USPTO Rejects SYMBICORT Patent Extension

In re Patent Term Extension for Patent No. 5,674,860 (Commissioner for Patents 2008)

Summary: The USPTO has rejected AstraZeneca’s request for an extension of its patent term on Symbicort. In its decision, the office gave two reasons: (1) new combinations of old drugs do not receive extensions; and (2) AstraZeneca missed the filing deadline by a day.

Intro: AstraZeneca’s drug Symbicort has two active ingredients: formoterol fumarate dihydrate and budesonide. Global Symbicort sales were $1.6 billion in 2007.  The original patent application covering the combo invention was filed in 1991 by two of Astra’s Swedish scientists. The US version issued in 1997.

“Human drug products” require pre-market FDA approval – a long and expensive process. The FDA approved Symbicort in July 2006 – some 15 years after the original patent application was filed.  This long delay is common, and the Hatch-Waxman provision of 35 USC 156 provides for an extension of the patent term based on these delays.

In this case, however, the USPTO has rejected Astra’s extension petition — finding the patent ineligible.

Combo Drugs: Under the statute, extensions are only granted if the patented “product … is the first permitted [and FDA approved] commercial marketing use of the product.”  35 USC 156(a)(5)(A). It turns out that each active ingredient in the Symbicort has been previously marketed – although the combination was new to the market.  Applying the rule to the facts, the PTO found that the “product” had been previously marketed:

“Because both active ingredients in SYMBICORT have been previously approved for commercial marketing or use before the approval of SYMBICORT, Applicant's approval of SYMBICORT does not qualify as the first permitted commercial marketing or use of either active ingredient, as required by section 156(a)(5).”

Synergy is Irrelevant: Importantly, the PTO rejected the argument that the relevant “product” must include both active ingredients because they have synergistic value when combined.

“The term "product" as used in 35 U.S.C. 156 includes any new drug or antibiotic drug, "as a single entity or in combination with another active ingredient." 35 U.S.C. 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic.”

This decision follows the CAFC precedent found in Arnold Partnership v. Dudas, 362 F.3d 1338 (Fed. Cir. 2004). In that case, the court rejected a PTE extension for Vicoprofen (hydrocodone/ibuprofen) announcing that the statute requires a component-by-component analysis for PTE extension:

“This statutory language requires this court to examine a drug product patent’s eligibility for extension on a component-by-component, or an ingredient-by-ingredient basis.  The final phrase in subsection (f) –“including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient” – emphasizes this point.  This final phrase of subsection (f) shows that the statute refers to a drug product on a component-by-component basis, not as a whole.” Arnold Partnership.

MPEP 2751 includes the interesting statement that “an approved product having two active ingredients, which are not shown to have a synergistic effect or have pharmacological interaction, will not be considered to have a single active ingredient made of the two active ingredients.”  The PTO in its decision rejected the negative implication of this statement.

One Day Late: As an alternative reason for its decision, the Commissioner found that the PTE Petition had been filed one day late. It is always a trick to figure out whether the first day of a time period “counts.” 

Section 156 announces that the due date is: "within the sixty-day period beginning on the date the product received [FDA] permission.” PTO rules spell this out more particularly – requiring the application be submitted “within the sixty day period beginning on the date the product first received permission.” 37 C.F.R. 1.720(f). Based on a “plain language” reading of the statute and rule, the PTO decided that the day that permission was granted counts as day one rather than day zero.

Because the FDA granted permission on July 21, 2006, PTO found that the sixty-day period ended on September 18, 2006. Astra filed its petition on September 19.

Astra can appeal “within TWO MONTHS of the mailing date of this letter.”  The PTO’s letter was sent on June 13 – query whether the reply is due on the 12th, 13th, or 14^th?

Comments

[Anon]

the patent laws have differing dates: if a patent expires on a Monday, does that mean it really expires at 12:01 am Monday morning (Sunday evening into Monday morning) or does the patentee have all of Monday with the expiry at 11:59 (Monday evening into Tuesday morning). The question is when the patent lives 20 years, do you get the full year? When the patent law says, "within 12 months" does that mean that if the 12 month deadline falls on Monday, do you have to take your action by Sunday night before Monday or does the action on Monday count. This makes the difference for, say, filing Convention priority applications. Within usually means before the date specified, not on the same date specified. Practitioners have to be very clear about when the statute provides for due dates in years, days, or "within" X days/months.

[newbie]

Does the PTO's findings dealing with the 60 day time period line up with how the FDA calculates the 60 day window when responding to the PTO's request for information regarding eligibility?

[GuyintheRed]

So long as we are quibbling, it seems to me that the 60th day is not "within the sixty day period beginning on the date the product first received permission." The 60th day actually forms one of the two ends of the period for items to be "within" it. The other end of the time period would be day zero or day one. In any event, if you file for term adjustment on the date the product first received permission, you're not actually within the time period. Also, it seems ironic that the USPTO would dismiss their own determination of inventiveness by looking at the individual elements rather than the claim as a whole. I think Symbicort may win on appealing the combo drugs issue. Their lawyers probably can come up with good arguments about the 60 day time period, but have a lower chance of winning on that issue. (FYI, The FDA granted permission on Friday, July 21, 2006, the PTO found that the sixty-day period ended on Monday, September 18, 2006.)

