By way of background,

Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy. To seek this approval, a generic applicant must provide in its application a ‘certification’ that a patent submitted to FDA by the brand-name drug’s sponsor and listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) is, in the generic applicant’s opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product. This certification is called a ‘paragraph IV certification.’ The first company or companies to submit an application that (1) is determined by the agency to be ‘substantially complete’ upon submission and (2) contains a paragraph IV certification to at least one of the patents listed in the Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.

Today, the FDA announced [press release] that it is increasing the amount of information provided to the public and generic-drug applicants in the FDA’s Paragraph IV Certifications List, “to provide transparency and assist generic drug applicants with planning regarding their [abbreviated new drug] applications” (ANDAs):

Today, we are enhancing the Paragraph IV Patent Certifications List by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products, along with other information about the dates of first approval, marketing status and expiration dates of blocking patents. Providing this information may help subsequent generic drug applicants determine when their products can be approved and marketed.

Previously, the Certifications List included a fairly modest amount of information for generic-drug applicants (including the name of the drug product, name of the reference listed drug, the drug dosage form and strength, and the date of filing of the first substantially complete ANDA with a Paragraph IV certification for the drug product).

FDA is now adding several other columns to its spreadsheet of relevant information, and its List will become more complete as the information becomes available or is determined. The additional columns include:

  • Number of Potential First-Applicant ANDAs
  • 180-Day Exclusivity Decision Status
  • 180-Day Decision Posting Date
  • Date of First Approval of “First Applicant” ANDA
  • Date of First Commercial Marketing
  • Expiration Date of Last Qualifying Patent

You can find more information, including a description of each of these fields, on the FDA’s website at this link: Field descriptions.

An example of the new certification list is here.

During the week of April 15–19, 2019, the Patent Trial and Appeal Board (“Board”) issued two IPR non-institution decisions (on the same patent), two PGR institution decisions, and one IPR final written decision in TC 1600. Continue Reading PTAB Tech Center 1600 Round-Up: Week of April 15-19, 2019

During the week of  April 8, 2019, the Patent Trial and Appeal Board (“the Board”) issued two final decisions and six decisions instituting inter partes review.  The six institution decisions involved two sets of actions, each with three related proceedings. Continue Reading PTAB Tech Center 1600 Round-Up: Week of April 8-12, 2019

In an April 11, 2019 order, Judge Andrews of the District of Delaware ruled that a Hatch-Waxman defendant’s obviousness defenses were precluded under 35 U.S.C. § 315(e)(2) even though the barring PTAB decision issued over a year after the court had held an obviousness trial.  Novartis Pharm. Corp. v. Par Pharm., Inc., No. 14-cv-01289 (D. Del. Apr. 11, 2019), Docket No. 198.  Read on for the details. Continue Reading Court Applies Post-Trial IPR Estoppel Where Final Judgment Didn’t Address All Obviousness Defenses

During the week of March 4, 2019, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600.  One decision denied institution of a petition, and one decision was a final decision finding all claims unpatentable.

Luitpold Pharm., Inc. v. Apicore US LLC, IPR2018-01640 (Decision Denying Institution Entered March 6, 2019): In Luitpold, Continue Reading PTAB Tech Center 1600 Round-Up: Week of March 4-8, 2019

During the week of March 11–15, 2019, the Patent Trial and Appeal Board (“Board”) issued 1 IPR non-institution decision, 1 IPR institution decision, and 4 IPR final written decisions (on the same patent) in TC 1600.

Alvogen Pine Brook LLC v. Celgene Corp., IPR2018-01714

The Board denied institution of Alvogen Pine Brook LLC’s (“Alvogen”) petition Continue Reading PTAB Tech Center 1600 Round-Up: Week of March 11-15, 2019