Top Ten Schools Patenting Multicell Organisms or Parts

So why do we want to know who is patenting multicellular organisms or their parts?  That will depend on whether the reader is interested in getting into a school that is actively considering commercialization possibilities in this particular area or a Research/Development  Engineer trying to determine who in the academic world is actively patenting.  Agricultural companies are particularly active in this area.  Next several posts will cover top ten schools and corporations in the area of medical devices, prosthetics, drugs, etc.  These articles will be of interest to any job seekers who want to narrow down their list of possibilities as well as practicing engineers, program managers looking for competitive intelligence.  Actual number of patents over a five year period is available for all the schools and companies listed.  Contact me if you are interested.

SCHOOL
University Of California, The Regents Of
Michigan State University
North Carolina State University
Iowa State University Research Foundation Inc.
Rutgers University
University Of Arizona
Louisiana State University
Ohio State Research Foundation
University Of Arkansas
University Of Georgia Research Foundation, Inc.

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Regulatory: FDA Is Equipping The Park Doctrine

The FDA has become increasingly active in its determination to discipline apparently unrepentant pharmaceutical firms.  Now its getting personal, again.  After years of neglect the usefulness of the Park Doctrine has been rediscovered by the FDA.  The evidence needed to apply it to a “responsible corporate official” appears to be nil.  The definition of a “responsible corporate official” is nearly as vague.  It would seem to be a good time for anyone attempting to skirt FDA regulations to tread lightly.   Although the initial violation of the Federal Food, Drug, and Cosmetic Act is considered a misdemeanor a second violation is a felony.  It should be noted that transgressions in the Food and Cosmetics areas are also included by default if not intent.

From 6-5-3 – Special Procedures and Considerations for Park Doctrine

Recommending Park Doctrine Prosecutions

The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense. A Park Doctrine prosecution, for the purposes of this section, refers to a recommended prosecution of a responsible corporate official for a misdemeanor violation of the Act.

Misdemeanor prosecution under the Act can be a valuable enforcement tool. Such prosecutions are referred to the Department of Justice. Once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is a felony, even without proof that the defendant acted with the intent to defraud or mislead. Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities. In some cases, a misdemeanor conviction of an individual may serve as the basis for debarment by FDA.

When considering whether to recommend a misdemeanor prosecution against a corporate official, consider the individual’s position in the company and relationship to the violation, and whether the official had the authority to correct or prevent the violation. Knowledge of and actual participation in the violation are not a prerequisite to a misdemeanor prosecution but are factors that may be relevant when deciding whether to recommend charging a misdemeanor violation.

Other factors to consider include but are not limited to:

  1. Whether the violation involves actual or potential harm to the public;
  2. Whether the violation is obvious;
  3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
  4. Whether the violation is widespread;
  5. Whether the violation is serious;
  6. The quality of the legal and factual support for the proposed prosecution; and
  7. Whether the proposed prosecution is a prudent use of agency resources.

As the Supreme Court has recognized, it would be futile to attempt to define or indicate by way of illustration either the categories of persons that may bear a responsible relationship to a violation or the types of conduct that may be viewed as causing or contributing to a violation of the Act. In addition, these factors are intended solely for the guidance of FDA personnel, do not create or confer any rights or benefits for or on any person, and do not operate to bind FDA. Further, the absence of some factors does not mean that a referral is inappropriate where other factors are evident.”

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Innovation: Don’t Be Afraid To Question The Accepted Theory

Apparently the gyroscopic and caster effects are not the only mechanical forces working on a bicycle to keep it upright as it rolls along.   According to a Cornell University based team a bicycle with a high center of gravity at the rear and low center of gravity up front can keep itself upright while rolling along a flat surface even if gyroscopic and caster effects are eliminated or cancelled. The explanation given is that once a suitably designed bicycle with the described characteristics, no caster and minimal gyroscopic effects, is set in motion the front end will always “fall” first and cause the bicycle to steer into the direction of the fall.

This is a striking example of how a commonly accepted engineering theory can turn out to be incomplete.  It shouldn’t be a surprise.  It happens in science all the time as old theories are found to be incomplete and new ones take their place.  This incomplete aspect of accepted theories can delay certain types of innovation.  Typically it takes a focused look by motivated engineers and scientists to tease out the most complete explanation and insights into the phenomenon in question.   Much of this learning is lost as experienced engineer retire and are not considered for lecturing or teaching positions.

I would also like to note that appropriate depth of theoretical and applied knowledge is very important to create an engineering solution.  Just knowing the correct equations to apply is not enough.  If that were the case then the CAD designed and FEA modeled automobiles of today would never have recalls for design defects.  An engineering team must see, feel and smell the results of their designs first hand in the laboratory to ascertain the limits of their engineering theories and tools.  Only then can they correct the identified shortcomings and eventually deliver a well designed product.

For a more complete explanation see below.

A Bicycle Can Be Self-Stable Without Gyroscopic or Caster Effects

Stable Bicycle

History of thoughts about bicycle self-stability

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