CONTRASTING FREEDOM TO OPERATE WITH PATENTABILITY - Patent law

The freedom-to-operate inquiry is much broader and more complex than the basic consideration of whether clear title to the patent is being offered—even a clean assignment or license to a particular patented invention does not mean that one has freedom to operate by making, using, or selling the claimed invention if that patent results in the infringement of one or more patents held by another party. Furthermore,the freedom-to-operate inquiry is relevant whenever one wishes to practice in an area,so it is entirely separate from the question of whether one has a patent, wishes to get a patent, can get a patent, etc. because the freedom to operate in quiryprimarily concerns itself with whether one can practice in a particular area without in fringinga patent or patents held by one or more outside interests. It is entirely possible that multiple overlapping patents are held by different parties such that no single party has freedom to operate. Because of this, the freedom-to-operate inquiry is in no way limited to whether the party initiating the inquiry has a patent on the technology or if she doesn’t—it simply asks whether the thing she wishes to do can be done without infringing somebody else’s patent. To solidify these abstract concepts, let’s consider a scenario that involves issues of patent ability and freedom to operate to demonstrate one commonly encountered way in which patent ability and freedom to operate might interrelate in an industrial chemical setting.

In our first example, a chemist working in the area of adhesives has been stuck trying to find a biodegradable adhesive useful for joining two surfaces together in a way that will provide for a strong bond but yet be degradable when exposed to protein hydrolyzing enzymes. Several approaches were tried and failed but in an entirely novel and non obvious (requirements of patent ability that will be discussed in great detail in future chapters) way, she polymerized a non-natural amino acid to form a material with strong but biodegradable properties. Her company decides to file for a patent, and after a period of several years, the patent issues with the single claim shown in Figure below.

The company is interested in producing the polymer in bulk for sale to several customers that have expressed an interest in the product.The polymer will be produced by heating the amino acid methyl ester precursor according to specially staged process conditions followed by base hydrolysis of the C-terminal ester and stoichio metric proto nation with dilute acid as shown in Figure below.

CONTRASTING-FREEDOM-TO-OPERATE-WITH-PATENTABILITY

FIGURE :Claim 1 for biodegradable polymer of non-natural amino acid.

Claim 1 for biodegradable polymer of non-natural amino acid.

FIGURE :Process for making biodegradable adhesive.

They intend to manufacture and sell the adhesive in the United States. Before scaling up their manufacturing process, they do a freedom-to-operate search and uncover a U.S. patent filed a year before they began their work that describes and claims certain amino acids and their certain corresponding esters. Claim 17 of this earlier issued patent is of particular relevance (Figure below). Notice that the genus of the compounds described in claim 17 generically covers the compound that the manufacturer’s of the biodegradable polymer need to use for their own synthesis. Thus if the adhesive chemists wish to prepare their biodegradable polymer according

to the method they have currently planned, they will infringe claim 17 of the prior issued patent. So even though the adhesive chemists own an issued patent that claims the polymer that they wish to make and sell, they cannot make it according to their current process without infringing the other party’s patent.

In such a case as outlined in this hypothetical, the choices available to the erstwhile manufacturer of the biodegradable adhesive include coming up with a process that does not infringe the recently issued patent, seeking a license from the patent holder(or another party that has a license to the compound and the right to sublicense), or buying the desired compound from the patent holder (or buying the compound from some other party that has a license to make and sell the amino acid methyl ester). Alternatively, the adhesive manufacturer may believe that the patent they are infringing is not legally valid or enforceable. In this scenario, they may seek out a

CONTRASTING-FREEDOM-TO-OPERATE-WITH-PATENTABILITY

FIGURE :Claim 17 from recently issued patent.

legal opinion to confirm their belief and then proceed to manufacture at risk of an infringement suit. If they are sued for infringement, they might argue many things,including that they are not actually infringing the patent or that the patent being enforced against them is invalid or unenforceable.5 Suffice it for now to appreciate that this latter strategy is not without risk because the assignee of the prior patent might be able to get an injunction forcing our erstwhile adhesive manufacturers to stop making their present precursor and/or be forced to pay up to three times the actual economic damages from their infringing activity. Add to this the high cost sand the great deal of uncertainty about any outcome due to the technical and legal complexities of the subject matter itself, and one can begin to appreciate the kind of risks involved with this latter strategy.

