Page numbers refer to the print edition but are hyperlinked to the appropriate location in the e-book.
Page numbers in italics represent figures or tables.
Abbreviated New Drug Application (ANDA), 191–92, 192–93, 215; for companies, 196–98, 197–98; exclusivity of, 201, 202–4, 215; FDA and, 193–94, 194; patent certification, 195–96, 196. See also Food and Drug Administration
acceptance, in enforceable contracts, 229, 229–30
adjustments: patent term extensions and, 73, 73–74; of patent term, 71–73, 72–74
affordability, of small-molecule drugs, 180; of biologic drugs, 207–8
agendas, for inventorship, 97, 97–98
American Type Culture Collection (ATCC), 50, 52
antiretroviral drug azidothymidine (AZT), 89–90, 90
appeals: in courts, 8; Patent Trial and Appeal Board, 128, 128
applications: for biosimilars, 219–20, 220–22, 222; under BPCI Act, 212, 217–19; CIPs, 79, 83–86, 84–87; continuations, 79, 81, 82–83, 87; dates in, 42, 52; unreasonable delays by Patent Office for, 71–72; divisionals, 66, 79–80, 80–81, 87; for drug approval, 174; examination of, 65–68, 66–69; expert declarations in prosecution of, 69; for FDA approval, 71, 220; filing of, 42, 52, 60–63, 63–64; §505(b)(2) applications, 193–96, 194, 196, 199, 213; INDs, 166–67, 168–71, 170, 177, 178–79, 268; internationally, 149; inventions in, 65–66, 66–67; licensing of, 253; nonprovisional, 61, 63, 80–82; parent, 67, 81, 81, 83, 83–85; for patents, 35, 60–61, 228; PCT, 61–63; pending, 67; prior-art references in, 39–40; provisional, 61, 63, 64, 72–73; substantive examination of, 67–68, 68–69; tactical considerations for, 63, 63–64; in U.S., 36–37, 37
approved drugs, new indications for, 175–76
articles of manufacture, 29
attainment, in education, 42–43
attorneys: clients and, 3, 131–32; drafting by, 241; education and, 4–5; informed beliefs by, 129–30; procedural nuances for, 6; in process of defining inventions, 58–59
authorship, distinguished from conception, 91, 91–92
bidirectional patent licenses, 253
biologics license application (BLA), 173, 177
Biologics Price Competition and Innovation Act (BPCI Act), 5; applications under, 212, 217–19; biosimilarity under, 212, 213; exclusivity under, 215; history of, 208, 210–11; interchangeability under, 214, 214; patent law and, 217–19
biosimilars: applications for, 219–20, 220–22, 222; biosimilarity, 212, 213; competitor rewards from, 211–12, 213–14, 214–15; economics of, 208; history of, 207–8; for innovators, 215–17, 216; patent law and, 217–19; small-molecule drugs and, 208–9; in U.S., 209–10
biotechnology. See specific topics
BRACAnalysis program, 158
Breakthrough Therapy approach, 173
broad scope, of patent claims, 15
bundles, of licensed patent rights, 254
Burroughs Wellcome v. Barr Laboratories, 89–90
business consequences, of incorrect inventorship, 98, 98–99
candidates, for drugs, 244
Center for Biologics Evaluation and Research (CBER), 167, 177
Center for Drug Evaluation and Research (CDER), 167, 177
claims: in courts, 104, 104–5, 137, 137–38; coverage, 18; declaratory judgment action regarding, 126–27, 127; definiteness of, 55, 55–56; scientific discovery supporting, 59; examination of, 69; inter partes review of, 128, 128; invalidity challenge of, 119, 120–24, 121, 123; inventions in, 74–75; legal language of, 55; noninfringement and, 117, 118–19; novelty of, 135, 135–37; assertion of, 116–17, 117; in patent law, 5, 13, 15–18, 16–21, 24–25, 26–28; prior-art references against, 45; rejection of, 67–68; scope of, 21, 21, 113–14; technology in, 18, 50; unenforceability of, 124–25, 125–26; in U.S., 50–51, 53–56, 68–69, 76–77. See also infringement
clinical investigation (CI) exclusivity, 185–86, 186
