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At the heart of any biotechnology company is its intellectual property. The very first products of a biotech company are often the patents surrounding a core technology. The acquisition of patent rights is therefore of paramount importance to the ultimate success of the company. Although many business professionals are aware of the general issues associated with acquiring patents, special problems exist with respect to prosecuting patent applications in the life sciences. In addition, the unique composition of many biotech startups requires special attention to certain recurring issues. Of the main statutory requirements for patentability, the areas that have perhaps provided the most uncertainty for biotech patent applicants in recent years are those relating to utility, enablement and written description. In January 2001, the U.S. Patent and Trademark Office issued Utility Examination Guidelines for biotechnological inventions. This move came in the wake of the flurry of data generated by the Human Genome Project and rising concerns that patent applications were being filed without any understanding of the physiological function of claimed nucleotide sequences. According to the new guidelines, a biotechnological invention must have a “well established” utility, which is further defined as a utility that is specific, substantial, credible, and readily apparent to one of skill in the art. For example, imagine that a scientist isolates Protein A from a cell membrane and, based on the fact that it binds to Protein B, concludes that Protein A is a receptor. For claims to that receptor, the PTO would require some showing regarding the receptor’s biological properties or its link to some physiological process. Applicants will not be saved merely by pointing to “throw-away” utilities such as “a method for identifying drugs acting on Protein A.” One strategy often used in such patent applications is to predict the function of the receptor by reference to sequence homology between the receptor and other known proteins or genes. In other words, the utility requirement can be satisfied by showing that Protein A is 90 percent identical to, perhaps, certain known receptors implicated in central nervous system disorders, and that therefore Protein A is likely to exhibit similar biological functions. Because sequence homology arguments will not work for all biotech inventions (e.g., DNA fragments), attorneys must carefully determine how best to deal with the utility issue on a case-by-case basis. CAN WE DO IT? The second major test for biotech applications is the enablement requirement, which says that a patent specification must be sufficiently clear to enable a person of skill in the art to make and/or use the claimed invention without undue experimentation. As set forth by the U.S. Court of Appeals for the Federal Circuit in the 1988 case of In re Wands, 858 F.2d 731, a variety of factors may be considered in determining whether an application satisfies enablement. These include the quantity of experimentation necessary to use the invention and the predictability or unpredictability of the technical field in question. Biotechnology and chemistry are considered by the PTO and the courts to be unpredictable technical fields. This means that it is more difficult to determine in advance how a proposed change to a biological invention will affect its function than it is to determine how a proposed change will affect a mechanical or electrical invention. Therefore, to meet the enablement requirement, patent applicants interested in acquiring broad claims around a core biotechnology must provide relatively more detail in their applications than applicants in predictable fields. For example, inventors often wish to obtain claims not only to a protein or DNA having one specific sequence, but also to slight and insubstantial modifications of these proteins or DNA molecules. The question is: How many of those insubstantial modifications need to be specifically listed in order to satisfy the enablement requirement? And therein lies a problem. The case law in this area has not provided much guidance as to the precise number of working examples that will enable claims to a broad class of biological compounds. All the cases so far have been relatively straightforward: The applicants asserted very broad claims to a class of genes or proteins, but disclosed very few examples of members of that class — and then lost in court. Case law has yet to clarify practices in the murkier area where multiple examples of members of the class are provided. For now, biotech patent attorneys can only advise clients who want to claim a broad class of genes or proteins that more examples are better than fewer, without any guide as to where the cutoff may lie. A WORD TO THE WISE Under the third main statutory requirement, written description, an applicant must provide enough detail in the specification to allow one of skill in the art to conclude that the applicant was actually in possession of the claimed invention at the time the application was filed. The July 2002 Federal Circuit decision of Enzo Biochem Inc. v. Gen-Probe Inc., 296 F.3d 1316, has settled some, but not all, questions with respect to how this requirement is satisfied for biotech patent applications. The Federal Circuit held that reference in an application to the deposit of a sample of a nucleotide or amino acid sequence with a central publicly accessible depository is sufficient to satisfy the written description requirement. This holding reversed the court’s own earlier ruling in the case, and thereby allowed biotech patent attorneys to return to a practice they had employed for decades. The court also indicated that attempts to broadly claim nucleotide or amino acid sequences by defining the sequence in terms of some functional characteristic may satisfy the written description requirement in some cases. Following Enzo, it appears that the written description requirement will be satisfied by claims to a nucleotide or amino acid sequence described in terms of its binding affinity to materials identified in the specification (such as to certain strains of bacteria). Enzo also appears to allow claims that describe a nucleotide or amino acid sequence in terms of its ability to specifically hybridize under defined stringent conditions to a disclosed sequence. What is unclear is whether the Federal Circuit also approves of other methods utilized to broadly claim nucleotide or amino acid sequences using different functional criteria. Such approaches include descriptions of the sequence in terms of its percent homology to a disclosed sequence. Until