Errors in Patent Grants: More Common in Medical Patents

By James Love

Recently I have become interested in the frequency of a “certificate of correction” on a granted patent, after two efforts to establish federal rights in patents granted.

The first case involved the University of Pennsylvania.  We had identified five patents on CAR T technologies granted to five inventors from the University of Pennsylvania where there was no disclosure of federal funding on the patents when they were granted by the USPTO, as is required by law.  All five patents had been filed in 2014.    We had reason to believe the five patents should have disclosed NIH funding in the invention, and we were right. But the error had been corrected by Penn, and five “certificate of correction” documents were granted by the USPTO in May 2016, something we had overlooked, in part because the corrections to patents are published as image files, and were not text searchable.

The second case involved the Cold Spring Harbor Laboratory.  KEI had identified two patents listed in the FDA Orange Book for the drug Spinraza,  which were assigned to Cold Spring Harbor, and which had not disclosed federal funding.  KEI was interested in pursuing a march-in case for Spinraza, on the grounds of excessive pricing.  The cost of Spinraza in the first year was $750,000, and the maintenance doses were priced at $375,000 per year.  Researchers listed on the two patents had received funding from the NIH to work on the subject of the two patents.

In January of 2017, KEI asked HHS to investigate the failure of Cold Spring Harbor Laboratory to disclose federal funding for the two Spinraza patents. The NIH did undertake an investigation, and has indicated they will report back to KEI soon. But we checked and found that one patent, 8,361,977, had been issued a certificate of correction on April 25, 2017, disclosing federal funding of the invention.  We assumed that the investigation prompted the disclosure.  We then checked other patents granted to Cold Spring Harbor, to see if other corrections had been issued, and found that between April and August of 2016, six additional patents that were corrected to report federal funding, for a total of seven patents receiving a certificate of correction on the subject of federal funding of the invention.   This seemed to be a fairly high error rate, and indeed, since 2012, Cold Spring Harbor had been granted 13 patents by the USPTO that the NIH identifies as having received federal funding for the invention, but only disclosed the federal funding on six (46 percent), until KEI asked for the investigation.

We are taking a deeper look on the failure of various businesses and institutions to report federal funding on inventions, but we also wanted to know more generally how common it was for anyone to correct patents, after they were filed, since we had earlier overlooked the corrections, which require one to view image files of scanned certificates of correction.

We found that between 2000 and 2015, 11.1 percent of all granted patents had received subsequent corrections.  These corrections cover all sorts of issues, and the failure to disclose federal funding is only one possible reason for the correction.

Next, over the same time period, we wanted to find out how many patents were granted a certificate of correction, in different subject matters.   We searched the USPTO online database using using two search strings, for each keyword:

  • isd/20000101->20151231 AND keyword
  • isd/20000101->20151231 AND keyword AND cofc/yes

The results were as follows

Table 1, Certificates of Correction, by key word, for patents granted from 2000 to 2015, queries on October 20, 2017

Search term Patents granted, 2000-2015 Patents with COFC percentage with COFC
All patents 3551058 392557 11.1%
Alzheimer 35897 8130 22.6%
asthma 34869 8040 23.1%
cancer 129908 27598 21.2%
diabetes 61868 13822 22.3%
hepatitis 52862 11232 21.2%
hiv 49650 11905 24.0%
multiple sclerosis 28681 6923 24.1%
Antibody-drug conjugates 547 147 26.9%
genomic 67958 14990 22.1%
pharmaceutical composition 86847 20178 23.2%
battery 289570 33691 11.6%
bicycle 19868 1890 9.5%
can opener 577 48 8.3%
coffee maker 1410 97 6.9%
engine 340411 37578 11.0%
missile 7141 846 11.8%
photovoltaic 35500 4308 12.1%
wind turbine 6428 583 9.1%

One finding is that the rate of corrections on the patents with a medical search term were considerably higher than the average for all patents.

We also looked at the rate of corrections for 17 businesses and institutions, to look at the rates of corrections, looking at all patents granted and all corrections, through October 20, 2017.  By including the most recently issued patents, the rate of correction is somewhat understated, since the corrections are filed later, after the grants. But in any case, it is surprising how frequently many institutions have to correct granted patents.  Non-profit research institutions seemed particularly prone to errors, except for the United States federal government, which had a correction rate of just 5 percent.

One reason for the low rate of corrections for the United States government is that it does not need to later correct the patent to disclose federal funding.

Table 2: The rate of a Certificate of Correction to a granted patent, by institution 

Search term Patents granted Patents with COFC percentage with COFC
City of Hope 374 127 34%
Cold Spring Harbor 156 48 31%
Kettering 633 187 30%
Yale University 801 211 26%
Wisconsin Alumni Research Foundation 2867 734 26%
Massachusetts institute of technology 5412 1317 24%
University of Pennsylvania 1618 352 22%
Gilead 638 109 17%
University of California 10577 1708 16%
Google 15760 1854 12%
Monsanto 7812 957 12%
General Electric 42954 4697 11%
JUNO 126 12 10%
Pfizer 4213 398 9%
Amazon 6471 500 8%
International Business Machines 113197 7099 6%
United States of America 43195 2180 5%

 

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