Code of Federal Regulations (CFR), 8
co-exclusive patent licenses, 256
collaboration agreements, 6, 226, 238; in contract law, 270–71; costs of, 278–79; definitions for, 271–74, 272–75; and intellectual property, 275–78, 277–78; payments for, 279, 279–80; profits from, 278–79; termination of, 280–83, 282–83
commercial goals, in collaboration agreements, 271–72
commercial success, 43, 63; of biologic drugs, 176; disclosures and, 79; technology for, 145
companies, 134–35; ANDAs for, 196–98, 197–98; patent applications for, 87; business consequences regarding incorrect inventorship, 98, 98–99; claims and, 113; in courts, 28; term extensions for, 74; FDA for, 70, 73; imbalances between, 271–72; INDs for, 171; infringement by, 27; nondisclosure for, 244–45; patent prosecution by, 111–12; provisional applications for, 72–73; scientists and, 228–29; technical services for, 243; in U.S., 103–4, 117. See also patent law; start-ups
competence, in enforceable contracts, 227
compositions: in inventions, 59–60; in pharmaceutical industry, 29–30
compounds: in relation to definiteness, 55; in relation to written description, 50
comprising, in patent claims, 16, 16, 26–27
conception: experimentation compared to, 93; of inventions, 89–90, 90; joint, 96, 97
consideration, in enforceable contracts, 231, 231
consisting, in patent claims, 16–17, 17
construing: of patent claims, 24–25, 26–28; of contract terms, 238
continuation-in-part application (CIP), 79, 83–86, 84–87
contract law, 2; biotechnology agreements in, 242–43; anatomy in, 236–40; breach in, 232, 232–33; clients in, 240–41; collaboration agreements in, 270–71; in enforceable contracts, 225–27, 227–31, 229, 231; exclusivity in, 260; expiration in, 281–82; facts in, 250; legal language of, 236–37; milestone payments in, 268, 268; MTAs in, 248–50, 251–52; CDAs in, 243; patent law and, 242–43; patent license agreements and, 252–53; payments in, 239, 266, 268; for pharmaceutical industry, 239–40; principles of note, 240–41; provisions in, 237, 242; remedies in, 233–35, 234–36; risks in, 239–40; state powers and, 10
contributory infringement, 108, 108–9
controversy, in case or controversy, 127
costs, in collaboration agreements, 278–79
courts: Alice Corp. v. CLS Bank in, 32, 157–58; AMP v. Myriad in, 157–58, 159; appeals in, 8; Association for Molecular Pathology v. Myriad Genetics in, 32; Burroughs Wellcome v. Barr Laboratories in, 89–90; patent claims in, 104, 104–5, 137, 137–38; Diamond v. Chakrabarty in, 31; doctrine creation by, 75–76; doctrine of equivalents by, 110–11, 111–15; federal courts and claim construction, 25; In re Wands in, 52; Markman v. Westview in, 25; Mayo Collaborative Services v. Prometheus Laboratories in, 31–32, 60, 157–58. See also Supreme Court
coverage, by patent claims, 18
credibility, as requirement of utility, 32–33; in life science, 35, 35
dates: filing of applications, 42, 52; priority, 188–89; split priority, 84; for patent term, 70
definiteness, of patent claims, 55, 55–56
delays, unreasonable by Patent Office, 71–72
derivatives, in MTAs, 250
design around, third party patents, 132, 133
Diamond v. Chakrabarty, 31
disclosures: anticipation of invention and, 36–39; of confidential information, 243–45; grace periods and, 37; nondisclosure terms, 244–45; in parent patents, 83; sufficiency for patent documents, 49; by prior-art references, 38, 38
discovery, distinguished from invention, 59, 78
divisional applications, 87; for nonelected inventions, 66; with Patent Office, 79–80, 80–81
drafting, of contracts, 240–41
