Archive for the ‘Organization/Business News’ Category

Limelight Networks v. Akamai Tech. – Cert. Denied

Monday, April 18th, 2016

Today the Supreme Court declined to hear Limelight’s petition for cert. on the question of whether an accused infringer may be held liable for direct infringement of a claim to a method where multiple parties perform the steps of the method.

On August 13, 2016, the S. Ct. remanded the en banc decision of the Fed. Cir. that set forth the law of divided infringement under s. 271(a), and found that Limelight directly infringed U.S. Pat. No. 6,108,703. The court held that an entity will be found responsible for others’ performance of method steps “(1) where that entity directs or controls others’ performance, [or] (2) where the actors form a joint enterprise.”  (more…)

Therasense In Action – Warren Woessner To Speak At AIPLA

Monday, October 22nd, 2012

On Saturday, October 27th, I will one of the speakers in the Closing Plenary Session of the Annual AIPLA Meeting in Washington, DC. Since I was assigned to do part of the “Ethics” track, I will be speaking on post-Therasense Fed. Cir. opinions. Is the defense of inequitable conduct a limping zombie that can be easily avoided if you don’t just run into a corner and scream, or does it still have fangs? Also speaking on “Ethics – Privacy” will be Prof. Paul Ohm from the University of Colorado School of Law. David H. Harper will sum up the year in copyrights and trade secrets, Steven J. Wadya will handle trademark law developments, and Mark Lemley of Stanford will do the patent law wrap-up.  Moderator Mary Kocialski of Oracle will try to keep us on schedule (Good Luck!).

From a biotech perspective, probably the most interesting session will be the Educational Session sponsored by the Biotechnology/IP Practice in Europe and (I think) the Chemical Practice Committees from 330-530 on Thursday that will – thoroughly, I am sure – discuss the “antibody exception” to the written description requirement. Apparently, reports of its demise in the wake of Ariad were untimely. I particularly anticipate learning the USPTO perspective. Now, how about a session on patenting diagnostic assays post-Prometheus and Myriad?

Savior or Candidate for “Worst Patentee”? Nutriset

Wednesday, September 8th, 2010

Last Sunday’s New York Times magazine had a provocative article about Plumpy’nut, a nutritive peanut paste that is foil-packaged so it does not need refrigeration. When eaten by malnourished children it can “cure” them in a relatively brief period of time. It is being touted as nearly a miracle food for countries in Africa or Central America, since peanuts are a cheap commodity in many of these countries and the product also does not require reconstitution with water.

However, Nutriset, a French company, is described as having patented this product essentially world-wide, and is characterized as aggressively defending its patents. (A copy of the U.S. patent is available at the end of this post.) Apparently, it has licensed the product in two African countries, but wants to make it in France. The advantages to, not just the health, but the economies of third-world countries, if they could manufacture and package the product locally, are clear. In fact, one organization has built a “factory” in Haiti and is making the product there. (Probably no Fed. Cir. equivalent to worry about.)

While recipes are notoriously difficult to patent in the U.S., it can be done, and the article reports that there is a U.S. patent on Plumpy’nut, which doesn’t expire until 2017. It is apparently the subject of an inter partes reexamination request, and so may not be around long. But if it is cancelled, the plot only thickens. The author speculates that big food companies, like General Mills or Cargill, may want to get into the business of manufacturing this or similar supplements and selling them to relief organizations, who would do the distribution. This may benefit a lot of children but it won’t do much for economic development in these countries and ultimately, may just provide lots of older and larger stomachs that need to be filled with something more substantial than fortified peanut butter.

patent 6346284


Is The “Golden Rule” Of Biological Drugs At Hand?

Tuesday, April 13th, 2010

I just finished speaking on IP issues involving biomarkers at a Q1 Conference in the Bay Area. Before the conference started, I spoke to the head patent counsel of a well-known bio/pharma company. He said, to my initial shock, that he thought new drugs based on small molecules were on the way out as commercial products. He was mostly focused on the difficulty he was having in getting claims allowed in the PTO, but his comments resonated with the comments of the first speaker, who pointed out, as did others, that it takes about 14.5 years from preclinical work to launch a new drug (small molecule or biological).

Now, taking that as a good estimate, and considering that a patent filed in the U.S on a drug at the beginning of the development period will have only about 5.5 years of life left when the product launches – less if it is filed in the pre-clinical stage – I jotted some quick notes from the speaker’s timeline. Patent term extension based on her figures for clinical trials and FDA approval delay would yield a patent term extension of only about 3.5-4.5 years. So the innovator only has about ten years to make a profit on its investment. The innovator will get five years of data exclusivity when the drug is approved, but the patent has more life than that, so the NCE exclusivity doesn’t add to the “product life cycle.” Also, the innovator can extend only one patent, so the generics have a clear target to zero in on via para. IV filings.

Of course, this is not the entire story, as the innovator can file add-on patents, including “label patents,” but these are both increasingly difficult to obtain post-KSR and easier to attack (e.g., via reexamination). Contrast this with the situation for a new biological drug, as set forth in the Obama Health Care Bill. No matter how long the development period, the innovator gets 12 years of data exclusivity from product approval/launch. Now there is no patent-based exclusivity for the generic company to attack or, I should say, attacking the patents won’t get the generic approved. So they are pretty much stuck in neutral. (See my recent post on the biologicals rules in the Health Care Bill.)

The FDA just announced an NIH-sponsored trial dubbed I-SPY 2 that will use genetic markers from patients’ tumors to identify which of five cancer drugs they will receive. The trial will evaluate the effectiveness of five investigational drugs from Abbott, Amgen, and Pfizer. Guess what? The names given in the post ( all end in “mab” or “nib.” So which business would you rather be in today, if drug discovery and development is your thing?