The Drug Price Competition and Patent Term Restoration Act 19 3. Is Safe Harbor Closed to Research Tools? 271(e)(1) was implemented to balance the patent term extension provided to patentees for regulatory approval delays under 35 U.S.C. by Stephen Jenei . A safe harbor provision in the patent statute, 35 U.S.C. Examiners should note that the securing of a patent usually occurs some time after the actual research year(s). Is the Use of a Patented Formulation or Delivery Technology Safe under the FDA Research Exemption “Safe Harbor”? Web: www.sutherland.com. This is known as the “patent safe-harbor”. Maximizing patent term is therefore a chief goal for many patent applicants. § 271(e)(1),15 was originally enacted to permit generic drug developers to use patented drugs to gain regulatory approval for their generic products. The need to file a terminal disclaimer in order to obviate obviousness-type double patenting, however, may result in a shortened patent term. Scope of § 271(e)(1) With Respect to Research Tools … In a follow-up on our earlier discussion regarding the Supreme Court’s broad scope of the research exemption to the Integra case, the question came up asking if a patented delivery formulation — say, a sustained release formulation as oppos The last few days of a patent are often its most valuable. William L. Warren (bill.warren@ sutherland.com) is partner and Donna Best is associate at Sutherland Asbill & Brennan. Confronted with this limitation, prospective users of the research tools may opt to take a license or pursue design-arounds. Procedural History 21 4. Ensuring Section 121 Safe Harbor Applies to Patent Law360 January 31, 2018. Judicial Interpretations 23 5. PART TWO: THE RESEARCH TOOL PATENT PROBLEM OF § 271(e)(1) 16 A. The Supreme Court’s express intention to avoid addressing the research tool question has left several open questions about the scope of the safe harbor. SPARSE PATENT PROTECTION FOR RESEARCH TOOLS: EXPANSION OF THE SAFE HARBOR HAS CHANGED THE RULES ABSTRACT The protection provided by patent rights benefits society by encouraging inventors to disclose their inventions, but these same rights can be wielded against competitors through infringement suits, causing a chilling effect on later innovation. By refusing to expand the § 271(e)(1) safe harbor to cover early stage drug discovery, the Federal Circuit's decision in Integra provides patentees with some assurance that their research tool patents can be enforced against at least pre-clinical discovery uses. What did Congress Really Mean? Pharmaceuticals Before Hatch-Waxman 17 2. In the field of … Be aware that the issuance of a patent is not conclusive evidence of qualified research, as the taxpayer still has to meet all the other activity requirements of section 41(d). Since Merck, a number of courts have reviewed the use of research tools under §271(e)(1). So far, only one court has found in favor of a research tool …

History of the Safe Harbor 17 1. § 156. Recent judicial interpretations of the provision, however, have broadened the scope of the provision to potentially exempt all uses of biotechnology research tools. August 3, 2007. That case explicitly excluded a determination of whether so-called "research tools" (which could include embodiments of the St. Jude's claims) should fall within the scope of the safe harbor; this case could provide an avenue for the Court to continue its expansion of non-infringing behavior with regard to patents relating to drug development and other invention related to the medical arts. (3). Research Exemption versus the Safe Harbor 30 B.