drugs: regulatory applications for, 174; approved, 175–76; candidates for, 244; delivery of, 55–56, 164–65, 165; international law and, 264; licensing of, 260–61; orphan, 187, 187; postapproval studies of, 175; preclinical development of, 164–65, 165; RLDs, 191–98, 192–94, 196–98. See also specific drug types
duty of confidentiality, 245, 246
economics: of biosimilars, 208; of collaboration agreements, 278–79; of new indications for approved drugs, 175–76; of patent filing strategies, 62–63; fixed royalty rates, 269; of generic drugs, 163–64; investment, 130, 130–32; of licensing, 256; of litigation relating to collaboration agreements, 278; of patent portfolio management, 145, 146–49, 150; contract damages, 235, 236. See also affordability
education, attainment regarding ordinary skill in the art, 42–43
elements, of claims, 18; of enforceable contracts, 226; taught in prior-art references, 42–43
emotion, in relation to inventorship, 89
enforceable contracts, 225; acceptance in, 229, 229–30; details of, 241; equitable remedies for, 233; lawful purposes in, 226, 227; legal capacity in, 227, 228–29; mutual consideration in, 231, 231; offer and acceptance in, 229, 229–30; unenforceability, 124–25, 125–26
European Medicines Agency (EMA), 209–11
European Patent Organisation, 64
evidence: contrary, 44, 45, 47; extrinsic, 25; intrinsic, 25; totality of, 212, 213
exclusivity: of ANDAs, 201, 202–4; of first licensed interchangeable biosimilar, 217; of licensed innovator biologics, 215–16, 216; CI, 185–86, 186; NCE, 184, 185, 194, 217; for orphan drugs, 187, 187; pediatric in relation to patents, 188–89, 189–91; of patent license agreements, 254–56; pediatric, 187–88, 188; in regulatory law, 184–89, 185–91
exemptions, to confidentiality obligations, 245
experimentation, undue in relation to enablement, 52, 53
expert declarations, for establishing utility, 47, 69
expiration, of contracts, 281–82
explanatory language, in claim construction, 25
extensions: patent term adjustment and, 70, 73; of patent term, 70, 71, 73, 183
Federal Food, Drug, and Cosmetic Act (FDCA), 10
federal powers: U.S.C. as, 8; CFR as, 8; in courts, 9, 25; state powers and, 7–8
filing: of patent applications, 42, 52, 60–63, 63–64; dates, 42, 52, 63; economics of, 62–63; of lawsuits under the Hatch–Waxman Act, 200–201; of continuing applications in the pharmaceutical industry, 86, 86
first licensed interchangeable biologics, 215
Food and Drug Administration (FDA), 5, 9–10, 163, 174–75, 183; approval applications for, 71, 220; for companies, 70, 73; EMA compared to, 209–11; first licensed interchangeable biologics for, 215; Food and Drug Administration Modernization Act, 187–88, 188; interchangeable biosimilars for, 214, 214; INDs for, 166–67, 168–69, 178–79, 268; for innovators, 174; NCE exclusivity for, 184, 185; Orange Book for, 191; RLDs for, 192–94, 192–98, 196–98; skinny labeling for, 196–98, 197–98; trial sponsors for, 172–73. See also generic competitors; regulatory law
foreign patents, prosecution history of, 25
freedom-to-operate opinion (FTO), 138, 139, 140
generic competitors: ANDAs for, 191–92, 192–93, 201, 202–4; evergreening as defense against, 204–5, 205–6; §505(b)(2) applications for, 193–96, 194, 196; Hatch–Waxman litigation for, 199–201; safe harbor for, 198–99; skinny labeling for, 196–98, 197–98; trademark protection as defense against, 206, 206
generic drugs: economics of, 163–64; Hatch–Waxman Act for, 182–83; history of, 181–82; pharmaceutical industry and, 5; regulatory law for, 180; in contrast to biosimilars, 212
goals: regarding inventorship, 92, 92–93; regarding collaboration, 270–72
grace periods: invention disclosures and, 36; in international law, 37
