28,746 research outputs found
Michael Rodriguez interviews fiction writer Michael Kimball
No full textAuthor Michael Kimball talks about moving away from Michigan to become a successful writer, his education, the fiction reading series he has started in Baltimore, the life-story-on-postcard project, and his book "Dear everybody." Kimball is interviewed by Michigan State University Librarian Michael Rodriguez for the Michigan State University Libraries' Michigan Writers Series
Michael Rodriguez interviews author Gary Gildner
No full textAuthor Gary Gildner explains why he left his tenured teaching position to move to Idaho to became a full-time writer of poetry. Gildner talks about donating his personal papers to Michigan State University Libraries' Special Collections, his writing style and how he approaches writing. Gildner is interviewed by MSU Librarian Michael Rodriguez for the MSU Libraries' Michigan Writer Series. Held at the MSU Main Library
Dr. Michael Janis, Morehouse College, August 2011, August 2011
No full textThis video is a conversation with Dr. Michael Janis. Dr. Janis talks about his book, "Africa After Modernism: Transitions in Literature, Media and Philosophy". Yolanda Gilmore-Bivins, AUC Woodruff Library, is the interviewer
Why A "Large and Unjustified" Payment Threshold is Not Consistent with Actavis
No full textFTC v. Actavis was a landmark antitrust decision. In rejecting the “scope of the patent” test that had immunized settlements by which brand-name drug firms pay generic companies to delay entering the market (“exclusion payment settlements”), the Supreme Court made clear that such agreements “tend to have significant adverse effects on competition” and could violate the antitrust laws.
Some lower courts and defendants have sought to sow ambiguity in the post-Actavis caselaw by creating new thresholds and frameworks not articulated or envisioned by the Court. In particular, they have latched onto the discussion in Actavis of a “large and unjustified” payment. The district court in In re Loestrin 24 FE Antitrust Litigation, for example, imposed a framework that required analysis of (1) whether “there [is] a reverse payment” and (2) whether “that reverse payment is large and unjustified” before addressing (3) the rule of reason. The Loestrin court borrowed this framework from the district court in In re Lamictal Direct Purchaser Antitrust Litigation. And defendants have contended, for example, that “Actavis requires a plaintiff challenging a reverse-payment settlement . . . to prove, as a threshold matter, that the . . . payment was both large and unjustified” and that “under Actavis, [plaintiffs] have to prove that [a] payment was ‘large’ (as well as unexplained).”
This article offers three reasons why a requirement that a plaintiff demonstrate a large and unjustified payment before reaching the Rule of Reason is not consistent with Actavis. First, nearly all of the Court’s discussion of large and unjustified payments occurred in contexts having little to do with the antitrust analysis that future courts were to apply. Second, the Court instructed lower courts to apply the Rule of Reason, not a new framework with a threshold it never mentioned. And third, such a threshold is inconsistent with the Court’s (1) allowance of shortcuts for plaintiffs to show anticompetitive effects and market power and (2) imposition of the burden on defendants to show justifications for a payment
Product Hopping: A New Framework
No full textOne of the most misunderstood and anticompetitive business behaviors in today’s economy is “product hopping,” which occurs when a brand-name pharmaceutical company switches from one version of a drug to another. These switches, benign in appearance but not necessarily in effect, can significantly decrease consumer welfare, impairing competition from generic drugs to an extent that greatly exceeds any gains from the “improved” branded product. The antitrust analysis of product hopping is nuanced. It implicates the intersection of antitrust law, patent law, the Hatch-Waxman Act, and state drug product selection laws. In fact, the behavior is even more complex because it occurs in uniquely complicated markets characterized by doctors who choose the product but don’t pay for it, and consumers who buy the product but don’t choose it. It is thus unsurprising that courts have offered inconsistent approaches to product hopping. They have paid varying levels of attention to the regulatory structure, offered a simplistic analysis of consumer choice, adopted an underinclusive antitrust standard based on coercion, and focused on whether the brand firm removed the original drug from the market. Entering this morass, we offer a new framework that courts, government enforcers, plaintiffs, and manufacturers can employ to analyze product hopping. This rigorous and balanced framework is the first to incorporate the economic characteristics of the pharmaceutical industry. For starters, it defines a “product hop” to include only those instances in which the brand manufacturer (1) reformulates the product in a way that makes the generic non-substitutable and (2) encourages doctors to write prescriptions for the reformulated product rather than the original. The test also offers two safe harbors, which are more deferential than current caselaw, to ensure that the vast majority of reformulations will not be subject to antitrust scrutiny. The analysis then examines whether a brand’s product hop passes the “no-economic-sense” test. In other words, would the reformulation make economic sense for the brand if it did not have the effect of impairing generic competition? Merely introducing new products would pass the test. Encouraging doctors to write prescriptions for the reformulated rather than the original product—“cannibalizing” the brand’s own sales—might not. Imposing antitrust liability on behavior that does not make business sense other than through its impairment of generic competition offers a conservative approach and minimizes “false positives” in which courts erroneously find liability. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them. By carefully considering the regulatory environment, practicalities of prescription drug markets, manufacturers’ desire for clear-cut rules, and consumers’ needs for a rule that promotes price competition without deterring valued innovations, the framework promises to improve and standardize the antitrust analysis of product hopping
Square Dancing with the Stars to Enhance Dynamic Hirschman Linkages?
