The Federal Trade Commission (FTC) has issued final changes to the premerger notification rules that require companies in the pharmaceutical industry to report certain proposed acquisitions of exclusive patent rights to the FTC and the Department of Justice for antitrust review. The revised rules clarify when a transfer of exclusive rights to a patent in the pharmaceutical industry results in a potentially reportable asset acquisition under the Hart Scott Rodino Act.
The FTC assumes that the rule will increase the number of non-index filings from 1,428 to 1,500 per year, which at 37 hours each would yield an incremental burden of 2,664 hours ((1,500 - 1,428) x 37 hours per non-index filing). Thus, added to the existing base of 53,759 hours, cumulative burden under the final amended HSR Rules totals 56,423 hours.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form C4 Non-index Filings
HSR-IP Licensing Final Rule Supplemental Supptg Stmt fin.pdf
Non-index Filings