Hatch–Waxman Act, 5, 193; for price reductions, 210; relating to the patent dance, 217–19; CI exclusivity under, 185–86, 186; for generic drugs, 182–83; history of, 180–81; infringement under, 199; innovator’s market dominance and, 204; litigation under, 199–201; NCE exclusivity under, 184. See also Abbreviated New Drug Applications; Biologics Price Competition and Innovation Act
hindsight, regarding nonobviousness, 42
history: of biosimilars, 207–8; of BPCI Act, 208, 210–11; of prosecution for courts, 111; of generic drugs, 181–82; of Hatch–Waxman Act, 180–81; limiting prosecution history, 114–15; of prosecution, 25, 78–79, 112
human effort, regarding patent eligibility, 30, 30
identical specifications, 80–81
imbalances, between parties to collaborations, 271–72
impermissible agendas, regarding inventorship, 97, 97–98
improper inclusion, regarding inventorship, 98, 98–99
inclusion, regarding inventorship, 96, 96, 98, 98–99
indications, new for approved drugs, 175–76
inducement, to infringe, 107, 107–8
information: confidential, 239, 243–44; data and, 248–49; in public domain, 36; published, 24; statutory exemption and, 36; technical, 140
informed beliefs, patent opinions and, 129–30
infringement, 18; by companies, 27; contributory, 108, 108–9; defenses to, 116–17, 117; direct, 106, 106; doctrine of equivalents and, 110–11, 111–15; under Hatch–Waxman Act, 199; inducement of, 107, 107–8; legal requirements of, 24, 103–4, 103–5, 109–10, 110; literal, 109–10, 110; litigation and, 101–3, 102; opinions, 133–34, 134–35. See also noninfringement
inherency, anticipation by, 38–39
innovators, 70; profitability for, 182–83, 208–9; INDs for, 166–67; biologic drugs and, 176–77, 177–79, 220, 220–22, 222; biosimilars and, 215–17, 216; clinical trials for, 167–68, 168–72, 170–73; new indications for approved drugs for, 175–76; biologics exclusivity for, 215–16, 216; FDA approval of NDAs by, 174; Hatch–Waxman Act and, 204; human testing for, 167; market dominance for, 204–6, 205–6; postapproval monitoring of, 175; in pharmaceutical industry, 163–64, 181–82; research for, 164–65, 165; rewarding, 183–89, 185–91, 191; RLDs for, 191. See also Biologics Price Competition and Innovation Act
inquiry, regarding MTAs, 249–50
insubstantial differences, regarding doctrine of equivalents, 111
intellectual contribution, regarding inventorship, 91, 91–92
intellectual property, 238; collaboration agreements and, 275–78, 277–78
international law: patent applications in, 149, 264; European biosimilars in, 209–10; grace periods in, 37; patent families and, 146, 146–49; patent protection in, 63–64; PCT applications in, 62–63, 71; patent domain in, 13–14; U.S. and, 2, 36
interpretation, claim construction in, 26–27
inventions: in patent applications, 65–66, 66–67; blocking patents for, 21, 22–23, 23; in claims, 74–75; components of, 23; compositions in, 59–60; conception of, 89–90, 90; continuing applications, 79; defining, 58–59, 59–60; examination of, 57; experimentation and, 14; facets of, 78–79; inventorship determination for, 60, 90–95, 91–95, 95–99, 96–100; legal language for, 16–17, 16–17; liability for omitting inventors, 99, 99–100; licensing of, 255; mode of action for, 94–95, 94–95; nonelected, 66; nonobviousness of, 42–43, 43–48, 47; novelty of, 36–41, 36–41; ownership of, 252–53; patent documents for, 49–50, 50–51, 52, 53–54, 55, 55–56; patent eligibility for, 29–32, 30; patent law and, 9, 13–14, 29; in pharmaceutical industry, 65; protection of, 79; in U.S., 252–53; utility of, 32–33, 33–35
investment, regarding noninfringement opinions, 130, 130–32
judicial process: declaratory judgment actions, 126–27, 127; judges, 42–43; lawsuits in, 24; obviousness in, 43. See also lawsuits
