In our first post on this blog, we talked about how many drug companies keep generic competitors out of the market – reducing competition and keeping prices artificially high – with a process called “evergreening.” Effectively, they extend the legal monopoly granted by patent protection for years beyond anything that’s reasonable by patenting some incremental change that often has nothing to do with efficacy of the drug and is not novel.

This blog post shows how one drug company – Celgene – and its law firm, Jones Day – appear to have gone beyond simply filing patents with claims of dubious novelty to behavior that is much more problematic. [1]

Patents are protected by the US Constitution and were one of the first areas of legislation taken up by the first US Congress.[2]   A patent is a deal between the inventor and the government. The government tells the inventor “in exchange for disclosing the details of your invention – which will increase knowledge and benefit the public – we will grant you a legal monopoly on that invention for a limited period of time.”

No Ball-Hiding Allowed

The law is very clear about the requirement for disclosure. 37 C.F.R. 1.56 states:

A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section…However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.

(Emphasis added.)

There’s no “hiding the ball” with the patent office — at least there’s not supposed to be. Inventors, lawyers — anyone connected with a patent application — is required to disclose any information they have that can have a significant affect on patentability.

Some laws are a little vague, this one isn’t. People of my generation enjoyed watching the TV lawyer Perry Mason outmaneuver the bungling district attorney. In a criminal case the defense lawyer has no obligation to reveal negative information about a client. It’s the prosecutor’s job to find the dirt.

That’s not true when it comes to patents. Getting a patent isn’t an adversarial proceeding – the patent office is relying on the applicant and the lawyers not to lie or hide things… and deception can have serious consequences.

Protecting Drugs

Once a chemical compound is known it can usually be easily copied; therefore, patent protection is especially important to branded pharmaceutical companies.

The more patents a brand has, the more likely it is that the owner can delay generic competition.[3]  Celgene and its lawyers at Jones Day have taken this practice to new heights and have 27 patents disclosed in the FDA’s “Orange Book” listing for Revlimid.   The Orange Book is an FDA database  where companies list patents they claim protect their drugs from generic competition.

Telling the European Patent Office (EPO) One Thing and the US Patent and Trademark Office (USPTO) the Exact Opposite

Celgene and Jones Day prosecuted three patent applications with the US Patent Office that had been on file for six years with many exchanges of information and back and forth arguments between the patent office and Jones Day.[4]  At the same time, Jones Day and Celgene were involved in defending a patent challenge on a different patent in the European Patent Office that covered the same crystal structure.[5]

The US Patent Office sent a Notice of Allowance to Celgene on May 15, 2015 with the wonderful news that the applications were allowed and patents would be granted upon payment of the required fee.

On August 14, 2015, Jones Day paid the fee and the US patents were ready to issue.

After you pay the fee, it typically takes five or so weeks for the patent office to act and formally issue the patent.[6]  One would assume based on the payment date that the patents would issue around September 22, 2015. The patent never issued; on September 21, a day before the expected issuance date, Celgene filed a Petition to Withdraw.

So, what happened?

In June of 2015 one of our lawyers hired an expert and asked him to make the same crystal structure following the specific procedure described in certain Celgene patents.[7]

A strange thing happened. The expert tried over and over, changing temperatures, pressures, drying agents and all the things an expert would try, but could not get to the crystal structure when following the “recipe” disclosed by Celgene.

This prompted us to look more closely to see if we were doing something wrong or if there was another explanation.

We reviewed the European filings Celgene had made (Jones Day was also acting as European counsel) and found the most curious thing.  The three US applications all stated that an expert could use a specific experiment from another Celgene patent to get to the particular crystal structure described in the US applications.[8]

In March of 2015, Celgene submitted a brief to the European Patent Office (EPO Submission)[9] and expert statement (Expert Statement)[10] that unequivocally stated an expert could not use this experiment to get to the particular crystal structure.

The first time we read this we had trouble processing what our eyes were seeing in black and white on the page.  More importantly, we reviewed the file on the three US patent applications that were about to issue and realized Celgene and Jones Day never filed the EPO Submission or Expert Statement with the US Patent Office.

A Strategic Withdrawal?

