What is a Patent A technical and legal

What is a Patent? • A technical and legal document – Description of invention – Legal definition • Legal protection – Exclusionary rights • Three types – Utility – Design – Plant

Utility Patent • Most patents • Protects the way an invention is used and how it works • Granted to anyone who invents a new and useful method, process, machine, device, manufactured item, or chemical compound - or any new and useful improvement to the same

Design Patent • Protects only the ornamental appearance of an invention

Plant Patent • Patent issued for newly invented strains of asexually reproducing plants • Tuber propagated plants or wild uncultivated plants may not be patented • Not all countries allow plant patents

Patent History United States Constitution Article 1, Section 8, Clause 8 “Congress shall have power…to promote the Progress of Science and useful Arts by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. ” • First U. S. patent law enacted in 1790 – Modern patent system-Patent Act of 1952 – Significant changes to patent law currently in Congress • Patents granted by U. S. Patent and Trademark Office (USPTO)

Patents-Purpose • Benefit the public – Brings technology to the market – Publicly discloses the details of the invention • Others can build upon the technology • Protect inventor – Limited monopoly- exclude others from practicing the invention – Provides incentive to make invention public • Discourages trade secrets

Patentability Criteria • • Novel Non-Obvious Useful Sufficiently described to allow (“enable”) others to use the invention

Patentable Inventions • Materials and chemical compounds • New uses of known chemicals and materials • New combinations and formulations of known materials • Manufacturing and other processes • Mechanical devices and machines • Instrumentation and electronic devices • Microorganisms, plants and animals • Purified or modified biological materials • Computer hardware and software • Consumer products and gadgets • Improvements to any of the above

Non-Patentable “Inventions” • • Ideas Laws of nature Naturally occurring substances in their natural state Mathematical formulas Perpetual motion machines Ways of doing business (some e-business exceptions) Music, art and photographs (Copyrightable)*** Written materials (Copyrightable)*** ***The U. S. Copyright Act (17 USC 100 et. seq. ) provides copyright protection "for original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device. ” http: //www. law. washington. edu/lta/swp/law/copyvpatent. html

Patent Components 1. Inventors 2. Owners 3. References 4. Abstract 5. Figures 6. Detailed description, the “specification” 7. Legal definition of the invention- “Claims”

The Biotech Industry Healthcare • Therapeutics – Natural products – Recombinant proteins – Monoclonal antibodies • • • Diagnostics Vaccines Gene therapy Personalized medicine Tissue engineering Plant-made pharmaceuticals • Cell transplants, xenotransplants

The Biotech Industry Agriculture • Crop improvements – – – Pest Resistance Herbicide resistance Environmental stress resistance Increased yield Optimized nutrition • Plant-made pharmaceuticals • Forestry – Increased yield – Optimized composition • Animal health • Animal improvements

The Biotech Industry Industrial, Environmental, Other • Biocatalysts – Industrial enzymes – Optimized enzymes – De novo enzymes • Biofuels – Cellulosic ethanol – Increased biomass • Bioplastics • Remediation – Bacteria – Plants • Forensics • Sensors

The Biotech Industry The Numbers • >400 biotech drugs and vaccines targeting >200 diseases • 4, 717 and growing public and private companies worldwide (2008) • 2012 revenue estimates: biotech drugs- 24% (14% m. Ab, 10% other); small molecules- 76% revenues (Datamonitor) • 170 million hectares (1 hectacre = 2. 47 acres) planted in 2012 (globally)

Biotech Development Timelines are Long Ag. Biotech 2 -7 Yrs. Trait Generation & Optimization 1 -2 Yrs. POP Model Plants RESEARCH Target ID Validation 1 -5 Yrs. 1 -2 Yrs. Early Event Testing 5 -8 Yrs. Field Trials Regulatory App. DEVELOPMENT Lead Generation & Optimization 2 -4 Yrs. Preclinical Pharmacology 1 -2 Yrs. Bio. Pharma Adapted From: Mc. Elroy (2003) Nat. Biotech. 21(9): 996 -1002 2 -3 Yrs. Commercialization COMMERCIALIZATION Clinical Trials FDA App. Process Dev. 5 -8 Yrs. Commercialization 2 -3 Yrs.

