PTO Prevails in Challenge to Drug Eluting Stent PTE Denial, and Encounters Some Interesting Characters Along the Way . . . Including a Unicorn!June 27, 2016
By Kurt R. Karst –
Earlier this month, the U.S. District Court for the Eastern District of Virginia issued a Memorandum Opinion granting a Motion for Summary Judgment filed by the U.S. Patent and Trademark Office (“PTO”) and denying a Motion for Summary Judgment filed by Angiotech Pharmaceuticals Inc. (“Angiotech”) in a case started on December 21, 2015 when Angiotech filed a Complaint challenging the PTO’s December 11, 2015 Final Decision denying a Patent Term Extension (“PTE”) for U.S. Patent No. 5,811,447 (“the ‘447 patent”) allegedly covering the ZILVER PTX Drug Eluting Peripheral Stent (“ZILVER PTX”). (Reply and Opposition briefs filed in the case are available here, here, here, and here.) Last October in a post concerning another PTE dispute (here), we noted in passing the PTO’s Initial Denial of a PTE for the ‘447 patent, but we hadn’t realized until recently that the PTE dispute moved quickly on to litigation after the PTO denied Angiotech’s Request for Reconsideration.
As we alluded to in our October 2015 post, the PTO’s denial of a PTE for the ‘447 patent is not what we’ve come to see as a “typical” PTE challenge. That is, it doesn’t involve the first permitted commercial marketing prong of the PTE statute (35 U.S.C. § 156), the length of a PTE, or even the timeliness of submission of a PTE application. Rather, Angiotech’s case involves whether or not the ‘447 patent actually claims ZILVER PTX.
By way of background, FDA approved (here and here) ZILVER PTX on November 14, 2012 under Premarket Approval Application (“PMA”) P100022 for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal (thigh) arteries having certain vessel diameters. ZILVER PTX is a drug-device combination product with a self-expanding, small metal, mesh stent with the outer surface coated with the drug paclitaxel (to help prevent artery restenosis) that can be implanted in a femoropopliteal artery. As a combination product, FDA determined that ZILVER PTX has a primary mode of action of that of a medical device, instead of as a drug, and FDA’s Center for Devices and Radiological Health took the lead on reviewing the PMA submitted by Angiotech’s partner, Cook Medical Technologies, LLC (“Cook).
Angiotech, on behalf of the patent owner, Boston Scientific Scimed, Inc. (“BSC”), submitted a PTE application to the PTO for the ‘447 patent on December 7, 2012 (Docket No. FDA-2013-E-0781) requesting the statutory 5-year maximum extension. (As an aside, Cook and BSC separately submitted PTE applications for other patents related to ZILVER PTX: U.S. Patent No. 6,299,604 (Docket No. FDA-2013-E-0677); U.S. Patent Nos. 6,515,009 (Docket No. FDA-2013-E-0681); and U.S. Patent No. 7,820,193 (Docket No. FDA-2013-E-0676).) Element number 9 of a PTE application (37 C.F.R. § 1.740(a)(9)) requires the following:
A statement that the patent claims the approved product, or a method of using or manufacturing the approved product, and a showing which lists each applicable patent claim and demonstrates the manner in which at least one such patent claim reads on: (i) The approved product, if the listed claims include any claim to the approved product; (ii) The method of using the approved product, if the listed claims include any claim to the method of using the approved product; and (iii) The method of manufacturing the approved product, if the listed claims include any claim to the method of manufacturing the approved product.
Angiotech asserted that Claim 12 of the ‘447 patent reads on methods of using ZILVER PTX. That claim states:
A method for biologically stenting a mammalian blood vessel, which method comprises administering to the blood vessel of a mammal a cytoskeletal inhibitor in an amount and for a period of time effective to inhibit the contraction or migration of the vascular smooth muscle cells.
Specifically, Angiotech asserted that the following Claim 12 elements correspond to ZILVER PTX:
Corresponding Feature of the Zilver® PTX Drug Eluting Peripheral Stent
12. A method for biologically stenting a mammalian blood vessel, which method comprises
“The Zilver PTX Drug Eluting Peripheral Stent is a self-expanding stent made of nitinol and coated with the drug paclitaxel.” Paclitaxel (i.e., taxol) is known to inhibit migration of arterial smooth muscle cells.
administering to the blood vessel of a mammal a cytoskeletal inhibitor
“The Zilver PTX Drug Eluting Peripheral Stent is a self-expanding stent made of nitinol and coated with the drug paelitaxel.” Paclitaxel (i.e., taxol) is defined as a suitable “cytoskeletal inhibitor" in the ‘447 patent (see Col. 19, lines 6-9).
in an amount and for a period of time effective to inhibit the contraction or migration of the vascular smooth muscle cells.
Paclitaxel is defined as a suitable “cytoskeletal inhibitor” in the ‘447 patent (sec Col. 19, lines 6-9).