Before leaving this section, let’s briefly appreciate that the claimed polymer by itself did not lead to infringement of the patent issued to the other party but rather it was the particular intermediate used in the manufacturing process of the polymer that infringed that patent. As a result, we saw that designing around the prior art patent was a viable option since it might be possible to make the polymer of the claimed invention if one could avoid the amino acid methyl esters of claim 17. For example,perhaps it would have been possible to polymerize the amino acid itself rather than the amino acid methyl ester of claim 17. Alternatively, perhaps a different ester

A method of providing contraception in a mammal

FIGURE : Claim to method using steroid al estrogen in combination with progestin.

might have been useful for the same task.7 However, in some cases a design around is not possible because the invention that is sought to be practiced is completely encompassed by one or more patented claim(s) held by one or more other parties.Let’s consider a second hypothetical example with somewhat different subject matter, a case in which a design-around solution is not available. A pharmaceutical chemist has synthesized a steroidal compound and found that it is a particularly potent estrogenic agent in pre clinical testing. The chemist’s company believes the compound could be useful in combined estrogen/progestin contraceptive regimens and so decides to place the compound into clinical studies and files a patent application for a method of using the compound in combination with a progestin for use as a contraceptive. The chemist’s company filed a patent application to the invention that included the two claims shown in Figure below.

A compound of formula X

FIGURE :Compound claim 13 from previously issued U.S. patent.

Between the time of their filing the patent application and its issue, the company was planning several clinical studies when it came to their attention that another issued U.S. patent existed, which was filed before their chemist synthesized the compound of formula I. The patent of concern was directed to steroidal compounds, although it did not disclose their particular compound of formula I, nor did it indicate any specific utility in combination with a progestin for contraception. The patent specification(the entirety of the document) disclosed a number of Markush structures of varying scope as well as a description of the compounds as having utility for the treatment of prostate cancer. Claim 13 from the issued patent is illustrated in Figure below and it particularly concerned them.

A quick comparison of the Markush structure XI of claim 13 of the prior patent to the structure of the contraceptive steroid I of claim 1 of the chemist’s patent indicates that the compound of formula I falls within its scope. In particular, consider when the compound of structure XI has X=OH, R=H, R_ =CH2CH3 (this is a C2 alkyl group,thus falling within the C1-4 alkyl definition), R__ = hydrogen and Rx = −C≡C−H(this is a C2 alkynyl, thus falling within the C1-4 alkynyl definition). The two dashed lines paralleling the backbone in the steroid’s B-ring indicate that those two bonds can independently be single or double bonds. The compound of formula I requires two double bonds in the B-ring of the steroid, and the presence of the two dashed lines in the B-ring of the Markush of formula XI indicate that this combination is covered in XI.

The chemist dutifully brought this prior patent to the attention of her company’spatent counsel, who promptly submitted the reference to the USPTO as prior art for their consideration. The USPTO found that the reference did not affect the patentability of claim 1, stating in the relevant part:

The broad genus of the prior art patent disclosed in claim 13 does not negatively affect the patent ability of applicant’s pending claim 1 or claim 2. In particular, the very breadth of the prior art genus does not render the particular compound of formula I not novel,nor does it render it obvious. There is no suggestion, teaching or motivation provided by this reference to arrive at the compound of formula I nor does this reference, combined with any other prior art references teach or suggest a compound of formula I.

