Lauren Battaglia

Firm/Organization: Hogan Lovells

Latest Articles

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

By Lauren Battaglia & Jonathan Elsasser on December 13, 2018

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This is the latest public step by the agency to highlight its continued close scrutiny of potential abuses of the citizen petition process to block or slow the entry of would-be competitors into pharmaceutical markets. Although substantively the FTC’s comment does not provide new guidance as…

Focus on Regulation

Outlook for Disgorgement Remedies in the Trump Administration

By Lauren Battaglia & Logan Breed on February 27, 2017

With the departure of now former Chairwoman Edith Ramirez earlier this month, among the most discussed vacancies in the new administration these days is the post of permanent Chair of the Federal Trade Commission. According to reports, one leading candidates is Acting Chairman Maureen Ohlhausen, and her selection could also have significant implications for FTC policy areas—particularly with respect to disgorgement remedies in antitrust cases. Specifically, should she become the permanent Chairman, Acting Chairman Ohlhausen’s…

Focus on Regulation

Price discrimination in the pharmaceutical sector: new decision, but plaintiffs face same challenges

By Robert Leibenluft, Leigh Oliver & Lauren Battaglia on October 28, 2015

The Second Circuit recently affirmed a lower court ruling dismissing claims brought by retail pharmacies against Johnson & Johnson, Caremark, Express Pharmacy Services of PA, and American Home Products, alleging that lower prices offered to certain “favored purchasers” amounted to unlawful price discrimination under the Robinson-Patman Act. Among other things, the Robinson-Patman Act makes it illegal “to discriminate in price between different purchasers of commodities of like grade and quality…where the effect of such…

Focus on Regulation

Outlook for 2015: Antitrust Litigation in the Pharma Industry – More Than Just Actavis Progeny

By Robert Leibenluft, Leigh Oliver & Lauren Battaglia on March 20, 2015

In 2014 there were a number of significant antitrust developments for the pharmaceutical industry. These involved not only challenges with respect to pharmaceutical patent litigation settlements (so-called “reverse payment” agreements), but also investigations and challenges to conduct related to product reformulations, Risk Evaluation and Mitigation Strategies (REMS), and FDA citizen petitioning activity. Read More: Outlook for 2015: Antitrust Litigation in the Pharma Industry – More Than Just Actavis Progeny…

Focus on Regulation

Federal Circuit Revives Certain Sham Petitioning Antitrust Counterclaims in Tyco-Mutual ANDA Litigation

By Lauren Battaglia, Robert Leibenluft & Leigh Oliver on August 26, 2014

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual Pharmaceutical Co. (“Mutual”) against Tyco Healthcare Group (“Tyco”), while vacating summary judgment on two others. Although the ruling is just the latest in a long line of cases analyzing sham petitioning issues related to the pharmaceutical space, the approach taken by the court could result in many more of these cases…

Focus on Regulation

Defining “Payments”: The First Post-Actavis Battleground in Pharmaceutical Reverse Payments

By Lauren Battaglia on May 7, 2014

In June 2013, the Supreme Court ruled in FTC v. Actavis that reverse-payment pharmaceutical patent settlement agreements are subject to rule of reason analysis under the antitrust laws. In doing so, the Court not only rejected both the FTC’s position that such agreements should be presumptively unlawful and the position of pharmaceutical manufacturers that such agreements should only be subject to scrutiny where they exceed the scope of the relevant patent, but also left it…

Focus on Regulation

DOJ and FTC to Shine Spotlight on Analysis of Conditional Pricing Practices Under the Antitrust Laws

By Robert Leibenluft, Leigh Oliver & Lauren Battaglia on May 7, 2014

The DOJ and FTC have announced a joint one-day workshop on June 23, 2014, in Washington, DC, and are requesting comments by August 22, 2014, on the topic of competition issues relating to conditional pricing practices among firms in a supply chain. Conditional pricing practices include loyalty or bundled pricing and other arrangements where “prices are explicitly or effectively contingent on commitments to purchase or sell a specified share or volume of a single product…

Focus on Regulation

CT AG Leads Charge to Increase Transparency of Hospital-Physician Acquisitions and Facility Fees

By Robert Leibenluft, Leigh Oliver & Lauren Battaglia on April 21, 2014

Last week Connecticut Attorney General George Jepsen issued a report detailing concerns regarding the recent trend in hospital-physician affiliations and acquisitions and the lack of consumer visibility into hospital-based facility fees that may be imposed following the affiliation of an independent physician group or outpatient facility with a hospital. …

Focus on Regulation

Actelion Settles REMS Dispute with Generic Drug Manufacturers

By Lauren Battaglia & Robert Leibenluft on March 6, 2014

Last week Actelion settled a lawsuit against two generic drug manufacturers regarding whether Actelion is required to supply those generic firms with samples of its drug Tracleer for use in the bioequivalence testing required as part of abbreviated new drug applications (ANDAs). Tracleer is subject to various distribution restrictions as part of its Risk Evaluation and Mitigation Strategy (REMS) filed with the FDA, and therefore the generic manufacturers were not able to obtain these samples…

Focus on Regulation

NY Attorney General Forges New Ground in Scrutiny of Pharmaceutical Agreements With First-Filer Exclusivity No-Challenge Settlement

By Robert Leibenluft & Lauren Battaglia on February 25, 2014

The New York Attorney General’s (NYAG) office has announced that it has reached a settlement with two generic drug manufacturers regarding allegations that an agreement between the firms not to challenge each other’s eligibility for regulatory exclusivity was anticompetitive. Although not a traditional reverse payment patent settlement agreement between branded and generic drug companies, the settlement reflects a move by antitrust enforcers to apply reverse payment case law and principles to a broader range of…

Lauren Battaglia

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

Outlook for Disgorgement Remedies in the Trump Administration

Price discrimination in the pharmaceutical sector: new decision, but plaintiffs face same challenges

Outlook for 2015: Antitrust Litigation in the Pharma Industry – More Than Just Actavis Progeny

Federal Circuit Revives Certain Sham Petitioning Antitrust Counterclaims in Tyco-Mutual ANDA Litigation

Defining “Payments”: The First Post-Actavis Battleground in Pharmaceutical Reverse Payments

DOJ and FTC to Shine Spotlight on Analysis of Conditional Pricing Practices Under the Antitrust Laws

CT AG Leads Charge to Increase Transparency of Hospital-Physician Acquisitions and Facility Fees

Actelion Settles REMS Dispute with Generic Drug Manufacturers

NY Attorney General Forges New Ground in Scrutiny of Pharmaceutical Agreements With First-Filer Exclusivity No-Challenge Settlement

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