Myriad Genetics, USPTO File Summary Judgment Motions in Gene Patent Case
Two of the defendants in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents organized by the American Civil Liberties Union, have now filed their own summary judgment motions. (Click through to read the memorandum in support of Myriad Genetics’ motion (pdf) filed on December 23 and the memorandum in support of the PTO’s motion (pdf) filed on December 24). As we explained in an earlier post, a summary judgment motion seeks to convince the trial judge that the facts are so clear-cut that there is no reason to go ahead with the trial—in legal jargon, that there is “no issue of material fact” that needs to be tried. This is the rare case in which both sides have asked for summary judgment (the plaintiffs filed their motion and supporting memorandum (pdf) back on August 26). The filings by both sides are not a surprise here, however, since the facts surrounding the challenged patents are largely undisputed and the real question is how to apply patent law to those facts.
Another Stop on the Road to the $1,000 Genome
The latest stop on the road to the $1,000 genome? San Francisco, CA, where J.P. Morgan’s 28th Annual Healthcare Conference is in full swing. There is an abundance of real-time Twitter coverage from the conference, but certain announcements warrant a more detailed discussion.
The announcement generating the biggest buzz today came from Illumina, Inc., whose CEO Jay Flatley unveiled a new genome sequencing machine, the HiSeq 2000. According to Matthew Herper of Forbes.com, Illumina’s new machine “will decode a person’s DNA in one week using $10,000 worth of materials – five times cheaper than any other competing gadget on the market.” Herper adds that the machines will begin shipping in February with a cost of $690,000 (compared to $500,000 for Illumina’s current model). Illumina’s own product page for the HiSeq 2000 provides more technical details, including coverage (~30x) and read length (2×100 bp). There have also been unconfirmed rumors that the machine will come equipped with an iPhone user interface, a concept that Flatley first pitched at last summer’s Consumer Genetics Show.
If it performs as advertised, the HiSeq 2000 is likely to be a huge hit with large genome sequencing centers, as evidenced by the announcement that the BGI (formerly the Beijing Genomics Institute) has agreed to purchase a whopping 128 of the new sequencing systems. But what, if anything, does the Illumina announcement mean for individuals consumers interested in receiving a complete genomic sequence?
What’s the Deal: Establishing the Ownership, Management, and Other Key Terms of the Business
This commentary in the Genomics Law Report’s ongoing series Bench to Market is contributed by David Miller, Robinson, Bradshaw & Hinson, P.A.
We discussed earlier in the Bench to Market series the selection and formation of the legal entity that will own the technology and carry on the business of the founders. In connection with this formation and prior to engaging with investors, contractors, and others, the founders of the new business should establish clearly the terms of the venture as between themselves. They need to consider carefully and come to agreement on the ownership, management, and other important aspects of the business. Ultimately, through their discussions and with the aid of an attorney, the founders should have a set of legal documents that completes the formation of the entity, reflects clearly and with precision the terms of the venture, and prepares them to operate the business in the market without disruption. Below is a summary of key terms of the venture arrangements that the founders of any new business should establish with each other.1
Weekly Twitter Roundup
The Weekly Twitter Roundup took a hiatus over the holidays, but that doesn’t mean that there was nothing worth Tweeting. Here’s a recap of the stories and developments from @genomicslawyer since the last Roundup that didn’t find their way into a full-length posting on the Genomics Law Report:
- Too soon to cheer the personal genome revolution? Peter Aldhous reviews Francis Collins’ new book: http://bit.ly/68g19q (via @neandrothal)
- “Who owns my DNA” http://bit.ly/53X0hZ (by @markgfh of @TimesScience) On how personal genomics companies handle genetic info
- “Cashing in on your genes” http://bit.ly/7Qvvx2 (from @markgfh of @TimesScience) Exploring the business of personal genomics
- Personalized Medicine: A Big Market, If We Can Just Figure Out How to Get People to Use It: http://ow.ly/16hWfF (from @crossborderbio)
- RT @BiotechPatent: My article on the effects of Bilski on diagnostic methods published today in Bio-IT World http://tinyurl.com/yddb8dv
- Myriad Genetics partners with MRS to Identify genetic test Candidates at mammography centers: http://bit.ly/78RF57 (via @GenomeWeb_News)
-
Read the rest of this entry »
Five Questions for Personal Genomics in 2010
Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010.
1. Will the $1,000 genome live up to the hype? Affordable whole-genome sequencing is coming, possibly as early as this year depending on whom you ask. But when the day inevitably arrives, after the media frenzy has subsided, will the $1,000 genome prove anti-climactic?
Whole-genome sequencing is a means to an end and not an end in itself. The understandable excitement surrounding Complete Genomics’ November announcement that it had sequenced three genomes for an average cost of $4,400 often neglected to focus on what the price tag did not cover: the substantial costs associated with interpreting the genomic data.
For genomics researchers, the falling cost of whole-genome sequencing is a continuing cause for celebration, enabling increasingly ambitious research projects. But the success of personal genomics, which is what really matters to consumers, patients and healthcare providers, requires more than inexpensive genomic data. The real breakthrough in personal genomics will come when we can offer individuals affordable access to their whole-genome sequence as well as to the genomic tools and knowledgebase necessary for those individuals to put that data to use.
Can You Keep a Secret?
The competitive landscape can be a dangerous place for an early-stage entrepreneur, and even the best business plan can fall prey to imitators unless the entrepreneur is able to protect her business with some type of exclusive rights. Patents can provide powerful protection, and provisional patents are often a good choice for creating early-stage exclusivity. However, no business should overlook the potential value of trade secret protection.
There are two key issues to consider when evaluating trade secret protection: what type of information can an entrepreneur protect and what does she have to do to protect it? In general, any information can be a trade secret if (1) it is non-public information that has value because it is not publicly known and (2) the holder of the information is taking adequate steps to hold it in confidence. Trade secrets can include things as diverse as business plans, business contacts, financial analysis, inventions, formulas, designs and methods.
Read the rest of this entry »