Even if the compound of formula I were structurally obvious in view of the prior art disclosure,there still would be nothing to suggest its combination with a progestin as is require byclaim1 of the pending application. Claims 1 and 2 are allowed.

The chemist and others at her company were quite pleased with the USPTO’s decision, as this indicated they would soon be issued a patent to their exciting discovery, and sure enough, they were correct. The chemist mistakenly assumed that this meant they were now free to pursue the development of their compound to which they hoped would eventually lead to its successful commercial launch. What she had failed to realize, however, was that even though her company had obtained the issued patent, her company was not so free to make, use, or sell the compound described in claim 1. As the company’s patent counsel explained to her and as we have already learned, a patent represents a right to exclude another from making, using, or selling the claimed invention but does not, by itself, allow one to make, use, or sell her own invention—it is a sword and not a shield. Likewise, the prior art patent grants its owner the same rights against others: It allows its owner to exclude one from making,using, or selling the subject matter of its claims. As we have already determined, the structural subject matter of claim 13 of the prior patent encompasses a compound of formula I of our chemist’s claimed method. Our chemist was quick to point out to the company’s attorney, however, that they were claiming and using the compound much more specifically—they required the compound to be used in combination with a progestin as a method of providing contraception, and the prior patent simply makes no mention of that use.

The company’s patent counsel explained to her that unfortunately for them, the prior patent was broad enough to encompass the method and the combination that they were proposing to test and eventually (they hoped)bring to market. The following conversation ensued:

The company patent counsel explained: “In the prior patent, they claimed the compound only, with no further limitation. The fact that their claim does not specifically list any use of that compound does not mean that any use of that compound is not covered, in fact, it’s quite the opposite. This means that the making, using, or selling of a compound falling within their claimed genus for essentially any purpose is an infringement of claim 13 of their patent.”

The chemist was understandably upset because she thought “Didn’t we just get a patent covering what we wished to do?” So she asked: “How did we get apatent if what we did was already covered by that other patent?”

The company’s lawyer responded, “The prerequisites for patent ability are different from whether your claim is ‘covered’ by somebody else’s claim. Patent ability with respect to the prior art requires novelty and non -obviousness. Their issued claim is part of the prior art, and so it will be considered only for whether it renders our claim not novel or obvious. In the last substantive office action we read why the patent examiner thought that the prior art patent claim did not negate the patent ability of our claim and for what it’s worth, I completely agreed with his reasoning!”

“Well okay, I think I’ve got that but then haven’t we already infringed their patent? I mean, isn’t the mere publication of our patent with its claim that uses their compound going to tip them off that we used their compound without their permission?”

The chemist said with a worried look on her face. “Shhhhh, let’s ease up on that infringement talk, somebody might hear us,” the company lawyer joked. “Seriously, that’s a very good question and the answer is yes, no, and maybe. It’s a good thing I work for the company and am not billing by the hour because you’d be running up some pretty good fees by now.

Well here goes. On its face, if we did what we describe in our claim then, yes,we are literally infringing their claim. However, as to whether our published claim itself would constitute proof of the infringing act then the answer is no.

For example, patents can rely on prophetic or constructive examples for support of the claimed subject matter, meaning the actual thing being claimed may not have been actually been performed as claimed. Alternatively, the thing being claimed might have been supported by work that might have taken place outside of the United States. In other words, our patent did not say where the actual work was done and any importation of information obtained from that work should not infringe their U.S. patent claim.”Pausing to catch his breath, the company patent counsel continued, “Even if one did accept the fact that we infringed the patent, there are exceptions that are sometimes available to infringers to allow them to escape damages normally available to the patent holder. In our particular circumstance, maybe we could qualify for an exception and thus escape the prior patent holder’s wrath. Finally, as a practical consideration,patent litigation is very time consuming and costly. Not only is the outcome of litigation uncertain, their patent could end up being declared invalid as a final result of all of their cost and effort. But for the sake of argument let’s say that hypothetically we did infringe their patent, what would the damages be?”Answering his own question, as by now it appeared the chemist’s attention had wandered elsewhere, the lawyer continued, “Chances are they would be nominal at best since our use was very limited and never sold or extensively practiced. If damages were to approximate a reasonable royalty negotiated between us and them in an arm’s length transaction, I’d say the amount would be very small.In fact, the prior claim holders would probably be more interested in letting us develop our invention and run our clinical trials. Eventually, we would need to approach them before commercializing the product, and the more developed it is when we do finally approach them, the more they will be able to charge us on a license because the more we will have invested in the project. Does this answer your question? Is there anything else you’d like to know? Hey, hey”

