Furthermore, most university technology transfer officerswho have different motivations from individual researchers-are not focused on increasing public access to public-sector inventions. A recent study found that "university technology transfer activities continue to be predominately patent-centric and revenue-driven with a single-minded focus on generating licensing income and obtaining reimbursement for legal expenses." Current Bayh-Dole patenting and licensing practices have thus been criticized for creating unnecessary increases in consumer prices and for creating patent hold-ups and a patent "anticommons." The access-oriented goals of the Bayh-Dole Act would be fulfilled best if universities and other recipients of federal research
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48 However, the Bayh-Dole Act has resulted in direct institutional ownership of parts of the intellectual property that protects many new drugs.49 To justify granting these private patent rights for government-sponsored inventions, one cannot use the typical innovation incentive of patents, because academic researchers have been innovating long before the Bayh-Dole Act and are primarily motivated by a desire for prestige.so Instead, Bayh-Dole patents typically are justified under commercialization theory-the idea that companies need exclusive patent rights to bring an invention to market."' Commercialization theory is not appropriate for many industries, but exclusive rights may be needed in the pharmaceutical industry because of the high cost of FDA approval and low cost of …show more content…
Under the Hatch-Waxman regime, a brand-name company seeking 26 FDA approval for a new drug must file a new drug application (NDA). In addition to detailed information about the properties of the drug, the application must include "the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted," and this information must be amended as new patents are issued.27 After the drug is approved, the FDA must make this list public. 28 The FDA publication containing new drug information is known as the Orange Book, and it may be searched freely
48 However, the Bayh-Dole Act has resulted in direct institutional ownership of parts of the intellectual property that protects many new drugs.49 To justify granting these private patent rights for government-sponsored inventions, one cannot use the typical innovation incentive of patents, because academic researchers have been innovating long before the Bayh-Dole Act and are primarily motivated by a desire for prestige.so Instead, Bayh-Dole patents typically are justified under commercialization theory-the idea that companies need exclusive patent rights to bring an invention to market."' Commercialization theory is not appropriate for many industries, but exclusive rights may be needed in the pharmaceutical industry because of the high cost of FDA approval and low cost of …show more content…
Under the Hatch-Waxman regime, a brand-name company seeking 26 FDA approval for a new drug must file a new drug application (NDA). In addition to detailed information about the properties of the drug, the application must include "the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted," and this information must be amended as new patents are issued.27 After the drug is approved, the FDA must make this list public. 28 The FDA publication containing new drug information is known as the Orange Book, and it may be searched freely