Originally presented to Div. of Chemistry and the Law, American Chemical Society National Meeting, Washington, DC, Fall 1990. Unpublished draft. Printed version with better graphics available upon request.
Trends in Biotechnology Patenting
Ronald A. Rader*
Porton Int.
727 15th St., N.W.
Washington, DC 20005
U.S. patents are the probably the best available basis for analysis of general characteristics and trends in biotechnology inventions. Among all countries and international bodies granting patents the U.S. patent system is probably the most important and accomodating for biotechnology inventions. The U.S. places few if any restrictions on biotechnology and pharmaceutical inventions which may be patented. Most European countries do not issue utility (use) patents for human and animal therapeutics and diagnostics and have avoided granting patents for modified organisms. A number of countries worldwide do not allow patenting of human pharmaceuticals. Obtaining U.S. patent protection is likely to be pursued for nearly all potentially valuable biotechnology inventions. U.S. patents provide intellectual property protection in the country with the largest market and the most competition for technological innovations. Multi-year analysis of large numbers of U.S. biotechnology patents permits observation of distinct patterns and trends in patenting activity, international and economic sector competitiveness and technological progress.
Biotech Patent Processing
Due to increasing patent application filings, a significant backlog of biotechnology patent applications has developed within the Patent and Trademark Office's (PTO) Group 180 formed in March 1988 to expedite review of a growing backlog of biotechnology patents. This has become a major factor increasing the length of time required to process and grant applications. Group 180 reports that pendency, the time druing which a patent application is pending or in process at the PTO, for Group 180 is now averaging 25.9 months (1). Over 18,000 patent applications are currently in-process within Group 180 and biotechnology patent filings have been increasing significantly in recent years. In FY1988 5,634 patent applications were received by Group 180; 8,169 in FY1989; and about 9,300 filings were received in the recently ended FY1990. Group 180 expects to receive 13,400 applications in FY1994.
A recent Government Accounting Office (GAO) study reported Group 180 applications as having an average pendency period of nearly 2.5 years (29.4 months), about double the pendency for all U.S. patents (2). GAO found average pendency for genetic engineering applications to be even longer, over 3.25 years. If one considers patent pendency from date of orginal filings, ignoring patent amendment and continuation filings, average biotech patent pendency rises to over 3.25 years. Much of the delay in processing biotech patents can be attributed to the large backlog awaiting processing. The time required to obtain a first action from Group 180, usually initial review of an application and its patentability, is now 14-15 months with genetic engineering patents requiring about 20 months for first action. This is twice the average time to first action for all patents (7.3 months). Over 7,500 patent applications are now awaiting first action by Group 180. Over 2,000 of these have been waiting over a year - more than all applications awaiting first action throughout the rest of the PTO.
The backlog of biotechnology patent applications at the PTO is largely due to insufficient experienced staff. Group 180 now has about 140 patent examiners and many more are needed. However, it is difficult for PTO to recruit and retain staff with sufficient biotechnology expertise who can command considerably higher salaries for less stessfull jobs outisde the federal government. Also, it takes several years to fully train a patent examiner. The PTO is working hard to catch up with biotech filings, including hiring and training more staff, computerizing processing and developing in-house sequence databases. There are signs that productivity has been increasing recently in Group 180. However, considerable more patent examiners will be needed to have any serious impact on the biotech patent backlog.
Pendency delay can be critical for biotechnology innovations. By establishing ownership, patents lower risk for product development and investment and permit inventions to be publicly promoted and offered for licensing. All types and sizes of commercial organizations often wait for receipt of patent protection before initiating major development efforts. For biopharmaceuticals, many products are in preclinical testing and development during patent pendency. A general pattern of U.S. patents being granted around the time pharmacetuicals are nearing clinical trials has been observed. Whether delays in obtaining patent protection have adverse effects on the biotechnology industry or have delayed development and introduction of new pharmaceuticals, including those in critical areas such as AIDS treatment, remains to be determined.
A recent survey of biotechnology company executives reported that most consider the lag in granting patents a hindrence to international competition with 43% agreeing that the most negative effects are the risks of unprotected exposure of technology to competitors (3). Patent delays were cited by 35% as undermining their company's competitive positions and by 29% as undermining their ability to obtain financing. However, for pharmaceutical and health care products, patents delays are not considered as critical as delays in processing applications within the Food and Drug Administration (FDA).
