...

UPDATE 3: Professor Shair received an equal share with his co-inventors, after Harvard took their percentage. 

23 comments:

  1. Does this lawyer just canvas Harvard patents and then reach out to former group members to see if they want to sue?

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    1. More likely, 20 mil award to Matt Shair made Arefolov (who ended up on unfriendly terms with his advisor) consider suing - and who else to hire than a lawyer who successfully sued Harvard in the past?
      1. I don't know anything about this particular case
      2. I know prof. Shair - I was taking his class before he got tenured. Definitely not a person I would work for.
      3. PI conflict of interest is all too common. When I was at Scrips FL, our advisor with whom I helped to start medicinal chemistry group kept telling us how generous the royalties are going to be (50% split amongst to the patent co-athors, 25% as hard cash and 25% as unrestricted internal grant). He urged us to work feverishly to meet deadlines for all these provisional patents that he was filing. He was also starting companies that would buy his own intel property from Scripps FL (it turns out his company was paying for Scripps patent lawyers doing his extensive patent filings). Then SEVEN patents were finally published, our PI was the sole author on all of them even though as computer modeler he did not really know much about making any of the compounds in his patents.
      4. I was retro-actively added as co-author on two patents and two publications - after they were already published. You can imagine how unpleasant was the argument. (But only one of the publication was Scripps related) I made the mistake of going through the internal process at Scripps - I e-mailed the PIs and my superiors and I protested. I should have hired a lawyer instead. And this is the kind of fight that even when you win you lose, in my case I earned deep animosity of a high-ranking management person, and since that day he worked hard to get rid of me. Eventually he succeeded when Scripps had funding problems, and there was push to replace all staff scientists with postdocs.

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    2. Professors at Harvard have had the reputation (in some cases) of not playing well with others. This doesn't necessarily mean that they treat their students unfairly, but it could. It also might mean that they would be less likely to have relationships to sacrifice with their advisors. At someplace like Harvard, there's a lot of room for people to get hosed and a likelihood that in earlier times, they would have accepted it and moved on (because they could make a career from what they received, and it would be career-limiting to fight). When there's no career, career limitation is much less of a threat. There's also a good chance that the hosing involves money, since there's lots around, and so there's an obvious currency for the vengeance to take. If your advisor was willing to monetize your relationship for (his, mostly) benefit, turnabout's fair play.

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    3. I heard Corey sued his former student who wrote chemdraw. The student was able to show he wrote the software at home on his own computer. Corey claimed to own all of the students time. Court ruled against Corey.

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    4. http://cen.acs.org/articles/92/i33/Reflections-ChemDraw.html

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    5. Not to nitpick, but a couple items at issue with your first post, milkshake. First, it seems from the article that the $20 million was paid to Harvard from Merck, not to Shair. From the $20 mil, 35% goes to the inventors (and that is usually after all patent costs are recouped by the University). If there are not that many patents then that amount may not be too much - but it can be in the ~$300K range if there are many. So, the amount paid to inventors would be ~$7 mil (not an insignificant amount of money for sure). Second, there are no authors on patents - there are inventors. The question I have regarding these cases is: what role did the patent attorney play in all of this. Having worked at an academic institution where royalties/licensing is given to inventors I've seen my share of disputes over amount of distribution. These have all arisen when the payment was distributed and all inventors had to sign a sheet agreeing to your participation (% effort or monetary outlay). When the disputes have occurred, then the money is not distributed until it is resolved - causing some strife between the inventors. However, this was resolved by having the patent attorney come in and review all the cases and give an opinion on inventors (also having worked in industry, this was pretty standard practice at my old company prior to submission and after allowance as some claims are not given and thus can affect inventorship). Now, maybe this was done and it was deemed appropriate and the person still feels they should have more of a share, don't know that. But, from my experience, it's not just the PI that is involved in determining inventorship (maybe initially, but not when it comes to filing as wrong inventorship can/will lead to invalidating the patent).

      And CJ, you admit the story is completely one-sided at this point, so I'm not sure you can honestly make this claim: "it's clear to me that Dr. Arefolov was convinced to leave his previous position at a small company in order to work with Professor Shair on the cortistatin project." Seems likely, but it isn't "clear" from a single persons account.

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    6. Anon9:59: Fair enough. What is your opinion as to why an industrial chemist would decide to take a postdoc?

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    7. Vrampire: Do you have any proof of a lawsuit between Corey and Rubenstein?

