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Bayh–Dole Act

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The Bayh–Dole Act or Patent and Trademark Law Amendments Act ( Pub. L. 96-517, December 12, 1980) is United States legislation permitting ownership by contractors of inventions arising from federal government-funded research . Sponsored by senators, Birch Bayh of Indiana and Bob Dole of Kansas, the Act was adopted in 1980, is codified at 94 Stat. 3015, and in 35 U.S.C. §§ 200–212, and is implemented by 37 C.F.R. 401 for federal funding agreements with contractors and 37 C.F.R 404 for licensing of inventions owned by the federal government.

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128-560: A key change made by Bayh–Dole was in the procedures by which federal contractors that acquired ownership of inventions made with federal funding could retain that ownership. Before the Bayh–Dole Act, the Federal Procurement Regulation required the use of a patent rights clause that in some cases required federal contractors or their inventors to assign inventions made under contract to the federal government unless

256-543: A board to report to, which is the situation for a corporation's CEO. Many people desire to make their own decisions, take their own risks, and reap the rewards of their efforts. Small business owners possess the flexibility and freedom to make their own decisions within the constraints imposed by economic and other environmental factors. However, entrepreneurs have to work for very long hours and understand that ultimately their customers are their bosses. Small businesses (often carried out by family members) may adjust quicker to

384-463: A "close out" letter stating that: "The December 2012 report from Genzyme stated that: (1) U.S. Fabry patients remain on full dose regimens, (2) Genzyme continues to accommodate new patients with full dosing and without placing them on a waiting list; and (3) Genzyme is able to provide full doses of Fabrazyme to patients transitioning to Fabrazyme. On October 25, 2012, the NIH received a petition on behalf of

512-462: A Stanford employee, who was under obligation to assign certain inventions to Stanford, if Stanford was required by law or contract to own them, was sent by Stanford faculty to work at a biotech company to learn polymerase chain reaction , a proprietary technique, and signed an agreement with that company assigning his future inventions, related to the PCR method, that he learned from the company. The company

640-413: A bachelor's degree or higher, 33% had some college background, and 28% received at least a high school diploma. The United States census data for the years 2014 and 2015 shows the women's ownership share of small businesses by firm size. The data explains percentages owned by women along with the number of employees including the owner. Generally, the smaller the business, the more likely it to be owned by

768-424: A bill, along the lines of the "Jeffersonian belief" described above. Accordingly, as described below, the legislation decentralized control of federally funded inventions, vesting the responsibility and authority to commercialize inventions with the institution or company receiving a grant, with certain responsibilities to the government, the inventor, and the public, as described below. The Bayh–Dole Act authorizes

896-460: A business may actually lose all its working capital and funds. The legal difficulties involved with cybercrime can become pricy and hurt the business itself for not having standard security measures and standards. Security not only for the business but more importantly the customer should be the number one priority when dealing with security protocol. The monetary dollar damage caused by cybercrime in 2016 equaled out to be over 1.33 billion dollars in

1024-400: A coalition of public interest groups to exercise its march-in rights against AbbVie over its antiretroviral drug ritonavir (sold under the name Norvir). On October 25, 2013, NIH denied the petition stating that, as in 2004 when similar pricing and availability issues regarding the same drug were raised and discussed at public hearings, the NIH'S role in the case was limited to compliance with

1152-412: A dual purpose, as business networks to provide marketing and connect members to potential sales leads and suppliers, and as advocacy groups, bringing together many small businesses to provide a stronger voice in regional or national politics . In the case of independent business alliances, promoting the value of locally owned, independent business (not necessarily small) through public education campaigns

1280-498: A fair portion (23 per cent) of the total value of all the government's prime contracts as mandated by the Small Business Act of 1953. Since 2002, a series of federal investigations have found fraud, abuse, loopholes, and a lack of oversight in federal small business contracting, which has led to the diversion of billions of dollars in small business contracts to large corporations. Another problem for many small businesses

1408-469: A franchise. The small business owner can leverage a strong brand name and purchasing power of the larger company while keeping their own investment affordable. However, some franchisees conclude that they suffer the "worst of both worlds" feeling they are too restricted by corporate mandates and lack true independence. It is an assumption that small business is just franchisees, but the truth is many franchisers are also small businesses. Although considered to be

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1536-611: A great deal in terms of size, revenues, and regulatory authorization, both within a country and from country to country. Some small businesses, such as a home accounting business, may only require a business license. On the other hand, other small businesses, such as day cares , retirement homes , and restaurants serving liquor are more heavily regulated and may require inspection and certification from various government authorities. Researchers and analysts of small or owner-managed businesses generally behave as if nominal organizational forms (e.g., partnership, sole-trader, or corporation), and

1664-459: A highly inflationary path: the price index quintupled between 1972 and 1995. Between 1965 and 1979, the public sector 's share of total employment rose from 12% to 30%, which greatly increased the total tax burden at a time of escalating costs and prices, which fed into wage settlements, competitiveness, and profitability, and contributed to a sharply deteriorated trade balance. Some newly industrialized countries saw some diversionary benefits from

1792-729: A lack of time for the owner to coordinate socially responsible efforts, such as supporting local charities or not-for-profit activities. Additionally, a small business owner's expertise often falls outside the realm of socially responsible practices, which can contribute to a lack of participation. Small businesses also face a form of peer pressure from larger forces in their respective industries, making it difficult to oppose and work against industry expectations. Furthermore, small businesses undergo stress from shareholder expectations. Because small businesses have more personal relationships with their patrons and local shareholders, they must be prepared to withstand closer scrutiny if they want to share in

1920-559: A link to the small business's own website. Posting to a blog about the company's business or service area regularly can increase web traffic to a company website. Marketing plan In the US, small businesses (fewer than five hundred employees) account for more than half the non-farm, private GDP and around half the private sector employment. Regarding small business, the top job provider is those with fewer than ten employees , and those with ten or more but fewer than twenty employees comes in as

