Biotechnology Law: A Primer for Scientists

FURTHER READING

INTRODUCTION

The notes that follow for each chapter provide statutes, rules, case law, treatises, and other resources relevant to that chapter. These notes for the introduction, though, provide resources germane to subjects that this book covers only briefly or not at all.

The same statutory title that governs utility patents also governs design patents and plant patents. Specifically, 35 U.S.C. §§ 171, et seq., govern design patents, which are discussed in MPEP chapter 1500. 35 U.S.C. §§ 161, et seq., govern plant patents, which are discussed in MPEP chapter 1600.

Like patent law, trademark law and copyright law also fall into the broad category of intellectual property law. Yet, each of these fields differs dramatically from the others. U.S. trademark law is governed by 15 U.S.C. §§ 1051, et seq., and 37 CFR §§ 2.1, et seq. U.S. copyright law is governed by 17 U.S.C. §§ 101, et seq., and 37 CFR §§ 201.1, et seq. For further reading on trademark and copyright law, see, e.g., Jerome Gilson and Anne Gilson LaLonde, Gilson on Trademarks, and Melville B. Nimmer and David Nimmer, Nimmer on Copyright, respectively.

Medical devices undergo approval processes different from those used for drugs. The FDA’s website provides information about medical device approval processes, such as those requiring 510(k) submissions.

Similarly, biotech drug regulation differs greatly from biotech plant regulation (which this book does not cover). Regulating biotech plants involves a coordinated effort among the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA–APHIS), the U.S. Environmental Protection Agency, and the FDA. The Coordinated Framework for Regulation of Biotechnology, available on the USDA–APHIS website, provides relevant details, as does the USDA website generally.

Numerous statutes, rules, and guidelines govern patent claims. They include, for example, 35 U.S.C. §112(b), 37 CFR §1.75, and MPEP 2173.

There are many fine treatises that exhaustively cover patent claims—and patent law generally. Perhaps the most robust of these is Donald S. Chisum, Chisum on Patents. Treatises focused on biotechnology-related patents include, e.g., Iver Cooper, Biotechnology and the Law and Pharmaceutical and Biotech Patent Law, Practising Law Institute (Arnold Porter Kaye Scholer LLP). The treatise Patents Throughout the World, edited by Henry D. Teegarden, Esq., is a comprehensive resource that complements this book’s focus on U.S. patent law. These treatises, of course, also add great depth to the material in chapters 2–13. For the sake of efficiency, though, the notes for those chapters don’t mention them again.

The Markman hearing is named after the U.S. Supreme Court decision in Markman v. Westview Instruments, 517 U.S. 370 (1996). For further reading on this subject, see, e.g., Thomas L. Creel, Patent Claim Construction and Markman Hearings, Practising Law Institute.

35 U.S.C. §101 names the four broad categories of patent-eligible subject matter, and MPEP 2106 provides a discussion of patent eligibility. In addition, the Patent Office publishes guidance documents on patent eligibility from time to time in accordance with the latest case law.

Important U.S. Supreme Court decisions on patent eligibility include, for example, Diamond v. Chakrabarty, 447 U.S. 303 (1980) (recombinant bacterium); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (isolated human DNA); and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014) (computer-related business method). Another major Supreme Court decision on patent eligibility is Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) (personalized medicine), as applied by the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (cffDNA-based diagnostic method), and Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019) (diagnostic method based on autoantibody detection).

35 U.S.C. §101 also requires that a patentable invention be useful. MPEP 2107.01 and 2107.03, for example, provide a discussion of the utility requirement. Brenner v. Manson, 383 U.S. 519 (1966) (method for making a steroid) is a seminal Supreme Court decision on utility.

35 U.S.C. §102 sets forth the novelty requirement for patentability. Importantly, the 2011 Leahy–Smith America Invents Act (AIA) amended this and other sections of the patent statute. As a result, the filing date of a patent or patent application determines whether the pre-AIA or post-AIA provisions apply to it. See, e.g., MPEP 2131 for a discussion of the novelty requirement. One of the Federal Circuit’s many interesting novelty decisions is Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2003) (anticipation by inherency in the case of loratadine).