Biotech Development Costs are High • November 2011 Report on the cost of developing a new biotechnology product (Tufts Center for the Study of Drug Development) – ~$1. 3 Billion for drugs • $615 Million Pre-clinical ($198 Million out-of-pocket) • $626 Million Clinical ($361 Million out-of-pocket) • Biotech development risks are high – Only 1 in 5, 000 biopharmaceuticals reach approval by the FDA – However, biopharmaceutical approval rate higher than conventional pharmaceuticals (30. 2% vs. 21. 5%)

Patents Are Needed to Recoup Biotech Development Costs • Patents grant a limited monopoly – Assures first-to-market status – Sales are only limited by size of the patient population and supply – Greater control over pricing – Revenue potential is generally secure for the life of the patent • US Patent life is 20 years from earliest filing date • Long development time doesn’t leave much patent life • Branded drugs lose 80% of market share within 6 to 8 weeks of patent expiration • Strong patent portfolio makes company a more attractive investment/buyout opportunity

Patents and the Birth of the Biotech Industry • In addition to the day-to-day operational benefits that patents bring to biotech companies, two patent -related events are credited with starting the biotech industry – Supreme Court ruling regarding patenting of living things • Diamond v. Chakrabarty – Congressional act regarding patenting of inventions made using government funds • The Bayh-Dole Act

Task • Research and record information about the following: • Diamond vs. Chakrabarty • The Bayh-Dole Act of 1980 ***WHO - WHAT - WHERE - WHY - WHEN HOW***

Diamond v. Chakrabarty

Diamond v. Chakrabarty • Ananda Chakrabarty-engineered Pseudomonas • Introduced plasmids to enhance crude oil degradation • Filed in 1972 -36 claims – Methods claims granted – Claims on the actual bacterium not allowed • USPTO contended that living things are not patentable • Appealed by GE-overturned • Appealed by USPTO • Decided in the Supreme Court March-June 1980

Diamond v. Chakrabarty • Supreme Court Ruling 1980 -5 to 4 vote • Summary-Chief Justice Warren Earl Burger “…Congress intended statutory subject matter to ‘include anything under the sun that is made by man’…. Judged in this light, [Chakrabarty’s] microorganism plainly qualifies as patentable subject matter. His discovery is not nature’s handiwork but his own”

Diamond v. Chakrabarty • Living things and components of living things now patentable if modified “by man” – – Genes Proteins Cells Organisms- Includes higher life forms, e. g. Harvard Onco. Mouse 1988 • Widely viewed as critical to the start of the Biotech industry

The Bayh-Dole Act of 1980

Bayh-Dole Act of 1980 Pre-1980 Of the ~28, 000 patents held by US Gov’t. only 5% licensed Source: Bayh-Dole 25, Inc. (2006) “The Bayh-Dole Act at 25”

Bayh-Dole Act of 1980 Source: Bayh-Dole 25, Inc. (2006) “The Bayh-Dole Act at 25”

Bayh-Dole Act of 1980 Benefits to Biotechnology Companies • Universities are the primary drivers of cutting edge research – Government grants allow technology generation on a large scale – Universities actively patent and license their technologies • Industry can access university technology through licensing – Exclusive licensing is possible – Faculty consulting brings critical expertise – Sponsored research can reduce personnel and infrastructure needs • ~70% of university spin-outs are biotechnology-based • Small companies receiving government funding (SBIR, STTR) can retain title on inventions

Patents and the Birth of the Biotech Industry Summary Diamond v. Chakrabarty made biotechnology patents possible The Bayh-Dole Act boosted the number and “useful” availability of biotechnology patents