2048-467: A local economy than the introduction of new chain stores. By opening up new national level chain stores, the profits of locally owned businesses greatly decrease and many businesses end up failing and having to close. This creates an exponential effect. When one store closes, people lose their jobs, other businesses lose business from the failed business, and so on. In many cases, large firms displace just as many jobs as they create. A disadvantage of having

2176-513: A low cost and on a part-time basis, while a person continues a regular job with an employer or provides care for family members in the home. In developing countries, many small businesses are sole-proprietor operations such as selling products at a market stall or preparing hot food to sell on the street, which provide a small income. In the 2000s, a small business was well suited to Internet marketing ; because, it can easily serve specialized niches, something that would have been more difficult before

2304-537: A minority government before winning a second election on 10 October by a majority of just three seats. Economic growth was re-established in 1975 as the recession's end was declared, but Britain's economy remained shaky. Inflation remained high, strikes continued to cripple manufacturing and public services, unemployment continued to rise above the 1,000,000 mark, and just after the resignation of Harold Wilson as prime minister in March 1976, his successor James Callaghan

2432-470: A period of recession. The Federal Reserve adjusted its mandate as a result, believing that the inflation-unemployment tradeoff was much higher than previously thought, and established a 6% target as full employment. Thus, unemployment, which had reached a peak of 9% in May 1975, did not dip below 6% until June 1978. The pre-1974 recession level of 4.6% unemployment was not reached again until November 1997, when

2560-510: A postwar high of 1,500,000), and opinion polls suggested that Labour could form a majority government if a general election was held. However, Callaghan ruled out an election in September 1978, and within weeks a series of strikes began which would spark the Winter of Discontent . In March 1979, a vote of no confidence issued by Tory opposition leader Margaret Thatcher sparked the collapse of

2688-432: A process which is often but not always financed by venture capital and angel investments . Successful entrepreneurs have the ability to lead a business in a positive direction by proper planning, adapting to changing environments, and understand their own strengths and weakness. Spectacular success stories stem from startups that expanded in growth. Examples would be Microsoft, Genentech, and Federal Express which all embody

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2816-542: A product or service. Another means by which small businesses can advertise is through the use of "deal of the day" websites such as Groupon and Living Social . These Internet deals encourage customers to patronize small businesses. Many small business owners find internet marketing more affordable. Google AdWords and Yahoo! Search Marketing are two popular options of getting small business products or services in front of motivated web searchers. Social media has become an affordable route of marketing for small businesses. It

2944-399: A risky choice, given that the interest rate on credit cards is often several times the rate that would be paid on a line of credit at a bank or a bank loan and terms can change unpredictably. Recent research suggests that the use of credit scores in small business lending by community banks is surprisingly widespread. Moreover, the scores employed tend to be the consumer credit scores of

3072-411: A small business is the challenge of finding and keeping talented employees. Small tech companies have difficulty in retention when larger companies are interested in the same talent. Workers can be acquired from out of country but strict immigration rules are limiting. Independence is another advantage of owning a small business. A small business owner does not have to report to a supervisor, manager, or

3200-437: A sole-proprietorship (an unincorporated business owned by a single person) is a type of family business" and "there are twenty-two million small businesses (fewer than five hundred employees) in the US and approximately 14,000 big businesses". It has been found that small businesses created the newest jobs in communities, "In 1979, David Birch published the first empirical evidence that small firms (fewer than 100 employees) created

3328-759: A subject invention in cases subject to this section, the Federal agency may consider and after consultation with the contractor grant requests for retention of rights by the inventor subject to the provisions of this Act and regulations promulgated hereunder." While the district court accepted that argument, both the Federal Circuit and the Supreme Court denied it, leaving the basic law of inventorship unchanged and making clear that Bayh–Dole did not give federal contractors any special right to inventions made in federally funded work. Only one case has discussed

3456-483: A subject invention that it has acquired, then the Federal agency may request title. The agency may waive its right to take title to the invention, and allow the inventors to retain title to their inventions. If an organization elects to retain title to a subject invention for which it has obtained assignment, the organization is obligated to do the following: Certain additional requirements apply to nonprofit organizations only. Nonprofits must also: A subject invention

3584-643: A successful way of doing business, literature has proved that there is a high failure rate in franchising as well, especially in the UK, where research indicates that out of 1658 franchising companies operating in 1984, only 601 remained in 1998, a mere 36%. A retailers' cooperative is a type of cooperative that employs economies of scale on behalf of its retailer members. Retailers' cooperatives use their purchasing power to acquire discounts from manufacturers and often share marketing expenses. They are often recognized as "local groups" because they own their own stores within

3712-464: A variety of problems, some of which are related to their size. A frequent cause of bankruptcy is under capitalization . This is often a result of poor planning rather than economic conditions. It is a common rule of thumb that the entrepreneur should have access to a sum of money at least equal to the projected revenue for the first year of business in addition to the anticipated expenses. For example, prospective owners anticipating 100,000 in revenue

3840-439: A very cost-effective way for small business owners to reach a targeted audience with a very specific message. In addition to the social networking sites, blogs have become a highly effective way for small businesses to position themselves as experts on issues that are important to their customers. This can be done with a proprietary blog and/or by using a back-link strategy wherein the marketer comments on other blogs and leaves

3968-447: A way to reach out to their loyal customers to give them news about specials of the day or special coupons, generate repeat business and reach out to new potential clients. The relational nature of social media, along with its immediacy and twenty-four-hour presence lend an intimacy to the relationships small businesses can have with their customers while making it more efficient for them to communicate with greater numbers. Facebook ads are

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4096-464: A woman. The data shows that about 22% of small businesses with 100-500 employees were owned by women, a percentage that rises the smaller the business. 41% of businesses with just 2-4 employees were run by women, and in businesses with just one person, that person was a woman in 51% of cases. Franchising is a way for small business owners to benefit from the economies of scale of the big corporation (franchiser). McDonald's and Subway are examples of

