Posts Tagged: "hatch-waxman"

Senators mistaken, IPRs do not frustrate Hatch-Waxman

Senators repeatedly brought up the Hatch-Waxman legislation. One after another Senators discussed how inter partes review (IPR) of pharmaceutical patents at the United States Patent and Trademark Office (USPTO) has, in an unanticipated way, upset the delicate balance reached in Hatch-Waxman to ensure that generic drugs would come to market quickly. Those familiar with IPR and Hatch-Waxman will undoubtedly recognize that this concern is entirely misplaced. A successful IPR would result in the immediate death of patent claims, which would inure to the benefit of all generics, which would in fact result in generics entering the market quickly.

Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

Acanya® Patent Litigation Settled, ANDA Approval Awaited

Actavis plc (NYSE: ACT) announced yesterday that it has entered into an agreement with Valeant Pharmaceuticals International (NYSE: VRX) to settle all outstanding patent litigation related to Actavis’ generic version of Acanya®… Actavis believes it was the first applicant to file an ANDA for the generic version of Acanya® Gel and, should its ANDA be approved, should be entitled to 180 days of generic market exclusivity.

FTC Files Amicus in 3rd Circuit Over Reverse Payments

The FTC brief explains that the no-authorized-generic (no-AG) commitment at issue raises the same antitrust concern that the Supreme Court identified in Actavis. A no-authorized-generic commitment means that the brand-name drug firm, as part of a patent settlement, agrees that it will not launch its own authorized-generic alternative when the first generic company begins to compete. An FTC empirical study of the competitive effects of authorized generics found that when a brand company does not launch an authorized generic during the exclusivity period reserved for the first-filing generic under the Hatch-Waxman Act, it substantially increases the first generic company’s revenues, and consumers pay higher prices for the generic product.

In re Effexor XR Antitrust Litigation: FTC Amicus Argues for No-Authorized-Generic in Patent Settlements

The Federal Trade Commission has asked the U.S. District Court for the District of New Jersey to accept an amicus brief that addresses the application of the U.S. Supreme Court’s recent ruling in FTC v. Actavis to a patent settlement containing a “no-authorized-generic” commitment. The FTC’s amicus brief states that the Effexor XR case presents “an issue with significant implications for American consumers”: whether pharmaceutical patent settlements are “immune from antitrust scrutiny so long as the brand-name drug manufacturer pays for delayed entry with something other than cash.” The brief explains why “[t]he allegations here raise the same type of antitrust concern that the Supreme Court identified in Actavis,” and thus should be treated in the same fashion.

Supremes Say Reverse Payments May Be Antitrust Violation

On Monday, June 17, 2013, the United States Supreme Court issued its much-anticipated decision on so-called “reverse payments.” This decision will impact how brand name drug companies and generics enter into patent settlements to resolve pending patent litigation. In a nutshell, speaking for the majority, Justice Breyer wrote that there is no valid reason for the FTC to be denied the opportunity to pursue reverse payments as an antitrust violation. Breyer, who was joined by Justices Kennedy, Ginsberg, Kagan, and Sotomayor, determined that reviewing courts should apply the rule of reason when determining whether reverse payments violate antitrust law.

Reverse Payments: Into the Belly Of The Hatch-Waxman Beast Part 3

“Reverse payment” cases are an outgrowth of a key feature I noted in my first article on the basics of Paragraph IV Certifications: the filing of an Abbreviated New Drug Application (ANDA) by the generic drug maker with a Paragraph IV Certification is treated as a technical act of patent infringement.[2] After receiving notice of the Paragraph IV Certification, the patent owner/NDA holder has 45 days to bring suit, otherwise the FDA can move forward on approving the ANDA.[3] Conversely, if the patent owner/NDA holder does bring an infringement suit within the prescribed 45 day period, the FDA cannot approve that ANDA for 30 months, unless the patent(s) that are the subject of the Paragraph IV Certification are earlier deemed invalid or not infringed in that suit.[4]