lawful purpose, in enforceable contracts, 226, 227
lawsuits: filing of, under Hatch–Waxman Act, 200–201; regarding claim construction, 24
legal capacity, in enforceable contracts, 227, 228–29
legal studies: contract law in, 5; for graduate students, 4; for scientists, 3–7; in U.S., 7–10
legal system, 1–2; contract law, 2; grace periods in, 36; hindsight in, 42; claim construction in, 26–27; for nonattorneys, 4; patent law and, 2; regulatory law and, 2; for scientists, 5; surrender of rights in, 231
liability, for willfully omitting inventors, 99, 99–100
licensing, 252; bidirectional patent licenses, 253; of drug patents, 260–61; economics of, 256; importing and, 260; of inventions, 255; multiple, 262–63; nonexclusive licenses, 256, 257–59; in patent law, 102, 236, 258; payments, 266, 268; for start-ups, 259; third-party licenses, 262. See also specific licenses
life sciences, establishing utility and, 35, 35
limitations, of claims, 18
limiting prosecution history, 114–15
litigation: economics of, 278; Hatch–Waxman Act and, 199–201; infringement and, 101–3, 129; negative rights in, 103; unpredictability of, 25, 26–28
locations, for filing patent applications, 64
Manual of Patent Examining Procedure (MPEP), 9
Mayo Collaborative Services v. Prometheus Laboratories, 31–32, 60, 157–58
mode of action, explaining in relation to inventorship, 94, 94–95
modified derivatives, 250
monitoring, of innovators, 175
Monsanto Roundup Ready seeds, 31
multiple licensing, 262–63
mutual assent, in enforceable contracts, 229
mutual consideration, in enforceable contracts, 226, 231, 231
narrow scope, regarding patent claims, 15
National Institutes of Health, 270
negative right: affirmative right and, 13; in litigation, 103; in patent law, 21, 21–23, 23, 252–53
nonelected inventions, 66
nonobviousness: of inventions, 42–43, 43–48, 47; as requirement, 29
nonprovisional applications, 61, 63, 80–82
objective indicia, of obviousness, 43
offer, in enforceable contracts, 229, 229–30;
opinions: FTO, 138, 139, 140; infringement, 133–34, 134–35; invalidity, 135, 135–37; knowledge and, 129–30; noninfringement, 130, 130–33, 132; reliance on, 140–41; validity, 137, 137–38
Patent Cooperation Treaty (PCT): applications, 61–63; dates of, 63, 64; with international law, 62–63, 71; prosecution of, 57; in U.S., 72–73
patent law, 2, 52, 60–61; inventorship agendas in, 97, 97–98; biosimilars in, 217–19; BPCI Act and, 217–19; business consequences of incorrect inventorship and, 98, 98–99; certification and, 195–96, 196; preemptive challenges in, 116, 126–28, 127–28; claims in, 13, 15–18, 16–21, 24–25, 26–28; co-exclusive licenses, 256; contract law and, 242–43; defenses in, 116–17, 117–26, 119, 121, 123–25; defining inventions in, 58–59, 59–60; documents for, 49–50, 50–51, 52, 53–54, 55, 55–56; double patenting, 74–76, 75–77; eligibility, 29–32, 30, 67; experimentation in, 93, 93–94; expert declarations in, 47; goals in, 92, 92–93; hindsight in, 42; inherency in, 38–39; inventions and, 9, 13–14, 29, 239; inventorship determination in, 60; issuing in, 69, 71–72; joint patent rights, 276–78, 276–78; licensing in, 102, 236, 258; MPEP, 9; negative rights in, 21, 21–23, 23, 252–53; nonobviousness in, 42–43, 43–47; inventor omission in, 99, 99–100; ownership in, 101–3; patentability in, 30, 49, 119; Patent Act, 9; Patent and Trademark Office, 15; Patent Trial and Appeal Board, 128, 128; portfolios in, 3, 142–45, 143–49, 150; prior-art references in, 38–39, 38–40; protection by, 76; publications in, 41; research in, 94; risks in, 140; scientific events in, 58; for scientists, 67, 91–92; secondary considerations in, 43; statutes in, 36; strategy in, 87–88; for Supreme Court, 60; terms in, 70–76, 71–77, 183, 204–5; territoriality in, 267; textbooks for, 6–7; third-party patents, 132, 133, 143, 219; trade secrets in, 154–55, 155–59, 157–58; in U.S., 29, 52, 256, 259–61, 263–64. See also applications; opinions