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    8. The article in Angewandte ("History of the Harvard ChemDraw Project", PMID 25131311) from a few years back briefly mentions a settlement. (It was Evans, not Corey. But it was Harvard.)

      http://onlinelibrary.wiley.com/doi/10.1002/anie.201405820/full

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    9. I don't know why this particular person would take a post-doc. But, depending on their background, having a post-doc at Harvard on your CV may be beneficial going forward even if there is a short term reduction in salary. Not sure if things went south with Makoto Life Sciences if this person would have the same advantages as having a Harvard post-doc going forward. All of this is supposition, of course, but I'm less inclined to make a definitive statement without hearing both sides.

      Your update 3 is interesting. In my previous experience, splitting licensing monies were never an equal split and that is what led to the issues.

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    10. Fair enough, re: Harvard versus Makoto. 4 years he worked on it! Yikes.

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    11. Another quick question, what is meant by the advice above..."might want to find out what your university's IP policy is...". I'm not sure what a university's IP policy would matter. Do you mean the royalty splitting? I don't think a university has an IP policy as far as inventors - that will be determined by the patent law and who should and should not be an inventor. Universities should not have a say or policy on that.

      More important advice would be to keep an inventor's or idea notebook. Take notes of what ideas were generated and who was present when they were developed and put to practice. Make notes of any and all changes to any procedures to make said compounds and have that counter-signed. In industry we would have these at the meetings and everyone signed them and then had them counter-signed. This may not be 100% effective, but if everyone signed them it would be much more difficult for someone to say person A didn't contribute. Again, it's important to note that just because you made the compound doesn't mean you are an inventor - something junior scientists or academic scientists tend to forget or don't know.

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    12. > It was Evans, not Corey.

      Rubenstein was working for Corey on his attempt to AI chemistry before AI existed (logic of chemical synthesis, and all that). So it makes sense that Corey would attempt to assert IP over a separate but still chemistry-related software package also built by his employee. Moreover suing a colleague is way more in line with Corey's personality than Evans'.

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  2. biotechtoreadorMay 9, 2017 at 3:33 PM

    I have always found it odd that on a good chunk, if not most, of Dale Boger's patents he's the sole inventor. Impressive amount of work, if it were even remotely possible.

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    1. There's a picture of Boger somewhere, maybe in Boger's notes or from his website, that a senior student in my graduate lab had printed out and taped on his hood sash and the entrance door of the lab and written across the picture was a 7 letter adjective that was also the title of a famous Dennis Leary song.

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  3. Simply because someone worked on a project and thinks she's an inventor doesn't mean she is. It's a complicated legal process and ultimately depends on the allowed claims. Co-inventors are not co-authors and it's a mistake to call them that for its a totally different concept. Rival companies occasionally fund such law suits to invalidate a patent. They have to look for a disgruntled former student but I have no idea if that's the situation here.

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    1. Let's assume that Arefolov is acting independently, and exclusively in his own interest.

      Doesn't that still poison the well on the Cortistatin patents? Would any pharma legal group in their right minds want to touch the patent, knowing that there's a question of inventorship which--due to Arefolov's likely limited funding--may not have been fully litigated?

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    2. Anon 12:17 : There are multiple patent applications and a single issued patent covering the Cortistatin work in Shair's lab. Many of these, including the issued patent, trace their priority filing date to 2008, well before Arefolov went to Harvard to postdoc. The answer from Merck's perspective will depend on what they licensed when they paid Harvard the $20 million - rights to license all of the IP or just portions of it. If they licensed only the cases with the 2008 filing date then Merck doesn't have a problem and Arefolov may not have a case.

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    3. Interesting--thank you.

      --Anon 12:17

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  4. Based on 62-63, then Arefolov may attempt to cite Chou vs. University of Chicago, 254 F.3d at 1362, for the proposition that a student-advisor relationship is fiduciary in nature, and was breached by Shair.

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    1. As an addendum, I guess this begs the big question, is a postdoc a "student" when it serves their interests?

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  5. I looked up the application ( not patent) 15/192,629 named in the Arefolov suit. It's a new application with an earliest possible priority date of 12/24/2013. It's not clear Merck paid any royalties based on this application. Arefolov points to some specific compounds on page 9 of his filling document as among his contributions. Right now a restriction requirement is the only office action issued by the USPTO. The attorneys hired by Harvard could make this suit go away by electing different rings and not pursuing these compounds. Assuming Arefolov's compounds are even claimed in this application, which I haven't read.

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  6. I guess it would be interesting to know when it became obvious that Makoto was in its death throes.

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