No full textIn this Presidential Address, the author takes the reader on a reconnaissance of his life and time as a regional scientist. He points out scenery he found scintillating along the way, hoping that some may pick up the banner and chew on a few of the ideas for a while. He suggests a revisit to Albert O. Hirschman’s notion of key sectors and more empirical analysis related to Marcus Berliant’s and Masahisa Fujita’s notion of knowledge creation and transfer.Presidential Address, San Antonio, Texas, March 29, 2014 (53rd Meetings of the Southern Regional Science Association
Author Response to the Review of Earning a Life by Michael Bourdillon
No full textAuthor Response to the Review of Earning a Life by Michael Bourdillo
Citizen Petitions: Long, Late-Filed, and At-Last Denied
No full textThe pharmaceutical industry is ground zero for many of the most challenging issues at the intersection of antitrust and intellectual property law. It also presents a complex regulatory regime that is ripe for anticompetitive behavior. It thus should not be a surprise that the industry has been subject to rigorous antitrust scrutiny in recent years.
While settlements between brand and generic firms and “product hopping” from one version of a drug to another have received attention, one behavior has avoided serious scrutiny. Brand firms’ filing of citizen petitions with the U.S. Food and Drug Administration (FDA) has almost entirely slipped beneath the radar. While citizen petitions in theory could raise concerns that a drug is unsafe, in practice they bear a dangerous potential to extend brand monopolies by delaying approval of generics at a potential cost of millions of dollars per day.
This Article offers an empirical study of “505(q)” citizen petitions, which ask the FDA to take specific action against a pending generic application. It analyzes every 505(q) petition filed with the FDA between 2011 and 2015, documenting (1) the number of petitions each year, (2) who filed the petitions, (3) the success rate of the petitions, (4) the petitions’ length, (5) whether petitions were filed in close proximity to the expiration of a patent or data exclusivity, and (6) occasions in which the FDA approved generics on the same day it decided petitions.
The study finds that brand firms filed 92% of 505(q) petitions. And it concludes that the FDA granted an astonishingly low 8% of petitions, rejecting a full 92%. Why is the grant rate so low? We consider several reasons. First, in the past 5 years, the average length of petitions has more than doubled, and the FDA almost never grants petitions with a length above the mean. Second, 39% of petitions are filed within 6 months of the expiration of a patent or FDA exclusivity, with almost all of these petitions denied. Third, the FDA resolved a number of petitions on the same day it approved the generic, suggesting that the Agency delayed generic approval until it resolved the petition. These three settings resulted in grants of only 3%, 2%, and 0%, respectively.
The Article concludes by offering examples of serial petitions, late-filed petitions, and a combination of petitions with other behavior, such as product hopping and settlements. In short, citizen petitions represent a hidden tool in a brand firm’s toolkit of entry-delaying activity that can lead to consumers paying high drug prices while providing no offsetting safety benefit
Eight Reasons Why "No-Authorized-Generic" Promises Constitute Payment
No full textDrug patent settlements present some of the most nuanced issues in patent and antitrust law today. Does a brand-name drug company’s payment to a generic firm cause delayed entry? Does a brand’s forgiveness of a generic’s potential damages constitute payment? How should courts evaluate parties’ simultaneous settlement of multiple cases?
