Posts Tagged: "Food and Drug Administration"

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday underscored its October 2020 ruling that generic company, Teva Pharmaceuticals, was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol. The court clarified, however, that its ruling should apply only narrowly to the facts of this particular case. Judge Prost again dissented.

Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in a Hatch-Waxman case “only when and where an ANDA-filer submits its ANDA to the FDA [Food and Drug Administration] or occurs wherever future distribution of the generic is contemplated.” Valeant Pharmaceuticals v. Mylan Pharmaceuticals. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. It was the first time the court has had a chance to address the question of where infringement occurs in an ANDA case since TC Heartland v. Kraft Food Group Brands.

IPWatchdog’s most recent webinar focused on the role of IP in the development of the most promising vaccines to combat COVID-19 and included speakers from the medical community, the U.S. Food and Drug Administration (FDA) and the biopharmaceutical industry. The upshot was: wear masks, get the vaccine when it’s available to you, trust the FDA, and stop targeting IP rights, since there’s no evidence they have hindered the process and, in fact, IP has so far played a crucial role in collaboration efforts.

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt of public comments regarding the types of patent information published in the FDA’s Orange Book, a collection of FDA-approved drugs and their therapeutic equivalents designed to improve competition from generic drugmakers. While the request for comments only seeks early input on the subject, public responses could influence regulatory action that later changes the types of patents that a branded pharmaceutical manufacturer must disclose to inform generic drugmakers of their infringement liability risk.

The U.S. Court of Appeals for the First Circuit has made brand companies think twice about creating patent thickets in the Orange Book by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine. In re Lantus Direct Purchaser Antitrust Litigation (Feb. 2020). The Sanofi decision provides a possible opportunity to seek antitrust liability against brand companies for abusing Food and Drug Administration (FDA) regulations. The decisions should make branded companies reconsider over-listing patents in the Orange Book, and potentially slowing down generic competition. While this decision sets the stage for further fights over what patents should not be listed as covering approved “drugs,” it also sets a clear test for courts to consider when evaluating other tactics that brands have used to create regulatory delays to stall approval of potential rival products.

The recent White House meeting with leaders from American pharmaceutical companies sought their help in solving the coronavirus that originated in Wuhan, China and is currently gripping the globe. The meeting was part of the U.S. government marshaling our nation’s private and public medical research and development (R&D) resources in a race to create therapeutics, vaccines, diagnostic tools and cures. The Wall Street Journal has noted that “a core U.S. strength is the breadth of its private medical resources. That’s on display now as the government is calling on private actors to buttress the federal response.” Ironically, the same U.S. government urging the same private industry whose intellectual property rights enable it to develop medical miracles to help is targeting American pharmaceutical firms with a number of IP-killing policy proposals. One such bad idea comes from the Food & Drug Administration in a rulemaking titled “Importation of Prescription Drugs Proposed Rule (Docket No. FDA-2019-N-5711).”

A recent article by Dr. Kristina M. L. Acri née Lybecker highlighted her research about the fiscal workability of state pharmaceutical importation programs from two important aspects. Dr. Acri’s whole paper is very good. I recommend you read it if you’re into policy and not sound bites. I noticed, however, that the comments on the article elicited some common myths about Canadian drug importation that are important to address if we’re going to really understand this issue.

According to Merriam-Webster, the “Word of the Year for 2019 is “they” when used in the singular, typically to avoid ascribing a gender to the person being referred to. The larger point is this: language matters. Since this is a space dedicated to secrecy, let’s consider how we use language to determine who gets access to our trade secrets. For today, we’ll be looking specifically at how government does this. After all, they write the laws and so should be practiced at defining exceptions to property rights. Why should the government care at all about business secrets? Examples will help us here. Locally, the fire department needs to know what hazardous chemicals you might be storing at your plant, in case they have to come and put out a fire there. For different but equally compelling reasons, the Food and Drug Administration (FDA) insists on knowing exactly how drugs are made, and the Environmental Protection Agency (EPA) requires submission of pesticide ingredients. And then there is the government as consumer: last year the U.S. spent over $550 billion on purchasing goods and services from the private sector, and with all that economic clout comes the right to demand access to a lot of related data.

Drug innovators are providing much needed focus on rare diseases and, at the same time, leveraging early-stage rare disease results to facilitate down-stream market entry in broad-spectrum diseases. This paper provides a data-based demonstration of how early- and mid-stage pharmaceutical companies are using the Orphan Drug Program—in combination with pursuing patent portfolio protection—to secure investment and de-risk their platforms, thus lowering the financial barrier for expanding their product pipeline. The Orphan Drug Program—which is available for drugs that treat diseases affecting fewer than 200,000 patients annually in the United States—provides a number of incentives that can lower the barrier for successfully getting a drug to market. For instance, due in part to the reduced size of clinical trials associated with rare diseases, gaining regulatory approval for treating rare diseases is widely perceived to be simpler and more cost-effective than gaining approval for broad-spectrum diseases. Indeed, the Food and Drug Administration (FDA) allows a number of alternative clinical trial designs to meet approval standards, and orphan drugs are also more likely to qualify for expedited review and approval procedures. On top of this, orphan drugs are eligible for a 25% tax credit for clinical trial expenses (which can be claimed up to 20 years after receipt of the designation, and can in some instances be applied to offset payroll taxes), eligibility for research grants, waiver of FDA user fees, and a seven-year post-approval market exclusivity.