4224-492: Is a fraction of the cost of traditional marketing and small businesses can do it themselves or find small social marketing agencies that they can hire out for a small fee. Statistically, social media marketing has a higher lead-to-close rate than traditional media. Successful online small business marketers are adept at utilizing the most relevant keywords in their website content. Advertising on niche websites that are frequented by potential customers can be effective, but with

4352-454: Is defined as "any invention of the contractor that is conceived or first actually reduced to practice in the performance of work under a funding agreement." The U.S. Supreme Court in Stanford v Roche made clear that "of" in "of the contractor" means ownership. ("And 'invention owned by the contractor' or 'invention belonging to the contractor' are natural readings of the phrase “invention of

4480-681: Is handled via the Bulgarian Small and Medium Enterprises Promotion Agency (BSMEPA), based in Sofia . In the United Kingdom, the Small Business Commissioner (SBC) provides information and advice for small businesses and deals with complaints resolution with specific reference to late payment problems and other unfavourable payment practices. The SBC's role is to make non-binding recommendations advising on how

4608-441: Is met. The most important of these is a failure by the contractor to take "effective steps to achieve practical application of the subject invention" or a failure to satisfy "health and safety needs" of consumers. Though this right is, in theory, quite powerful, it has not proven so in terms of its practical application—as of January, 2015, no federal agency has exercised its march-in rights. Five march-in petitions have been made to

4736-490: Is one of the major reasons for small business failure. Common marketing techniques for small business include business networking (e.g., attending Chamber of Commerce events or trade fairs ), " word of mouth " promotion by existing customers, customer referrals, Yellow pages directories, television, radio, and outdoor ads (e.g., roadside billboards), print ads, email , and Internet marketing . TV ads can be quite expensive, so they are normally intended to create awareness of

4864-468: Is one of the most contentious provisions in Bayh–Dole. It allows the funding agency, on its own initiative or at the request of a third party, to effectively ignore the exclusivity of a patent awarded under the act and grant additional licenses to other "reasonable applicants". This right is strictly limited and can only be exercised if the agency determines, following an investigation, that one of four criteria

4992-457: Is termed the 'Entrepreneurial Myth' or E-Myth. The mythic assumption is that an expert in a given technical field will be an expert at running that kind of business. Additional business management skills are needed to keep a business running smoothly. Some of this misunderstanding arises from the failure to distinguish between small business managers as entrepreneurs or capitalists. While nearly all owner-managers of small firms are obliged to assume

5120-416: Is the capacity of much larger businesses to influence or sometimes determine their chances for success. Business networking and social media has been used as a major tool by small businesses in the UK, but most of them just use a " scattergun " approach in a desperate attempt to exploit the market which is not that successful. Over half of small firms lack a business plan , a tool that is considered one of

5248-486: Is timely disclosed and the contractor elects to retain ownership in that invention. A second key change with Bayh–Dole was to authorize federal agencies to grant exclusive licenses to inventions owned by the federal government. The Bayh–Dole Act grew out of the Congress's efforts to respond to the economic malaise of the 1970s . One of Congress's efforts was focused on how best to manage inventions that were created with

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5376-586: The Great Depression , where unemployment peaked at 25% in 1933; and the COVID-19 recession where unemployment peaked at 14.7% in 2020.) [REDACTED] The recession also lasted from 1973 to 1975 in the United Kingdom . GDP declined by 3.9% depending on the source. It took 14 quarters for the UK's GDP to recover to that at the start of recession. The oil crisis was largely to blame for

5504-573: The National Institutes of Health . In In Re Petition of CellPro, Inc. , CellPro petitioned the NIH in March 1997 after five years of patent litigation with Johns Hopkins University and Baxter Healthcare . CellPro had a patented, FDA-approved device for purifying stem cells for use in hematopoietic stem cell transplantation procedures; Johns Hopkins had patents on a different method to purify stem cells and had licensed them to Becton Dickinson, which had sublicensed them to Baxter, which

5632-552: The United States Congress , to exercise march-in rights for patents owned by Abbott Labs covering the drug ritonavir, sold under the trade name Norvir , a prescription drug used in the treatment of HIV infection . In 2003 Abbott raised the price of Norvir 400% for U.S. customers (but not for consumers in any other country), and had refused to license ritonavir to another company for purposes for providing protease inhibitors coformulated with ritonavir. The NIH denied

5760-438: The economic recovery from the 1973 to 1975 recession had many of the characteristics of a typical U-type recovery. GNP (the measure at the time) reached and exceeded its pre-recession level by first quarter 1976. Industrial production had recovered to its pre-recession levels by the end of 1976. The major influence of the experience of the 1974 recession came in the form of the concept of stagflation , that is, inflation during

5888-672: The long tail of the Internet, it can be time-intensive to advertise on enough websites to garner an effective reach . Creating a business website has become increasingly affordable with many do-it-yourself programs now available for beginners. A website can provide significant marketing exposure for small businesses when marketed through the Internet and other channels. Some popular services are WordPress , Joomla , Squarespace , and Wix . Social media has proven to be very useful in gaining additional exposure for many small businesses. Many small business owners use Facebook and Twitter as

6016-422: The Bayh–Dole Act and that "...   the extraordinary remedy of march-in is not an appropriate means of controlling prices of drugs broadly available   ...". A more comprehensive list for "march-in petitions" can be found here: Unlike march-in rights, the government has occasionally exercised its ability to use patented inventions pursuant to 28 U.S.C. § 1498(a), particularly when HHS sought to stockpile

6144-532: The Department of Commerce to create standard patent rights clauses to be included in federal funding agreements with nonprofits, including universities, and small businesses. The standard patent rights clause is set forth at 37 CFR 401.14. The clause is incorporated into federal funding agreements through a number of contracting instruments, including grants made to universities and contracts made with for-profit companies. The Department of Commerce has delegated to

