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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

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Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...

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Post-Therasense inequitable conduct: a pharmaceutical perspective.

Patricia A Carson¹, Daniel Forchheimer, David N Draper

¹Kirkland & Ellis LLP, 601 Lexington Avenue, New York, NY 10022, USA.

Pharmaceutical Patent Analyst

|November 19, 2013

Summary

US patent law

Area of Science:

Patent Law
Intellectual Property
Legal Policy

Background:

The inequitable conduct defense in US patent law has faced scrutiny.
Previous standards for materiality and intent to deceive were problematic.
The pharmaceutical industry is significantly impacted by patent litigation.

Purpose of the Study:

To explore the policies and recent changes to the inequitable conduct defense.
To analyze the impact of the Therasense decision and the America Invents Act.
To discuss the practical implications for pharmaceutical patent litigation.

Main Methods:

Analysis of landmark court decisions (Therasense).
Examination of legislative reforms (America Invents Act).
Review of supplemental examination mechanisms.

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Main Results:

The Federal Circuit raised standards for materiality and intent to deceive in 2011.
The America Invents Act introduced mechanisms to address prior nondisclosure.
Supplemental examination offers a way to mitigate inequitable conduct challenges.

Conclusions:

Recent reforms aim to clarify and refine the inequitable conduct defense.
These changes are expected to alter patent litigation strategies, particularly in the pharmaceutical sector.
The interplay between judicial decisions and legislative action continues to shape patent law.