The implication of the Hatch-Waxman Act for universities

“[It is] well-settled, that an experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement, is not an infringement of the rights of the patentee.” Poppenhusen v. Falke, 19 F. Cas. 1048, 1049 (C.C.S.D.N.Y. 1861) (No. 11,279) The Hatch-Waxman (Drug Price Competition and Patent Term Restoration) Act of 1984 was created in the United States to shield activities including supplying active ingredients, using research tools, and…

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Is NSERC turning the ship around?

Nearly five years ago, I alerted readers to an alarming trend in postdoctoral fellow awards at the Canadian Natural Sciences and Engineering Research Council (NSERC). In my blog entitled Come on NSERC, really – you’ve completely missed the point…, I was complaining that in order to improve on their abysmal <8 percent funding rate in their fellowship program, their solution of reducing applications was the wrong one.  Instead of a 66 percent decrease in the absolute…

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How the Hatch-Waxman Act of 1984 protects startups

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation…

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Experiments in peer review: Getting the decision right

A number of weeks back I had reviewed a paper for the Journal of Experimental Medicine (JExpMed) and shortly after submitting I received an email that said “Reviewer collaboration” had been started. After opening the email, it was apparent that the journal was allowing a two day window for each peer reviewer to read the comments of other reviewers and to (if they so desired) make changes to their initial review. All of this took…

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The challenges of crowdfunding academics

From Jonathan: Earlier in the year I wrote about needing to fix tech transfer at universities. This post generated a lot of incoming texts, mail, and calls from like-minded persons with similar experiences to mine. Among the more interesting stories shared was one from Kevin Leland, the CEO and founder of Halo, a crowdfunding platform for early-stage research, who has volunteered a post this week. Below is his story: As a non-academic who reads the…

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What makes a great scientific advisory committee?

This question has been on my mind a lot recently, having just stepped out of a very successful program grant review for a large German consortium, and stepped in to a renovation of our scientific advisory board at Platelet BioGenesis for the purposes for exploring a new (very large) market opportunity. Whether assembling a PhD committee, choosing reviewers for a new manuscript submission, or ranking abstracts for an upcoming scientific conference, the challenge is surprisingly…

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Meta-research: improving the way we communicate (and perform!) scientific research?

Often on our blog and others like it, a topic is inspired by an event or series of events that elicits quite a visceral reaction from the author of the blog. Something is unfair, the system is corrupt, the solution to this problem is so simple, why can’t we all just do the right thing, etc, etc.  As a result, articles often feel anecdotal, sort of the equivalent of a medical case study, interesting to…

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Quarterly Summary: Access to people and their research & reimagining how we fund translational research

Our summaries have become less “quarterly” and more ad hoc – so apologies to those who have been waiting since January for a recent roundup of the topics covered at the Black Hole. Recent efforts from Jonathan have focused on how we can best support and fund translational research so it actually makes the journey from the lab; and I’ve been exploring some of the dark corners of peer review and engaging with new tools on…

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We need to fix tech transfer at universities

I’m stepping away this week from my ongoing series on how to improve federally-supported translational research programs to broach a sensitive topic that is long overdue for discussion. University tech transfer is broken, and its purpose and structure need to be re-thought. Of course, my criticisms are not of ALL tech transfer offices at all universities. I have not dealt with many of them, and there is huge variability between institutions; however, I have interacted…

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A glimpse past the smoke and mirrors at Nature magazine

A colleague (thanks Elisa!) tipped me off to a new development at one of the most prestigious scientific journals: At some point over the last year, Nature magazine has begun to reveal the identities of some reviewers for their published letters and research articles. This is a big step toward transparency and openness in peer review, and I applaud the journal for taking this first step. There is obviously much more that can be done,…

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