6272-560: The Federal Reserve deviated from its prior policy. The interpretation regarding the cause of stagflation was and continues to be controversial. The oil embargo of 1973–1974, which pushed prices of petroleum from $ 15 to $ 45 a barrel (2010 dollars) almost overnight, certainly contributed to inflationary measures during this period, taking a larger share of incomes (an "oil tax") at a time of falling consumer spending . The price of petroleum products continued to rise throughout

6400-622: The Internet revolution which began in the late 1990s. Internet marketing gives small businesses the ability to market with smaller budgets. Adapting to change is crucial in business and particularly small business; not being tied to the bureaucratic inertia associated with large corporations, small businesses can respond to changing marketplace demand more quickly. Small business proprietors tend to be in closer personal contact with their customers and clients than large corporations, as small business owners see their customers in person each week. One study showed that small, local businesses are better for

6528-609: The Labour government and in the election in May that year, the Tories returned to power. In the first year of the Thatcher-led Tory government inflation rose to 15.3%, but then fell to 5% by the time of their election win in 1983. However, the monetarist policies designed to curb inflation caused a recession in 1980 and resulted in a steep rise in unemployment from 5.4% (1,390,46 people) to 11.5% (3,104,66 people). It

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6656-524: The National Institute of Standards and Technology to promulgate implementing regulations for Bayh–Dole. Under the standard patent rights clause, small businesses and non-profit organizations , if they obtain title by assignment to "subject inventions," can retain that title by complying with certain formalities. No small business or nonprofit organization, however, is required to obtain ownership of such inventions. All organizations agree to do

6784-565: The National Science Foundation. In the 1970s, faculty at Purdue University in Indiana had made important discoveries under grants from the Department of Energy, which did not issue Institutional Patent Agreements. Officials at the university complained to their senator, Birch Bayh, whose staff investigated. At the same time, Senator Robert Dole was made aware of similar issues, and the two senators agreed to collaborate on

6912-402: The U.S. Small Business Administration indicates that employees of large firms are 17% more likely to receive benefits including salary, paid leave, paid vacation, bonuses, insurance, and retirement plans . Both lower wages and fewer benefits combine to create a job turnover rate among U.S. small businesses that is three times higher than large firms. Employees of small businesses must adapt to

7040-400: The U.S. Army through a specific form, DD Form 882s. Campbell Plastics never disclosed its subject invention through this form. Campbell Plastics argued instead that it disclosed all parts of its invention over the course of the contract, but simply never used the form. The court did not specifically address the legitimacy of the particular form, but assumed that it was sufficient. Nevertheless,

7168-563: The UK Companies Act 2006 were allowed to use this standard. For accounting years ending on or after 1 January 2016, FRSSE is no longer available, but there are options known as "abridged accounts" and "filleted accounts": Alternatively, the smallest companies are able to file "micro-entity accounts". FRS 105 is a Financial Reporting Standard applicable to the Micro-entities Regime. Small businesses often face

7296-631: The UK, the Companies, Partnerships and Groups (Accounts and Reports) Regulations 2015 transposed the EU Directive into UK law and amended the reporting regime for reduced disclosure accounts for any accounting period commencing on or after 1 January 2016. "Abbreviated accounts" were permitted for smaller entities under "FRSSE", the Financial Reporting Standard for Smaller Entities . Until 2015, companies deemed small under

7424-399: The US since 2007. Local businesses provide competition to each other and challenge corporate giants. Of the 5,369,068 employer firms in 1995, 78.8 per cent had fewer than ten employees, and 99.7 per cent had fewer than five hundred employees. Small businesses use various sources available for start-up capital : Some small businesses are further financed through credit card debt—usually

7552-535: The US were felt through the Jimmy Carter presidency until the mid-term of Ronald Reagan 's first term as president, characterized by low economic growth. Although the economy was expanding from 1975 to the first recession of the early 1980s , which began in January 1980, inflation remained extremely high until the early 1980s. The U.S. Bureau of Labor Statistics estimates that 2.3 million jobs were lost during

7680-548: The United States alone. In 2016, California alone had over 255 million dollars reported to the IC3. Certain cyber attacks can vary on how long it takes to solve a problem. It can take upwards to 69 days for an average everyday attack on a business. The types of attacks include viruses and malware issues. Employee activities within the workspace can also render a cyber attack. Employees using mobile devices or remote work access off

7808-480: The United States at two to five times the prices in other high income countries. The NIH held that "the extraordinary remedy of march-in was not an appropriate means for controlling prices." In In the Case of Fabrazyme patients with Fabry disease petitioned on August 2, 2010, for march-in rights in response to Genzyme 's inability to manufacture enough Fabrazyme to treat all Fabry patients. In 2009, Genzyme rationed

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7936-457: The United States, some of the largest concerns of small business owners are insurance costs (such as liability and health ), energy costs, taxes , and tax compliance . In the United Kingdom and Australia, small business owners tend to be more concerned with perceived excessive governmental red tape . Contracting fraud has been an ongoing problem for small businesses in the United States. Small businesses are legally obligated to receive

8064-426: The antibiotic ciproflaxin (brand name Cipro) in the wake of the 2001 anthrax attacks . Under § 1498(a), the government may use patented inventions without permission from a patentee, while paying the patent holder 'reasonable and entire compensation' which is usually "set at ten percent of sales or less". Despite an ambiguity noted by commentators as to the effects on the public of a contractor's failure to comply with

8192-624: The bank of some of the risk of extending the loan to a small business. The SBA requires business owners to pledge personal assets and sign as a personal guarantee for the loan. The 8(a) Business Development Program assists in the development of small businesses owned and operated by African Americans , Hispanics, and Asians. Canadian small businesses can take advantage of federally funded programs and services. See Federal financing for small businesses in Canada (grants and loans) . In Bulgaria , government support for small and medium-sized enterprises

