Parts is Parts? A few thoughts about some of the comments that were submitted to the FDA about Orange Book listings

The deadline for submitting comments to the FDA about patent listings in the Orange Book has long passed. The result was the submission of seventeen comments by a variety of organizations.


A big issue discussed in the comments is the eligibility for listing in the Orange Book of patents that claim a drug administration device or a part thereof. This issue can be broken down into:


1) for a patent claiming the device as a whole, does there have to be a claim that recites the presence of a drug (or “the” drug) in the device in order to make the patent eligible for listing in the Orange Book?


2) is a patent that claims only an individual part of the device eligible for listing in the Orange Book?


Presence of “a” drug or “the” drug?


            Presence of “a” drug?


Yes, patent attorneys have drafted claims for patent administration devices that, even when they know that the device was designed with a particular active ingredient in mind, do not include a drug as an element in at least one claim. They would write that Part A is connected to Part B which, in turn, is received within Part C. When I spoke to CLE conferences about Orange Book listings over the years I referred to these patents as “empty” device patents. When the claimed empty device was eventually filled and marketed with a formulation containing an active ingredient, the patent attorney would list the empty device patent in the Orange Book.


I was responsible for Orange Book patent listings for much of my in-house career. When I was asked about listing an empty device patent in the Orange Book I looked to the “Drug Product” definition in 21 CFR 314.3(b) which says in relevant part that a drug product is “a finished dosage form . . . that contains a drug substance.” [Emphasis added].To me, that means that an empty device patent would not claim a “drug product” because the claims of the patent lack the required drug substance. But rather than rely upon my conclusion, we asked outside counsel for their opinion. They felt the same way.


There is, of course, no definitive court opinion on this question. So innovator companies are free to exercise their own judgment until the day such an opinion is available. In my presentations at CLE conferences, I used to talk about the “conservative-to-aggressive” continuum of patent listing decisions. The companies that I worked for took the conservative route with empty device patents by not listing them in the Orange Book. There were other companies who took a more aggressive position by listing them.


Presence of “the” drug?


There are some generic drug companies who go a step further than simply demonizing empty device patents. They insist that the mere generalized mention that some kind of drug is contained in the device should not sufficient to make a patent eligible for listing in the Orange Book. They argue that the specific active ingredient that is in the approved drug product for which the patent is being listed should be recited in at least one claim.


On this question, my former companies were more aggressive. The use of so-called “genus” claims is routine in patents. So a claim element reciting, e.g., “a reservoir containing a drug” was thought to be sufficient to overcome any shortcomings that an empty device patent might have. So we listed such patents.


This question was actually presented to a court in a 505(b)(2) litigation (King Pharmaceuticals, Inc. and Meridian Medical Technologies, Inc. v. Intelliject, Inc., 1:11-cv-00065, D. Del.) in the form of a delisting counterclaim by Intelliject. The case involved the EPIPEN injection device which is used to administer epinephrine with which it is prefilled. The patent in question was 7,794,432, assigned to Meridian. One element of claim 1 is:


a cartridge having an opening therein and containing a medicament.


The phrase “containing a medicament” avoids the issue of claiming an empty device. So we felt that listing patents in the Orange Book that have a claim like the one in the ‘432 patent could be justified. Yet Intelliject argued in their counterclaim that the patent should be delisted because it does not claim or disclose a composition or formulation of the specific drug for which the EPIPEN was approved, epinephrine. In fact, Intelliject pointed out that the word “epinephrine” is not found anywhere within the patent.


Unfortunately or fortunately (depending upon your point of view), the parties settled the case before the delisting counterclaim could be addressed. So the question is still open. If your company is interested in getting this question settled, please feel free to make the appropriate patent delisting counterclaim, 21 USC 355(c)(3)(D)(ii)(I) for 505(b)(2) applications or (j)(5)(C)(ii)(I) for ANDAs, in your answer to the complaint.


