Goal To increase innovation through grants of exclusive rights. To ensure safety and efficacy of drugs.
Defaults “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.
Reviewer Only one or two examiners. (Two examiners if the primary examiner does not have signatory authority). Multiple reviewers from an array of specialties.
Who Reviews 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.
Timing 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.
Costs 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. Long-term involvement.
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.