8320-403: The basis of Vannevar Bush 's famous report entitled, "Science The Endless Frontier", which stated: "Scientific progress is one essential key to our security as a nation, to our better health, to more jobs, to a higher standard of living, and to our cultural progress." However, the government did not have a unified patent policy governing all the agencies that funded research, and the general policy

8448-648: The benefits of committing to socially responsible practices or not. While small businesses employ over half the workforce in the US and have been established as a main driving force behind job creation, the quality of the jobs these businesses create has been called into question. Small businesses generally employ individuals from the Secondary labor market . As a result, in the U.S., wages are 49% higher for employees of large firms. Additionally, many small businesses struggle or are unable to provide employees with benefits they would be given at larger firms. Research from

8576-480: The business has enough capital, the small business owner must be mindful of contribution margin ( sales minus variable costs ). To break even, the business must be able to reach a level of sales where the contribution margin equals fixed costs . When they first start, many small business owners underprice their products to a point where even at their maximum capacity, it would be impossible to break even. Cost controls or price increases often resolve this problem. In

8704-494: The changing conditions; however, they may also be closed to the absorption of new knowledge and employing new labor from outside. Small businesses benefit from less extensive accounting and financial reporting requirements than those faced by larger businesses. The European Union 's Directive on annual financial statements of 2013 aims to "limit administrative burdens and provide for simple and robust accounting rules, especially for small and medium-sized enterprises (SMEs)". In

8832-490: The community. It is common for locally owned grocery stores, hardware stores, and pharmacies to participate in retailers' cooperatives. Ace Hardware , True Value , and NAPA are examples of a retailers' cooperative. Retail cooperatives allow consumers to supply their own earnings and gain bargaining power outside of the business sector. Retail cooperatives mainly reside within small communities where local businesses are often shut down. Many small businesses can be started at

8960-427: The consequent legal and accounting boundaries of owner-managed firms are consistently meaningful. However, owner-managers often do not distinguish between their personal and business interests. Lenders also often skirt organizational (corporate) boundaries by seeking personal guarantees or accepting privately held assets as collateral. Because of this behavior, researchers and analysts may wish to be cautious in assessing

9088-439: The contractor.”). If an invention is not owned by a party to the federal funding agreement, then it cannot be a subject invention and does not come within the scope of Bayh–Dole. The CFR addresses the relationship between federal funding and other funding that may supplement the federally supported research. If an invention is made outside the research activities of the federally funded research "without interference with or cost to

9216-595: The country and industry. Small businesses range from fifteen employees under the Australian Fair Work Act 2009 , fifty employees according to the definition used by the European Union , and fewer than five hundred employees to qualify for many U.S. Small Business Administration programs. While small businesses can be classified according to other methods, such as annual revenues, shipments, sales, assets, annual gross, net revenue, net profits,

9344-417: The country were widespread. There was also double-digit inflation during this period, which peaked at more than 20%. Edward Heath's offer of a 13% pay rise was rejected by the miners, and he then responded by calling a snap election on 28 February 1974 in what he saw as an opportunity for the electorate to show the miners that the government – and not the miners or the unions – were responsible for running

9472-468: The country. Most opinion polls suggested that the Tories would be re-elected with a majority, but when the election results came through on the morning of 1 March 1974, no party had an overall majority. The gap between Ted Heath's Tory government and the Labour opposition led by Harold Wilson (who had been prime minister for nearly six years until his surprise defeat by Heath's Tories in the 1970 election )

9600-399: The court found that the "piecemeal submissions [did] not adequately disclose the subject invention under the contract." The result was a forfeiture of the subject invention. In a footnote in a famous experimental use case, Madey v. Duke University , 307 F.3d 1351 (Fed. Cir. 2002), the court briefly mentions Bayh–Dole in suggesting that experimental uses by researchers are supported under

9728-458: The court rejected a claim that Bayh–Dole altered the grounds for patentability . The court, quoting an Amicus curiae , stated no connection exists between the Bayh–Dole Act and the legal standards that courts employ to assess patentability. Furthermore, none of the eight policy objectives of the Bayh–Dole Act encourages or condones less stringent application of the patent laws to universities than to other entities. The government's march-in right

9856-476: The crisis, namely Spain, Korea, Taiwan, Singapore, Mexico, and Brazil, as their low-cost environments attracted new investments and gave their products a competitive edge over competitors in higher-cost, developed countries suffering from higher energy costs. These countries gained increased market share both in their domestic markets and abroad at accelerating rates during the 1970s. In the United States ,

9984-455: The cyber attack would require experts outside of their field to further the investigation and find the problem. Being down for a business means losing money at the same time. This could halt the online operations and mean the business could potentially be down for a long period of time. Loss of capital and assets ties well in with the cost of fixing the issue. During a cyberattack, a business may lose its funds for that business. Worst-case scenario,

10112-701: The decade, reaching a peak of about $ 73 a barrel (2010 dollars) in 1979 as a result of the Iranian revolution , a price not exceeded until 2008 in the wake of dislocations due to the war in Iraq. Small business Small businesses are types of corporations , partnerships , or sole proprietorships which have a small number of employees and/or less annual revenue than a regular-sized business or corporation. Businesses are defined as "small" in terms of being able to apply for government support and qualify for preferential tax policy. The qualifications vary depending on

10240-545: The demographic of small business owners was published. The study showed that the median American small business owners were above the age of 50. The ages were distributed as 51% over 50 years old, 33% between the ages of 35 and 49, and 16% being under the age of 35. As for sex: 55% were owned by males, 36% by females, and 9% being equal ownership of both males and females. As for race: 72% were white/Caucasian, 13.5% were Latinos, 6.3% were African American, 6.2% were Asian, and 2% as other. As for educational background: 39% had obtained