35 U.S.C. §103 sets forth the nonobviousness requirement for patentability. MPEP 2141, et seq., provide a discussion of that requirement. Although it does not relate to a biotech invention, the Supreme Court’s decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) is a seminal one for nonobviousness determinations, including those in biotechnology cases.

Typically, foreign countries have requirements analogous to patent eligibility, utility, novelty, and nonobviousness. However, they are often referred to using different language. For example, that which is called nonobviousness in the United States is referred to as inventive step in Europe.

35 U.S.C. §112(a) sets forth the enablement and written-description requirements for the patent document, and 35 U.S.C. §112(b) sets forth the definiteness requirement. MPEP 2161, et seq., discuss these requirements. In the case of In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (monoclonal antibodies), the Federal Circuit describes various factors (Wands factors) to be considered in determining whether a specification satisfies the enablement requirement. The Federal Circuit’s decision in Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (human versus rat nucleic acids) nicely illustrates the written-description requirement and its application to biotechnology patents.

35 U.S.C. §112(a) also requires that the patent document set forth the best mode for practicing the invention. Unlike with the enablement, written-description, and definiteness requirements, however, failure to satisfy the best mode requirement is not a basis for invalidating a patent.

The MPEP is entirely devoted to patent prosecution. It presents each prosecution topic in an integrated fashion and cites all statutes, rules, and case law relevant to that topic. With that said, requirements for U.S. nonprovisional and provisional applications are found at 35 U.S.C. §111(a) and (b), respectively. MPEP 201 provides further information about these and other application types. The Patent Cooperation Treaty (PCT) and its implementing rules govern PCT application practice, which the World Intellectual Property Organization (WIPO) oversees. MPEP chapter 1800 provides further information on this subject.

Restriction practice is based on 35 U.S.C. §121 and is further detailed in MPEP chapter 800. 35 U.S.C. §§ 131, et seq., govern the substantive examination of patent applications, and MPEP chapter 700 provides further discussion of this topic.

35 U.S.C. §154(b) governs patent term adjustment, and MPEP 2710 provides further information on this topic. 35 U.S.C. §156 governs patent term extension, and MPEP 2750, et seq., further discuss this topic.

The statutes and rules relevant to this chapter are a subset of those relating to patent prosecution generally. That being said, for this chapter, we again refer to MPEP 201, which provides information about applications used in continuing-application practice, namely, divisional, continuation, and CIP applications.

35 U.S.C. §101 states that “whoever invents” a patentable invention may obtain a patent for it, subject to the patent statute’s requirements. 35 U.S.C. §§ 116(c) and 256(a) permit correcting inventorship in patent applications and patents, respectively.

Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223 (Fed. Cir. 1994) (AZT’s anti-HIV effect) is seminal to U.S. inventorship law. Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456 (Fed. Cir. 1998) (endoscopic surgery tool) illustrates business consequences of omitting an inventor on a patent. Chou v. Univ. of Chi. & Arch Dev. Corp., 254 F.3d 1347 (Fed. Cir. 2001) (herpes simplex virus technology) illustrates adverse consequences under state law of intentionally omitting an inventor.

35 U.S.C. §§ 271 (a), (b), (c), and (g) govern direct infringement, inducement to infringe, contributory infringement, and infringement by importation, respectively.

For the U.S. Supreme Court’s treatment of infringement under the doctrine of equivalents, see, e.g., Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950), and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002).

35 U.S.C. §282(a) sets forth the rebuttable presumption of patent validity, and §282(b) establishes various defenses to a patent infringement suit.

37 CFR §1.56 sets forth a duty to disclose to the Patent Office any information material to the patentability of a claimed invention. Depending on the facts, violating this duty can amount to inequitable conduct. In Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011), the Federal Circuit articulates the standard for finding inequitable conduct.

28 U.S.C. §2201 and Rule 57 of the Federal Rules of Civil Procedure govern declaratory judgment actions. 35 U.S.C. §§ 311, et seq., govern inter partes reviews.

35 U.S.C. §284 provides that a court may increase patent infringement damages by up to three-fold, as might be the case in the event of willful infringement. In Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016), the Supreme Court addresses §284 and its proper application.