patent license agreements, 102, 236; contract law and, 252–53; for drugs, 226–27, 228; exclusivity of, 254–56; field of use and, 259–61, 260–65; grant clauses in, 254; nonexclusive licenses, 256, 257–59; ownership in, 239, 249; payments in, 266, 268, 268; royalty payments, 269, 269; territory and, 264, 265–66, 266; up-front payments in, 268, 268
payments: for collaboration, 279, 279–80; in contract law, 239, 266, 268, 268; licensing, 266, 268, 268; milestone, 239, 268, 268, 279, 279–80; royalty, 269, 269; up-front, 268, 268
permanent injunctions, 103
permission, as a role of patent licenses, 253
pharmaceutical industry: AZT for, 89–90, 90; biologic drugs for, 176–77, 177–79; collaborative agreements in, 274–75; commercial success in, 63; compositions in, 29–30; contract law for, 239–40; discovery in, 78; elution profiles in, 46; filing patent applications in, 86, 86; generic drugs and, 5; innovators in, 163–64, 181–82; inventions in, 65; portfolios for, 259; prior-art references in, 46; regulatory law for, 180–83; scientists with, 34–35; small-molecule drugs for, 164–68, 165, 168–72, 170–76; technology and, 57; terminology for, 55; in U.S., 61
postapproval studies, of drugs, 175
predictability, regarding enablement, 53
principles of note, regarding contracts, 240–41
prior-art references, 39; anticipation by, 39, 39–41; enabling disclosures by, 38, 38; elements in, 42–43; in pharmaceutical industry, 46
profits: from collaboration agreements, 278–79; maximization of, 264
prosecution: examination and, 79–80; patent-term adjustment formulas in, 72; history of, 25, 112; limiting history of, 114–15
protection: regarding CIPs, 85; in international law, 63–64; of inventions, 79; by trademarks, 206, 206
provisions: in contract law, 237, 242; ownership and, 238; regarding patent law, 275–76
public domain: disclosures in, 37, 37–38; information in, 36; knowledge in, 152, 152–54; publications in, 37, 40–41, 43–45, 60–61, 120–21
published information, 24
quid pro quo, patents and, 14
reasonable expectations, nonobviousness and, 43
recitals, in contracts, 237
regional stage, PCT applications and, 63
regular patent applications, 61
regulatory law, 2, 5, 9–10; biobetters in, 219–20, 220–22, 222; for biologic drugs, 215–16, 216; congressional intervention and, 70; exclusivity in, 184–89, 185–91; for generic drugs, 180; history of, 211–12; innovators in, 70; for pharmaceutical industry, 180–83; in U.S., 163–64. See also innovators
rejections: of claims, 67–68; in examination, 75
reliance, on patent opinions, 140–41
requirements: for claims, 119; nonobviousness as, 29; novelty as, 29; for patent documents, 49; quid pro quo relating to enablement, 52; restriction, 65–66, 66; utility as, 29
research: agreements for, 247–48; for innovators, 164–65, 165; by start-ups, 257; at universities, 94
risks, of relying on patent opinions, 140; for attorneys, 129; in contract law, 239–40
sales activities, patent filing strategy and, 64
science: commercial goals in, 270–71; education in, 3; fields of, 42; infrastructure for, 1; inquiry in, 249–50; journals for, 36; legal system and, 5; nonprofit world of, 248–49; scientifically neutral statutory language, 30–31; scientific events, 58; skill in, 32–33
