Posts Tagged: "Drug Maker"

Reverse Payment Settlements and Holdup Under PTAB

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow legal authority. Further, while there is a statute requiring agreements between Hatch-Waxman firms to be submitted to the Federal Trade Commission (FTC) for antitrust review, the parties may attempt to evade it. The statute requires submission of agreements that relate to the manufacture or sale of either firm’s drug. The parties might therefore feel justified (rightly or wrongly) in not submitting a consent decree stating that the patent is valid and would be infringed by the proposed generic, since this does not expressly address manufacture or sales. Alternatively, it could be that the parties submit a district court consent decree (which includes no reverse payment), but not the PTAB settlement (which could include a reverse payment). After all, a PTAB settlement simply says that the parties agree to terminate the IPR – it need not declare the patent valid – and this arguably does not relate to manufacture or sales.

Erik Hovenkamp & Jorge Lemus

July 31, 2016

Will More Regulation Create Cheaper Drugs?

The idea of reducing drug prices through more government control is always simmering on the backburner and doesn’t require much to bring it to a full boil. Two recent actions turned up the heat to full blast. The response is often calls for more regulation, but ever increasing regulation benefits established players, which while inconvenienced, can afford to play the game. Start-ups can’t survive in endless oceans of red-tape that increase their costs while restricting market entry. Before rushing to impose more federal control, it might be wise to ask if government regulations inadvertently contribute to the problem.

Joseph Allen

October 20, 2015

The looming patent nightmare facing the pharmaceutical industry

During the last hearing of the House Judiciary Committee there was an attempt to insert language via amendment that would make it impossible for Kyle Bass and others to challenge pharmaceutical patents via post grant challenge at the Patent Office. Judiciary Chair Congressman Bob Goodlatte (R-VA) vociferously objected saying that if the amendment to prevent post grant challenges to pharmaceutical patents passed it would create a so-called scoring problem with the Congressional Budget Office (CBO). What an admission by Goodlatte! No legislative help is coming for pharma’s post grant challenge problem because the federal government likes the idea of some patents on important drugs being invalidated, which will save Medicare money.

Gene Quinn

July 8, 2015

Pharma Update July 2013: FDA, Preemption & SCOTUS

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.

Ed Silverman

July 24, 2013