Creating and managing a patent portfolio is not a matter of adhering to a statute or rule specifically governing those tasks. Instead, it is simply an exercise in repeatedly and tactically applying the prosecution concepts presented in chapters 5 and 7 to one or more technologies. Ideally, the attorney guides this process.

The Uniform Trade Secrets Act, amended in 1985, is a federal law that has been adopted by a majority of states. The Economic Espionage Act (1996) makes it a federal crime to commit, among other things, trade secret theft and misappropriation. The Defend Trade Secrets Act (2016) permits a trade secret owner to sue another in federal court for misappropriation. For further reading on trade secret law, see, e.g., Roger M. Milgrim and Eric E. Bensen, Milgrim on Trade Secrets.

21 U.S.C. §355, corresponding to §505 of the FDCA, governs, among other things, approval applications for new drugs (§355(b)(1)), new indications for and formulations of an approved drug (§355(b)(2)), and generic drugs (§355(j)). 42 U.S.C. §262 governs, among other things, biological product approval (§262(a)) and biosimilar and interchangeable products (§262(k)). For further reading on innovator drug approval, see, e.g., Donald O. Beers and Kurt R. Karst, Generic and Innovator Drugs: A Guide to FDA Approval Requirements, eighth edition.

The FDA’s website provides information about the drug development and review process, patents and regulatory exclusivities, approved drug products (in the form of the Orange Book), and biological products (in the form of the Purple Book).

The Hatch–Waxman Act is codified in titles 21 and 35 of the U.S.C., and the corresponding regulations are found in titles 21 and 37 of the CFR, respectively. Some of the act’s key features and their governing provisions include the following: ANDA applications generally (21 U.S.C. §355(j)); §505(b)(2) applications generally (21 U.S.C. §355(b)(2)); Paragraph IV certifications (21 U.S.C. §355(j)(2)(A)(vii)(IV)); the status of a Paragraph IV certification as an act of patent infringement (35 U.S.C. §271(e)(2)); the thirty-month stay of approval (21 U.S.C. §355(j)(5)(B)(iii)); the safe harbor provision (35 U.S.C. §271(e)(1)); NCE exclusivity (21 CFR §314.108(b)(2)); CI exclusivity (21 CFR §314.108(b)(4)); and skinny labeling (21 CFR §314.94(a)(8)(iv)). The Orphan Drug Act is codified in 21 U.S.C. §§ 360aa, et seq., and pediatric exclusivity is governed by 21 U.S.C. §§ 355a, et seq.

For further reading on generic drug approval, see, e.g., Donald O. Beers and Kurt R. Karst, Generic and Innovator Drugs: A Guide to FDA Approval Requirements, eighth edition. For further reading on the Hatch–Waxman Act through the prism of patent law, see, e.g., John R. Thomas, Pharmaceutical Patent Law, third edition. For an introduction to product hopping and the antitrust issues it raises, see, e.g., New York v. Actavis PLC, 787 F.3d 638 (2^nd Cir. 2015).

The BPCI Act is codified in 42 U.S.C. §262. Some of the act’s key features and their governing provisions include the following: the requirements for biosimilarity (§262(k)(2)(A)), the requirements for interchangeability (§262(k)(2)(B) and (4)(A)), exclusivity for first licensed interchangeable biologics (§262(k)(6)), the twelve-year exclusivity period for innovator biologics (§262(k)(7)(A)), and the patent dance (§262(l)).

The FDA’s website provides information, including guidelines, about biosimilars. For further reading on biosimilars and the patent dance, see, e.g., John R. Thomas, Pharmaceutical Patent Law, third edition.

For further reading on contract law, see, e.g., Timothy Murray, et al., Corbin on Contracts, and John Edward Murray Jr., Murray on Contracts.

For further reading on CDAs, see, e.g., Roger M. Milgrim and Eric E. Bensen, Milgrim on Trade Secrets. For further reading on MTAs, see, e.g., Alan B. Bennett, et al., Specific Issues with Material Transfer Agreements, chapter 7.3, “Handbook of Best Practices.” For further reading on patent licenses and know-how licenses, see, e.g., Roger M. Milgrim and Eric E. Bensen, Milgrim on Licensing. And, for further reading on a wide range of topics underlying agreements relating to pharmaceutical development, see, e.g., Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, second edition, Michael E. Clark, editor-in-chief.