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.

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

On February 20, 2019, the PTAB held that the statutory grace period for PTO papers and fees due on a weekend or federal holiday applies to the one-year deadline for filing IPR petitions under 35 U.S.C. § 315(b). Under longstanding PTO practice, the Office has accepted filings after a formal deadline if that deadline fell on a weekend or federal holiday and the filing is completed on the next Continue Reading PTAB Applies Statutory Grace Period for Weekends and Holidays to IPR Petitions

We previously published a post on the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., and Helsinn’s subsequent petition for certiorari.

On January 22, 2019, the Supreme Court affirmed the Federal Circuit in a unanimous decision, holding that a commercial sale to a party who is required to keep the invention confidential can still constitute prior art Continue Reading Helsinn Update: The Supreme Court Preserves the Substance of the Pre-AIA On-Sale Bar

In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.

Continue Reading ANDA Filers with Paragraph III certifications = standing to appeal Inter Partes Review decisions according to Federal Circuit

Today, the U.S. Patent and Trademark Office announced “revised guidance for subject matter eligibility under 35 U.S.C. § 101,” and “guidance on the application of 35 U.S.C. § 112 to computer-implemented inventions.”  The guidance documents are available in the Federal Register and will take effect on Monday, January 7, 2019. Continue Reading USPTO Announces Revised Guidance for Sections 101 and 112

In a previous post, we reported that in Proppant Express Investments v. Oren Techs., a panel of the PTAB held that 35 U.S.C. § 315(c) allows only joinder of other parties to an IPR, and not same-party joinder of new patentability issues.  See IPR2018-00914, Paper 21 at 4-6.

In a recent order, the PTAB’s new Precedential Opinion Panel decided to review the Proppant holding on issue joinder, which appeared to differ from earlier rulings in similar cases.  The Panel expressly noted that “Board decisions conflict on the proper interpretation of 35 U.S.C. § 315(c)”:

Compare, e.g., Target Corp. v. Destination Maternity Corp., Case IPR2014-00508 (Paper 28) (Feb. 12, 2015) (concluding that 35 U.S.C. § 315(c) permits a petitioner to be joined to a proceeding in which it is already a party), with SkyHawke Techs., LLC v. L&H Concepts, LLC, Case IPR2014-01485 (Paper 13) (Mar. 20, 2015) (reaching opposite conclusion).
IPR2018-00914, Paper 24 at 2.  The Panel will include Andrei Iancu, Director of the US Patent and Trademark Office, Drew Hirshfeld, Commissioner of Patents, and Scott Boalick, Acting Chief Judge of the PTAB.
The Panel will address three questions related to issue joinder:
  1. Under 35 U.S.C. § 315(c) may a petitioner be joined to a proceeding in which it is already a party?
  2. Does 35 U.S.C. § 315(c) permit joinder of new issues into an existing proceeding?
  3. Does the existence of a time bar under 35 U.S.C. § 315(b), or any other relevant facts, have any impact on the first two questions?

IPR2018-00914, Paper 24 at 2.  The parties and any amicus curiae may submit briefs, of no more than 15 pages, no later than December 28, 2018.  Id. at 3.  The parties may then file response briefs, of no more than 10 pages, no later than January 14, 2019.  Id.

IPR petitioners Proppant Express Investments, LLC and Proppant Express Solutions, LLC (collectively, “PropX”) have a pending instituted inter partes review (IPR) on certain claims of U.S. Patent No. 9,511,929 (“the ’929 patent”).  Unfortunately for PropX, it mistakenly grouped its arguments against one of the dependent claims—claim 4—into the wrong ground, which led the Patent Trial and Appeal Board (the “Board”) to deny institution of IPR of that claim, due to inadequate support.  IPR2017-02103, Paper 19 at 32, 34.  After institution, PropX sought to amend the petition to move claim 4 into the proper ground.  The Board denied PropX’s request because PropX was not diligent: despite Patent Owner’s (“Oren”) Preliminary Response pointing out PropX’s mistake, PropX failed to notice the mistake until after institution.  IPR2017-02103, Paper 22.

Continue Reading PTAB Holds that 35 U.S.C. § 315(c) Prevents Same-Party Joinder of Issues to An Instituted IPR

As we have reported in several recent posts, the PTAB often rigorously evaluates public accessibility when considering non-patent prior art.  Disputes over accessibility are often pivotal because insufficient evidence of accessibility can disqualify a reference as a “printed publication” under § 102.  The Federal Circuit recently expanded on the applicable standard for online publications in a case rooted in computer technology, but the decision provides relevant insights for life science practitioners as well. Continue Reading Federal Circuit Upholds PTAB Decision Finding Library Website’s Indexing and Search Capabilities Insufficient to Establish Public Accessibility