Bio-Pharma at the U.S. Supreme Court

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

Carve Outs: Into The Belly of the Hatch-Waxman Beast Part 2

“Carve outs” essentially involve a situation where there is an FDA approved drug for which the generic drug maker seeks to market that drug, again through an Abbreviated New Drug Application (ANDA), but instead for an FDA approved use, where also that FDA approved use is unpatented. While these “carve outs” also involve the filing of a Paragraph IV Certification, there is a slight but important twist in that Certification: inclusion of what is called a “section viii statement” that the generic drug maker “is not seeking approval for a method of use that is claimed in the patent.” When submitting the “section viii statement,” the generic drug maker must also provide a proposed label that removes or “carves out” the claimed method of use.

FTC Amicus Brief: Improper Use of Restricted Drug Distribution Programs May Impede Generic Competition

Among other claims, the generic firms allege that Actelion’s conduct violates the federal antitrust laws. Actelion seeks a broad declaration that it is under “no duty or obligation” to sell its products to potential competitors. Although Actelion contends that its distribution restrictions are required by the FDA, it argues that its right to refuse to sell to the generic firms is nearly absolute and would apply even without any FDA mandate. The FTC’s amicus brief explains that Actelion’s legal position, if adopted by the court, could pose a significant threat to competition in the pharmaceutical industry.

In FY 2012, Branded Drug Firms Increased the Use of Pay-for-Delay Settlements to Keep Generic Competitors off the Market

In Fiscal Year (FY) 2012, the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased significantly compared with FY 2011, jumping from 28 to 40, according to a new Federal Trade Commission staff report. The study also found that in nearly half of these settlements, branded firms may have used the promise that they would not develop or market an authorized generic (AG) as a payment to stall generic drug firms from marketing a competing product.

Supreme Court Agrees To Tackle Drug Patent Settlements

In the past several years, the Second, Eleventh, and Federal Circuits have upheld these settlements (known as “reverse payment” agreements since the money flows from the patentee to the alleged infringer rather than the other way around). These courts have focused on the benefits of settling cases and the presumption of patent validity, and they have explained that payments fall within the “scope of the patent.” In contrast, the Third Circuit recently applied more aggressive scrutiny, rejecting the scope test and finding that payments for delay were “prima facie evidence of an unreasonable restraint of trade.”

Patent Litigation Settlement Roundup – Nov. 16, 2012

Acacia announced that the Company’s Board of Directors has authorized a program for repurchasing shares of the Company’s outstanding common stock. The stock repurchase program will be put into effect immediately. Under the stock repurchase program, the Company is authorized to purchase in the aggregate up to $100 million of its common stock through the period ending May 15, 2013. Meanwhile, HTC settles with Apple and more.

FTC Seeks SCOTUS Review in AndroGel “Pay-for-Delay” Case

At the request of the Federal Trade Commission, the Solicitor General of the United States petitioned the U.S. Supreme Court to review a recent federal appeals court ruling concerning the FTC’s case against a “pay-for-delay” agreement. The petition for certiorari, the mechanism for asking for the Supreme Court to review a case, argues that the agreement that postponed generic competition for the testosterone-replacement drug AndroGel is anti-competitive and should not be legal. But thanks to the byzantine legal rules created by the Hatch-Waxman Act, the brand name owner was doing nothing more than what seems to explicitly be authorized by the law.

Santarus v. Par Pharmaceutical: Rader and Newman Disagree on Written Description Support for Negative Limitations

Last week the Federal Circuit decided the case of Santarus, Inc. v. Par Pharmaceutical, Inc., which dealt with whether a drug covered by an Abbreviated New Drug Application (ANDA) infringed the patents owned by that patent owner relative to the proton pump inhibitors (PPI) product omeprazole. The big issue in the case is what might at first glance seem to be a rather innocuous statement relative to the support necessary in a patent specification for a negative claim limitation. But after reading the Newman dissent (which joins in the other aspects of the Court’s decision) it starts to become clear that this could be a much larger issue of significant consequence.