||To increase innovation through grants of exclusive rights.
||To ensure safety and efficacy of drugs.
||“A person shall be entitled to a patent unless . . . .” Thus, the default is to allow a patent.
||No presumption of safety or efficacy. The default position is to reject a drug application.
Default is rejection unless applicant shows otherwise. This is an important difference because you might get more information in the FDA process compared to the USPTO process.
|Burden of Proof
||The USPTO examiner has the burden to show that the application is not patentable. The examiner must locate and analyze the most relevant prior art references.
||The applicant has the burden to show that the new drug is safe and effective.
The applicant must submit references and data (clinical trials) to show safety and efficacy.
|Access to Agency to Applicant Exchanges
||Information is open, available, and easily accessible to the public. Conversations between the patent examiner and applicant are made of record and placed on a publicly available website, Public Patent Application Information Retrieval (PAIR).
||Most information is confidential, difficult to obtain, and not readily available to the public.
||Only one or two examiners. (Two examiners if the primary examiner does not have signatory authority).
||Multiple reviewers from an array of specialties.
||Usually a Ph.D. scientist in TC1600. (Not an M.D.).
||A host of Ph.D.s and M.D.s, often including e.g., statisticians, microbiologists, pharmacologists, and therapeutic subject matter experts.
||Patent prosecution usually 1–2 years after first office action.
||Approval process can take several years. But then you still have follow-up involvement throughout marketing and post-approval monitoring.
|Hours in Review
||Usually less than forty hours.
||Thousands of man hours.
||Usually less than $30,000.
||Average of $985.3 million.
|Post Grant Review
||IPR/ex parte reexamination/supplemental examination
||Automatic-continuous monitor of safety/efficacy.
|Involvement After Agency Grant
||Very little involvement—most examiners don’t even know if their granted patents underwent litigation.
|Consequences of Agency Error
||Higher drug prices.
Patent thickets might deter market entry.
Lack of improvements by others.
Unavailability to certain populations.
|Large negative costs, including health and economic consequences.
Nonadherence to drug regimen due to high drug costs.