Recent court rulings ensure pharma expansion overburdens the system

The Court of Appeals for the Federal Circuit’s decision in Roche

Products v. Bolar Pharmaceutical Co. only exacerbated the issues plaguing generic market entry. 30 Prior to Roche, generic companies would conduct experiments with brand-name drugs before the brand’s patent term expired in order to gather data for application to the FDA.31 However, the Court in Roche refused to expand the “experimental use” defense and held that a generic company would infringe on a brand’s patent where there were “unlicensed experiments conducted with a view to the adaption of the patented invention to the experimenter’s business.”32 As Bolar argued, this holding had the effect of extending brand company monopolies under the FDCA “for an indefinite and substantial period of time while the FDA consider[ed] whether to grant a pre-marketing clearance” to generic companies.33 If a generic company failed to gain clearance, it was required to wait until the brand drug’s patent expiry to start the test trials required for approval.34

The Court of Appeals for the District of Columbia Circuit described the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act,35 as a “product of compromise,” noting that it “emerged from Congress’ efforts to balance two conflicting policy objectives: to induce name-brand pharmaceutical firms to make the investments necessary to research and develop new drug products, while simultaneously enabling competitors to bring cheaper, generic copies of those drugs to market.”36 Put simply, the Act sought to: [E]xpedite[ ] the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA’s approval process.37 As the costs of branded drugs and new drug development rise, bringing generic drugs to market in a timely fashion has been, and continues to be, an issue that pervades the pharmaceutical industry and the health care system as a public policy matter.38 The FDA defines a generic drug as “a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use,”39 before noting that the goal for drug similarity is to “demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version.”40 Because pharmaceutical expenditures increased rapidly, concern grew among consumers, healthcare providers, employers, and the government.41

As this Note has demonstrated, patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing the pharmaceutical market due to the misuse and misapplication of the patent laws. While there is no simple way forward, “it is imperative that the law regulating pharmaceuticals be vigilantly analyzed.”188 It can “literally be a matter of life and death.”189