these questions are resolved, biotech attorneys can continue to utilize different claiming methods, but it is advisable that they make sure also to include those specifically approved by the Enzocourt. THOUSANDS OF NUCLEOTIDES Besides meeting the statutory requirements for patentability, the idiosyncrasies of biotechnology may also produce some unexpected effects when it comes to applying general rules of patent law. In Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 122 S. Ct. 1831, the U.S. Supreme Court in May held that there is a rebuttable presumption that prosecution history estoppel will apply to claims narrowed for any reason relating to patentability, even in response to enablement or written description rejections. Where prosecution history estoppel applies, a patentee is prevented from using the doctrine of equivalents, whereby those who have made minor, nonfunctional changes to a patented invention can be found liable for infringement. Under Festo, the presumption of estoppel can be rebutted by evidence that the amendment was not made for patentability reasons, or by evidence that it was not foreseeable by one of skill in the art that the applicant was giving up rights to those insubstantial changes. For example, consider a patent applicant who is attempting to claim a wide range of variants for a given nucleotide sequence. If the applicant is forced to make a narrowing amendment during prosecution, the scope of any issued claim to the nucleotide sequence will be limited to the exact claimed sequence. But nucleotide sequences can contain thousands of nucleotides each. Copyists might later be able to make a nonfunctional change to any one of those thousands of nucleotides and then use someone else’s innovation with impunity. Although it is possible to rebut the presumption that estoppel should apply, under Festothe patentee would need to show that it was not foreseeable that copyists could make that particular change to the sequence. For biotechnology, this means that applicants would have to literally claim the thousands of foreseeable nucleotide variants or risk a finding in court that any minor, nonfunctional substitutions in the claimed sequence were foreseeable. One method for dealing with this problem is to include a number of independent claims of different scope in the initial application. If necessary, applicants can delete broader claims and rely upon narrower independent claims that will issue without amendment. Although this adds costs during prosecution because the PTO charges additional fees for extra independent claims, the cost is negligible compared to the potential loss of millions of dollars in later litigation. EYES ON THE PRIZE Ultimately, commercialization of the fruits of years of research is the goal of most biotech enterprises — as business professionals usually understand. But newly formed biotech companies, especially spin offs from university research, tend to contain a high percentage of trained academics, who often retain an academic’s perspective on their work. As a result, biotech patent attorneys must be especially mindful of certain issues that tend to recur in this setting. Publications and presentations.Recent transplants from academia tend to retain the desire to publish in peer-reviewed journals and participate in scientific conferences. It is therefore important to remind inexperienced company executives of the consequences such activities can have on their ability to later obtain certain patent rights. Although the United States generally provides a one-year grace period for filing a patent application after an inventor publishes or presents results at a conference, most countries follow an “absolute novelty” rule whereby any such activities before filing prohibit any patent grant at all. In order to preserve foreign rights, it is therefore advisable to wait to publish or present until after a patent application has been filed (either in the United States or through the Patent Cooperation Treaty). Offense and defense.Academically trained scientists are highly attuned to the biological implications of their research and are typically used to thinking of patents as defensive measures to protect discoveries with major therapeutic value. It is important to remind researchers they are also part of a business and that what may seem to be a relatively insignificant scientific finding may still confer significant advantages in the marketplace. For example, the discovery that a standard method can be optimized by something as simple as a lower pH range for a given step may provide a patenting opportunity. Even where another company holds a patent on the general method, an offensive patent can potentially keep that company from practicing the optimal mode of its method without obtaining a license. Lab notebooks as legal documents.While all other countries provide priority rights to the first person to file a patent application, the United States still provides priority rights to the first person to conceive of an invention. This means that well-maintained, well-documented laboratory notebooks can assist in protecting important rights here. Because academics may not be used to thinking of their notes as potential legal documents, patent attorneys may need to encourage companies to insist that notebooks be kept by anyone engaged in research. Pages should be bound, numbered, and dated to minimize accusations of fraud, and each page should be dated and witnessed by individuals who are not likely to be co-inventors. Last but certainly not least, a good attorney in any technology area always remembers that patenting decisions should be driven by the needs of the business today and tomorrow. Given the lengthy development time involved in bringing biotech products to market, patents can often be used to attract investment capital long before tangible goods are sold. After products are on the market, patent protection allows biotech companies to recoup their development costs and fuels further research to feed the product pipeline. The goal always is to vigorously protect the company’s innovative technology in ways that serve the company’s overall objectives. Edward R. Ergenzinger Jr. is an associate in the Raleigh, N.C., office of Alston & Bird ( www.alstonbird.com), practicing with the biotechnology patent group. W. Murray Spruill is a partner in the Raleigh office of Alston & Bird and serves as chair of the biotechnology patent group. They can be reached at [email protected]and [email protected], respectively. If you are interested in submitting an article to law.com, please click herefor our submission guidelines.

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