Parts is Parts, Integral or Not?


Even more controversial than “empty” device patents are patents that claim only a part of a drug administration device. When I think of “parts” patents I can’t but  think of the WENDY’S® fast food company’s ad campaign in the 1980’s for their chicken sandwiches. They implied that their chicken sandwiches, which were allegedly made from 100% chicken breast meat, were superior to a competitor’s that were allegedly made from various parts of the chicken that were “fused” into one “part.” In the ad, when a customer asks the competitor’s counter person what their sandwiches are made from, the man answers, “parts.” When the customer presses him on what kind of parts, the man answers “parts is parts.”


So while “parts may be parts,” some comments distinguished parts that the authors believed are “integral” to the delivery of the drug substance from those parts that are somehow not integral. Those commenters proposed that patents claiming “integral” parts should be eligible for listing in the Orange Book, while non-integral parts should not be eligible. PhRMA, on the other hand, suggested in their comments that “integral” is too subjective of a standard, and does not recommend its use [PhRMA comments at 12].


Now, I am not a fan of “parts” patents, and I will tell you why. I was once asked if I would consider listing a patent that claimed a new type of rubber tip for use on the end of the plunger in an otherwise ordinary syringe that my company sold prefilled with one of our drugs. So I took a look at the statute once again, particularly where is says that we should submit:


any patent which claims the drug


and that was all I needed. You see, there might be a cascade of statutes and regulations that could allow an attorney to conclude that a rubber syringe plunger tip should be considered to be a “drug.” However, is it realistic to expect a lay judge or jury to make such a finding? Their eyes will likely have glazed over long before the attorney gets to the final conclusion!


Moreover, what purpose would listing a “part” patent in the Orange Book actually serve? In their comments, Teva suggests a framework that “covers all potentially competition-blocking patents.” [Teva comments at 6 (emphasis added)]. With the chances of a part patent providing exclusivity for the product being extremely low, I feel that the only effect of listing such patents would be to give critics of the innovator drug industry another reason to disparage them.


The Association for Accessible Medicines (“AAM,” the generic’s trade association) concedes that there could be a basis for the listing of patents directed to individual parts of drug delivery devices. However, this concession has a caveat. The device-related patent:


must also ‘read on’ (i.e., claim or otherwise identify) the approved drug product. [AAM comments at 16, emphasis added].


Does that mean that the specification could be used to supplement the claims and so make the patent eligible for listing? I think further clarification of their point would be helpful. However, they recommend that the FDA create a set of questions, similar to those in the 3542 form for listing polymorph patents, to help innovators determine which device patents should be listed in the Orange Book.


There is one argument made by a couple of commenters in favor of the eligibility of parts patents with which I must respectfully disagree. In their comments, PhRMA argues (and BIO essentially agrees [BIO comments at 5]) that:


1.    a drug substance is a “part” of a drug product,

2.    drug substance patents are eligible for listing in the Orange Book, 

3.    therefore patents that claim device parts are also be eligible for listing.


It is clear from FDA’s regulations that a patent need not claim the entire approved drug product to be required to be listed. Indeed, patents covering only the drug substance—i.e., one component of the drug product—must be listed as a “patent which claims the drug.” [PhRMA comments at 11, emphasis added].


It is my humble opinion that history shows that the FDA has always considered drug substance patents to be a category of eligible patents that is separate from drug product patents. So it is not the presence of a drug substance as a part of a drug product that makes a drug substance patent eligible for listing in the Orange Book. Instead, drug substance patents are an independent category of eligible patents. As stated by the FDA in the Orange Book Volume 5 (1985) which was the first volume of the Orange Book published following the enactment of Hatch-Waxman:


The patents that FDA regards as covered by the statutory provisions for submission of patent information are: patents that claim the active ingredient or ingredients, drug product patents, which include formulation/composition patents, but exclude process patents, and use patents for a particular indication or method of using the product. [Patent And Exclusivity Information Addendum, AD1 (emphasis added)] 


Yes, I know that every drug product has to have a drug substance in it. Otherwise, the so-called “drug product” would not be a drug! But that does not change the fact that at the dawn of Hatch-Waxman the FDA described drug substance patents separately from the drug product category of patents that would include devices. So with this historical background established, is there really a satisfactory analogy between the eligibility of drug substance patents and the eligibility of device “part” patents? I do not think so, but you can be the judge.