To this universe of complex questions, courts have added one that is embarrassingly easy: Is there a payment when a brand promises not to introduce its own generic (known as an “authorized generic” or “AG”), which could be worth millions of dollars to the generic? Under any reasonable interpretation of economics, the Supreme Court’s 2013 decision in FTC v. Actavis, or common sense, such a promise constitutes payment.
In two recent cases, however, courts held that brands’ no-AG promises did not count as payment. The New Jersey district court in In re Lamictal Direct Purchaser Antitrust Litigation found that “nothing in Actavis” indicated that “a no-AG agreement is a ‘payment.’” And in In re Loestrin 24 FE Antitrust Litigation, the Rhode Island district court found that Actavis “fixates on the one form of consideration that was at issue in that case: cash.”
This article first provides background on drug patent settlements and authorized generics. It then examines the Lamictal and Loestrin cases. Finally, it offers eight reasons why a no-AG promise constitutes payment. First, such a conclusion is consistent with the language of Actavis. Second, it accords with the facts of Actavis. Third, a no-AG pledge typically provides significant value to generics. Fourth, generics receive more through such promises than they would by winning patent litigation. Fifth, brands act against their self-interest in making no-AG promises, which reveals generics’ gain from the pledges. Sixth, treating no-AG promises as payment emphasizes substance over form. Seventh, such pledges can be more coercive than cash payments. And eighth, the clauses present a classic example of market division
How Not To Apply Actavis
No full textOne of the most pressing issues in patent and antitrust law today involves agreements by which brand-name drug companies pay generic firms to delay entering the market. In June 2013, in FTC v. Actavis, Inc., the U.S. Supreme Court concluded that these “exclusion payment”1 settlements (in which exclusion comes from the payment rather than the patent) could have “significant anticompetitive effects” and violate the antitrust laws.
In ensuring a robust role for antitrust analysis, the Court handed down one of the most important business cases in the past generation. And it articulated a blueprint for future analysis based on antitrust law’s “rule of reason.” But the Court did not specify every step in the analysis or consider every type of settlement. Instead, it called on “lower courts . . . [to] structur[e] . . . the present rule-of-reason antitrust litigation.”
Along these lines, two recent district court rulings portend ominous signs. In the first case, In re Lamictal Direct Purchaser Antitrust Litigation, the District of New Jersey granted a motion to dismiss plaintiffs’ challenge to a settlement on a drug treating epilepsy and bipolar disorder. In doing so, the Lamictal court used the five factors that the Actavis Court had employed to justify more aggressive antitrust scrutiny to instead excuse its decision to employ less vigorous scrutiny. Just as concerning, it substituted its own armchair analysis for the burdens of proof articulated in Actavis.
In the second case, In re Loestrin 24 FE Antitrust Litigation, the Rhode Island District Court relied on Lamictal’s flawed framework to grant motions to dismiss plaintiffs’ challenge to a settlement delaying generic entry of an oral contraceptive.5 The court agonized over the “close call” presented by the case while failing to recognize that it was its own following of the Lamictal court’s framework that led it into briar patches of confusion, uncomfortable policy conclusions, neglect of pleading standards, and encouragement of conduct that it knew would “evade [antitrust] scrutiny.”
If the Lamictal and Loestrin decisions are upheld and adopted by other courts, plaintiffs will face insurmountable hurdles, rendering the landmark Actavis decision nothing more than a dead letter. This Essay shows that the Lamictal and Loestrin courts erred in (1) applying a framework never anticipated in Actavis; (2) ignoring crucial holdings from Actavis; and (3) amassing unjustified powers for themselves.
By blocking affordable generic prescription drugs, exclusion-payment settlements cost consumers billions of dollars and have profound consequences for public health. But if the trend unleashed by the Lamictal and Loestrin cases is not quickly reversed, courts will be relegated to the role of traffic cops waving anticompetitive settlements through flashing green lights of judicial “scrutiny.
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