An order from the Federal Circuit on October 15 suggests the court may be close to holding that the PTAB has been operating in violation of the Appointments Clause, which could significantly disrupt PTO operations.  The case presents important questions: whether the PTAB’s judges have been lawfully appointed, and if not, what happens to decisions that have been issued by panels of those judges? Continue Reading Constitutional Challenge under the Appointments Clause May Upend PTAB Proceedings

Today, the PTAB’s Precedential Opinion Panel issued a precedential decision holding that even a deficient pleading triggers the one-year IPR filing period.  GoPro, Inc. v. 360Heros, Inc., IPR2018-01754 (PTAB Aug. 23, 2019) (Paper 38)Continue Reading PTAB Issues Precedential GoPro Decision That Even Service Of “Deficient” Complaint Starts IPR Time Clock

On July 30, the Federal Circuit issued a decision in Celgene Corporation v. Peter (Nos. 2018-1167, -1168, -1169, and -1171), where the patent owner argued that the PTAB’s authority to cancel claims through IPR amounted to an unconstitutional taking as applied to pre-AIA patents. Numerous patent owners have raised similar challenges since the Supreme Court expressly reserved judgment on the issue in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 138 S. Ct. 1365, 1379 (2018). The Federal Circuit’s decision puts that issue to rest (at least for now) and confirms that all issued patents remain subject to IPR.

Background

The Celgene appeal arose Continue Reading Federal Circuit Rejects Latest Constitutional Challenge to Inter Partes Review

Previously, Emily Greb posted on the Supreme Court’s decision in SAS Inst. Inc. v. Iancu, Dir. U.S. Pat. & Trademark Off., 138 S. Ct. 1348 (2018), which held that when the Board institutes an inter partes review, it must decide the patentability of all claims challenged in the IPR.

Now, Emily and Tyler Bowen, with assistance from Gene W. Lee, Bryan D. Beel, and Maria A. Stubbings, have published a short research paper entitled The Supreme Court’s SAS Decision: Has All-Or-Nothing Institution Created A Wave Of Change? [PDF] Continue Reading The Effect Of SAS Institute v. Iancu On IPR Practice

On June 10, 2019, the Supreme Court held that a federal agency is not a “person” who can file a petition for review of a patent under one of the three new proceedings created by the America Invents Act (“AIA”).  Return Mail, Inc. v. United States Postal Service, 587 U.S. ____, 2019 WL 2412904, at *3 (U.S. June 10, 2019) (“Return Mail“).  Specifically, the Court held that federal agencies cannot file a petition for inter partes, post-grant, or covered business method review with the Patent Trial and Appeal Board (“PTAB”) (collectively, “PTAB proceedings”).  Id. Continue Reading Supreme Court Prevents the Government from Challenging Patents in PTAB Proceedings

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