USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
2.4 Publicly Available Drug and Patent Information In the US, The Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) provides a list of all approved prescription drug products with thera - peutic equivalence evaluations, as well as pat - ents identified by the drug sponsors as covering those products. It is updated with an Annual Edi - tion and monthly Cumulative Supplement. When seeking approval of a drug product, an ANDA applicant must certify to the FDA – for each patent listed in the Orange Book for that drug – a statement that: • the patent information has not been filed; • the patent has expired; • the date on which the patent will expire; or • the patent is invalid or not infringed by the manufacturer, use, or sale of the ANDA drug product (21 USC Section 355(j)(2)(A)(vii)). If the applicant certifies that the patent will not be infringed or is invalid, the applicant must also give notice of such paragraph IV certification to the patent owner and the holder of an approved application under 21 USC Section 355(b) for a drug that is claimed by the patent (21 USC Sec - tion 355(j)(2)(B)). However, an ANDA applicant need not provide certifications for method-of- use patents claiming a use that the ANDA appli - cation does not seek approval to use (AstraZen - eca Pharms LP v Apotex Corp, 669 F.3d 1370, 1374 (Fed Cir 2012)). 2.5 Reimbursement and Pricing/Linkage Markets In the US, grant of marketing authorisation for pharmaceutical products is linked with patent status but only with regard to those patents listed in the Orange Book that:
affecting under 200,000 people in the US – or drugs that have no reasonable expectation of recouping the costs of developing and making the drug available (21 USC Section 360bb(a)(2); 21 USC Section 360cc). • Paediatric exclusivity confers six months of exclusivity to drugs from the end of other exclusivity protection or patent protection when, in response to a written request from the FDA, a sponsor has submitted paediat - ric studies on the active moiety in their drug product (21 USC Section 355a). • 180-day exclusivity is conferred to the first ANDA applicant(s) seeking approval. The exclusivity generally begins after the first commercial marketing of the drug or after a court decision holding the patent invalid, unenforceable, or not infringed (21 USC Sec - tion 355). 2.3 Acceptable Pre-Launch Preparations The Hatch-Waxman Act contains a safe harbour provision providing that it “shall not be an act of infringement to make, use, offer to sell, or sell... a patented invention... solely for uses reason - ably related to the development and submission of information under a federal law [that] regu - lates the manufacture, use, or sale of drugs” (35 USC Section 271(e)(1)). Such protection extends to not only drug products but also to medical devices and food or colour additives (Eli Lilly & Co v Medtronic, Inc, 496 US 661 (1990)). However, only allegedly infringing activities sub - ject to FDA pre-market approval that are “rea - sonably related” to submission of information qualify (Proveris Sci Corp v Innovasystems, Inc, 536 F.3d 1256, 1265–66 (Fed Cir 2008)). Such use includes not only preclinical studies but may also extend to scenarios where no data is actu - ally submitted to the FDA (Merck KGaA v Integra Lifesciences I, Ltd, 545 US 193, 205–08 (2005)).
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