scientists: patent applications for, 47–48; companies and, 228–29; confidentiality for, 246–47; credibility for, 34–35; diagnostic methods by, 66; education for, 6; evidence by, 48; experimentation by, 272–73; journals for, 37–38; laboratories and, 249; legal studies for, 3–7; MTAs for, 251–52; offer and acceptance by, 230; patent law for, 67, 91–92; pharmaceutical inventions and, 34–35; at universities, 251–52; written contracts for, 229–30
scope: of claims, 18, 18–21, 21, 24, 113–14; of collaborative agreements, 274; complexity and, 279; of grant clauses, 254–55; legal language and, 18, 18–21; of MTAs, 250
secondary considerations, 43
shortening, of patent term, 77
skill: written description and, 50; persons of, 53; persons of ordinary skill, 42, 44; in science, 32–33; enablement and, 52
specificity, for utility, 32, 34; of dosing regimens, 54
start-ups, 129, 134–35; agendas for, 97, 97–98; clinical trials for, 281; licensing for, 259; research tools by, 257; screening libraries by, 247–48; in U.S., 142–43, 143–45, 245–46
state powers: contract law and, 10; federal powers and, 7–8
statutory double patenting, 75, 75
statutory exemption to prior art, 36, 36
strategy, patent family creation and, 87–88
structural features, written description and, 50–51
successors, contractual obligations and, 240
Supreme Court: Alice Corp. v. CLS Bank for, 32; Association for Molecular Pathology v. Myriad Genetics for, 32; Diamond v. Chakrabarty for, 31; Markman v. Westview for, 25; Mayo Collaborative Services v. Prometheus Laboratories, 31–32, 157–58; patent categories for, 30–31; patent law for, 60
surrender, legal rights, 231
tactical considerations, patent prosecution and, 63, 63–64
technical information, 140
technology: written description and, 50; for commercial success, 145; claim coverage of, 18; facets of, 151; industry and, 15; investment in, 130, 130–32; conception and, 94–95, 94–95; medical devices, 7; trade secrets and, 154–55, 155–57; pharmaceutical industry and, 57; infringement and, 103
temporary injunctions, 103
termination: of collaboration agreements, 280–83, 282–83; of contracts, 240
terms: adjustments of, 71–73, 72–74; construing, 238; double patenting and, 74–76, 75–77; extensions of, 70, 71, 73–74, 183, 204–5; nondisclosure, 244–45; shortening of, 77
third-party licenses, 262
totality of evidence, 212, 213
trademarks: Patent and Trademark Office, U.S., 15; protection by, 206, 206
United States (U.S.): Affordable Care Act in, 210–211; Biologics Price Competition and Innovation Act in, 5; biosimilars in, 209–10; bundles of patent rights in, 254; claims in, 50–51, 53–56, 68–69, 76–77; companies in, 103–4, 117; constitutional law in, 8; prior-art disclosures in, 120; economics in, 208; exclusive licensing in, 257–58; federal courts in, 25; Food and Drug Administration Modernization Act in, 187–88, 188; Hatch–Waxman Act in, 5; importing into, 252–53; infringement in, 141; international law and, 2, 36; inventions in, 252–53; legal studies in, 7–10; MPEP in, 9; Orphan Drug Act in, 187, 187; patent applications in, 36–37, 37; patent law in, 29, 52, 256, 259–61, 263–64; Patent Office in, 15, 62, 65, 71–72, 78–80, 80–81, 126, 128; PCT in, 72–73; pharmaceutical industry in, 61; protection of technology in, 151–52; regulatory law in, 163–64; start-ups in, 142–43, 143–45, 245–46; third-party licenses in, 262; twenty-year rule in, 70; validity presumed in, 95–96. See also Food and Drug Administration
United States Code (U.S.C.), 8
unmodified derivatives, 250
unpredictability, claim construction and, 25, 26–28
unpublished data, know-how licenses and, 253
utility: of inventions, 32–33, 33–35; nonobviousness and, 47; as requirement, 29
valuation, patent portfolios and, 150
variant of unknown significance (VUS), 158–59
variations, of clinical trials, 172–73