Law under the Microscope

NIH Opens Investigation into Potential Financial Conflict of Researcher

In the past several months, the NIH has been dealing with various scientists who have not disclosed payments to them by outside companies for doing research. The ethical rules guiding whether researchers had to disclose money they made from outside research were rather obtuse. Last September, Dr. Elias Zerhouni, the director of the NIH, imposed a one-year moratorium on receiving an honoria by NIH scientists for any outside research, because the NIH has to conduct an across-the-board investigation into the scope of the problem. Recently, the NIH opened an investigation into a particular researcher who allegedly received over $500,000 from Pfizer for collaboration in doing research regarding Alzheimer's disease as well as for representing Pfizer at certain conferences.

The researcher's defense seems weak at best.

Stem Cell Lines Contaminated

Woo boy. This just doesn't sound good. The US federal government had already restricted funding of stem cell research to work using stem cell lines that were in existence as of the date of President Bush's address to the nation seven months after taking office in his first term.  Since then, there have been varied responses to the restricted funding - some U.S. scientists have left for Europe, where some countries (like the UK) are more supportive; some schools report a drop-off in the number of US students taking up related research because of the uncertainty of a job; and there has been a spate of states raising initiatives to fund stem cell research with state money.

Even with the increase in state money, though, one thing is still needed - stem cell lines. Even with piles of money, you can't do embyronic stem cell research without those cells, after all. Privately created stem cell lines are difficult for researchers to access and the ones remaining that were okayed by the federal government for federal funds were dwindling. And now we receive the not-so-good news that the non-private lines have been contaminated.

NIH Announces Plan for Access to Trial Results

NIH finally announced its plan regarding the publication of clinical trial results and, as expected, the new policy will be to request that researchers post their trial results 12 months after completion of the trial. This policy angered many public access and taxpayer watchdog groups, who argued that 6 months was more appropriate.

Senators Press Leavitt to Name Permanent FDA Commissioner

It's as if they've been reading my mind ... .  At the confirmation hearings for Michael Levitt yesterday, the Senators urged Mr. Levitt to name a permanent FDA Commissioner as soon as possible, and preferably by the end of January.  Mr. Leavitt promised to fill the position quickly, but demurred on setting a deadline.

Can't you just hear the resume paper being run through the printers in DC?

University-Private Sector Collaborations Can be a Boon for the Universities

Thanks very much to Stephen Nipper of The Invent Blog for sending me a tidbit about a neat company in England that is raising funds for its research. Biofusion, 70% owned by the University of Sheffield, is looking for 10M pounds to commercialize its products from various areas of research, ranging from stem cell research to relief for burn victims.

Companies like Biofusion and IP2IPO, mentioned in the article, are the kind of companies that many universities salivate when they meet. They understand the tech transfer process and how to commercialize something that at the time might only be a research product. They have the patience to keep digging and finding equity partners to bring the research to life - something universities usually just don't have the resources to do.

California Stem Cell Board to Delay Giving Out Money

Robert Klein, the new head of the California Institute for Regenerative Medicine, is showing that he is at least listening to critics and watchdogs of the stem cell research initiative. Since he was installed as the head, several group have loudly complained that the ethical guidelines for the board are not adequately in place and money should not be given out until they are.  That is, admittedly, a very smart criticism of the board.

Mr. Klein has promised that no money will be given out until those ethical guidelines are decided. He raised the ire of several groups when he mentioned (before the Board had convened) that he believed they would be starting to hand out money in May. If you know anything about groups that give out grants, this is moving pretty darn fast, especially when you don't have all of the procedures yet in place. Mr. Klein explained that May was not meant to be a hard-and-fast deadline. He likely just figured he wanted to say some date that wasn't absolutely ludicrous but was fast enough that the Board would have to start hopping, as one of the most difficult things about being on any Board is how long it can take for them to even convene. 

Heck, if they can meet by May and have those ethical guidelines in place, I'll be pretty impressed with their efforts.

By the way, for those readers in California, there will be an open meeting of the Board Committee for the IRM on Jan. 24. The places, time and agenda for the meeting can be found here.

NIH Delays "Open Access" Announcement to Allay White House Concerns

Back in September, the NIH had released a draft proposal (is that redundant?) that requests the release of NIH-funded research results to a public database within 6 months after being accepted for journal publication.  Dr. Elias Zerhouni, DIrector of NIH, had scheduled a teleconference for this past Tuesday, the 11th, and was expected to announce the final rule for publication of such results. It had been widely speculated that the Final Rule would include a compromise with the journals, and allow a 12 month window to publish such results. This really would not be that big a deal - 12 months is a fairly typical timeframe in the industry to allow for the publication of results after either the trial is over or publication in a journal.  And remember, this is a request to publish results - not a requirement.

Unfortunately, that teleconference was canceled, and again it is speculated that it was due to concerns from the White House that the rule would become an issue at the confirmation hearings for Michael Levitt as the new head of Health and Human Services.  In my opinion, this was a boneheaded move by the White House, NIH or whoever was the person who made the decision.

NIH Scientists Must Disclose Financial Interest in Research

For years, private researchers have had to disclose significant financial interests in research and the companies sponsoring the research (above $25,000). Now, scientists at NIH will likewise have to disclose their financial interests in research, such as entitlement to royalties for developed technology.

On Monday, NIH Director Elias Zerhouni officially implemented a policy requiring NIH researchers to divulge whether they are receiving royalties and other outside payments for their scientific research.

IBM Retains Honor of Most Patents Awarded

Not necessarily dealing with biotechnology, but it's been announced that IBM has, for the 12th consecutive year, been awarded the most patents in the U.S.  The juggernaut was granted 3,248 patents in 2004.  That is a helluva lot of claims, and the mind boggles at the fees paid both in terms of filing fees and attorney fees.

I love how the CNET article states that they "won" the patents.  Even with how it occasionally seems disorganized, the US PTO isn't exactly holding a raffle or lottery.  Still, perhaps this is indicative of the perception that large companies more easily sail through patent review while smaller inventors struggle to be heard.  Personally, it seems like it's really more an indication that IBM is mammothly huge and is trying to patent every thought that comes out of an employee's mind.  Can you imagine those lab notebooks?

Government Contractors: Disclose Your Inventions!

If you or your company has ever received federal funding (from any of the various agencies) for research, you’re likely very aware of the numerous Federal Acquisition Regularionts (FARs) and HHS Acquisition Regulations (HHSARs) that may be imposed as contract terms for receiving the money. In particular, you might have come across FAR 52.227-11, “Patent Rights – Retention by Contractor.” This clause discusses the contractor’s obligations to disclose inventions developed under a government contract, and the requisite format of the disclosure.

Unfortunately, far too many companies are ignoring this provision and trying to still go ahead and claim various intellectual property rights to inventions developed under the contracts. The recent opinion of Campbell Plastics Mfg., Inc. v. Brownlee shows why this is a really bad idea and cautions against trying to sneak around the government.