“Understanding Claim Drafting in Biotech, Chemical and Pharma Patent Applications: Part II”

Understanding Patent Claim Terms

When it comes to patent claims, the devil is in the details. A single term can have multiple ordinary meanings, and it is crucial to define all of these meanings in the specification. This is not just a prudent step, but an essential one. This is especially true in the fields of biotech, chemical and pharma patent applications, where the complexity of the subject matter can lead to multiple interpretations of a single term. In this article, we will delve into the importance of defining claim terms, and how changes in the law have impacted this process.

Indefiniteness and the “Reasonable Certainty” Standard

One of the most significant changes in patent law in recent years is the shift from the “insolubly ambiguous” test for indefiniteness to a “reasonable certainty” standard. This change came about as a result of the Supreme Court’s decision in Nautilus, Inc. v. Biosig Instruments, Inc., and has had a profound impact on how patent claims are drafted and interpreted.

In the case of Teva Pharmaceuticals USA v. Sandoz, Inc., the Federal Circuit applied this new standard and found that a claim term that had no default meaning to one of skill in the art and was subject to multiple different meanings was invalid as indefinite. This case underscored the importance of defining all ordinary meanings of a claim term in the specification.

The Role of Functional Language in Claim Terms

Functional language can play a crucial role in providing the requisite “reasonable certainty” in a claim term. In the case of BASF Corp. v. Johnson Matthey Inc., the Federal Circuit held that functional language can provide reasonable certainty to the person of ordinary skill in the art as to the meaning of a claim term. This means that when drafting patent claims, practitioners should consider whether a skilled person would be reasonably certain about the scope of the claim based on the functional language used.

Product-by-Process Claims

Product-by-process claims are another area where the definition of claim terms can be crucial. These claims are not limited to the manipulation of the recited steps, but are limited only by the structure implied by the steps. This means that the patentability of a product-by-process claim is based on the product itself, not the steps of the process used to create it. This was affirmed in the seminal case of In re Thorpe.

Means Plus Function Claims

Means plus function claims, or claims invoking 35 U.S.C. §112(f), are another area where the definition of claim terms can be crucial. These claims are often used in the computer/software fields, but can also be used in the biotech/pharma/chemical arts field. The key to drafting effective means plus function claims is to ensure that the specification sets forth adequate disclosure showing what is meant by the functional language used in the claim.

Negative Claim Limitations

Negative claim limitations are sometimes used to avoid prior art. However, it is important to ensure that there is proper support in the specification for any negative claim limitations. A recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc., highlighted the importance of this, holding that a negative limitation added during prosecution to overcome prior art failed to satisfy the written description requirement of 35 U.S.C. §112(a).

Staying on Top of Changes in Patent Law

As the law around patent claims continues to evolve, it is crucial for patent practitioners to stay up-to-date with the latest developments. By understanding the importance of defining all ordinary meanings of a claim term in the specification, and by staying aware of changes in the law, practitioners can ensure that they are drafting effective and enforceable patent claims.