10368-771: The downturn in the United Kingdom, just as it was in the US, although an additional crisis came in the form of the Three-Day Week , which was the result of fears over power shortages as a miner's strike was announced in December 1973. The three-day week was a state of emergency imposed by Conservative prime minister Edward Heath , which came into force on 1 January 1974, meaning that commercial users of electricity were limited to three specific consecutive days' consumption of electricity, and forbidden to work longer hours of those days, although services deemed essential were exempted from these regulations. Electricity blackouts across

10496-410: The drug to less than a third of the recommended dose as a result of manufacturing problems and FDA sanctions, but did not anticipate being able to meet the market needs until late 2011. The patients had a return of their symptoms and were put at greater risk of morbidity and mortality at the reduced dosage. The petitioners contended that where a licensee of a public invention has created a drug shortage,

10624-795: The fall of the Bretton Woods system after the Nixon shock . The emergence of newly industrialized countries increased competition in the metal industry, triggering a steel crisis , where industrial core areas in North America and Europe were forced to re-structure. The 1973–74 stock market crash made the recession evident. The recession in the United States lasted from November 1973 (the Richard Nixon presidency) to March 1975 (the Gerald Ford presidency), and its effects on

10752-509: The first year with 150,000 in start up expenses should have at least 250,000 available. Start-up expenses are often grossly underestimated adding to the burden of the business. Failure to provide this level of funding for the company could leave the owner liable for all of the company's debt in bankruptcy court under the theory of undercapitalization. Start-up businesses are often faced with reduced or no credit terms from suppliers due to lack of funds or trading history. In addition to ensuring that

10880-469: The following: The U.S. Supreme Court clarified in Stanford v Roche (2011), that the Bayh-Dole Act did not change the constitutional provision, that the original ownership of patents always vests with their inventor(s), and that the inventors' employers can own patents, only when inventors explicitly assign their patents to their employers. If an organization does not elect to retain title to

11008-615: The funding agency determined that the public interest was better served by allowing the contractor or inventor to retain principal or exclusive rights. The National Institutes of Health, National Science Foundation, and the Department of Commerce had implemented programs that permitted non-profit organizations to retain rights to inventions upon notice without requesting an agency determination. By contrast, Bayh–Dole uniformly permits non-profit organizations and small business firm contractors to retain ownership of inventions made under contract and which they have acquired, provided that each invention

11136-432: The government to the private sector." In 1968, the Department of Health, Education, and Welfare (HEW) introduced a uniform "Institutional Patent Agreement" (IPA) to allow grantee nonprofit institutions to obtain assignment of patentable inventions made with federal funding for which the institution had decided to seek patents. By 1978, over seventy universities and research organizations had negotiated an IPA with HEW or with

11264-446: The government-funded project," then the invention is not a subject invention. Similarly, an invention is not a subject invention if it arises in closely related research outside the "planned and committed activities" of the federally funded project, and the closely related research does not "diminish or distract from the performance" of the federally funded project. There is a growing body of case law on Bayh–Dole. Stanford v. Roche ,

11392-449: The growth is slow, as small business owners shy away from exporting due to actual and perceived barriers. Learning the basics of a foreign language could be the solution to open doors to new trade markets, it is a reality that not all foreign business partners speak English. China is stated to grow by 7.6% in 2013 and still, 95% of business owners who want to export to China have no desire and no knowledge to learn their local language. When

11520-416: The higher failure rate of small firms, which means that they are more likely to lose their job due to the firm going under. In the U.S. 69% of small businesses last at least two years, but this percentage drops to 51% for firms reaching five years in operation. The U.S. Small Business Administration counts companies with as much as $ 35.5 million in sales and 1,500 employees as "small businesses", depending on

11648-427: The implications of disclosing subject inventions. In Campbell Plastics Engineering & Mfg., Inc. v. Les Brownlee , 389 F.3d 1243 (Fed. Cir. 2004), the court held that since the appellant failed to comply with the invention disclosure provisions of a contract, the court upheld the transfer of title to an invention to the U.S. Army . Specifically, the contract required, per Bayh–Dole, that an invention be disclosed to

11776-636: The industry. Outside government, companies with less than $ 7 million in sales and fewer than five hundred employees are widely considered small businesses. Cybercrime in the business world can be broken down into 4 main categories. They include loss of reputation and consumer confidence, cost of fixing the issue, loss of capital and assets, and legal difficulties that can come from these problems. Loss of reputation and consumer confidence can be impacted greatly after one attack. Many small businesses will struggle to gain confidence and trust in their customers after being known for having problems prior. The cost of fixing

11904-549: The job makes it easier for a cyber attack to occur. Although small businesses have close relationships with their existing customers, finding new customers and reaching new markets is a major challenge for small business owners. Small businesses typically find themselves strapped for time to do marketing, as they have to run the day-to-day aspects of the business. To create a continual stream of new business and find new clients and customers, they must work on marketing their business continuously. Low sales (the result of poor marketing)

12032-453: The law. Specifically, the Madey court quoted the district court as holding that where a subject invention exists and the defendant is a recipient of government funding, "in light of the Bayh–Dole Act ... use of the patents that has been authorized by the government does not constitute patent infringement ." In University of Rochester v. G.D. Searle & Co. , 358 F.3d 916 (Fed. Cir. 2004),

12160-415: The more than $ 75 billion a year invested in government-sponsored R&D. Three philosophies were debated: "a Hamiltonian belief that the solution lay with a strong central government, which should take charge and actively manage these resources"; "a Jeffersonian belief that the solution lay with the individual and that the best thing government could do to provide incentives for success was to get out of

12288-532: The most important factors for a venture's success. Business planning is associated with improved growth prospects. Funders and investors usually require a business plan. A plan also serves as a strategic planning document for owners and CEOs, which can be used as a "bible" for decision-making An international trade survey indicated that the British share of businesses that are exporting rose from 32% in 2012 to 39% in 2013. Although this may seem positive, in reality,

