Reexamination of Patents Listed in the FDA’s Orange Book: Surprising Facts For Brands and Generics

Did you know that while a total of 4,849 ex parte and inter partes patent reexamination requests were filed from 1999 to 2009, only 55 are reexaminations of patents associated with FDA approved products and listed in the FDA’s Orange Book? This is just one of the most surprising and interesting facts that emerged from our first of its kind study – “Reexamination Practice of Biotech/Pharma Patents in Group Art Unit 3991.” (For a full analysis and discussion, download the full paper at The Reexamination Center.) Other interesting facts emerged from our study, including:

  • The patent owner is much better off putting its own patent into reexamination than having a third party do it.
  • Of the 55 reexaminations, the top 5 patent owners were attacked by third parties almost 40% of the time.
  • Of the 55 reexaminations, 36% were owner initiated, whereas 64% were third-party initiated.
  • 21 of the 55 reexaminations went abandoned either for failing to respond to an office action or file an appeal brief (all were third-party initiated).
  • 30% of owner initiated reexamination proceedings are associated with litigation as compared with 46% of third-party initiated reexamination proceedings.
  • In 31% of owner initiated reexaminations all the original patent claims were confirmed, as compared to just 11% of third-party initiated proceedings.

How Did These Trends Evolve?

The Central Reexamination Unit (CRU) of the United States Patent and Trademark Office (USPTO) is currently made up of three Group Art Units: AU 3991, AU 3992, and AU 3993. Group AU 3991 is the art unit within CRU that handles those reexamination proceedings involving biological, chemical, and pharmaceutical patents.

From 1999 to 2009, out of 792 ex parte requests in AU 3991, 52 (6.6 %) were associated with an FDA approved product as compared to 3 out of 69 inter partes reexaminations (“IPRs”) (4.3 %). That’s 55 out of 861 or 6.4% of all reexaminations in AU 3991, a surprisingly small number, considering the thousands of FDA approved products.

The top owners of FDA approved patents and products put into reexamination during the 1999-2009 period were also identified. Surprisingly, these parties represent ownership of 21 of the 55 patents or 38% of the total, a relatively large number. As shown in Figure 1 below, 6 patents assigned to Alkermes Controlled Therapeutics Inc. were put into ex parte reexamination, 5 Pfizer patents, 4 Gilead Sciences, Inc. patents, 3 Cima Labs, Inc. patents (2 ex parte and 1 inter partes), and 3 patents assigned to General Hospital Corporation. Interestingly, all of the proceedings associated with these top owners were initiated by a third-party.

For all 55 reexaminations we determined whether: (1) Rule 130, 131, or 132 affidavits had been filed; (2) petitions had been filed for any reason; (3) the request was substantively denied or terminated before completion; (4) the PTO issued a NIRC; and (5) the PTO issued a RAN or the owner filed a Notice of Appeal.

We found that a Notice of Intent to Issue a Reexamination Certificate (“NIRC”) issued in 16 out of 20 (80%) of owner initiated reexaminations, as compared to 18 out of 35 (51%) of third-party initiated reexaminations, suggesting that a higher number of third-party initiated cases are still pending (see Table 1 below). Affidavits were filed 45% of the time in owner initiated reexaminations as compared to 69% of the time in third-party initiated reexaminations. Similarly, petitions were filed more often in third-party initiated reexaminations (46%) than in owner initiated reexaminations (25%). Correspondingly, only a quarter of owner initiated reexaminations received a Right of Appeal Notice as compared with 40% of third-party initiated reexaminations.

Thus, compared with owner initiated reexaminations it appears that proceedings initiated by a third-party have a tendency to involve: a) affidavits, b) petitions, and c) appeals. This is not all that surprising considering that when a commercial pharmaceutical product is at stake, the patent owner vigorously defends its patent(s). In addition, coupled with the 21 abandoned reexaminations, these results suggest that, in general, third-party initiated cases are having a tougher time getting out of the patent office than owner initiated proceedings.

For sake of comparison, we also examined all 66 remaining IPRs and found similar trends with a NIRC issuing in 28 proceedings.

Additionally, we examined the outcome of the 62 reexamination requests in which a NIRC issued to determine whether it would be more advantageous for the patent owner (the NDA holder) to put its patent into reexamination as compared to a third-party requester. Specifically, we characterized the outcome in terms of (1) survival of all original claims without amendment, (2) total cancellation of all claims undergoing reexamination, or (3) some variation of the two.

As shown in Table 2 below, in only 6% of owner initiated reexaminations all the claims were cancelled, as compared to 17% of third-party initiated NIRCs, and 79% of the IPRs. Similarly, in 31% of owner initiated reexaminations all the original patent claims were confirmed, as compared to 11% of third-party initiated proceedings, and 7% of the IPRs.

This data is highly suggestive that third-party initiated reexaminations for patents listed in the FDA’s Orange Book are having a harder time getting out of the patent office compared to owner-initiated reexaminations. In addition, in AU 3991, third-party initiated reexaminations (inter partes) for patents other than those listed in the FDA’s Orange Book have a surprisingly high chance of resulting in the cancellation of all claims (79%). It will be interesting to see whether these trends continue.


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