Archive for the ‘Organization/Business News’ Category

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 (fdanews.com) all end in “mab” or “nib.” So which business would you rather be in today, if drug discovery and development is your thing?

UNIVERSITY OF PITTSBURGH v. HEDRICK – ON A (CLEAR) CONCEPTION DAY

Monday, July 27th, 2009

From a prosecutor’s standpoint, the ’231 patent (link at bottom of this post) has “dream claims” to a new class of stem cells. Claim 1 reads:

An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

Adipose is “fat”, and because there is so much of it around, and it is easy to obtain, it may nearly be an ideal source for “pluripotent stem cells.” During prosecution, the inventors had to convince the Examiner that these fat-derived stem cells were patentably distinct from mesenchymal stem cells (MSC). Other groups had derived these pluripotent MSCs from bone marrow, and they could be induced to form the same tissue types. Several companies are investigating the use of these cells to repair heart attack damage. For those two or three of you who have not been keeping up with stem cell technology and patent developments, I refer you to my article in JPTOS, vol. 83, 830 (2001).

An inventorship dispute arose between the two inventors who began the work that led to the ’231 patent at the University of Pittsburgh, and a visiting scientist who worked at Pittsburgh and then returned to UCLA and worked with another scientist to further characterize the cells. Although Pittsburgh listed both their inventors and the two UCLA inventors on a provisional, a PCT and the application that issued as the ’231 patent, Pittsburgh tried to remove the two UCLA inventors from the ’231 patent shortly after it issued. Not surprisingly, the UCLA inventors resisted being removed. (Decision is App. No. 2008-1468, July 23, 2009, a link is provided at the bottom of this post.)

The Federal Circuit found sufficient evidence to hold that the two Pittsburgh inventors had conceived of the claimed invention prior to the involvement of the UCLA researchers. The fact that the UCLA researchers confirmed certain properties of the cells was not a contribution sufficient to make them co-inventors, and ultimately, the court held that, while the Pittsburgh inventors were not certain that the stem cells would behave as expected, nonetheless they had the “firm and definite idea that these properties existed in [the cells].” At this point, work by others that confirms your educated guess is simply part of reduction to practice.

As interesting as is the resolution of the inventorship dispute, the resolution of the claim construction issue occupies almost four pages of the decision, and helps expand the notion of “patent profanity” that I discussed in the earlier post about the Sandoz decision. Here, the UCLA scientists urged a more limited definition of “adipose-derived stem cell” that they believed would encompass their contributions: “a species of stem cell distinct from the mesenchymal stem cell (MSC) that is obtainable from bone marrow tissue.”

The Federal Circuit affirmed that the plain meaning of the claim term was simply “derived from fat tissue.” The court then examined the specification and prosecution history to determine if there were any contradictory definitions in the specification or a “unmistakable disavowal” of the plain meaning by applicants during prosecution. The court found that the proposed narrower definition would require that the cells be a “separate species” than MSCs and that the specification did not assert that this was the case (even though the fat-derived stem cells have different isolation requirements).

Notably, even though the applicants submitted evidence derived from work at UCLA to establish that the cells were patentably distinct from MSCs, and the Examiner relied on this submission, the court specifically held: “This is not a disavowal.” The court found only a “weak inference from the summary [by the Examiner] that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term.” The court even delved into the science to support its holding, stating that there was a theory that MSCs could travel to fat tissue and be changed by the new environment they encountered. (Are all adult stem cells the same cell?)

If there is a take-away lesson here, it is that unmistakable disavowal of otherwise undisturbed plain meaning must be really unmistakable before it will be used to narrow claim scope. Here, the patentee was saved from the effects of “patent profanity” because they apparently did not urge during prosecution that the claimed cells were a “distinct species” of stem cell, as opposed to simply having some distinct properties. A close call, but in the end, the Pittsburgh inventors were “safe” and the UCLA inventors were out at the plate.

Patent 206777231
Univ of Pittsburgh v Hedrick