By Donald Zuhn --
Last Wednesday, a panel of representatives from the Japanese Patent Office (JPO), European Patent Office (EPO), Chinese Patent Office (SIPO), and U.S. Patent Office (USPTO) participated in a breakout session at the BIO International Convention to update attendees on recent developments regarding the patent law, rules, and procedures in Japan, Europe, China, and the United States. Appearing on behalf of the various offices were Dr. Yoshihiro Fuji, Director of the Protein Engineering Sub-Division of the JPO, and Dr. Takayuki Yamanaka, Assistant Director of the Examination Standards Office of the JPO; Dr. Reinhard Hermann, Director of Biotechnology of the EPO; Dr. Aiqun Pan, Director of the Genetic Engineering Division of the Pharmaceutical Invention Examination Department of the SIPO; and Dr. George Elliott, Group 1600 Director of the USPTO.
Dr. Fuji began the presentation by acknowledging that Japan, which had garnered a reputation in the 1980's as a "Rising Sun," had more recently experienced a sharp decline with respect to patent application filings. Dr. Fuji noted that when compared with other patent offices, the JPO ranked only 24th with respect to "competitiveness" in 2007. He also noted that while approximately 80% of all applications filed with the JPO come from domestic applicants, the numbers were much more encouraging for biotech applications, where the majority of applications come from applicants located outside Japan.
Dr. Takayuki's presentation focused on changes in the examination of biotech applications in the JPO, and more specifically on applications directed to medical activities and human embryonic stem cells. With respect to medical activities, Dr. Takayuki noted that guidelines promulgated by the JPO in 2003 permitted applicants to claim in vitro methods using samples extracted from human patients (methods of extracting such samples or putting them back into patients, however, are still considered by the JPO to lack industrial applicability). With respect to human ES cells, Dr. Takayuki stated that guidelines promulgated by the JPO in 2001 rendered such subject matter patentable.
Turning to developments in Europe, Dr. Hermann observed that with the recent addition of several new member states, the EPO was now able to offer its applicants a market almost twice as large as that of the United States. However, Dr. Hermann's discussion of his group's workflow and application backlog was likely of more interest to session attendees. Noting that the EPO's biotech examining corps had increased by only 22 examiners in the past five years (from 239 in 2003 to 261 in 2007), Dr. Hermann informed attendees that the group's backlog of unexamined applications had substantially dropped over that same period. In particular, the portion of pending applications that had not received a first official communication fell from 52% in 2003 to 23% in 2007. At the same time, European biotech examiners managed to increase the number of searches (rising from 6090 in 2003 to 8460 in 2007) and examinations (increasing from 5310 in 2003 to 6234 in 2007) performed.
Dr. Hermann concluded his presentation with a discussion of a few changes brought about by the London Agreement and EPC2000. As a result of the passage of the London Agreement, Dr. Hermann noted that applicants would typically enjoy translation cost reductions of between $5,000 to $15,000 per nationalized application (not surprisingly, Dr. Hermann neglected to mention that recent increases in claims fees at the EPO would likely eat into these cost savings; see "New Excess Claim Fees for EP Applications"). Among the changes implemented as a result of EPC2000, Dr. Hermann listed new procedures for:
• Searches of multiple claimed inventions -- the EPO will no longer send out invitations to pay fees, but instead will search the first invention recited in the claims;
• Examination of method of treatment claims -- such claims constitute exceptions to patentability as opposed to exclusions to patentability, and thus, European examiners can now offer "opinions" on such claims;
• Submission of missing parts -- the EPO will now send out invitations to submit missing parts, permitting applicants two months to file omitted drawings or omitted portions of the description;
• Sequence listings -- the EPO will impose a fee of €200 for late submissions of sequence listings, and an applicant's failure to submit a sequence listing within a specified time period will result in the EPO's refusal of the application; and
• Providing prior art -- European examiners can request that applicants provide prior art cited by other offices in the examination of foreign counterparts (Dr. Hermann believed that EPO biotech examiners would make such requests infrequently).
Dr. Pan opened her presentation on recent SIPO developments by focusing on subject matter that would be unpatentable under Articles 5 and 25 of Chinese Patent Law. Article 5 defines subject matter that contravenes public order and morality as being unpatentable and Article 25 defines methods of diagnosis or treatment as unpatentable. Dr. Pan noted that SIPO refused 13% of biotech applications last year for failing to comply with Articles 5 and 25 (she also noted that human ES cells complied with Article 5). Dr. Pan concluded her presentation with a discussion of the requirements for sufficient disclosure in China, stating that Chinese Patent Law requires applicants to disclose how to use the claimed invention in the originally-filed specification. Thus, according to Dr. Pan, a recited protein must be shown in a working example to have a specific function (or a recited gene must be shown to encode such a protein), and the specific conditions for administering a recited pharmacological compound must be disclosed.
Dr. Elliott, one of four Directors in Group 1600, was the last patent office representative to address the session's attendees. During his presentation, Dr. Elliott discussed the impact of the KSR Int'l Co. v. Teleflex Inc. decision on the examination of biotech applications, the USPTO's worksharing programs, and the USPTO's new written description training materials.
Reiterating a point made by Group 1600 Director Bruce Kisliuk in an ACI conference last February (see "USPTO's Bruce Kisliuk Addresses ACI Conference"), Dr. Elliott asserted that the KSR decision "hasn't really changed a lot," and that the basic approach for determining obviousness remains the same. In particular, the burden is on examiners to go through the Graham factors and "explain in a rationale way" why the claimed invention is obvious. Like Mr. Kisliuk, Dr. Elliott appeared to be similarly unimpressed with the usefulness of the obviousness examination guidelines for examining biotech applications (stating at one point during his talk that he was unsure about the meaning of the phrase "ready for improvement" in rationale 4; see "Patent Office Issues Examination Guidelines Regarding Obviousness after KSR").
