Wednesday, February 20, 2013

Patent Rights, Exhaustion Doctrine, and Monsanto

On February 19, 2013, the Supreme Court heard oral arguments in Bowman v. Monsanto Co., involving an Indiana farmer who replicated Monsanto’s patented seeds them without paying the company a fee. Farmers who buy this patented seed must generally sign a contract promising not to save seeds from the resulting crop, which means the farmers must buy new seeds every year. Vernon Bowman had signed such contracts for his main crop but used what he thought was loophole: Rather than replant his own seed, he bought seed from a grain elevator filled with a mix of other farmers’ seeds.

The Roundup Ready soybean is the most popular variety in the U.S., so it was reasonably certain Bowman would receive mostly patented soybeans from the elevator. Mr. Bowman planted these seeds, then sprayed them with Roundup, so only the Roundup Ready soybean plants survived, and he saved those seeds for further plantings.

Mr. Bowman argued that the doctrine of patent exhaustion allowed him to do what he liked with products he had obtained legally. Under this doctrine, when an owner of intellectual property sells a copy of the property, the buyer is free to do what it wishes with the product. However, Justice Sonia Sotomayor noted, “The exhaustion doctrine permits you to use the good that you buy. It never permits you to make another item from that item you bought.”

The farmer’s lawyer said that companies could rely on contracts rather than patent law to protect their inventions. Justice Elena Kagan said, “It seems to me that that answer is purely insufficient in this kind of a case, because all that has to happen is that one seed escapes the web of these contracts, and that seed, because it can self-replicate in the way that it can, essentially makes all the contracts worthless.”

Justice Stephen G. Breyer said that there are lots of things someone could do with the seeds he had bought from the grain elevator. “You can feed it to animals, you can feed it to your family, make tofu turkeys … But I’ll give you two that you can’t do. One, you can’t pick up those seeds that you’ve just bought and throw them in a child’s face. You can’t do that because there’s a law that says you can’t do it. Now, there’s another law that says you cannot make copies of a patented invention.”

This intentional replication of the patented seeds infringes the patent, the same as someone makes thousands of copies of a CD he purchased. As Justice Breyer implied, this case really has nothing to do with the exhaustion doctrine and really is groping for a new doctrine or a new right for farmers to reproduce patented seed. This would make seed patents largely worthless.

As Chief Justice Roberts asked, “Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?”

Sunday, February 10, 2013

Listeria and soft-ripened cheese risk assessment

On Friday the U.S. Food and Drug Administration announced a draft quantitative assessment of the risk of listeriosis from soft-ripened cheese consumption in the United States and Canada. The risk assessment is a joint effort between FDA and Health Canada. View the Federal Register Notice for the assessment.

The new FDA/Health Canada draft risk assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

While raw milk and raw milk products put all consumers at risk, the bacteria they may contain can be especially dangerous to people with weakened immune systems, older adults, pregnant women and children. View guidelines for avoiding illness by choosing milk and milk products carefully.

FDA invites comments that can help FDA and Health Canada improve:
·       the approach used;
·       the assumptions made;
·       the modeling techniques;
·       the data used; and
·       the clarity and transparency of the draft quantitative risk assessment documentation.
To submit comments electronically, go to docket FDA-2012-N-1182 on The comment period opens February 11, 2013 for 75 days.

Tuesday, February 05, 2013

Improving Import Safety

Improving Import Food Safety presents diverse authors on the issues and difficulties involved in import food safety. The cases histories and factual information highlight both U.S. and international perspectives and provide insight for going forward.