A Clearinghouse: The Solution to Clearing Up Confusion in Gene Patent Licensing

Article excerpt

TABLE OF CONTENTS

I. INTRODUCTION
II. WHY GENE PATENTS SHOULD NOT BE BANNED
III. STEPPING STONE TO CLARITY: RESOLVING CONFUSION IN
  PATENT TERMINOLOGY AS APPLIED TO BIOTECHNOLOGY
IV. THE SOLUTION: A BIOTECHNOLOGY CLEARINGHOUSE
  A. A Patent Pool: Not the Best Solution
  B. A Clearinghouse: Higher Probability of Success
    1. Providing an Online Searchable Database
    2. Overseeing Licensing Deals
    3. Standardizing Licensing
    4. Setting Licensing Prices
    5. Incorporating Know-How Licensing
    6. Monitoring and Enforcing Licensing Deals
    7. Establishing an Alternative Dispute Resolution System
    8. Divvying Royalty Payments
V. ESTABLISHING THE CLEARINGHOUSE
  A. Membership Fee Schemes
    1. Unequal Fee Scheme
    2. success-Based Fee scheme
    3. Advertisement-Based Funding
  B. Patent Holder Membership is Key
VI. CONCLUSION

I. INTRODUCTION

ALL THE MEANS OF ACTION-- THE SHAPELESS MASSES, THE MATERIALS-- LIE EVERYWHERE ABOUT US. WHAT WE NEED IS THE CELESTIAL FIRE TO CHANGE THE FLINT INTO TRANSPARENT CRYSTAL, BRIGHT AND CLEAR. THAT FIRE IS GENIUS ! (1)

--Henry Wadsworth Longfellow

Although it is safe to assume that Longfellow was not writing about the patent crisis plaguing the biotechnology industry, his words are appropriate to the current situation. over the past half-century, innovations within the genetic diagnostics sector have increased by leaps and bounds. We now have the ability--"[a]ll the means of action"--to detect whether a person has inherited the genes associated with a certain disease well in advance of the onset of any symptoms. Patients who choose to undergo these genetic tests can subsequently take preventive measures that might stave off a disease that they are likely to develop. However, patient access to such tests has been limited due to the intellectual property protection granted to diagnostic tests and the underlying genes--creating a barrier between patent holders and laboratories that would otherwise offer these genetic tests. (2) We have "the shapeless masses, the materials" to diagnose patients with these diseases, but "What we [still] need Is the ... transparent crystal"--the solution to increasing patient access to genetic testing.

A gene patent can be one of three distinct types: (1) a diagnostic patent, (2) a composition of matter patent, or (3) a patent on functional uses. (3) Diagnostic patents typically cover all known methods of testing for a disease based on differences from a normal gene sequence. (4) Composition of matter patents cover a specific isolated and purified gene as well as any derivative products such as recombinant proteins or drugs. (5) Functional use patents typically claim methods or small-molecule drugs that are capable of up- or down-regulating the expression of a gene within a cell--ultimately affecting the gene's functioning. (6)

In the United States, there are approximately 40,000 patents related to human genes. (7) Although only 20% of the human genome is patented, (8) existing patents cover important genes such as those associated with hereditary breast and ovarian cancer, Huntington's disease, and muscular dystrophy. (9) The 40,000 gene patents also include methods and devices used in the diagnosis of genetic diseases. Innovations in diagnostic testing have led to the recent implementation of multiplex testing, which allows clinicians to screen a wide array of genes all at once, saving both time and money. However, the arrays of multiplex testing typically analyze hundreds or thousands of genes (10)--many of which a typical lab is not licensed to use. (11) Consequently, labs will decide to take one of two routes. Either they will forego the use of such tests, even though the technology is available, or they will complete the tests anyway and avoid reporting results on the genes they are not licensed to use. (12)

Gene patents may also be interfering with innovation in multiplex testing technology, as innovators may find it daunting to obtain licenses from all of the many different patent holders of genes that can be simultaneously screened. …