August 3, 2007. 271(e)(1) was implemented to balance the patent term extension provided to patentees for regulatory approval delays under 35 U.S.C. The last few days of a patent are often its most valuable.

Pharmaceuticals Before Hatch-Waxman 17 2. by Stephen Jenei . 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.

Recent judicial interpretations of the provision, however, have broadened the scope of the provision to potentially exempt all uses of biotechnology research tools. So far, only one court has found in favor of a research tool … This is known as the “patent safe-harbor”. PART TWO: THE RESEARCH TOOL PATENT PROBLEM OF § 271(e)(1) 16 A. Scope of § 271(e)(1) With Respect to Research Tools … Maximizing patent term is therefore a chief goal for many patent applicants. 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. 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).

Judicial Interpretations 23 5. The need to file a terminal disclaimer in order to obviate obviousness-type double patenting, however, may result in a shortened patent term. 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 Drug Price Competition and Patent Term Restoration Act 19 3. William L. Warren (bill.warren@ is partner and Donna Best is associate at Sutherland Asbill & Brennan. In the field of …

Confronted with this limitation, prospective users of the research tools may opt to take a license or pursue design-arounds. Procedural History 21 4. (3). § 156. A safe harbor provision in the patent statute, 35 U.S.C.

Web: What did Congress Really Mean? Examiners should note that the securing of a patent usually occurs some time after the actual research year(s). 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. Ensuring Section 121 Safe Harbor Applies to Patent Law360 January 31, 2018. Research Exemption versus the Safe Harbor 30 B.

History of the Safe Harbor 17 1. Is the Use of a Patented Formulation or Delivery Technology Safe under the FDA Research Exemption “Safe Harbor”? Since Merck, a number of courts have reviewed the use of research tools under §271(e)(1). 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. § 271(e)(1),15 was originally enacted to permit generic drug developers to use patented drugs to gain regulatory approval for their generic products. Is Safe Harbor Closed to Research Tools?

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