12416-549: The name of Rock The Post. Several organizations in the United States provide help for the small business sector, such as the Internal Revenue Service 's Small Business and Self-Employed One-Stop Resource. The Small Business Administration (SBA) runs several loan programs that may help a small business secure loans. In these programs, the SBA guarantees a portion of the loan to the issuing bank, and thus, relieves

12544-459: The newest jobs", and Edmiston claimed that "perhaps the greatest generator of interest in entrepreneurship and small business is the widely held belief that small businesses in the United States create most new jobs. The evidence suggests that small businesses indeed create a substantial majority of net new jobs in an average year." The U.S. Small Business Administration has found small businesses have created two-thirds of net new private-sector jobs in

12672-438: The next 20 years. Furthermore, the ripple effects also compounded issues in the iron ore mining industry, at a time when Swedish iron ore was experiencing rising mining costs and facing increased low-cost competition from new mines in places such as Australia and Brazil. The inflationary recession, combined with an expansionary government fiscal policy and a generous collective wage agreement among unions in 1974–1976, put Sweden on

12800-802: The number of employees is one of the most widely used measures. Small businesses in many countries include service or retail operations such as convenience stores , gun shops , antique shops , small grocery stores , bakeries or delicatessens , barbers , hairdressers or tradespeople (e.g., mechanics , plumbers , carpenters , electricians ), car dealerships , laundromats , dry cleaners , restaurants , motels , photographers , very small-scale manufacturing, and Internet-related businesses such as web design and computer programming . Some professionals operate as small businesses, such as lawyers , accountants , dentists , medical doctors and developers (although these professionals can also work for large organizations or companies). Small businesses vary

12928-409: The number of employees, methods used to classify small companies include annual sales (turnover), the value of assets and net profit (balance sheet), alone or as a combination of factors. Small businesses usually do not dominate their field. The following table serves as a guide to business size nomenclature. Business size definitions (by number of employees) In 2016 a study that examined

13056-769: The number of invention disclosures or patent applications at a university," but it found that 60% of patents licensed by US universities were non-exclusive, which suggests, that patent incentive was not necessary to commercialize these inventions. All most profitable university patents were licensed non-exclusively and were related to biotechnology: Cohen–Boyer patents on recombinant DNA technology, which were licensed nonexclusively to over 400 firms, brought in $ 255 million to Stanford University . Columbia University Axel patents on methods of introducing genes for foreign proteins into cells brought in $ 790 million in revenue through nonexclusive licensing to Columbia. 1970s recession The 1973–1975 recession or 1970s recession

13184-628: The opportunity to buy cheaper health insurance in bulk. There was a study research done between 1990 and 2002 about how relationships like partnerships and alliances can make a big difference for small businesses. They go deep into the three main ideas, of how a business owns its own resources help, how much they have to rely on outside help and how changes in these relationships affect the businesses . These organizations include local or regional groups such as Chambers of Commerce and independent business alliances , as well as national or international industry-specific organizations. Such groups often serve

13312-514: The organizational types and implied boundaries relating to owner-managed firms. This includes the analysis of traditional accounting disclosures and studies that treat the firm as defined by a formal organizational structure. The concepts of small business, self-employment , entrepreneurship , and startup overlap but carry important distinctions. These four concepts are often conflated. Their key differences can be summarized as: Many small businesses are sole proprietor operations consisting only of

13440-422: The owner files bankruptcy. Researchers have examined small business failures in some depth, with attempts to model the predictability of failure. Small businesses can encounter several problems related to engaging in corporate social responsibility , due to characteristics inherent in their size. Owners of small businesses often participate heavily in the day-to-day operations of their companies. This results in

13568-454: The owner, but many have additional employees. Some small businesses that offer a product, process or service, do not have growth as their primary objective. In contrast, a business that is created to become a big firm is known as a startup. Startups aim for growth and often offer an innovative product, process, or service. The entrepreneurs of startups typically aim to scale up the company by adding employees, seeking international sales, and so on,

13696-548: The parties can resolve a dispute. Small businesses are encouraged per public policy on taxation. For example, from January 1, 2020, Armenia introduced a special micro-entrepreneurship tax system with a non-taxable base of 24 million AMD. Accordingly, a micro-business will be exempted from taxes other than income tax which will not exceed 5,000 AMD per employee. Small businesses often join or come together to form organizations to advocate for their causes or to achieve economies of scale that larger businesses benefit from, such as

13824-613: The patents due to the agreement that the Stanford employee had signed earlier with the startup company. Among the arguments Stanford made at the District, Federal Circuit, and Supreme Court levels, was one that stated that the Bayh–Dole Act gave grant recipients a "right of second refusal" subject to the Government's right of first refusal, based on the following language of the statute: "If a contractor does not elect to retain title to

13952-415: The petition finding no grounds to exercise its march-in rights. The NIH cited: In In the Case of Xalatan the NIH received a request from Essential Inventions in January 2004 to adopt a policy of granting march-in licenses to patents when the patent owner charged significantly higher prices in the United States than they did in other high income countries, on the basis of Pfizer's glaucoma drug being sold in

14080-450: The public health requirements of the Bayh–Dole Act are not met and other manufacturers should be allowed to enter the market. On November 3, 2010, the NIH denied the petition for march-in, stating that under the then-current FDA drug approval process, it would take years of clinical testing to bring a biosimilar of Fabrazyme to market and therefore march-in would not address the problem. The NIH also stated that it would continue to monitor

14208-596: The recession; at the time, this was a post-war record. Although the recession ended in March 1975, the unemployment rate did not peak for several months. In May 1975, the rate reached its height for the cycle of 9 percent. (Four cycles have had higher peaks than this: the late 2000s recession , where the unemployment rate peaked at 10 percent in October 2009 in the United States; the early 1980s recession where unemployment peaked at 10.8% in November and December 1982;

