News Roundup: Patent Reform Passes House, Human Provenance Project Pulled by UK

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Patent Reform Legislation Passes House. Several months after the U.S. Senate passed patent reform legislation that would make sweeping changes to America’ patent system, including a switch from a first-to-invent to a first-to-file system for awarding patents, the U.S. House of Representatives finally followed suit yesterday, passing a similar piece of legislation by a vote of 304-117. The version passed by the House, while similar to that passed by the Senate, contained a number of last-minute amendments (pdf).

One change of particular relevance to the personalized medicine community was the removal of a proposed safe harbor for second opinion genetic diagnostic testing, which was replaced by a requirement that the U.S. Patent and Trademark Office (USPTO) investigate the relationship between genetic diagnostic tests, gene patents and exclusive licenses. The USPTO would be given nine months to complete its investigation and to return to Congress recommendations for ensuring the availability of second opinion genetic diagnostic testing. (The USPTO study on genetic diagnostic testing was not included in the bill passed by the Senate in March.)

With both the House and the Senate having now passed patent reform legislation, the next step appears to be a House-Senate conference to resolve inconsistent provisions in the two bills, although according to The Hill it is unclear how soon such a conference will take place.

UK Government Pulls Plug on Human Provenance Project. Nearly two years after the Human Provenance Project was first unveiled (to substantial scientific criticism), the government agency responsible for the project, the UK Border Agency, has finally pulled the plug. The project would have used DNA and isotope analysis of tissues from asylum seekers in an attempt to evaluate their nationality and render immigration decisions. After a wave of criticism following the program′s announcement, and after spending more than $300,000 on screening, the UK Border Agency has scrapped the program in its entirety.

As we wrote back in 2009, the poorly conceived project threatened to disrupt what has been—in both the UK and in the United States—a slow and delicate process to craft legislation, regulation and policies that promote genomic science and the use of personalized genomic data while addressing concerns over the potential misuse of those data. As we wrote then, “with so much genomic science and policy yet to be written, even minor developments produce outsized effects, which makes the potential consequences of the Border Agency’s project so worrisome.”

Thankfully, the UK Border Agency quickly paused the project following initial concerns and, nearly two years later, it appears that no lasting damage has been done. Still, the Human Provenance Project should serve as a reminder to governments worldwide of the need to carefully and publicly vet state-directed personal genomics programs prior to their implementation.

Roundup of tweets from the intersection of genomics, personalized medicine and the law:

  • Combined w/ this week’s GenomeQuest announcement ( & it’s clear clinical, commercial WGS is here. Now.
  • Omicia releases genome annotation software (incl. for clinical/commercial applications) HT @neandrothal @EricTopol
  • FDA report on challenge of monitoring imported food, drugs ( hints at > difficulty monitoring info-based Dx/devices.
  • Study: FDA device clearance times rose 37% since 2006: Other news: FDA device studies criticized:
  • FDA accused of focusing too much on safety ( & of doing too little: Damned if you do…
  • Finally responding to this @genomesunzipped thread. Agree w/ @dkgppc re: need for more data: Any ideas how to collect?
  • The beat(down) goes on: FDA accused of being a “wet blanket” & “crushing innovation” by MA senator:
  • GLR Post: Prometheus Returns to the Supreme Court, Medical Method Patent Speculation Intensifies:
  • MT @danielg280: Doing a Webinar 6/21 on legal issues re healthcare & social media w/ @healthblawg
  • High-level explanation from @wilbanks why for patents, unlike copyrights, transparency is priority #1:
  • Great idea. MT @RyanMFierce: NC wants to help cash-strapped biotechs w/ $100M in loans cc @GlenCaplan
  • Still, for efforts like the Human Provenance Project, it can be difficult to unring the bell:
  • $300K too late, but right decision. RT @NatureNews: UK immigration cancels DNA screening programme
  • “The 3 letter word for-the gene FOR something-is the most dangerous word in genetics.” HT @eurogene
  • MT @matthewherper @ivanoransky @charlesornstein: Despite FDA Criticism, Cancer Drugs Reach Pts Sooner In US Than Europe
  • RT @SampleGW: New Consortium Aims to Streamline Accreditation, Proficiency Testing:
  • Let’s just hope we do better than MSWord. RT @FierceHealth: Patient rights, safety at heart of #EHR track changes debate
  • RT @SampleGW: Medicare to Cover Pathwork Diagnostics’ Tissue of Origin IVD Nationwide:
  • Well said, @23andMe: “research is a two-way process, where participants are valued as partners in sci. discovery.”
  • GLR Post: Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn:
  • ACLU-led coalition opposes proposed safe harbor for 2nd opinion Dx testing, citing “unintended harms”:
  • Not only co. to shift focus, at least for moment. MT @RyanMFierce 95% of @Knome revenue from R&D, 5% from customers.
  • House debate on patent reform bill delayed until (at least) next week:
  • RT @dgmacarthur: New community forum for @CompleteGenomic users: Just signed up – interested to see how active it gets.
  • GLR Post: DTC Genetic Testing and the FDA: is there an end in sight to the regulatory uncertainty?
  • GLR Post: House Introduces Patent Reform Proposal to Permit 2nd Opinions in Genetic Diagnostic Testing
  • AdvaMed’s “competitiveness policy” urges creation of “office of medical innovation policy” w/in White House: Good idea.
  • “Med-tech CEOs storm Capitol Hill”: by @MassDevice Seem unlikely to hear Shuren’s plea for mercy
  • Meanwhile, @dgmacarthur @lukejostins & I wonder when DTC regulatory uncertainty might end:
  • CDRH Director Shuren says criticism is affecting hiring, slowing agency: HT @dgmacarthur
  • Ion Torrent ($LIFE) expects 400bp reads by year end, $1K genome beginning of ’13: @InSequence
  • Update on Noblegen’s “optipore” sequencing tech; targeting clinical seq tests, ’14 debut: @InSequence
  • RT @BVBigelow: BioNanomatrix Moves HQ and nano-scale molecular analysis tech to San Diego’s diagnostics cluster.
  • RT @RyanMFierce: Broad Institute’s planned expansion roughly the size of two Wal-Mart stores. Wow. by @BBJNewsroom
  • RT @DailyNewsGW: NIH Awards $200M for New CTSA Sites:
  • Twin’s rare disease diagnosed, cured. Another “win” for whole-genome seq: by @Erika_Check HT @drgitlin
  • RT @PGxReporter: MDx/PGx Highlights from ASCO 2011:
  • GLR Post: House Introduces Patent Reform Proposal to Permit 2nd Opinions in Genetic Diagnostic Testing
  • RT @JohnCFierce: Cancer collaborations are all the rage – but you already knew that. by @robertlangreth
  • The “strangest biotech of all” ($UTHR) by @matthewherper, incl a look at its comic book annual report (really):
  • RT @dgmacarthur: MT @westr Illumina launching 5M-variant whole-genome genotyping array – the Omni5 – focus on rare variants:
  • RT @ldtimmerman: Getting ready for debate on open source bio w/ @sagebio founder Stephen Friend, MIT’s Phil Sharp
  • +1. RT @neandrothal: Chrome extension soon? MT @dgmacarthur: update to handy @SNPTips FireFox plugin for @23andMe data:
  • The perfect Father’s Day gift? It’s probably not a paternity test: by @SampleGW
  • Here’s more from @23andMe on the breakdown of their database: Note that not entire 100K have opted in for research.
  • DTC company @23andMe continues to reposition itself, emphasizing reasearch database (now 100K):
  • Following @phylogenomics for tweets from #synbio5, including current coverage of @geochurch’s talk.
  • RT @dgmacarthur: Serious congrats to @markgfh, who won both the European Best Cancer Reporter award & Royal Statistical Society prize today!
  • Beginning w/ improved understanding of heterogeneity. RT @FierceBiotech @MaverickNY: changing cancer research paradigm.
  • RT @JohnCFierce: My take on E&Y’s annual biotech report: It’s tough out there, says Giovannetti
  • MT @Knome: Today we announce the launch of kGAP 2.0, the 2nd ver. of our #genome interpretation engine
  • RT @genomesunzipped: New Interpretome website provides many handy tools for analysing your @23andMe data:
  • RT @LifeSciVC: Welcome my Atlas partner @JFFormela to the Twittersphere. He will undoubtedly have blazing content & sharp wit to add
  • RT @westr: 23andMe’s customer breakdown by ethnicity, via @CeCeLMoore
  • RT @GenCounsNews: Update on advanced degree task force for genetic counselors, including a webinar later this summer
  • & SEC. Still, can be done. RT @elainewestwick: suspect IP/secrecy concerns a challenge re: Twitter/biotech @ldtimmerman
  • Brief recap from last week’s MDMA meeting, including familiar FDA criticism from Senator Hatch: by @FierceMedDev
  • Commons Principles from @Sagebio posted: Ambitious, essential & endorsement-worthy. Add your voice.
  • Congrats to @KeonaHealth, Sarda Tech (my dad’s new venture) & others on NC IDEA innovation grants:
  • Exciting news. RT @neandrothal @NextBio: blog is back w/ a screenshot of upcoming new public site!
  • DTC genetic testing company @Lumigenix: “our response to a recent letter from the FDA”:
  • “I joined GenomeQuest b/c they offer technology to make whole genome dx avail. to patients today-not 10 yrs from now.”
  • Why Twitter matters for biotech, by @ldtimmerman: No surprise, lawyers even slower to adopt Twitter.
  • Post by @eurogene on breast feeding, IQ, genetic testing & DTC: Comments from @23andMe or @ExistenceG?
  • $0.02 from @matthewherper on @patientslikeme tool to match patients to trials using
  • RT @dgmacarthur: Congrats to @genomesunzipped colleague Don Conrad on his new Nat Genet paper on human mutation rates:
  • RT @drjonboyg: Raised in this wk’s In Our Time: was germ theory or cracking genetic code biggest leap in human health?
  • Will need more than 31 senators. RT @NatureNews: NIH finds a few new friends in budget chill
  • RT @westr: “Consumer Genetics Conference Wrap-up – Most Interesting Moments?: #CGC2011″ -via @wimufi
  • MT @mary_carmichael: @dgmacarthur Screenshots don’t do it justice. Key is in use: easy to navigate, cross-ref diff types of content.
  • Privacy vs. efficacy driving debate over opt-in or opt-out approach to state EHR systems:
  • GLR Post: News Roundup: Perception Gaps and Progress in Personalized Medicine:
  • Company for Shuren? “Health Canada upbraided for inspections of medical devices.”
  • RT @BiotechPatent: FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology
  • Drugmakers’ Commitment to Personalized Rx Growing Despite Barriers, PhRMA CEO Says: by @PGxReporter
  • RT @dgmacarthur: Screenshots of the $ILMN iPad personal genome browser (HT @BioITEditor): Surprisingly amateurish.
  • RT @genome_gov: Cool 7/18 meeting: Using crowdsourcing for scientific innovation @ NIH’s Natcher auditorium (also webcast)
  • FDA ruling on $OREX’s Contravene obesity drug risks driving scarce R&D resources from important field, says @LifeSciVC:
  • RT @cwhogg: Wireless dominates patents for heart, glucose monitors
  • RT @scotthensley: Curious to see how it’ll work. RT @phrma: Forthcoming @US_FDA Facebook page that will answer ppl’s questions about drugs
  • #ASCO11 wrap-up from @ldtimmerman for those (read: all of us) who had difficulty following all of the news: