**6. Look before litigating**

Infringement occurs when someone unauthorized makes, uses, offers for sale or sells a patented invention within territories where it is protected, or imports into that territory the patented invention during the term of the patent. Infringement and litigation is mainly about the power to regulate the manner in which patented goods and services are traded, not how people use them. Patent disputes seldom throw up clear-cut good guys and bad guys. Each feuding party is likely to honestly believe its actions are reasonable and lawful. Litigation costs are usually very high, so anticipate spending a million or more U.S. dollars. No infringement occurs outside the term of a patent. Patent offices have no jurisdiction over infringement issues, only designated courts have. The relief sought from courts for infringement may be an injunction to prevent further infringement, and award of damages for past infringement. Alleged infringers, if challenged, are quite likely to counter-challenge by questioning the validity of the disputed patent. While the Government that granted the patent may use the patented invention without permission of the patent owner, it must, nevertheless, compensate the owner.

#### **6.1. Obviousness and obvious–to-try**

Obviousness and "obvious to try" are not synonyms. The mere fact that something is "obvious to try" in view of prior art does not automatically imply that the invention resulting therefrom is obvious. This is especially true where the number of things one can obviously try are very many (say tens-of-thousands or millions as can happen with respect to chemical molecules) and the search would amount to finding a needle in a haystack. That is, the prior art does not contain any suggestion or teaching that might suggest how the invention might be accomplished or any basis for reasonable expect‐ ation that beneficial results will accrue by proceeding along the lines taken by an inventor. There are, however, situations where "obvious to try" or "worth a try" may be indicative of obviousness. In *KSR* v. *Teleflex* [49], the SCOTUS indicated one:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product [is] not of innovation but of ordinary skill and common sense.

#### **6.2. Doctrine of equivalents**

The judicially created doctrine of equivalents, universally followed, is a rule of claim inter‐ pretation wherein a product or process, although not literally infringing nevertheless infringes if it performs substantially the same function in substantially the same way to obtain the same result as a patented product or process. The doctrine extends patent protection beyond the literal language of the claim.

Literal infringement of a patent, though rare, occurs when the alleged infringing product or process is an obvious near replica. Generally, people try to work around a patented invention by introducing differences and variations they hope will be large enough to beat the doctrine of equivalents. Deciding equivalency is tricky as it must deal with two opposing public policies: (1) the need to provide public notice as to what infringes by requiring clear and distinct claims, and (2) the need to prevent an infringer from avoiding liability by covert means. Of course, one may ask, "What if a device performs substantially the same function in a substantially *different* way to obtain the same result?" This leads us to the reverse doctrine of equivalents (Section 6.3). In determining equivalency, courts may seek expert opinion as to scientific or engineering facts and the decision may well lean on the more believable expert. Note that things that are equivalent for one purpose may not be so for other purposes.

#### **6.3. Reverse doctrine of equivalents**

The reverse doctrine of equivalents circumscribes the doctrine of equivalents. The SCOTUS in *Graver Tank* [50] ruled that:

The wholesome realism of this doctrine [of equivalents] is not always applied in favor of a patentee but is sometimes used against him. Thus, where a device is so far changed in principle from a patented article that it performs the same or similar function in a substantially different way, but nevertheless falls within the literal words of the claim, the doctrine of equivalents may be used to restrict the claim and defeat the patentee's action for infringement. [Citations omitted.]

Thus, where an invention relies on the fundamental concept embodied in a patent but, say, relies on "a significant advance" in technology, the accused device does not infringe by virtue of the reverse doctrine of equivalents. Once a patentee establishes literal infringement, the burden is on the alleged infringer to establish non-infringement under the reverse doctrine of equivalents.

