| 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. |