14336-474: The requirements of Bayh–Dole, the courts have clarified that any such failure does not in and of itself divest an owner of title or render a patent invalid. Several studies tried to understand, what were the effects of the Act on patenting by university researchers and on technology transfer from academia to industry. 2022 Stanford study was "unable to conclude that higher inventor’s royalty shares have any effect on

14464-470: The role of capitalist, only a minority will act as entrepreneurs. The line between an owner-manager and an entrepreneur can be defined by whether or not their business is growth-oriented. In general, small business owners are primarily focused on surviving rather than growing; therefore, not experiencing the five stages of the corporate life cycle (birth, growth, maturity, revival, and decline) as an entrepreneur would. Another problem for many small businesses

14592-420: The second, and those with twenty or more but fewer than one hundred employees comes in as the third (interpolation of data from the following references). The most recent data shows firms with fewer than twenty employees account for slightly more than 18% of the employment. According to "The Family Business Review", "there are approximately seventeen million sole-proprietorship in the US. It can be argued that

14720-461: The sense of new venture creation on small businesses. Self-employment provides work primarily for the founders. Entrepreneurship refers to all new businesses, including self-employment and businesses that never intend to grow big or become registered, but startups refer to new businesses that intend to grow beyond the founders, to have employees, and grow large. The legal definition of "small business" varies by country and by industry. In addition to

14848-592: The shipping, ship-building, and logging and mining industries. The increase in oil prices caused export revenues from shipping to drop by 25% within a few years. Sweden at this time had the world's second largest ship building industry (after Japan), and the spillover effects devastated shipbuilders (Swedish shipbuilders lost some 3 billion SEK in 1974), which in turn led to problems in Sweden's steel industry. The loss of shipbuilding jobs devastated port cities such as Malmö , home to Kockums ' shipyard, which would struggle for

14976-435: The situation and if Genzyme could not meet its production deadlines, or if a third party licensee requested a license, the march-in request would be revisited. The NIH additionally required regular updates from Mount Sinai School of Medicine , the patent holder, which agreed to not seek injunctions for potentially infringing products being sold during the shortage. On February 13, 2013, NIH's Office of Technology Transfer issued

15104-620: The small business fails, the owner may file for bankruptcy. In most cases, this can be handled through a personal bankruptcy filing . Corporations can file bankruptcy, but if it is out of business and valuable corporate assets are likely to be repossessed by secured creditors, there is little advantage to going to the expense of a corporate bankruptcy. Many states offer exemptions for small business assets so they can continue to operate during and after personal bankruptcy. However, corporate assets are normally not exempt; hence, it may be more difficult to continue operating an incorporated business if

15232-493: The small business owners rather than the more encompassing small business credit scores that include data on the firms as well as on the owners. Many owners seek a bank loan in the name of their business; however, banks will usually insist on a personal guarantee by the business owner. In October 2010, Alejandro Cremades and Tanya Prive founded the first equity crowdfunding platform for small businesses in history as an alternative source of financing. The platform operates under

15360-524: The way of these individuals"; and a belief that "held that government could only hurt and that it should make sure that everyone benefited financially from government's efforts". Prior to the enactment of Bayh–Dole, the U.S. government had accumulated 28,000 patents, but fewer than 5% of those patents were commercially licensed. These patents had accumulated because after World War II, the government under President Harry S. Truman decided to continue and even ramp up its spending on research and development, on

15488-435: Was a case decided by the Supreme Court that held that title in a patented invention vests first in the inventor, even if the inventor is a researcher at a federally funded lab subject to the Bayh–Dole Act. The judges affirmed the common understanding of US Constitutional law that inventors automatically own their inventions, and contractual obligations to assign those rights to third parties are secondary. The case arose because

15616-523: Was a period of economic stagnation in much of the Western world during the 1970s, putting an end to the overall post–World War II economic expansion . It differed from many previous recessions by involving stagflation , in which high unemployment and high inflation existed simultaneously. Among the causes were the 1973 oil crisis , the deficits of the Vietnam War under President Johnson , and

15744-402: Was developing products but had none on the market. CellPro argued that the march-in provisions were created for this situation, especially because (in its view) availability of essential medical technology was at stake. The NIH denied this claim citing: In In the Case of NORVIR , the NIH received requests from Essential Inventions in January 2004, and other members of the public and members of

15872-586: Was forced to call on the International Monetary Fund for a multibillion-pound bail-out in an attempt to bolster Britain's flagging economy. The Labour government's tiny majority was wiped out by early 1977 as a result of by-election defeats, and Callaghan managed to form a coalition with the Liberals to hang onto power. The pact concluded in the summer of 1978, by which time economic growth had picked up (although unemployment now stood at

16000-413: Was later purchased by Roche. Stanford filed patents on PCR-related inventions, that the employee made, after he returned to Stanford. Roche, that purchased the startup soon thereafter, introduced the first commercially successful HIV tests, which embodied the PCR technology of the Stanford's patents. When Stanford sued Roche for infringing its patents, Roche countered, that it had an ownership interest in

16128-405: Was not until 2000, by which time Labour had been re-elected as New Labour under Tony Blair that unemployment fell to the level in 1979. The oil crisis of 1973 also had similarly large negative effects on other countries that relied heavily on imported oil, such as France, Sweden, Japan, Finland, Belgium, Luxembourg, and Denmark. In Sweden's particular case, the recession proved devastating to

16256-509: Was so narrow that the Tories received the most votes but Labour won slightly more seats. Heath fought to keep the Tories in government by attempting to form a coalition with the Liberal Party and offering a cabinet post to Liberal leader Jeremy Thorpe , but this attempt to remain in power proved unsuccessful for Heath and he was forced to resign as prime minister on 4 March, paving the way for Harold Wilson's Labour to return to power as

16384-497: Was that government would retain title to inventions and would license them only nonexclusively. A report by the Government Accountability Office found that "Those seeking to use government-owned technology found a maze of rules and regulations set out by the agencies in question because there was no uniform federal policy on patents for government-sponsored inventions or on the transfer of technology from

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