The spectacular failure of blood-testing firm Theranos is the subject of a riveting book, Bad Blood by investigative reporter John Carreyrou, and an engaging documentary, “The Inventor” on HBO, focusing on Elizabeth Holmes, the once-celebrated wunderkind who dropped out of Stanford at age 19 to “change the world” with a device that would perform hundreds of diagnostic tests with a few drops of blood from a finger stick. It’s a story made for Hollywood (Jennifer Lawrence will play Holmes in the forthcoming movie), filled with lies, deception, threats and sex, set in a Silicon Valley startup. But even the Theranos story doesn’t mean that trade secret law is inherently dangerous. Consider Apple, one of the world’s most secretive companies. (Holmes famously modeled her clothing and business habits after Steve Jobs.) Apple has consistently used NDAs and secrecy management to protect products under development, to great effect when they are ultimately unveiled, all without touting non-existent technology. And it’s easy to imagine how Theranos might never have happened if investors and business partners had been less credulous and more insistent to understand the technology.

Trying to rationally address hot button issues in an election year is always a dangerous proposition. That’s particularly true as we approach what promises to be one of the nastiest political years in history. Because so much time will be taken up campaigning, for legislation to pass it needs to get moving soon. It shouldn’t be long before we know whether anything meaningful will happen with attempts to reduce the costs of drugs, where intellectual property rights are in the crosshairs. Let’s keep our fingers crossed that, if action is taken, it’s based on careful consideration of all the related issues rather than raw emotion. While this may be wishful thinking, several thoughtful new articles contain important warnings against jumping down some of the beckoning gopher holes. Critics of the Bayh-Dole Act, which provides the incentives of the patent ownership to commercialize federally funded inventions, claim that the government is developing drugs from its R&D and giving them to companies that then make “obscene profits.”Despite numerous rebuttals, this red herring is continually deployed as the justification for the government setting the price of drugs coming out of public/private sector partnerships.

The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a Senate Judiciary Committee markup scheduled for tomorrow, June 27, Senator Lindsey Graham (R-SC) plans to offer language as an amendment in the form of the No Combination Drug Patents Act. The language of the bill would prohibit the patenting of new forms, new uses and new methods of administration of new medicines unless the patent applicant can show “a statistically significant increase in efficacy”. This language is oddly similar to India’s Section 3(d), something the Trump Administration’s U.S. Trade Representative has complained “restricts patent eligible subject matter in a way that poses a major obstacle to innovators” (see here, page 49). Other Senators have also weighed in against “a generally deteriorating environment for intellectual property” in India (see here), including Judiciary Committee ranking member Dianne Feinstein (D-CA) and Judiciary Committee members Mike Crapo (R-ID), Amy Klobuchar(D-MN)and Chris Coons (D-CT).

A Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on May 8 (the “Final Rule”) that requires direct-to-consumer (DTC) television advertisements for a prescription drug or biologic covered by the Medicare or Medicaid programs to disclose the product’s “list price,” will become effective on July 9, 2019. The Final Rule mandates price disclosures for any covered drug that is $35 or more for a one-month supply or the usual course of therapy, and includes a unique enforcement mechanism whereby CMS would rely for enforcement on private lawsuits filed pursuant to Section 43(a) of the Lanham Act. In a conference call with reporters, Department of Health and Human Services (HHS) Secretary Alex M. Azar II analogized the new requirement to mandatory price disclosures required for the automobile industry—despite the fact that cars are not reimbursed by the government, subject to co-pays, prescribed by third parties who function as gatekeepers, or subject to complex arrangements with prescription benefit managers (PBMs) and other healthcare providers. The strained analogy to automobile price disclosures reflects the legal complexities implicated by this requirement and the absence of relevant precedent.

On the morning of Thursday, March 7, the House Ways & Means Committee’s Subcommittee on Health held a hearing titled Promoting Competition to Lower Medicare Drug Prices. The hearing focused a great deal on the effect of patents in the pharmaceutical industry as they relate to pricing. Although some of the Republican membership of the subcommittee pointed out issues with various proposals to limit patent protections for drugmakers, the panel acted largely as a firing squad for patents. In his closing statement, Rep. Doggett expressed his dissatisfaction with the tenor of the day’s debate. “I view it as encouraging that there is bipartisan recognition of the serious problems so many Americans are facing with, really, prescription price gouging,” he said. “The question is whether we’ll have any bipartisan agreement on doing anything about it.”

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”