The chemist, groggily coming back to her senses and not knowing how long she had drifted away realized that the lawyer was asking her something and panicking a little bit, managing to squeeze out “Yeah, sure thanks. Look, I think I just remembered that I have a reaction to turn off so I better get back to the lab real quick,” before rapidly turning and walking briskly back down the hallway, careful not to turn and look back lest the lawyer might be tempted to start talking to her again.

While our somewhat worn-out chemist may have run out of questions, perhaps there still is a question or two yet worth considering. For example, if the chemist’s company cannot practice claim 1 or claim 2 of her own issued patent without infringing the prior patent, can the owner of the prior patent practice the subject matter of chemist’s company issued claim without infringing the chemist’s company’s claim?

The answer is (drum roll please) . . . no! Just as the prior patent owner can exclude the chemist’s company from using a compound falling within the formula XI (which encompasses their compound of formula I) for any purpose including contraception,the chemist’s company may exclude the owner of the prior patent from using the compound of formula I in combination with a progestin for contraception. If this seems a little bit odd and perhaps even unfair to the owner of the prior patent (after all, they were first) then you need to think again about what it is that the prior paten tactually does and doesn’t grant its owner. The prior patent owner was awarded their patent first and it covers any compound falling within the scope of their genus defined by formula XI for any purpose. But their patent never gave them freedom to operate,only the right to exclude others. Just as the prior patent holders were granted a right to exclude others, others can still have the right to exclude them, even when those others obtained their patents after the holder of the earlier patent.

In the example we just discussed, the first (and typically broader patent) is often referred to as the dominant patent, and the second, narrower patent is often referred to as a selection patent. Since the initial patent covers the use of a broad genus of compounds for any use, the later claim covering a single compound for a particular use might be thought of as a double selection—a selection of a compound from the prior genus as well as a selection of a single use from a full range of possible uses. The practical outcome in our example is that both parties are blocked from commercializing a small portion (in the case of the prior patent holder) or all (in the case of chemist’s company) of their claimed invention. In order for our chemist’s company to commercialize their invention they would need to license the right to use of the prior patent from its owner. Likewise, if the prior patent owner wished to use the compound of formula I in combination with a progestin for contraception, they would need to license or purchase the patent from the chemist’s company.

From a public policy perspective, the patenting of selection inventions is a good thing because most of the time such inventions reflect a refinement or often an improvement on the earlier described invention, and the patent system exists largely to encourage and reward such improvements, even when the changes are evolutionary rather than revolutionary. To each inventor should go the rewards of her invention, and it should not matter whether her invention came before or after another’s; it should matter only whether she has actually made an invention. Overlapping inventions are a natural outcome of a system that encourages competition, and any attempt to limit this aspect runs contrary to the purpose of patent law. Furthermore, to the extent that patent law is criticized for stifling competition at the same time that it encourages it,allowing dominant patents to exist monolithically would lend further weight to such criticism.

The two hypothetical examples we just discussed served to illustrate that patent ability and freedom to operate are truly different inquiries. The challenge facing a party seeking to get a patent is whether their invention meets the criteria fragmentarily. The challenge facing the party wishing to practice their invention or technology is whether they can do so without infringing another party’s patent. As we can see from the examples,having one does not secure the other.


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