The Biden administration says it will support lifting patent protections

[BumRushDaShow]

6. That's because of all the patent law

involved in drug and biologics products, as well as medical devices.

https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

Orange Book Frequently Asked Questions

1. What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.

2. How long is a patent term?
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.

3. How long does an exclusivity period last?
It depends on what type of exclusivity is at issue.

Orphan Drug Exclusivity (ODE) – 7 years

New Chemical Entity Exclusivity (NCE) – 5 years

Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities

New Clinical Investigation Exclusivity – 3 years

Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity

Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)

Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

(snip)

6. Where can I find patent and exclusivity regulations in the Code of Federal Regulations (C.F.R.)?

See 21 C.F.R. 314.50 Content and format of an NDA
See 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
See 21 C.F.R. 314.53 Submission of patent information
See 21 C.F.R. 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
See 21 C.F.R. 314.60 Amendments to an unapproved NDA, supplement, or resubmission
See 21 C.F.R. 314.70 Supplements and other changes to an approved NDA
See 21 C.F.R. 314.94 Content and format of an ANDA
See 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
See 21 C.F.R. 314.96 Amendments to an unapproved ANDA
See 21 C.F.R. 314.97 Supplements and other changes to an ANDA
See 21 C.F.R. 314.101 Filing an NDA and receiving an ANDA
See 21 C.F.R. 314.107 Date of approval of a 505(b)(2) application or ANDA
See 21 C.F.R. 314.108 New drug product exclusivity
See 21 C.F.R. 316.31 Scope of orphan-drug exclusive approval
See 21 C.F.R. 316.34 FDA recognition of exclusive approval

Code of Federal Regulations on the Government Publishing Office web site.

They'll probably have to work out NDAs (in this case "NDA" = "Non-Disclosure Agreements" ) and compensation stipulations, etc. I'm not sure (haven't researched it) when they filed the patent for the entity used in the vaccine but I expect it may have been awhile ago (multiple entities including the one they eventually selected to use for the actual vaccine).