Posts Tagged: "Biologics Price Competition and Innovation Act"

Two Pharma and Biotech Cases to Watch in 2022

As we enter the second month of 2022, the old saying, “If at first you don’t succeed, try, try again” and the famous line, “I’m not dead,” from Monty Python and the Holy Grail, come to mind to describe two issues we’ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.

New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.

Hatch-Waxman and BPCIA Cases and Trends to Watch in 2021

As we turn the page to 2021, we expect at least two major cases to be resolved that could have long-lasting effects on where and how Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) cases are litigated. Specifically, the future of skinny labels is in doubt, and available venues for Plaintiffs could be significantly narrowed. The number of new drugs eligible for generic competition will also rebound in 2021, but only time will tell if the global pandemic affects the overall number of generic filings. While there are many more Hatch-Waxman and BPCIA developments to watch this year, these are a few that we will be following closely.

Accelerating Generic Entry: A Proven Solution to the Problem of Prescription Drug Pricing

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, and pressured drug companies to hold the line. The Department of Health and Human Services (HHS) has proposed two regulatory initiatives—price disclosure in drug advertising and foreclosing rebates from manufacturers to pharmacy benefits managers (PBMs)—aimed at pushing prices down. Some Democrats have urged more sweeping actions, such as having the government negotiate Medicare drug pricing as a single buyer or regulating drug prices by reference to an international index based on government-negotiated drug prices abroad. These proposals cannot solve the drug pricing problem. The Administration’s proposals merely tweak the status quo and put no effective restraint on new drug prices. Jawboning by the Executive has had a minimal impact. Disclosure of manufacturers’ list prices, unless accompanied by numerous and inherently confusing caveats highlighting the difference between those prices and the co-pay an insured consumer must bear at retail, is potentially misleading and, in any event, has no direct impact on prices. Eliminating rebates, as HHS’s rulemaking acknowledged, will inevitably raise health insurance costs now partly paid for by rebates while manufacturers’ pricing power remains unabated. The Democrats’ call for government power buying or price regulation would impact drug prices but also require politically sensitive government determinations about the “worth” of prescription drugs to patients—a significant step on the road to government-allocated health care. 

Freedom to Operate and the Interplay of Patent and Regulatory Exclusivity for Life Sciences

While part one of this two-part series on intellectual property (IP) due diligence focused on a life science company’s own IP portfolio, part two will address a company’s understanding of how it fits into the market by considering its freedom to operate, as well as its competitors’, and the interplay of patent and regulatory exclusivity as it relates to the company’s product. Patent and regulatory exclusivity—two areas that can provide the most value and protection to a life science product—are very interrelated. Simply identifying when a key patent naturally expires is not sufficient, because regulatory exclusivity could possibly extend the company’s ability to keep competitors off the market or allow competitors to speed up entry in certain situations.