navigating the patent maze

The USPTO has proposed rules to alter the filing of "children" patent applications.  Essentially, the rules will remove an applicant’s right to re-file her application more than one time.  Currently, there isn’t a limit on the number of continuations that can be filed.  Ostensibly, this new rule is being promulgated to reduce the back-log of pending applications and to reduce the amount of time applications spend in the patent office before being granted (or rejected).  Patent strategy will need to dramatically change if these rules withstand challenge that is sure to come; similar rules were proposed, but not approved by the U.S. Congress.  To say that the rules are controversial is a gross understatement - more than 300 comments were filed in response to the USPTO’s announcement. 

The "children" applications at issue are generally called "continuation" applications.  The continuation is a filing that presents the original claims for another examination.  Continuations are filed for any of a number of reasons:  the parent application issues with narrow claims and the applicant wants to try to obtain claims for the full scope of the invention; the applicant wants to keep an application pending for when the law is more favorable or for a potential licensee to pursue protection for a particular form of the invention, among others. 

While continuation practice is peculiar to the United States, patent office procedures in other countries are more favorable to applicants making continuations less necessary.    In the U.S. a patent application is examined a first time, resulting in an "Office Action" - usually a rejection of the claims.  The applicant gets ONE chance to respond to the rejections before a "Final Office Action".  Although an applicant can respond to a Final Office Action, the patent office is not required to consider the response.  At this point, options are limited for an applicant - appeal, file a continuation or abandon.  In other countries, multiple rounds of examinations and responses are the norm.  It often takes a few rounds for both the examiner and the applicant to fully develop an appreciation for subject matter that is patentable.  I, for one, prefer the style of patent examination in other (non-U.S.) countries. 

When it comes to patentability, my working theory is "the most damaging prior art is your own."  It makes sense though - whose work is more like your own than your own?  Dr Crish fell victim this way and lost his chance for a patent as a result (In re Crish, Fed. Cir., No. 04-1075, 12/21/04). 

The patent application claimed purified DNA molecules having promoter activity for the human involucrin gene (hINV).  Involucrin is a protein that interacts with keratin along with other intracellular proteins to form a cross-linked structure within dead cells and strengthens the plasma membrane.  Skin cells, which are mostly dead cells, benefit from this.  The hINV promoter was sequenced from a plasmid that was the subject of an article authored by Dr Crish and others. 

Crish tried to distinguish the claims from the damaging effect of his publication first by asserting that the rejected claims did not encompass the whole plasmid, and second, by asserting that the publication did not disclose any nucleotide sequence of the promoter.  The Court did not buy either of these arguments because (1) the use of "comprising" in the claim language meant that the whole plasmid was encompassed by the claim, and (2) the sequence conferred indentification and characterization of a prior art material and "one cannot establish novelty by claiming a known material by its properties." 

The following shows how I think Crish could have successfully claimed the promoter sequence. 

(more…)

One form of legal protection for biotechnology inventions, which is not often used, is trade secrecy. This right, in contrast to patents and copyrights, is not registered and is of unlimited duration, as long as the holder of the trade secret makes reasonable efforts to maintain secrecy. With regard to keeping parental lines of hybrid seed as a trade secret, for example, identification by private code of fields of inbred parent lines of corn has been deemed, in the 1994 Iowa case Pioneer Hi-Bred v. Holden Foundation Seeds, sufficient to constitute a reasonable effort to maintain secrecy, even though the corn was grown outdoors and subject to misappropriation by informed “flashlight breeders.”  Furthermore, acquisition of the viable parent seeds that occasionally appear in bags of hybrid seeds is not antithetical to trade secrecy. But what if the parental lines are protected by Plant Variety Certificates (akin to plant breeder’s rights)?  One might think that the disclosure requirement to register a plant variety would destroy the secrecy necessary for maintaining the lines as trade secrets. 

The short answer from the District Court of the Western District of Wisconsin is NO, registration does not extinguish trade secrecy. 

(more…)

The CREATE Act, which sets a new standard for obviousness, is about to be signed into law.  Under this Act, certain "secret" prior art that is the work of researchers from different research organizations will be disqualified as prior art as long as certain conditions are met. 

Specifically, there must be a pre-existing agreement for the research collaboration and:

1. the agreement covers the inventive activites;
2. the patent application includes an express statement disclosing the names of the parties;
3. the agreement is written;
4. the filed of the claimed invention is within the scope of the agreement; and
5. a terminal disclaimer is filed (if needed).

The Act will apply retro-actively — meaning that reissuing patents or pending applications can benefit from this law.  It is important that if you may be affected that you seek advice on writing or amending a research agreement appropriately. 

Yours truly, along with two agricultural economists (Phil Pardey of University of Minnesota and Bonwoo Koo of IFPRI), have published an article in this week’s Science journal.  If you have an account, you can view the article on-line.  Because journals hold the copyrights, I will ask for permission to post a copy here.

Summary:  Much of the debate on the implications of intellectual property (IP) for protecting plant varieties occurs in the absence of an understanding of the specifics of the rights in particular jurisdictions, a practical sense of the rights claimed or granted, and their evolution over time. Moreover, existing information highlights rich-country developments, with little attention to developing countries. This Policy Forum reviews the approaches to plant-related IP protection worldwide, with data on the applications of plant breeders’ rights, and discusses possible implications of IP protection for food production and human health.

Since 1991, when the NIH (National Institutes of Health) in the U.S. filed a patent application claiming thousands of EST sequences, controversy and disagreement about the legalities and wisdom of patenting such sequences has permeated law reviews and scientific journals. Now, despite other U.S. patents issuing with claims to EST (expressed sequence tags, i.e., partial sequences of cDNA molecules) sequences, the Board of Appeals of the USPTO recently affirmed a rejection of claims to EST sequences. (Ex parte Fisher, Appeal No. 2002-2046). The bases for the rejection upheld by the Board were (i) lack of utility and (ii) lack of enablement. The opinion of the Board is being appealed to the Federal Circuit, who will hear and decide on the case early next year.

Is there a difference between the EST sequences in Fisher and those in already issued patents? The EST sequences in Fisher are “naked sequences”, that is, sequences with no known function, sequence motifs, or other features that would demonstrate a specific use of the EST. Fisher argued that several uses were taught in the application, including: identification and detection of polymorphisms, use as probes in hybridization, and as primers for amplification. But without more information, such as the genes these ESTs are derived from, the Board concluded that the stated uses are general uses for nucleic acids and thus do not satisfy the particularity requirement for utility.

The opinion of the Board contains some useful guidance of the degree of disclosure that might be required to have patentable EST sequences in the future, assuming that the Federal Circuit ultimately agrees.

Under United States patent law, if you are found to be a ‘willful infringer’(infringing a patent while knowing that you are infringing), liability can include up to triple damages and in exceptional cases, payment of the prevailing party’s attorney fees. The severity of the penalty spurs many companies to obtain a legal opinion about whether or not the company is infringing because a well-done opinion that concludes non-infringement will protect the company from a finding of willful infringement. In a recently-decided critical case, Knorr-Bremse, the Federal Circuit examined several issues about willful infringement. (See … recent post discussing one of the holdings in this case.) One of the issues decided was about the legal obligation to respect valid patent rights.
(more…)