Instead of focusing on KSR or the guidelines, Dr. Elliott directed the attendees' attention towards five of the eleven obviousness cases that Mr. Kisliuk first discussed during his ACI presentation back in February. In particular, Dr. Elliott briefly touched on:
1. Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007);
2. Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007);
3. Ex parte Kubin (B.P.A.I. 2007);
4. Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007); and
5. Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007).
With respect to Kubin, Dr. Elliott described the case as "an attempt by the Board to get away from Deuel," and argued that "with twenty years of technology under the bridge, things have changed a little bit."
Dr. Elliott next discussed the USPTO's efforts to reduce application pendency through four worksharing programs: the Patent Prosecution Highway (PPH), New Route, Strategic Handling of Applications for Rapid Examination (SHARE), and Triway. Surprised by Dr. Hermann's revelation that the EPO biotech group was actually reducing its backlog, Dr. Elliott joked that coming into the session, he had "thought everyone was getting a little swamped." With respect to the permanent PPH program with Japan (pilot programs also exist with Australia, Canada, Korea, and United Kingdom), Dr. Elliott noted that examiners were finding that participating applications contain smaller and more focused claim sets than typical U.S. filings, and require a narrower field of search as a result of the better base of prior art being forwarded to the USPTO by Japanese examiners.
Touching on the SHARE and Triway programs, Dr. Elliott noted that the first program was essentially a prioritization method in which applications filed first in the U.S. were given examination priority over applications filed first elsewhere (with the intent that the examination results of the latter applications would be used by U.S. examiners to accelerate the examination of those applications), and that the second program was intended to allow the three major offices (USPTO, EPO, and JPO) to share examination results for applications that are filed with all three offices. Interestingly, Dr. Elliott noted that the USPTO had discovered that when an application is rejected for lack of novelty by one of the three major offices, it is also generally rejected for lack of novelty by the other two offices but on the basis of different art. Dr. Elliott said that the Triway program should therefore help to get the best art in front of USPTO examiners.
Dr. Elliott concluded his presentation by discussing the new written description training materials. Acknowledging that time limitations prevented him from going over many of the fourteen biotech-related examples, Dr. Elliott limited his discussion to Example 11, which concerns claims directed to a polynucleotide or polypeptide sequence that shares percent identity with another sequence. As we noted in an earlier report, Example 11 seems to suggest that the recitation of a functional limitation can render an otherwise allowable claim unallowable (see "An Analysis of the New Written Description Training Materials - DNA Hybridization & Percent Identity"). In particular, Example 11 introduces the following exemplary claims:
Claim 1: An isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2.
Claim 2: An isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has activity X.
Example 11 concludes that despite the specification's disclosure of only a single species encoding the polypeptide of SEQ ID NO: 2 (i.e., SEQ ID NO: 1), and the lack of any teaching in the specification regarding which amino acid residues in SEQ ID NO: 2 are tolerable to change, the specification satisfies the written description requirement with respect to claim 1 (because the skilled artisan could use a computer to identify all of the nucleic acids encoding a polypeptide sharing at least 85% sequence identity with SEQ ID NO: 2), but not claim 2 (because the specification lacks any teaching of the residues associated with the recited function).
Dr. Elliott noted that with respect to the situation presented in Example 11, the USPTO had reversed its position, having previously asserted that claims lacking functional language failed to comply with the written description requirement and that claims possessing such language complied with the requirement. According to Dr. Elliott, claims with functional language (where the specification lacks any teaching regarding the amino acid residues that are tolerable to change) do not satisfy the written description requirement because "the minute you add function, you've limited the claim to a subset of species, and you don't know which species are in the subset and which species aren't." In other words, absent any teaching of structure/function relationships, the USPTO's (and Dr. Elliott's) position is that one cannot determine the species that share at least 85% sequence identity with the recited sequence and also possess the recited function (this explanation does not, of course, take into account case law that allows for the recitation of a genus containing some inoperative species).
Dr. Elliott also acknowledged that Example 11 may be a little disingenuous in that it appears to suggest that an applicant would be better off omitting a functional limitation from a claim. However, he pointed out that this example includes a practice note stating that it "deals only with the written description analysis of the claimed nucleic acids," and that "[e]nablement issues that may be raised by the recited facts are not addressed here, but should be considered during examination." Dr. Elliott informed session attendees that just because claim 1 in Example 11 satisfied the written description requirement, this does not mean that the claim would necessarily satisfy the enablement and utility requirements. For a more thorough discussion of the rationale behind the USPTO's reversal on functional limitations, Dr. Elliott recommended that attendees read the decision in Ex parte Porro.
For additional information on this and other related topics, please see:
• "Docs at BIO: Steve Burrill's State of the Biotechnology Industry Report 2008," June 19, 2008
• "An Analysis of the New Written Description Training Materials - DNA Hybridization & Percent Identity," May 6, 2008
• "Patent Prosecution Highway Extended to IP Australia," April 2, 2008
• "Dealing with the EPO's New Excess Claims Fees," March 11, 2008
• "USPTO's Bruce Kisliuk Addresses ACI Conference," March 3, 2008
• "New Excess Claim Fees for EP Applications," January 31, 2008
• "London Agreement to Take Effect May 1, 2008," January 30, 2008
• "'New Route' Created between USPTO and JPO," January 25, 2008
• "Patent Office Issues Examination Guidelines Regarding Obviousness after KSR," October 10, 2007
• "Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007)," September 12, 2007
• "Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007)," September 5, 2007
• "Ex parte Kubin (B.P.A.I. 2007)," July 18, 2007
• "Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007)," July 12, 2007
• "Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007)," July 4, 2007
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