Intellectual Property Law

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Unpredictability —
The Two-Edged Sword In Patenting Biotechnology

Biotechnology has increased the availability of many natural biological products useful in treating various diseases. These products, such as human growth hormone (hGH), often exist in such minute quantities that isolation from natural sources is impractical or extremely expensive. Sometimes, such as in the case of insulin, the product can be isolated from alternative natural sources (e.g., pig), but may be less effective or accompanied by undesired side effects.

Biotechnology has also been used in disease detection. For example, HIV diagnostic tests have been developed using recombinant DNA technology.

Biotechnology research is extremely risky and expensive and often involves time-consuming, resource-intensive characterization of the genes that encode the desired biological product. Sometimes, the product itself has to be characterized to determine which gene is the "right" one. Organizations who do biotechnology research are very interested in protecting their investment by obtaining patents to prevent others from freely practicing the "fruits" of this research.

What "fruits" of biotechnology research can be patented? The list is almost endless. For example, patents can be (and have been) obtained on the isolated gene, modifications of the gene, purified and modified biological products encoded by the gene, methods for making the gene and its encoded products, as well as methods for using the gene and its encoded products.

The ability to obtain patents on these "fruits" has been aided by the perception of biotechnology as an "unpredictable" art. One of the requirements for getting patent coverage is that the invention not be obvious to one of ordinary skill in the art. The perception of biotechnology as an unpredictable art tends to negate obviousness, as reflected in many court cases that have upheld the validity of biotechnology patents.

As owners of biotechnology patents have unfortunately found out, the perception of biotechnology as unpredictable is a two-edged sword. To be valid, the patent must also contain a written description of the invention "in such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use the invention ("enablement requirement"). The predictability as to what will (and will not) work greatly determines how much of the patented invention is enabled.

The enablement requirement has proven to be a significant barrier to enforcing broad biotechnology patents. Many broad biotechnology patents claim the invention in terms of its functional characteristics, rather than its chemical structure, to obtain broader coverage. For example, some biotechnology patents claim the gene in terms of its ability to encode a class of proteins that are functionally analogous to a particular biological protein. Other broad biotechnology patents claim the biological protein (e.g., hormone) in terms of its activity.

These broad "functionalized" biotechnology patent claims have not faired well in court. The courts have applied a fairly stringent enablement standard to such broad claims because of the perceived unpredictability of biotechnology. This stringent standard has been difficult to satisfy, especially since the litigated patents usually have had only one or a few working examples of the gene or product.

The difficulty in satisfying the enablement requirement in the biotechnology area has led alternatively to claims limited to genes or encoded products that are specifically exemplified in the patent. However, as the litigated patents show, a competitor may slightly alter the gene or encoded product, and thus avoid infringing such narrow patent claims.

So how does one get broad biotechnology patent claims that will satisfy the enablement requirement? Here are some suggestions:

  1. Exemplify as much as possible in the patent disclosure the scope of the biotechnology being claimed. This includes how to make and how to use the claimed biotechnology. It is also important to understand as much as possible the operative limits of the claimed biotechnology and to put that knowledge into the patent disclosure. Be careful in relying on "illustrative" or "prophetic" examples without actually testing a representative selection of such examples to see if they do work. The litigated patents have shown the danger of relying on such examples when they later turn out not to work. Also, make sure each term, component and step recited in the patent claim is defined in sufficient detail. As one 1996 court case painfully demonstrates, reliance on general teachings in the art can be extremely risky in the biotechnology area.
  2. Augment the initial patent disclosure by filing continuation or provisional patent applications to include new working examples or learnings. To preserve patent rights in "first to file" countries such as Europe, it is not unusual for a biotechnology patent to be filed with broad claims, but with only a few or possibly only one working example disclosed. Rather than rely on what later may be held to be inadequate enablement, consider filing continuation or provisional patent applications to include new working examples or learnings. Provisionals are especially valuable for doing multiple filings (at relatively low cost) to augment the initial patent disclosure. For example, five U.S. provisional applications can be filed for less than the cost of one traditional U.S. patent application.
  3. Where possible, pursue broad claims to methods for making the gene or biological product. Do not overlook the value getting patent coverage on the method for making the gene or biological product. Under appropriate circumstances, importation of the gene, and more importantly the biological product, into the U.S. can be prevented if the gene or biological product is made by a patented method. Indeed, one court case that prevented importation of hGH made by a patented method involving recombinant DNA suggests broad method claims for making genes or biological products may be less likely to run afoul of the enablement requirement.

The perceived unpredictability of biotechnology has certainly made it more difficult to get enforceable broad claims on the "fruits" of biotechnology research. However, as the courts have made clear, broad patent coverage on these "fruits" is not precluded. The challenge is to craft patent disclosures that satisfy the more stringent enablement standard applied by the courts to the biotechnology area.

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