[Just Visiting]

"So long as we are quibbling, it seems to me that the 60th day is not 'within the sixty day period beginning on the date the product first received permission.'"

I can't argue with your math, but AstraZeneca points out that the PTO has been granting petitions filed on the 60th day. At least the 2 or 3 PTE petitions of the cases they point to and that I can see on PAIR were granted despite being filed on the 60th day just as in the case turned down here.

[Andrew Dhuey]

It's painful to read cases involving missed deadlines. That's a tough one to explain away to a client.

[anonymous]

Was there some benefit to waiting until the 60th day, instead of the 59th day? Would it mean that AstraZeneca would have gotten an extra day of patent term if it waited until the 60th?

[Malcolm Mooney]

"AstraZeneca points out that the PTO has been granting petitions filed on the 60th day. At least the 2 or 3 PTE petitions of the cases they point to and that I can see on PAIR were granted despite being filed on the 60th day just as in the case turned down here."

That would be the end of the debate, in a just world.

[anonymous]

"Was there some benefit to waiting until the 60th day, instead of the 59th day? Would it mean that AstraZeneca would have gotten an extra day of patent term if it waited until the 60th?"

No, it wouldn't. There is no good reason why they filed on the 60th as opposed to 59th day. PTE is based on the length of the FDA regulatory review period, not when you file the PTE application.

[anonymous]

Perhaps a reading of Unimed v Quigg (from 1989) is needed by many of the commenters/readers. The Federal Circuit was pretty darn clear that the beginning of the 60 day count starts on the FDA approval date, specifically they stated, "[t]herefore, section 156(d)(1) admits of no other meaning than that the sixty-day period begins on the FDA approval date." Furthermore, regarding the combination in Symbicort, the PTE statute is fairly clear and the Federal Circuit has spoken that eligibility for extension of a drug product having multiple active ingredients is determined on a component-by-component basis (see Arnold Partnership v. Dudas from 2004). While such a combination may be patentable, it does not necessarily follow that a patent so granted could be granted term extension under 35 USC 156.

[Just Visiting]

Is Unimed v Quigg helpful?

In that case the patentee wanted the start date of the sixty day perod to be more than a year after the FDA approval date. I don't think the case answers the question of whether the last allowable petition date is day 59 or day 60.

Arnold Partnership v Dudas does seem to address the combination drug issue and perhaps the patentee won't bother appealing an ultimately losing case just to clear up the deadline stuff.

[My other brother Darryl]

Thanks for the picture of the broad with the big blue ones!

[anonymous]

Although Unimed was decided in the context of DEA rescheduling (and whether that additional regulatory burden sets a different 156(d)(1) date for timely PTE submission), the Fed. Circ. was, nonetheless, interpreting 156(d)(1). Their interpretation of 156(d)(1) is applicable to ALL CASES, not just those where there is an additional regulatory burden before the FDA marketing applicant can legally commercially market or use the product (this means any product). Knowing when to start the 60-day count (i.e., beginning on the FDA approval date as stated by the Fed. Circ. way back in 1989), and of course having the ability to count to 60 (perhaps harkening back to elementary school for this skill), would ensure timely filings.

[Anon]

The PTO's interpretation is silly. The clock has to start at zero not one.

[Response to anon]

Fine, start the clock at zero, just be sure to end it at fifty-nine. The statute gives the length of the period, 60 days, and the first day of the period, the approval date. The approval date is thus one of the 60 days. Whether the PTO failed to count correctly in the past is beside the point. They have no choice but to follow the statute as written--as so many here are quick to point out.

Try this, a work week is five days long and begins on Monday. What's the last day of the week?

[BigGuy]

"Try this, a work week is five days long and begins on Monday. What's the last day of the week?"

Trick question - the last day of the week is Saturday. The last day of the WORK week is Friday. Unless you work at my firm, in which case there is no answer.

[Malcolm Mooney]

"Whether the PTO failed to count correctly in the past is beside the point."

Really?

"They have no choice but to follow the statute as written"

Except when they don't. Got it.

[Anonymous]

""Whether the PTO failed to count correctly in the past is beside the point."
Really?"
"They have no choice but to follow the statute as written"
Except when they don't. Got it."

So you would have the PTO perpetuate an improper application of the statute? What would your position be should the PTO improperly application of 103? An applicant for patent can appeal. What is the PTO's recourse once an error in application of the law is discovered? The PTO is the agency who administers 35 USC 156 in conjunction with the regulating agency (typically FDA, but could also be USDA), by your remarks, all 3 agencies should continue to perpetuate the misapplication of the law.

[KC]

The problem with PTEs is that they are so rare and there are no specialists; and, consequently not too many resources available. However, the USPTO has been known to be very helpful when called upon in answering questions dealing with PTEs and other little known nuisances found deep within the MPEP. It is always better to file a day early, especially when you know a hard deadline may cost your client millions of dollars (if not hundreds of millions).

[Children Anxiety Disorder]

im agree with the “an approved product having two active ingredients, which are not shown to have a synergistic effect or have pharmacological interaction, will not be considered to have a single active ingredient made of the two active ingredients.”