scholarly journals What will happen with the generic drug companies’ lawsuit: Lessons from the Tobacco Settlement

2019 ◽  
Vol 18 (6) ◽  
pp. 155-156
Author(s):  
Richard Robbins ◽  
Keyword(s):  
Generic Drug ◽  
Drug Companies ◽  
Tobacco Settlement

Commentaries & Analyses — Strategic Balancing Of Patent And FDA Approval Processes To Maximize Market Exclusivity

2003 ◽  
Vol 07 (16) ◽  
pp. 997-1005
Author(s):  
DENNIS S. FERNANDEZ ◽  
JAMES T. HUIE
Keyword(s):  
Research And Development ◽  
Drug Administration ◽  
Generic Drug ◽  
Market Entry ◽  
Market Exclusivity ◽  
Federal Drug Administration ◽  
Biotech Company ◽  
Company Value ◽  
Drug Companies ◽  
Fda Approval

The patentability of products is essential in the biotechnology field, for limited market exclusivity compensates biotech companies' investments in research and development. The biotechnology field also uniquely faces Federal Drug Administration (FDA) approval, which includes considerable additional expense and time issues a biotech company must address. Although balancing the patent and FDA approval processes may be complex, various strategies of patent extension, of accelerating approval processes, and of prolonging generic drug companies' market entry can yield higher profit returns and maximize value company value.

scholarly journals Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Generic Drug ◽  
Legal System ◽  
Generic Company ◽  
Drug Companies ◽  
Pharmaceutical Patent ◽  
Weak Patents

“Reverse” or “exclusion” payments to settle pharmaceutical patent lawsuitsare facilitated because the Hatch-Waxman Act has been interpreted to give180 days of generic exclusivity to the first generic company to file forFDA approval, whether or not that company succeeds in invalidating thepatent or finding a way to avoid infringement. As a result, the patenteecan “buy off” the first generic entrant, paying them to delay their entryinto the market while still offering them the valuable period of genericexclusivity. And if that first generic is entitled to its 180 days, no oneelse can enter until after the exclusivity period has expired or beenforfeited. The result is that the 180-day exclusivity period is not servingits purpose of eliminating weak patents. True, it is encouraging lots ofchallenges to those patents. But it is encouraging the challengers toaccept compensation to drop those challenges, rather than taking them tojudgment and benefiting the rest of the world.We propose a change to the Hatch-Waxman statutory scheme. Our alternativeis straightforward: first-filing generic drug companies should be entitledto 180 days of exclusivity only if they successfully defeat the patentowner, for example, by invalidating the patent or by proving that they didnot infringe that patent. The point of 180-day exclusivity was to encouragechallenges to patents because the invalidation of bad patents benefitssociety as a whole. Society doesn’t benefit from a private deal to drop achallenge. That doesn’t mean settlement is never a good idea; it is acommonplace in our legal system. But it seems bizarre to insulate a companyfrom competition just because it settles the case. Indeed, we expect thatour proposal, if implemented, would facilitate more rational settlements,in which the settlements that result accurately reflect the likelihood ofsuccess in litigation.

General News

2005 ◽  
Vol 09 (20) ◽  
pp. 1098-1101
Keyword(s):  
Generic Drug ◽  
Working Group ◽  
Keystone Symposium ◽  
Drug Companies ◽  
Set Up

India Works With EU to set up 'Working Group on Pharmaceuticals and Biotechnology. International Keystone Symposium held in Singapore. MedTech Concept in Singapore. Roche To Partner with 4 Generic Drug Companies on Flu Drug Tamiflu.

Product Switching in the Pharmaceutical Industry: Ripe for Antitrust Scrutiny?

2010 ◽  
Vol 7 (2) ◽  
pp. 119-130
Author(s):  
Seth Silber ◽  
Kara Kuritz
Keyword(s):  
Market Share ◽  
Generic Drug ◽  
Prescription Drugs ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Brand Name ◽  
Generic Entry ◽  
Product Switching ◽  
Drug Companies ◽  
Antitrust Laws

Since the Hatch-Waxman Act was enacted in 1984, generic drug companies have benefited from its provisions to facilitate approval of generic alternatives to brand-name pharmaceuticals. Upon generic entry, consumers of prescription drugs benefit from large discounts as brand manufacturers lose significant market share to these lower-priced alternatives. Over time, brand-name drug manufacturers have undertaken strategies, such as ‘product switching’ or ‘product hopping’, that may delay or prevent generic entry and protect their market share. Generic drug manufacturers, drug purchasers and antitrust authorities have begun looking to the antitrust laws to address these strategies and their impact on generic entry. This article discusses the regulatory framework under which pharmaceutical companies introduce new drugs, two prominent cases in which courts have wrestled with whether product switching violates the antitrust laws, factors that might support an antitrust claim for product switching, and the FTC's interest in challenging product switching.

Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs

2021 ◽  
pp. 174113432110351
Author(s):  
Paul Grootendorst
Keyword(s):  
Drug Development ◽  
Generic Drug ◽  
Drug Market ◽  
Drug Costs ◽  
Development Projects ◽  
Drug Companies ◽  
Development Costs ◽  
The Us ◽  
Additional Costs ◽  
Using Data

Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.

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