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

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

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

In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.
Continue Reading Obviousness of Overlapping Ranges – The Burden-Shifting Framework Applies to Inter Partes Review: E.I. du Pont de Nemours & Co. v. Synvina C.V.

This morning, the US Patent and Trademark Office issued its final rule implementing district court-style claim construction at the PTAB, replacing the “broadest reasonable interpretation” standard.  The official text of the rule will publish in the Federal Register on October 11, 2018, in final form.  The new rule is not retroactive and will apply to petitions filed on or after the effective date of the final rule, which is Nov. 13, 2018 (i.e., the first federal business day after 30 days from publication). [Note: 30 days from an October 11, 2018 publication falls on Saturday, November 10, 2018, but the PTO’s press release [PDF] reports the effective date as November 13, 2018.]
Continue Reading USPTO Issues Claim Construction Final Rule for Patent Office Trials – In with Phillips, Out with BRI

The Federal Circuit recently held that a product catalog distributed at a trade show was “publicly accessible,” and therefore qualified as prior art. In Nobel Biocare Services AG, v. Instradent USA, Inc., decided on September 13, 2018, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) finding that a catalog distributed at the International Dental Show (“IDS”) Conference in Cologne, Germany was publicly accessible. The court’s decision in Nobel hinged largely on the testimony of two declarants, one who went to the conference (Zvi Chakir), and another who Chakir gave the catalog to upon his return (Yechiam Hantman).
Continue Reading Federal Circuit again finds product catalog distributed at trade show to be “publicly accessible”