PhRMA makes another argument to support the eligibility of listing “parts” patents in the Orange Book with which I also disagree. That argument relies upon FDA draft guidances in which the parts of nasal aerosols and sprays, and the parts of metered dose and dry powder inhalers, are described as “together” or “collectively” constituting a drug product. [PhRMA comment at 9, FN38]. I disagee with PhRMA’s position since I do not see anything in the cited guidances that would lead me to conclude that each of the individual parts of a device should be considered, independently, to be a “drug product.” I believe that it would be the presence of a claim to the a drug product as a whole, which are all the parts considered “together” or “collectively” as described in the guidances, that would be a better rationale for making a device-related patent eligible for listing in the Orange Book.


Mylan (now rebranded as Viatris) also supports listing parts patents in the Orange Book. In their comments, Mylan uses the definition of “drug” found in 21 USC 321(g)(1)(D) to justify their position. Yes, clauses (A), (B) and (C) recite some standard definitions of a drug, and clause (D) adds:


 “articles intended for use as a component of any articles specified in clauses (A), (B) or (C).” [Emphasis added].


From this clause it might be easy to think that the word “component” can encompass the individual, physical parts of a device. However, there is an alternative to such an interpretation. That alternative can be derived from the FDA’s definition of the word “component” found in 21 CFR 314.3(b) were it states that a drug “component” is:


[a]ny ingredient intended for use in the manufacture of a drug product, including those that may not appear in such product. [emphasis added].


Under that definition, would you consider the dosage counter part in an inhaler or the rubber tip part on a syringe plunger to be an “ingredient” of your drug? Wouldn’t that be like telling a carpenter on your jury that the blade in their circular saw is an “ingredient” of the saw? Not when we commonly think of an “ingredient” as a substance that is mixed together with other substances like in a food recipe or, more relevant to this issue, in a pharmaceutical drug formulation. 


For the above reasons I believe that it would be a good idea to consider the word “component” in 21 USC 321(g)(1)(D) in view of the FDA’s definition of  “component” in 21 CFR 314.3(b) before making a decision to list a device “part” patent in the Orange Book.


Now, am I alone in not being a fan of listing device part patents in the Orange Book? Apparently not! I recently found that there are others, much more prestigious and likely more learned than I am, who are also not fans of listing “parts” patents in the Orange Book. Those others are a unanimous panel of judges from the 1st Circuit Court of Appeals! Their opinion in the Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020) held that a drive mechanism that is used in an injection device called the Lantus® SoloSTAR®could not be considered to be a “drug” even if the drive mechanism was an integral part of the injection device:


We see nothing in the statute or regulations that welcomes such a further expansion of the already stretched statutory terms, whereby an integral part of an injector pen becomes the pen itself, and in turn is a drugLantus at 8 (emphasis added).


Moreover, on the following page of their opinion, the 1st Circuit panel allowed for the sake of argument that even if a part might be considered to be a drug, the patent that claimed the part would still be ineligible for listing:


More importantly, even assuming that the drive mechanism claimed by the ‘864 patent is itself a drug, we still find Sanofi falling short of its goal because the drive mechanism is not the “drug for which [Sanofi] submitted” the sNDA. 21 U.S.C. § 355(b)(1). For that reason alone the patent for the drive mechanism does not a qualify for listing in the Orange Book as claiming the Lantus SoloSTAR. Lantus at 9.


So it is nice to know that I am not alone!


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