Ultimately, the PTO denied Angiotech’s PTE request on the basis that Claim 12 of the ‘447 patent does not claim a method of using ZILVER PTX:
A predicate to finding a patent eligible for patent term extension based on FDA review of a product subject to premarket regulatory review (“a regulated product”) requires that the patent claim the product, a method of using the product or a method of manufacturing the product. Here, the regulatory review period was conducted under section 515 of the FFDCA. Where FDA reviews a regulated product under section 515 of the FFDCA, the regulated product is a medical device. Therefore, substituting that term into 35 U.S.C. § 156(a) yields, “(a) [t]he term of a patent which claims a [medical device], a method of using a [medical device], or a method of manufacturing a [medical device] shall be extended ….” Because claim 12 is directed to a method of biologically stenting a mammalian blood vessel, Applicant and USPTO agree that eligibility rests on whether claim 12 of the ‘447 patent claims a method of using the approved medical device. In other words, it is undisputed that claim 12 does not claim the approved medical device itself or a method of manufacturing the approved medical device.
Angiotech promptly filed suit against the PTO.
An important issue in the case (though not one we will detail here) was whether or not the PTO’s interpretation of the Hatch-Waxman Amendments, which, among other things, amended the patent law, is entitled to any deference at all. In his June 8, 2016 decision, Senior Judge T.S. Ellis, III concluded that no deference is due to the PTO’s final decision interpreting the law. “[G]iven the PTO’s function in this context,” which Judge Ellis described elsewhere in his Opinion as “more analogous to [that] of an agent engaged in the ordinary private law task of complying with contract-like agreements affecting the disposition of property rather than [that] of a public law entity engaged in regulation,” “there is no compelling reason to believe that the PTO’s positions on the meaning of the Patent Act are ‘wise and correct’ in a manner that justifies deference under an administrative law doctrine . . . . Like any party attempting to enforce the terms of a contract, the PTO is entitled to no special deference in assessing the meaning of the terms.”
Despite this ruling on the lack of deference to the PTO’s decision, Judge Ellis ultimately sided with the PTO, granting the Office’s Motion for Summary Judgment. “[T]he dispute boils down to a single question: Does the ‘447 patent ‘claim . . . a method of using” a ‘medical device’ as those terms are used in the Hatch-Waxman Act?” The answer is “No,” according to Judge Ellis. But it was a long and tortured road for the PTO to get that “No” decision.
“A ‘medical device’ for purposes of § 156(f)(1)(B) should not be construed to have the same meaning as ‘device’ under [FDC Act § 201(h) (21 U.S.C. § 321(h))], but should instead take its ordinary meaning,” wrote Judge Ellis, referencing various dictionary definitions of “device” and “medical.”
The fact that the FDA reviewed the Zilver PTX as a medical device does nothing to change this analysis. When the FDA determines a combination product’s primary mode of action for purposes of FDCA review, the FDA is not identifying the nature of the product itself. Rather, the FDA’s determination of a primary mode of action is merely an identification of the predominate means by which the product achieves its therapeutic effect. . . . For purposes of classifying a product under the Hatch-Waxman Act, it makes no difference whether the FDA reviews a product as a device, as a drug, as a biological product, or as a unicorn – if the product is a contraption, contrivance, or related article with a purpose related to the diagnosis, treatment, or prevention of disease, then it is a medical device under § 156(f)(1)(B).
In short, the PTO’s statutory analysis of § 156 is flawed. Section 156’s language is adequate (i) to classify the Zilver PTX as a drug or as a medical device for purposes of the Hatch-Waxman Act and (ii) to analyze the ‘447 patent’s eligibility for a [PTE]. There is no need or warrant to refer to the FDCA or the actions of the FDA to reach these conclusions.
Despite these findings, however, Judge Ellis states that “it does not necessarily follow that the PTO’s ultimate conclusion must be set aside.” And, in fact, here Judge Ellis did not do so. Finding support in the ordinary meaning of “a product” in 35 U.S.C. § 156(a), in the ordinary meaning of “medical device” in 35 U.S.C. § 156(f)(1)(B), and in the meaning of claims in 35 U.S.C. § 156(a) as interpreted by the Federal Circuit in Hoechst-Roussel Pharms. Inc. v. Lehman, 109 F.3d 756 (Fed. Cir. 1997) (here), Judge Ellis concluded that:
[I]n order for a method claim to qualify for a [PTE] under § 156(a), the method must claim the use of the particular product that underwent FDA review. Where the product in issue is a “medical device,” it follows from the ordinary meaning of that term that the claimed product will be physical in nature and have some structure. Claim 12 of the ‘447 patent recites no structure and does not expressly contemplate the use of any structure, and it therefore cannot be said that the patent claims a method of using any particular product, much less the Zilver PTX. Thus, although the PTO erred in concluding that [FDC Act § 201(h)] requires that a patent claiming a method of using a medical device recite some structure in order to qualify for a [PTE], the PTO’s ultimate conclusion was not in error. [(Emphasis in original)]
It’s unclear whether or not Angiotech will appeal Judge Ellis’ decision to the Federal Circuit for another look.