Granting or success rates for U.S. and foreign biotechnology patent applications were also examined by the GAO. This was partially in response to allegations by a senior Department of Commerce official, that Japan has been trying to overwhelm the U.S. patent office with trivial biotechnology patent filings. Overall, U.S.-origin filings handled by Group 180 had a 49.6% granting rate. The foreign granting rate was 51.4% with Japanese patent filings having a 48.6% granting rate. Data on success rates patents show that U.S., foreign and Japanese inventors have comparable success at gaining U.S. biotechnology patents. However, comparable granting rates do not mean that patents are worthy of development and commercialization, and this analysis doEs not address patents filed in the past few years still in process at the patent office.
Biotech Patents
Even though the large, multi-year backlog of patents pending at the PTO has limited the number of patents granted in recent years, general patterns and trends can be reliably identified from analysis of recent years' granted biotechnology patents. The patterns and trends discussed below are based on evaluation of large numbers and the four most recent years patent acitivity. Over 6,000 U.S. biotechnology patents granted from 1986-1989 have been analyzed in studies sponsored and released by the Pharmaceutical Manufacturers Association (PMA) as shown in Figure 1. These analyses include examination of country and type of organization of the primary assignee (owner) with particular emphasis on pharmaceutical/health care applications and use of genetic engineering technologies.
The 1986-1988 analyses and others were based on patents included in BioINVENTION, a monthly periodical presenting abstracts of U.S. biotechnology patents (4). These patents were selected and analyzed using the official abstracts for granted U.S. patents published weekly in the Official Gazette of the United States Patent and Trademark Office (5). Abstracts in the Gazette include the major claim(s) for each patent, assignees, inventors and other information. Patents were selected manually from the Gazette, rather than using less reliable computer-based, classification or keyword-based retrieval methods. Analysis of 1989 patents was performed by the PMA using the same critera.(6).
The scope of biotechnology used for these analyses includes products and uses of microbial and cellular components, cells, microorganisms and modified organisms. Included were patents with claims for products, processes or devices involving: microbial transformations; fermentation; enzymes; novel organisms; antibodies; cell fusion; hybridomas; immunodiagnostics; vaccines; recombinant DNA; gene and protein sequences; polynucleotide hybridization; DNA probes and primers; bioreactors; cell and tissue culture; blood products; and other biotechnology applications and products. Patents for biotech products subjected to subsequent chemical modification or derivatization, such as chemically modified antibiotic derivatives, were generally not classed as biotech, especially where non-naturally occuring chemical structures were claimed.
The distribution of biotechnology patents and those involving pharmaceutical applications and use of genetic engineering technologies for the most recent four years is shown in Figure 1. Of the over 6,000 biotechnology patents granted from 1986-1989, about 64% were assigned to U.S. organizations. The distribution of biotech patents for the each of the years 1896-1989 with U.S., European Community (EC) countries, Japanese and foreign country assignees is shown in Figures 2 and 3. The U.S. received two-thirds of biotechnology patents granted in 1989 and U.S. dominance tends to be increasing. In most recent years, both Japan the the EC have received comparable percentages of all biotechnology patents granted, in the range of 13-16% each. All the other countries of the world accounted for only 6% of biotech patents.
The total number of biotechnology patents granted increased to nearly 2,000 in 1989. This is nearly 2% of all U.S. patents granted. The distribution of biotechnology patents differs from the distribution of the over 100,000 U.S patents granted in 1989 where U.S. assignees received 53%, foreign assignees 47%, and Japan received 20%. Generally, the U.S. is more dominant in biotechnology than other technologies.
Pharmaceutical Biotech Patents
Patents were classed as "Pharmaceutical/health care," (called pharmaceutical) on the basis of specific or strongly presumed claims involving human therapeutic, diagnostic and other health care applications. Lacking specific pharmaceutical claims, patents for diagnostics, antigens, antibodies, vaccines and other biomedical inventions were classed as pharmaceutical where this was presumed to be among their primary uses. For example, most patents not specifically claiming pharmaceutical uses but involving interferons, immunodiagnostics and human biomolecules and pathogens were classed as pharmaceutical. Lacking human pharmaceutical claims, patents claiming or presumed primnarily relevant to animal health care and patents describing generic biotechnologies applicable to a variety of biotech products were not classed as pharmaceutical patents. Generic biotechnology patents include enabling technologies, such as patents for broadly useful plasmids and expression systems or generic immunochemical technologies.
The majority (55%) of biotechnology patents granted in recent years involve pharmaceutical applications as shown in Figure 2. In 1989, 935 pharmaceutical biotech patents were issued, up from 752 in 1986. However, pharmaceutical biotechnology patents have been decreasing as a percentage of all biotechnology patents. The percentage of pharmaceutical biotech patents relative to all biotech patents decreased to 48% in 1989 from 61% in 1986. Other applications of biotechnology not primarily directed to pharmaceutical applications evidently are increasing. This includes patents in the chemical, food and agricultural areas and generic biotechnologies.
Country of assignee for 1986-1989 pharmaceutical biotech patents is shown in Figure 2 and 3. Assignee country and type of organization were taken from the first listed assignee. The U.S. held 72% of all pharmaceutical biotechnology patents in 1989 with Japan and the EC each receiving 11%. All other countries combined received only 6%. Japan received 11% for the years 1987-1989 and 15% in 1986. The percentage of U.S. patents in this area has steadily increased from 64% in 1986 to the current 72%. The number of U.S.-assigned patents increased 40% from 481 in 1986 to 673 in 1989, while the total number of foreign pharmaceutical biotech patents held steady in the range 262-272 from 1986-1989.
The top 10 countries assigned patents are shown in Figure 3. The rankings for biotechnology and pharmaceutical biotechnology patents are the same - U.S., Japan, West Germany, France, U.K., Canada, Italy, Sweden, Netherlands, Switzerland and Israel. West Germany is far ahead of the other European countries in biotechnology and pharmaceutical biotechnology patents.
Types of assignee organizations receiving pharmaceutical biotech patents for 1986-1989 are shown in Figure 4. Corporations dominate pharmaceutical biotechnology patents receiving 67% for 1986-1989. U.S. corporations receiving the single largest share, 44% in 1989, up from 38% in 1986. The U.S. public sector (government, university and nonprofit organizations) received 20% of pharmaceutical biotech patents in 1989, while the foreign public sector received only 4.4%. U.S. universities receiving 13% of pharmaceutical biotech patents, while foreign universities received only 1%. Governments received a total of only 3.5% of pharmaceutical biotech patents. The U.S. government received more patents (2.0%) than all others worldwide (1.5%). Non-profit organizations received a total of 19.8% of pharmaceutical biotechnology patents with foreign non-profits receiving 12.7% and those in the U.S. received 7.1%
Pharmaceutical Manufacturers Association (PMA) full member companies received about 50% (208/414) of all pharmaceutical biotech patents issued in 1989 and 20% in 1988. PMA member companies generally are the larger, profit-making U.S. pharmaceutical companies with multiple prescription drugs on the market (although Genentech is a member). This indicates the strength of the established, integrated, pharmaceutical companies in pharmaceutical biotechnology. Smaller biotechnology and other companies received the other half of corporate-assigned pharmaceutical biotechnology patents.
The top 10 recipients of U.S. pharmaceutical biotechnology patents ranking in the top 10 during 1986-1989 are listed in Figure 5. These organizations received a total of 424 or nearly 13% of all pharmaceutical patents granted from 1986-1989. Most of these organizations are large U.S. pharmaceutical companies.
Genetic Engineering Patents
Genetic engineering was defined to include three broad classses of patents with claims involving: 1) recombinant DNA (including genetic recombinations and gene sequences); 2) hybridomas/monoclonal antibodies (including cell fusions) and; 3) DNA probes (including oligonucleotide hybridizations, PCR). This definition of genetic engineering was designed to capture "new biotechnology" patents involving precise manipulations of genetic materials. Analysis of genetic engineering patents granted in 1988 found 62% involved recombinant DNA (54% in 1987), 23% hybridomas (36% in 1987) and 14% DNA probe related technologies (4% in 1987)(6).
Genetic engineering patents exhibit the largest and most significant growth of all areas examined, increasing from about 100 (8% of all biotech) in 1986 to 400 (20%) in 1989 as shown in Figure 2. This increase occurred despite the backlog and long pendency delays at PTO in processing these applications.
U.S. and foreign genetic engineering patents for 1986-1889 are shown in Figures 2 and 3 The percentage of foreign genetic engineering patents has increased from 16% in 1986 to 22% in 1989. The U.S. still clearly dominates with 78% in 1989 followed by Japan receiving 10%, the largest share (45%) of foreign genetic engineering patents. The EC countries received 6% of genetic engineering patents, 28% of foreign patents. While far behind the U.S., Japan is leading the combined EC countries and all other countries in genetic engineering patents. All other countries combined received a total of only 6%.
Pharmaceutical Genetic Engineering Patents
Genetic engineering patents with pharmaceutical applications (called pharmaceutical genetic engineering) constituted 10.7% of all biotech patents from 1986-1989. The majority (60.6%) of all pharmaceutical biotech patents from 1986-1989 involved use of genetic engineering technologies. In 1989, 45% of genetic engineering patents involved pharmaceutical uses, down from 86%, 96% and 76% for the years 1986, 1987 and 1988. The 1989 lower percentage of pharmaceutical genetic engineering patents may be due to the trend of decreasing percentages of pharmaceutical biotech patents and/or granting of pharmaceutical genetic engineering patents may have been disproportionately delayed at the PTO in 1989.
The U.S. clearly dominates what will be the the most profitable area of biotechnology - genetic engineered pharmaceutical products and technologies. For each of the years 1986-1989, the U.S. received over 80% of all pharmaceutical genetic engineering patents with Japan receiving the next largest share, ranging 6-10%. In 1989, both Japan and the EC countries each received only 6% of pharmaceutical genetic engineering patents.
Among types of organizations, corporations received the largest share (83%) of pharmaceutical genetic engineering patents as shown in Figure 4. In 1989 worldwide, 58% were assigned to corporations (46% in 1988), 14% to universities (24% in 1988), 3% to government (5.5% in 1988), 19% to nonprofit organizations (8.2% in 1988) and 6% to individuals (5.0% in 1988). U.S. corporations held the largest share (47%) of pharmaceutical genetic engineering patents in 1989.
U.S. public sector organizations (including government, university and nonprofit organizations) received 45% of pharmaceutical genetic engineering patents from 1986-1989, about the same as U.S. corporations. This is much greater than the total pharmaceutical genetic engineering patents granted to foreign public sector organizations (less than 4%) from 1986-1989. In 1989 the U.S. public sector received 31% of pharmaceutical genetic engineering patents, while the total foreign public sector receive only 4.4% in 1989, up slightly from 3.7% in 1986. Non-profit organizations (universities and non-profit organizations) and PMA member companies each held 20% of all pharmaceutical genetic engineering pharmaceutical patents in 1989, while foreign corporations received 12% and foreign non-profit organizations held 2.4%.
The top 10 countries receiving genetic engineering and pharmaceutical genetic engineering patents are shown in Figure 3. The rankings are much the same as for biotechnology and pharmaceutical biotechnology, except Japan has a significant lead compared to the European Community and the U.K. leads France.
The top 10 organizations receiving genetic engineering pharmaceutical patents in 1989 are listed in Figure 6. Four companies acheived this rank in both 1988 and 1989: Genentech; Cetus; Genetics Inst.; and Ortho Pharmaceutical.
PTO Analysis
The U.S. Patent and Trademark Office has analyzed U.S. "genetic engineering" patents issued in the last 25 years (7). The PTO analysis is valuble for its long-term tracking of industrial microbiology and, more recently, genetic engineering, patents. The PTO reported 1462 patents assigned to certain subclasses of patent classifications 435 or class 935 issued from 1963 to mid-1989. Class 935 is a new classification for genetic engineering which corresponding with the scope of genetic engineering used above. The subclasses of 435 included in this analysis involving mutant, modified or specially selected naturally occuring microorganisms and microbial products, a much broader use of the term "genetic engineering" than used above. For example, a total of 52 patents were reported for the years 1963-1970, significantly before the advent of modern genetic engineering. Most of the earlier reported patents were for microorganisms and microbial products, especially involving enzymes and antibiotics.
Despite different selection criteria, the overall results of the PTO analyses are similar to those presented above. A total of 988 or 67.6% of all patents were reported for 1986-1989, the same period for which 941 genetic engineering patents were reported above using narrower genetic engineering criteria. This indicates that most of the patents included in the PTO analysis for recent years involve modern genetic engineering technologies, rather than traditional industrial microbiology.
The PTO analysis covering 1963-1989 reports: 71% of patents originated in the U.S.; Japan 12%; 3% each from West Germany and the United Kingdom; 2% from France and; 1% or less from other countries. Overall, 91% of patents were assigned to corporations; 5% each to universities and non-profit institutions and; 4% assigned to government organizations. U.S organizations were assigned 97% of patents from U.S.-based inventors and 13% of foreign inventors' patents. This indicates that U.S. inventors, most within corporations, are generally retaining ownership of pending biotech patents. However, as observers of biotechnology are well aware, assignments for patents are frequently transfered or marketing and production rights licensed to foreign companies after patents are granted.
The U.S. share of patents increased greatly in the past 25 years. From 1963-1975, the U.S. received 35%, while Japan received 23% and the EC countries received 29%. The U.S. received over 70% for each of the years since 1984. This data reflects the strong positions held by Japan and Europe in industrial microbiology in the period prior to genetic engineering and shows that the U.S. has not always been totally dominant in biotechnology. The U.S. clearly acheived dominance and a majority of these patents about 10-15 years ago.
Of the 1044 U.S.-origin patents, 90% were assigned to U.S. corporations, 4% to the federal government, 5% to U.S. individuals and 1% were assigned to foreign organizations. Of the 418 foreign-origin patents, 78% were assigned to foreign corporations, 5% to foreign governments, 9% to foreign individuals and 9% were assigned to U.S. organizations.
The top 10 assignees of these industrial microbiology and genetic engineering patents since 1963 are shown in Figure 5. Note, only one foreign organization, Ajinomoto Co., a large Japanese company with strengths in fermentation and biotechnology, ranks among the top organizations for 1963-1989.
[Optional paragraph].
Several other biotech-related patent analyses confirm some of the general patterns reported above. An analysis of 197 U.S. antiviral (including some drug and other chemical patents) and virus-related patents granted in 1988 found 71% granted to U.S. assignees; Japan and the EC countries each receiving about 12% and; 5% granted to all other countries.(6) Among U.S. assignees, corporations held the largest share with 40%, universities 15% and non-profit organizations 12%. The largest share (23%) involved HIV and AIDS, 15% herpes simplex and 12% hepatitis B viruses. Two Japanese organizations were the only non-U.S. organization among the 17 assignees receiving 3 or more patents. An analysis of 40 immobilized enzyme patents granted in 1985 found 51% assigned to U.S. organizations, 24% to Japan, and 4.8% each to West Germany and France.(7) Over 90% of U.S. patents and 74% of foreign immobilized enzyme patents were assigned to corporations.
Conclusions
U.S. biotechnology patent applications have been increasing to such an extent that a multi-year backlog of pending patents has developed within the patent office. The average biotech patent application now requires well over two years to process and those involving genetic engineering require well over three years. At best, with over 18,000 biotechnology patent applications in process within the patent office, only slight improvements (if any) in decreasing pendency delays can be expected in the next few years.
A number of trends are observable from analysis of U.S. biotechnology patents, including:
- U.S. and foreign inventors have comparable success rates for obtaining patents from their patent applications.
- Most biotechnology patents involve human pharmaceutical and health care applications.
- The percentage of pharmaceutical biotechnology patents has been decreasing in recent years, but remains the single most dominant application of biotechnology.
- Most pharmaceutical biotechnology patents involve use of genetic engineering technologies.
- Genetic engineering patents have been growing at a high rate, despite the patent office's delays in processing these applications.
- In most area, the top 10 leading countries receiving patents are the U.S., Japan, West Germany, France, U.K., Canada, Italy, Sweden, Netherlands, Switzerland and Israel, although the U.K. leads France in genetic engineering and pharmaceutical genetic engineering patents.
- The U.S. is dominant is all major aspects of biotechnology examined, including biotechnology in general, human pharmaceutical and health care applications of biotechnology, genetic engineering and pharmaceutical applications of genetic engineering.
- Japan and the European Community lag significantly behind the U.S. in all areas of biotechnology patenting. Other countries' shares of various types of biotechnology patents are very small.
- Japan and the European Community patenting activities are roughly comparable in most areas of biotechnology.
- The U.S. is significantly more dominant in biotechnology than most other technologies.
- In what will likely be the most profitable areas of biotechnology, pharmaceutical biotechnology and pharmaceutical genetic engineering, U.S. dominance is increasing. Japan and the European Community receive only small percentages of these high value patents. Recent surveys of the status of Japanese biotechnology pharmaceuticals in development (11) and of the opinions of U.S. biotechnology executives (3) confirm the U.S. lead.
- Corporations dominate pharmaceutical applications of biotechnology with U.S. corporations receiving the largest share.
- Large U.S. integrated pharmaceutical companies receive a large percentage of pharmaceutical biotechnology and pharmaceutical genetic engineering patents. Pharmaceutical company involvement in biotechnology is even greater, once one considers their increasing acquisition of biotechnology companies and licensing of their patents.
- The foreign public sector and foreign governments receive relatively few pharmaceutical biotechnology and pharmaceutical genetic engineering patents. This suggestis that foreign government-sponsored biotechnology R&D may not be as productive as that in the U.S and that these efforts may not currently be a significant a threat to the U.S. lead in pharmaceutical applications of biotechnology and genetic engineering.
- Analysis of industrial microbiology and genetic engineering patents granted over the past 25 years shows that the U.S. share has increased significantly over this period and that the U.S. acheived its current dominance in the past 10-15 years.
Literature Cited:
1) according to Charles Warren, Group 180, PTO, Sept. 1990.
2) "Biotechnology: Backlog of Patent Applications," U.S. General Accounting Office, Washington, DC, GAO/RCD-89-120BR, April 1989.
3) Burrill, G.S., Lee, K.B., Biotech91: A Changing Environment, Ernst & Young, San Francisco, 1990.
4) Rader, R.A., Young, B.K., Zaborsky, O.R., "Analysis of U.S. Biotechnology Patents," issued annually, 1986-1988, Pharmaceutical Manufacturers Association, Washington, DC; various articles published 1987-1989 in BioINVENTION, OMEC International, Washington, DC.
5) Official Gazette of the United States Patent and Trademark Office, Government Printing Office, Washington, DC.
6) "Analysis of U.S. Biotechnology Patents 1990," Pharmaceutical Manufacturers Association, Washington, DC [includes much 1986-1989 data; available upon request from PMA].
7) Young, B.K., Rader, R.A., Zaborsky, O.R, "Analysis: U.S. Biotechnology Patents, 1988," BioINVENTION, vol. 8, no. 8, August, 1989, p. 318-321.
8) "Technology Profile Report: Genetic Engineering," Office of Technology Assessment and Forecast, U.S. Patent and Trademark Office, Arlington, VA, 1990.
9) Rader, R.A., "Analysis of U.S. Antiviral and Virus-Related Patents," Antiviral Agents Bulletin, vol. 2, no. 5, May, 1989, p. 109, 131-133.
10) Rader, R.A., "Analysis: Immobilized Enzyme Technology Patents, 1985," BioINVENTION, vol. 5, no. 4, April, 1986, p. 156-7.
11) Miller, H.I., "Japanese Pharmaceutical Biotechnology: Perception vs. Reality," BIO/TECHNOLOGY, vol. 7, July, 1989, p. 736.
*Ronald A. Rader is Manager of Information Services, Market Planning Dept., Porton International Inc. He is also Editor of the periodicals Antiviral Agents Bulletin and BioINVENTION.
Figure 1. U.S. Biotechnology Patents, 1986-1989
. . . . . . . . . . . . % . . . . % of All . . . . . . . . . . . . . . . . . . 1989 . . % 1989
. . . . . . . . Total . . . . in Class . . Biotech . . . . . . . . . . . . . . . . . . Total . . in Class
. .
Biotechnology . . . . 6,046 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,949 . . . . . .
. . U.S. . . . . . . 3,856 . . . . . . . . 63.8% . . . . . . . . . . . . . . . . . . 1,297 . . 67% . .
. . Foreign . . . . 2190 . . . . . . . . 36.2% . . . . . . . . . . . . . . . . . . 651 . . 33% . .
. .
Pharmaceutical Biotech . . 3,379 . . . . . . . . 55.7% . . . . . . . . . . . . . . . . . . 935
. . U.S. . . . . . . 2,302 . . . . 68.3% . . 38.1% . . . . . . . . . . . . . . . . . . 673 . . 72% . .
. . Foreign . . . . 1,067 . . . . 31.7% . . 38.1% . . . . . . . . . . . . . . . . . . 262 . . 28% . . . .
Genetic Engineering . . . . 941 . . . . . . . . 15.5% . . . . . . . . . . . . . . . . . . 395 . . . . . .
. . U.S. . . . . . . 751 . . . . 80.0% . . 12.4% . . . . . . . . . . . . . . . . . . 309 . . 78% . . . .
. . Foreign . . . . 188 . . . . 20.0% . . 3.1% . . . . . . . . . . . . . . . . . . 86 . . 22% . . . .
Pharmaceutical
Genetic Engineering . . . . 645 . . . . . . . . 10.7% . . . . . . . . . . . . . . . . . . 177 . . . . . .
. . U.S. . . . . . . 538 . . . . 83.4% . . 8.9% . . . . . . . . . . . . . . . . . . 147 . . 83% . . . .
. . Foreign . . . . 107 . . . . 16.6% . . 1.8% . . . . . . . . . . . . . . . . . . 30 . . 17% . . . .
-----------------------------------------------------------------------------------------------------------------
Figure 2. Number and Percentages for Biotechnology Patents 1986-1989
. . . . . . . . . . . . 1986 . . . . . . 1987 . . . . . . 1988 . . . . . . 1989 . . . . . .
Biotechnology . . . . . . 1,231 . . . . . . 1,476 . . . . . . 1,391 . . . . . . 1,949 . . .
. . . Percentage
. . . U.S. . . . . . . . . . 61% . . . . . . 62% . . . . . . 64% . . . . . . 67%
. . . Foreign . . . . . . 39 . . . . . . 38 . . . . . . 36 . . . . . . 33
. . . Japan . . . . . . . . . 16 . . . . . . 15 . . . . . . 13 . . . . . . 13
. . . EC . . . . . . . . . 31 . . . . . . 16 . . . . . . 15 . . . . . . 14 . . . . . . . . . . . . . . . . . .
Pharmaceutical Biotech . . . 752 . . . . . . 845 . . . . . . 837 . . . . . . 935
. . . Percentage
. . . U.S. . . . . . . . . . 64% . . . . . . 68% . . . . . . 69% . . . . . . 72%
. . . Foreign . . . . . . 36 . . . . . . 32 . . . . . . 31 . . . . . . 28
. . . Japan . . . . . . . . . 15 . . . . . . 11 . . . . . . 11 . . . . . . 11
. . . EC . . . . . . . . . 14 . . . . . . 13 . . . . . . 13 . . . . . . 11
. . .
Genetic Engineering . . . . . . 101 . . . . . . 206 . . . . . . 237 . . . . . . 395
. . . Percentage
. . . U.S. . . . . . . . . . 84% . . . . . . 79% . . . . . . 82% . . . . . . 78%
. . . Foreign . . . . . . 16 . . . . . . 21 . . . . . . 18 . . . . . . 22
. . . Japan . . . . . . . . . 9 . . . . . . 11 . . . . . . 9 . . . . . . 10
. . . EC . . . . . . . . . 5 . . . . . . 7 . . . . . . 6 . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical
Genetic Engineering . . . . . . 87 . . . . . . 199 . . . . . . 182 . . . . . . 177
. . . Percentage
. . . U.S. . . . . . . . . . 87% . . . . . . 80% . . . . . . 85% . . . . . . 83% . . .
. . . Foreign . . . . . . 13 . . . . . . 20 . . . . . . 15 . . . . . . 17
. . . Japan . . . . . . . . . 8 . . . . . . 10 . . . . . . 8 . . . . . . 6
. . . EC . . . . . . . . . 2 . . . . . . 7 . . . . . . 5 . . . . . . 6 . . .
________________________________________________________________
Figure 3. Top 10 Country Assignees of Biotechnology Patents, 1986-1989
. . . . . . Biotech . . . Pharm . . . . . . Genetic . . . Pharmaceutical
. . . . . . . . . . . . Biotech . . . Engineering . . . Genetic Engineering
U.S. . . . . . . 3,856 . . . . . . 2,302 . . . . . . 751 . . . 538
EC . . . . . . 898 . . . . . . 439 . . . . . . 60 . . . . . . 34 . . .
Japan . . . . . . 837 . . . . . . 406 . . . . . . 93 . . . . . . 52
W. Germany . . . 357 . . . . . . 170 . . . . . . 15 . . . . . . 13
France . . . 171 . . . . . . 88 . . . . . . 8 . . . . . . 6
U.K. . . . . . . 149 . . . . . . 82 . . . . . . 16 . . . . . . 10
Canada . . . 85 . . . . . . 29 . . . . . . 10 . . . . . . 4
Italy . . . . . . 81 . . . . . . 29 . . . . . . 2 . . . . . . 1
Sweden . . . 76 . . . . . . 49 . . . . . . 6 . . . . . . 5
Netherlands . . . 71 . . . . . . 31 . . . . . . 6 . . . . . . 4
Switzerland . . . 62 . . . . . . 37 . . . . . . 3 . . . . . . 2
Israel . . . . . . 52 . . . . . . 31 . . . . . . 9 . . . . . . 5
________________________________________________________________
Figure 4. Pharmaceutical Biotechnology and Genetic Engineering Patents by . . . . . . Type of Assignee, 1986-1989 Totals
. . . . . . . . .
. . Pharmaceutical Biotechnology . . . Pharmaceutical
. . . . Genetic Engineering
. . . . .Patents . . . . . . Percent . . . Patents . . . Percent
U.S.
Corporations . . . 1488 . . . . . . . . . 44.2% . . . 288 . . . . . . 44.7%
Universities . . . . . . 434 . . . . . . . . . 12.9 . . . . . . 188 . . . . . . 29.1
Non-Profit . . . . . . 238 . . . . . . . . . 7.1 . . . . . . 80 . . . . . . 12.4
Government . . . . . . 65 . . . . . . . . . 2.0 . . . . . . 23 . . . . . . 3.6
Individuals . . . . . . 208 . . . . . . . . . 6.2 . . . . . . 22 . . . . . . 3.4
Foreign
Corporations . . . 790 . . . . . . . . . 23.4 . . . . . . 79 . . . . . . 12
Universities . . . . . . 32 . . . . . . . . . 0.9 . . . . . . 5 . . . . . . <1
Non-Profit . . . . . . 91 . . . . . . . . . 12.7 . . . . . . 13 . . . . . . 2
Government . . . . . . 50 . . . . . . . . . 1.5 . . . . . . 6 . . . . . . <1
Individuals . . . . . . 104 . . . . . . . . . 3.0 . . . . . . 4 . . . . . . <1
________________________________________________________________
Figure 5. Top 10 Assignees of Biotechnology Patents
. . . . . . . . . . . . Pharm . . . Pharm . . . PTO
. . . . . . . . . . . . Biotech* . . . Genetic . . . Analysis
. . . . . . . . . . . . . . . . . . Eng.* . . . 1969-1989
. . . . . . . . . . . . Rank - . . . Rank - . . . Rank -
Organization . . . . . . . . . Patents Patents . . . Patents
Univ. of California . . . . . . 1 - 62 . . . . . . 5 - 14 . . . . . . 1 - 57
Eli Lilly . . . . . . . . . 2 - 52 . . . . . . 7 - 11 . . . . . . 2 - 49
Miles . . . . . . . . . . . . 3 - 50 . . . . . .
Merck . . . . . . . . . . . . 4 - 44 . . . . . . 9 - 7 . . . . . . 8 - 9 . . .
Genentech . . . . . . . . . 5 - 37 . . . . . . 1 - 30 . . . . . . 3 - 44
Cetus . . . . . . . . . . . . 6 - 35 . . . . . . 2 - 27 . . . . . . 2 - 49
DHHS/NIH . . . . . . . . . 7 - 34 . . . . . . 6 - 13 . . . . . . 6 - 28
Syntex . . . . . . . . . 8 - 32 . . . . . . . . . . . .
Scripps Inst. . . . . . . . . . 8 - 32 . . . . . . . . .
Hoffmann-La Roche . . . . . . 9 - 13
Salk Inst. . . . . . . . . . 9 - 13
Becton-Dickenson . . . 10 - 10
Smith-Kline Beecham 10 - 10
Sloan-Kettering Inst. . . . . . . . . . . . . 4 - 18 . . . . . . 7 - 23
Ortho Pharm . . . . . . . . . . . . . . . 3 - 19 . . . . . . 5 - 31
Genetics Inst. . . . . . . . . . . . . . . . 8 -10 . . . . . . 8 - 20
MIT . . . . . . . . . . . . . . . . . . 9 - 7 . . . . . . 7 - 23
Chiron . . . . . . . . . . . . 10 - 5
Ajinomoto . . . . . . . . . . . . . . . . . . . . . 4 - 34
*Compiled from annual top 10 recipients 1986-1989
-------------------------------------------------------------------------------------------------------
Note, some corrections need to made on this page, but in general the rankings do not change much.