#### **6.4. Prosecution history estoppel**

suggest how the invention might be accomplished or any basis for reasonable expect‐ ation that beneficial results will accrue by proceeding along the lines taken by an inventor. There are, however, situations where "obvious to try" or "worth a try" may be indicative of obviousness. In *KSR* v. *Teleflex* [49], the SCOTUS indicated one:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product [is] not of innovation but

The judicially created doctrine of equivalents, universally followed, is a rule of claim inter‐ pretation wherein a product or process, although not literally infringing nevertheless infringes if it performs substantially the same function in substantially the same way to obtain the same result as a patented product or process. The doctrine extends patent protection beyond the

Literal infringement of a patent, though rare, occurs when the alleged infringing product or process is an obvious near replica. Generally, people try to work around a patented invention by introducing differences and variations they hope will be large enough to beat the doctrine of equivalents. Deciding equivalency is tricky as it must deal with two opposing public policies: (1) the need to provide public notice as to what infringes by requiring clear and distinct claims, and (2) the need to prevent an infringer from avoiding liability by covert means. Of course, one may ask, "What if a device performs substantially the same function in a substantially *different* way to obtain the same result?" This leads us to the reverse doctrine of equivalents (Section 6.3). In determining equivalency, courts may seek expert opinion as to scientific or engineering facts and the decision may well lean on the more believable expert. Note that

The reverse doctrine of equivalents circumscribes the doctrine of equivalents. The SCOTUS in

The wholesome realism of this doctrine [of equivalents] is not always applied in favor of a patentee but is sometimes used against him. Thus, where a device is so far changed in principle from a patented article that it performs the same or similar function in a substantially different way, but nevertheless falls within the literal words of the claim, the doctrine of equivalents may be used to restrict the claim

Thus, where an invention relies on the fundamental concept embodied in a patent but, say, relies on "a significant advance" in technology, the accused device does not infringe by virtue of the reverse doctrine of equivalents. Once a patentee establishes literal infringement, the

and defeat the patentee's action for infringement. [Citations omitted.]

things that are equivalent for one purpose may not be so for other purposes.

of ordinary skill and common sense.

**6.2. Doctrine of equivalents**

214 Biotechnology

literal language of the claim.

**6.3. Reverse doctrine of equivalents**

*Graver Tank* [50] ruled that:

Estoppel means a bar preventing one from making an allegation or a denial that contradicts what one has previously claimed as the truth. This can happen, *e.g.*, during patent prosecution, if a claim is rejected by the patent examiner citing prior art and the claim is then amended and narrowed to avoid the prior art. In such a case the patentee is barred from asserting the narrowed claim in a broader sense under the doctrine of equivalents or recapture what was surrendered in the amendment. Thus when prosecution history estoppel applies, only literal infringement may be invoked.

#### **6.5. Research exemption**

Generally, use of patented inventions in pure research is exempt from infringement liabilities. That is, if the pursuit is no more than "for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." [51]. Still caution is warranted as the scope of exemption varies from country to country and whether the research is associated with a commercial goal. If it is, exemption is unlikely. Researchers in synthetic biology need to be very cautious, especially if their research is funded by industry or is likely aimed towards a commercial product. Generally, use of patented inventions in research and tests in preparation for regulatory approval from government bodies is exempt if conducted within a limited period prior to the patent's expiry. This *e.g.*, allows generic manufacturers to prepare generic drugs in advance without infringing relevant patents.

### **6.6. Method claims**

Unlike product claims, process or method claims are generally problematic in litigation. In the United States where patent litigation is rampant, the SCOTUS has often enough reversed the decisions of the Court of Appeals for the Federal Circuit (CAFC) in patent litigation [52]. In a recent case, *Limelight* v. *Akamai* [53] the SCOTUS while unanimously overturning the CAFC's decision, commented, "The Federal Circuit's analysis fundamentally misunderstands what it means to infringe a method patent. A method patent claims a number of steps; under this Court's case law, the patent is not infringed unless all the steps are carried out." It also held that a defendant is not liable for induced infringement if there is no direct infringement. The decision has raised some concerns in the biotech industry since biotech patents often include complicated, multi-step methods. It now appears that the patent system could be gamed by infringers by simply outsourcing part of the process to avoid lawsuits.

#### **6.7. Balancing conflicting requirements**

Balancing the requirements for non-obviousness in litigation, with the constraints imposed by the doctrine of equivalents, reverse doctrine of equivalents, and prosecution history estoppel can be tricky because much depends on prior art related to the patent-in-suit, the profile of the PHOSITA, and exact wordings of the patent's claims. In most cases, the issue involves the expansionary scope of the doctrine of equivalents and whether obvious-to-try is the same as obvious from the perspective of the PHOSITA. Some of the trickiest situations involve the opposing tendencies of the doctrine of equivalents and prosecution history estoppel. Such matters are best left to experienced lawyers.
