High Stakes for Patent Holders, Challengers in SCOTUS “Oil States” Case

Kaminski_Jeffri_LRFeatured Expert Contributor, Intellectual Property—Patents

Jeffri A. Kaminski, Venable LLP

The U.S. Supreme Court is set to hear arguments in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, which could strike a devastating blow to extant patent procedure. On November 27, the Court will consider Oil States’ challenge to the constitutionality of the Inter Partes Review (“IPR”) process used by the Patent and Trademark Office (“PTO”) to scrutinize the validity of already-issued patents. While this is not the first constitutional challenge to IPRs, Oil States marks the first time the Supreme Court will confront the issue. Continue reading “High Stakes for Patent Holders, Challengers in SCOTUS “Oil States” Case”

Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle

FTC_Man_Controlling_TradeThe U.S. Supreme Court’s 2013 FTC v. Actavis, Inc. decision held that “reverse payment” settlement agreements—in which a drug company suing a generic competitor for patent infringement pays the alleged infringer a substantial amount of cash to settle the litigation—are subject to antitrust scrutiny.  The Court reasoned that such reverse payments are unusual and may indicate that the generic company is really being paid not to compete.

An August 21, 2017 decision from the U.S. Court of Appeals for the Third Circuit has stretched the Actavis holding far beyond anything intended by the Supreme Court.  If the appeals court’s decision in In re: Lipitor Antitrust Litigation is allowed to stand, it may become virtually impossible for drug companies to settle patent-infringement litigation. Continue reading “Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle”

Eastern District of Texas Refuses to Accept Supreme Court’s Patent-Venue Ruling

hydraBy Ryley Bennett, a 2017 Judge K.K. Legett Fellow at Washington Legal Foundation who will be entering her third year at Texas Tech University School of Law in the fall.

The US District Court for the Eastern District of Texas (EDTX) is known as one of the federal judiciary’s most patent-plaintiff-friendly districts. With TC Heartland LLC v. Kraft Food Groups Brand LLC, 137 S. Ct. 1514 (2017), the US Supreme Court recently cut off one avenue for filing patent-infringement claims there. It ruled in that patent-infringement lawsuits may be brought only in the infringer’s home state or else in a federal district where it maintains a regular place of business. But like the resilient, mythical Hydra, when one head is cut off, more grow back. In a recent decision, Eastern District of Texas Judge Rodney Gilstrap developed a broadly-sweeping four-factor “totality” test seemingly aimed at keeping patent-infringement suits in his jurisdiction. Continue reading “Eastern District of Texas Refuses to Accept Supreme Court’s Patent-Venue Ruling”

USPTO Again Finds State University-Owned Patent Immune From Patent Challenge

brinkerhoffGuest Commentary

By Courtenay C. Brinckerhoff,* a Partner at Foley & Lardner LLP, and editor of the firm’s PharmaPatentsBlog.

In January 2017, the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office (“USPTO”) ruled in three parallel decisions that state university-owned patents could not be challenged in inter partes review proceedings.  See, e.g., Covidien LP v. Univ. of Florida Research Foundation Inc., Case IPR2016-01274 (PTAB Jan. 25, 2017). I authored a Legal Opinion Letter on that decision for WLF, which is available here. Continue reading “USPTO Again Finds State University-Owned Patent Immune From Patent Challenge”

“Sandoz v. Amgen”: High Court to Weigh in on Biosimilars’ “Patent Dance”

Kaminski_Jeffri_LRFeatured Expert Contributor – Intellectual Property (Patents)

Jeffri A. Kaminski, Partner, Venable LLP, with Tyler Hale, Associate, Venable LLP.

In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, and redrew the legal landscape for intellectual property in the pharmaceutical industry.  The law balanced the need for brand-name drug innovators to profit from their research and development investments with the public good of low-cost generic drugs by creating a pathway for swift FDA approval of generic drugs immediately following the expiration of patent exclusivity.  By all accounts, the law has been a success, creating the drug lifecycle we know and expect today: new drugs enter the market at a high price with a limited period of exclusivity, after which several generic competitors enter the market and drive prices down to a fraction of their original cost. Continue reading ““Sandoz v. Amgen”: High Court to Weigh in on Biosimilars’ “Patent Dance””

FTC Must Refocus on Harm to Consumers and Competition

FTC_Man_Controlling_Trade

Federal agencies regularly use statistics to demonstrate their relevance and justify their exorbitant budgets. The Justice Department, for instance, boasts about the billions it brought in from False Claims Act lawsuits last year. The Environmental Protection Agency brags about the amount of fines and years in jail resulting from its enforcement actions in 2016. But the public is rarely provided concrete evidence of how those incarcerations and billions in fines, say, actually reduce contracting fraud or improve the environment.

So, too, with the Federal Trade Commission. In recent years, FTC hasn’t missed an opportunity to tout its statistical successes to the public and congressional appropriators. In the process of piling up the number of cases brought and fines extracted trumpeted by Chairwoman Edith Ramirez in her resignation press release, however, a critical limitation on FTC’s mission and authority has taken a backseat: the need to prove consumer harm. Continue reading “FTC Must Refocus on Harm to Consumers and Competition”

Will Federal Circuit Finally Bring an End to “Form 18” Minimal Pleading for Direct Patent Infringement in 2017?

jhighGuest Commentary

By J High, Sidley Austin LLP*

In Bell Atlantic Corp. v. Twombly and Ashcroft v. Iqbal, the US Supreme Court tightened the pleading standard for civil cases.  Because of a quirk of the exemplary forms formerly included with the Federal Rules of Civil Procedure (specifically, Form 18), the US Court of Appeals for the Federal Circuit held that Twombly and Iqbal did not apply to claims of direct infringement of a patent (In re Bill of Lading Transmission & Processing Sys. Pat. Litig.).  I discussed this state of affairs in two 2012 Washington Legal Foundation Legal Backgrounders (3/23/12 and 10/5/12).

This past fall, the Federal Circuit issued another decision on the pleading standard in patent cases, Lyda v. CBS Corp., 838 F.3d 1331 (Fed. Cir. 2016).  However, Lyda did not address the question many have been waiting for the Federal Circuit to answer—how to implement the pleading standard of Iqbal and Twombly for claims of garden-variety direct infringement after the abrogation of Form 18.  The district court proceedings in Lyda all occurred while Form 18 was part of the Federal Rules of Civil Procedure, and on appeal the Federal Circuit stated “that the repeal of Form 18 does not apply to this case.”  Id. at 1337 n.2. Continue reading “Will Federal Circuit Finally Bring an End to “Form 18” Minimal Pleading for Direct Patent Infringement in 2017?”