Hatch-Waxman Patent Litigation support

Solid-State Expertise for Patent Defense & IP Protection

The Hatch-Waxman Act was designed to strike a balance between innovation and market competition in the pharmaceutical industry. It allows generic drug manufacturers to file an Abbreviated New Drug Application (ANDA). With this, generic companies seek FDA approval by demonstrating that their product is bioequivalent to an already approved drug. However, if a brand-name drug is listed in the FDA’s Orange Book with active patents, the generic company may file a Paragraph IV certification. In it, the generic company will claim that these patents are invalid or not infringed. This often leads to patent litigation between the innovator and the generic manufacturer.

In these legal disputes, demonstrating the presence or absence of an infringing solid form within the generic formulation is critical. These forms can be any patented polymorph, salt, cocrystal or solvate. Therefore, solid-state analysis plays a key role in these cases, as even the smallest detectable amount of an infringing form impact the outcome of the litigation. Because of this, high-resolution analytical techniques, particularly synchrotron X-ray diffraction (SXRD), are often required to provide clear scientific evidence.

At Enantia, we specialize in solid-state analysis to support intellectual property matters in Hatch-Waxman Act patent litigations:

XRPD analysis to detect crystalline infringing forms in drug substance and drug product during solid form analysis for Hatch-Waxman Patent Litigation support. The infringing form can be a polymorph, a co-crystal, a solvate or a salt.
Detection of Infringing Solid Forms

We conduct in-depth analyses to identify even trace amounts of crystalline infringing forms like polymorphs of the free form, its salts, solvates and cocrystals, in drug substances and drug products.

Synchrotron Analysis for Unparalleled Sensitivity and Resolution

We have access to synchrotron radiation sources (ALBA Synchrotron), which allows us to achieve the highest resolution and lowest detection limits possible using X-ray analysis.

Comprehensive Drug Substance and Drug Product Analysis

We have experience with a wide range of pharmaceutical formulations, including tablets, capsules, suspensions, powders, rings and patches.

Expert Support in Patent Litigation

We have successfully collaborated with leading US law firms, providing scientifically robust evidence for litigation strategies.