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Liam Nelson
Liam Nelson


Published international applications are available on PATENTSCOPE, one of WIPO's global databases. This database also includes patent documents from 76 participating Offices providing public access, free of charge to over 107 million technology disclosures.


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Today the White House announced major steps to improve incentives for future innovation in high tech patents, a key driver of economic growth and good paying American jobs. The White House issued five executive actions and seven legislative recommendations designed to protect innovators from frivolous litigation and ensure the highest-quality patents in our system. Additionally, the National Economic Council and the Council of Economic Advisers released a report, Patent Assertion and U.S. Innovation, detailing the challenges posed and necessity for bold legislative action.

Today the Administration is also announcing a number of steps it is taking to help bring about greater transparency to the patent system and level the playing field for innovators. Those steps include:

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.

See 21 C.F.R. 314.50 Content and format of an NDASee 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patentSee 21 C.F.R. 314.53 Submission of patent informationSee 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 resubmissionSee 21 C.F.R. 314.70 Supplements and other changes to an approved NDASee 21 C.F.R. 314.94 Content and format of an ANDASee 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patentSee 21 C.F.R. 314.96 Amendments to an unapproved ANDASee 21 C.F.R. 314.97 Supplements and other changes to an ANDASee 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 ANDASee 21 C.F.R. 314.108 New drug product exclusivitySee 21 C.F.R. 316.31 Scope of orphan-drug exclusive approvalSee 21 C.F.R. 316.34 FDA recognition of exclusive approval

9. What is a patent submission date?A patent submission date is the date on which the FDA receives patent information from the new drug application (NDA) holder. See 21 C.F.R. 314.53(d)(5).

12. How should an NDA holder correct or request removal of patent information?An NDA holder must submit a correction or change to previously submitted patent information on a new Form FDA 3542. For changes to descriptions of approved methods of use, see question 14.

13. Should an NDA holder submit patent information when seeking approval of a supplement?An NDA holder must submit patent information when it seeks approval of a supplement to add or change the dosage form or route of administration, to add or change the strength or to change the drug product from prescription use to over-the-counter use.

For supplements that seek approval for other changes (for example, to change the formulation, to add a new indication or other condition of use, or to make any other patented change regarding the drug substance, drug product, or any method of use), the requirements for submitting patent information depend on whether the existing patent information in the Orange Book for the original NDA continues to claim the changed product:

14. When may an NDA holder amend the description of the approved method(s) of use claimed by the patent?An amendment to the description of approved method(s) of use claimed by the patent will be considered timely if it is submitted within 30 days of: (1) patent issuance, (2) approval of a corresponding change to product labeling, or (3) a decision by the U.S. Patent and Trademark Office or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent (and the amendment contains a copy of the decision). Outside of these circumstances and except as provided in the patent listing dispute regulation (21 CFR 314.53(f)(1)), an amendment to the description of the approved method(s) of use claimed by the patent will not be considered timely filed.

15. What actions must a pending ANDA or 505(b)(2) applicant take if patent information is untimely filed?If patent information is untimely filed, generally a previously submitted ANDA or 505(b)(2) applicant is not required to submit a patent certification or statement to address the patent or patent information that is late-listed with respect to the pending ANDA or 505(b)(2) application.

16. Is there a specific format in which patent information needs to be submitted to the agency?If the NDA applicant is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, use Form FDA 3542a. If the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug after approval of an NDA or supplement, use Form FDA 3542. The agency will not list or publish patent information in the Orange Book if it is not provided on Form FDA 3542.

18. Does previously submitted patent information have to be re-submitted on the new Forms FDA 3542 and 3542a? No. While any patent information submitted after the effective date of the final rule must be submitted in a manner consistent with the final rule, including use of the new forms, NDA holders and applicants are not required to re-submit patent information previously submitted on a prior version of the form.

These rules apply to all civil actions filed in or transferred to this Court which allege infringement of a utility patent in a complaint, counterclaim, cross-claim or third party claim, or which seek a declaratory judgment that a utility patent is not infringed, is invalid or is unenforceable. The Court may accelerate, extend, eliminate, or modify the obligations or deadlines set forth in these Patent Rules based on the circumstances of any particular case, including, without limitation, the complexity of the case or the number of patents, claims, products, or parties involved. If any motion filed prior to the Claim Construction Hearing provided for in P. R. 4-6 raises claim construction issues, the Court may, for good cause shown, defer the motion until after completion of the disclosures, filings, or ruling following the Claim Construction Hearing. The Civil Local Rules of this Court shall also apply to these actions, except to the extent that they are inconsistent with these Patent Rules. The deadlines set forth in these rules may be modified by Docket Control Order issued in specific cases.

These Patent Rules shall take effect on February 22, 2005 and shall apply to any case filed thereafter and to any pending case in which more than 9 days remain before the Initial Disclosure of Asserted Claims is made. The parties to any other pending civil action shall meet and confer promptly after February 22, 2005, for the purpose of determining whether any provision in these Patent Rules should be made applicable to that case. No later than 7 days after the parties meet and confer, the parties shall file a stipulation setting forth a proposed order that relates to the application of these Patent Rules. Unless and until an order is entered applying these Patent Local Rules to any pending case, the Rules previously applicable to pending patent cases shall govern.

(c) Electronic Filings. All patents attached as exhibits to any filing submitted electronically shall be in searchable PDF format. Any other documents attached as exhibits to any filing submitted electronically should be in searchable PDF format whenever possible.

(b) Requests seeking to elicit from the patent claimant a comparison of the asserted claims and the accused apparatus, product, device, process, method, act, or other instrumentality;

Not later than 10 days before the Initial Case Management Conference with the Court, a party claiming patent infringement must serve on all parties a "Disclosure of Asserted Claims and Infringement Contentions." Separately for each opposing party, the "Disclosure of Asserted Claims and Infringement Contentions" shall contain the following information:

(f) If a party claiming patent infringement wishes to preserve the right to rely, for any purpose, on the assertion that its own apparatus, product, device, process, method, act, or other instrumentality practices the claimed invention, the party must identify, separately for each asserted claim, each such apparatus, product, device, process, method, act, or other instrumentality that incorporates or reflects that particular claim. 041b061a72


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