Back in February the Supreme Court heard arguments from farmer Vernon Bowman on why he didn't need to pay royalties to Monsanto for growing their patented GMO soybeans that have been genetically modified to be resistant to the pesticide in Round-Up. Today, Mr. Bowman lost his case when the Court unanimously ruled against him.  He owes Monsanto $84,000 in royalties.

Bowman bought uncharacterized soybeans intended as animal feed from a local supplier. He admited that he thought most of the generic soybeans would probably be Round-Up ready GMO varieties even though they weren't labeled that way or sold as crop seeds. Since he didn't specifically buy Round-Up ready seeds, however, he argued that he didn't infringe on Monsanto's patent. In fact, he claimed it was the seeds themselves that replicated the patented invention.

All the Justices disagreed with Bowman. "But we think that blame-the-bean defense tough to credit." noted Justice Elena Kagen in delivering the Court's opinion. "Bowman was not a passive observer of his soybeans' multiplication; or put another way, the seeds he purchased...did not spontaneously create eight successive soybean crops....Bowman devised and executed a novel way to harvest crops from Roundup Ready seeds without paying the usual premium."

Justice Kagen points out that the Court's opinion is based understanding that, "Under the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article. Such a sale, however, does not allow the purchaser to make new copies of the patented invention."

For more on the ruling, see a summary on ScienceInsider.

The lab of Rudolf Jaenisch, who developed the first transgenic mouse in 1974, has developed a new approach to genetically engineer mice in just weeks, rather than years which are currently needed. This new technique does not rely on engineering embryonic stem (ES) cells, but rather, directly introduces the genetic changes in developing mouse embryos. In addition to making production of transgenic mice and rats for laboratory research faster and easier, it should also work with other types of organisms whose embryonic cells are difficult to engineer and manipulate.

The new approach takes advantage of a unique response bacterial developed as a defense against invading viruses. Bacteria can target and cut the DNA of invading viruses. To do this, they use short sequences of DNA that match some part of the DNA of the invading virus. Many bacteria seem to have a "catalog" of short stretches of DNA that match parts of many different types of viruses. These regions of DNA were dubbed Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) when they were first discovered.

Researchers found that they could co-opt this bacterial defense system to target and inactivate specific genes in more advanced non-bacterial cells. To do this, they only needed to introduce the gene that cuts the targeted viral DNA in bacteria--the CRISPR-associated protease (Cas). Basically, it seems that almost any gene in most cells can be cut by introducing DNA that makes the Cas protein and a CRISPR construct with a short sequence that recognize some small part the gene. Even though a cell will fix a gene that has been cut, it does not get fixed correctly (because of the way Cas cuts it).  Then, the gene will no longer work, so it has been "knocked out".

Inactivating or "knocking out" genes is a common approach researchers use to understand how particular genes function and also generate mice or rat strains that model various human diseases. One of the big difficulties of engineering animals with certain genes knocked out, though, is that almost all genes come in pairs--one from each parent. Both copies of a gene need to be inactivated to fully knockout a gene. Unless the knock out technique is very efficient, this is rare. However, the CRISPR approach seems to be exceptionally effective.

In a Cell publication this week, the researchers in Dr. Jaenisch's lab describe how they were able to simultaneously and specifically knock out two genes with a single injection of a mouse embryo. Further, they also used the technique to produce embryonic mouse stem cells with disruptions of 5 distinct genes simultaneously. Mice produced using these embryonic stem cells would then carry all 5 of these mutations.

For a more information, you can read the press release from the Whitehead Institute at MIT describing the paper.

Thirteen of the world's leading stem cell researchers just published a statement in the European Molecular Biology Organization (EMBO) Journal expressing alarm about initiatives to deregulate stem cell therapies. Recent actions by the Italian government allowing unapproved stem cell treatments precipitated the researchers' statement.

Last year, the Italian Medicines Agency or AIFA (equivalent to the FDA in the US), ordered a halt to unapproved stem cell treatment program being carried out at the Brescia Civilian Hospital on the basis that there was no scientific evidence for its effectiveness. The treatment was being done under the direction of the Stamina Foundation, founded by Davide Vannoni, a psychology professor at the University of Udine. According to an article in Nature, 32 terminally ill patients, mostly children, were being treated using the therapy. However, the treatment was never approved by AIFA.

Protests in response to the interruption of the treatment prompted Italy's Minister of Health, Renaldo Balduzzo to override the AIFA order in March. Despite the strong objections in an open letter to the Minister from thirteen Italian scientists researching stem cells, the Italian Parliament, in one of its last acts before new elections, issued a decree allowing the Stamina therapy to continue.

As a result, the authors of the EMBO article felt the need to emphasize the importance of "strident regulation" of medical applications of stem cells to ensure "the translation of science into effective therapies." They point to the current situation in Italy, as well as recent stem cell regulatory battles in the US and a case in Germany in which unregulated stem cell treatments resulted in death, as examples of how rules set out by regulatory bodies such as the FDA and EMA have so far been effective in protecting patients from serious risks associated the indiscriminate use of unproven therapies, and voice their concern that these rule seem to be changing for stem cell therapies.

In reference to the current case in Italy, the article notes that, "The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulation." Also, the authors understand the augment for reinstating treatment in the Italian case was that "safety is not a concern in the face of severely ill children or adults, for whom there are no therapeutic alternatives." However, they emphasize that:

"Compassion only applies when one offers a safe and potentially effective remedy. That a remedy is effective must be supported by published clinical data. If such data are not available, there is no legitimate assumption of effectiveness in the individual patient, and therefore no 'compassion'."

You can read more about the article in the press release from EMBO.

Much has been made of the importance of the lawsuit brought by the Association of Molecular Pathology and the ACLU against Myriad Genetics over the BRCA patents. The case was just heard by the Supreme Court and some feel a decision in favor of Myriad's patents would stifle research and enable companies to own our genes, whereas others voice concern that a decision against Myriad would undermine the biotech industry and stop the flow of innovative new medical technology. In fact, both positions seem a bit overblown.

Although the case has important legal implications, the Court's ruling is unlikely to cause a sea change in the biotech industry or biomedical research. Myriad Genetics is a 20 year old biotech company with over $500 million in annual revenue and a strong technology base, and investigators have been busily pursuing gene-related research since before Myriad was founded without running afoul of the tens of thousands of gene patents that have been granted since the mid-1980s. Large numbers of life science researchers at public and academic institutions regularly interact and collaborate closely with companies, and have done so for a few decades. The situation with Myriad is actually an outlier that seems to have arisen more from Myriad's business practices than from legal issues.

To get a sense of what prompted the lawsuit and what is really at stake in the Myriad Case, take a look at The Significance of the Myriad Gene Patent Decision.