On September 17, days before the patent was due to issue, I sent an email[11] to Hoon Choi and Anthony Insogna, attorneys at Jones Day who handle patents for Celgene.

I attached to the email a formal letter advising them of the potential breach of their duties owed to the US Patent Office. The email and letters pointed out that the EPO Submission and Expert Declaration both contained unequivocal statements exactly the opposite of what was said in the applications that were about to become US patents.

What happened next was really interesting.

On September 21 – a few days after I sent my email and the business day before the patent was likely to issue—Celgene filed a Petition to Withdraw with the US Patent Office.  This petition had attached to it not the EPO Submission or the Expert Declaration, but some random document from the same EPO proceeding that only vaguely referenced the content of the EPO Submission and made no reference to the Expert Declaration.

Then on September 29, Celgene filed an Information Disclosure Statement (IDS) and attached over 40 articles and patents for the examiner to consider.  The IDS did include among the 40 –buried in the middle of the 40 — the EPO Submission and Expert Declaration.   The IDS doesn’t say why any articles or patents were filed or how they were in any way relevant to the applications.   If I were the examiner, I would be curious how it was Celgene did not find these 40+ publications until the day before the patent was supposed to issue—I might even be suspicious that I was being gamed.

I can’t say for certain that Celgene filed the petition to withdraw and the IDS because of my email, but the timing certainly suggests that there may be a connection.   Perhaps there’s another explanation beyond the obvious, but I’m not sure what it would be.

Approving Generics

ANDA (Abbreviated New Drug Application) is the FDA procedure used by generic drug manufacturers to get approval for generic drugs. Celgene is currently in litigation with two companies seeking ANDA approval for generic versions of Revlimid. The information disclosed in this post will no doubt be of interest to those companies.

Two key patents in that litigation are 5,635,517 (‘517) and 7,465,800 (‘800).  The ‘517 is subject to an IPR challenge that should reach an institution decision soon.  The ‘800 is not.

The ANDA filers may want to think about whether the fact that Celgene has admitted an expert can’t make lenalidomide following the procedure in these patents might raise other validity issues that can’t be raised in an IPR — but certainly could be raised in court.

[1] The footnotes in this post are mostly for the benefit of “patent wonks” who may want to see original source material. Links in the text link to the actual Celgene documents.

[2] History of United States Patent Law, Wikipedia  

[3] Post coming soon on how Hatch Waxman does not promote efficiency and evergreening and why evergreening needs to be stopped. Also see a post by Gene Quinn on IPWatchdog.

[4] There are three relevant applications: 12/353,383 (‘383); 13/241,022 (‘022); and 13/240,976 (‘976).  At minimum these patents would have given additional exclusivity to Celgene for Revlimid through 2023.  Identical action was taken with respect to all three, but to keep the footnotes down, I am only footnoting with respect to the ‘383.

[5] Opposition in the European Patent Office regarding European Patent No. 1667682

[6] See blog post from PatentlyO “Timing of the Notice of Allowance, Issue Fee Payment, and Patent Issuance

[7] In particular Experiment 1 of US Patent Nos. 5,635,517 (‘517) and 6,281,230 (‘230).  See ‘517 at col. 7, lines 21 – 55 and ‘230 at col. 8, line 62 to col. 9, line 30.  The disclosures are identical.

[8] See the ‘383 specification at para 0070.  Disclosure directs you to Experiment 1 of the ‘517 and ‘230.

[9] Submission pursuant to Rule 116 EPC – Oral proceeding on May 7, 2015 (EPO Submission). See page 15 (Upon repeating the conditions in Example 1 of the ‘517 patent “no Lenalidomide could be detected.”) See Note 15 for copy of EPO Submission.

[10] In making the statements in the EPO Submission, Celgene relied on a Declaration of Ravi Narajan which stated that following Expirement 1 of the ‘517 and ‘213, no Lenalidomide was formed. See Note 15 for copy of Expert Statement.

[11] This is a link to the email. If you are just going to read one thing, read this one.  The attachments to the email lay out the specifics: see the letter for the ‘383 patent (the other two letters are the same), the EPO Submission and the Expert Declaration.