The Federal Circuit issued a long-awaited decision late last week in  the case of Tafas v. Doll. 

At issue in this case was whether or not the USPTO had the authority to adopt a set of rules in 2007, which were aimed at reducing the backlog of unexamined patent applications and also at addressing the USPTO’s difficult in examining applications that contained a large number of claims.  The Federal Circuit held in its decision that the rules at issue were procedural in nature, and that they therefore did fall in the scope of the USPTO’s rulemaking authorit y.  However, the Court found that one of the rules, Final Rule 78, conflicts with 35 U.S.C. Section 120 and is therefore invalid.  The final decision on the status of the other rules is left to the lower courts, to which this issue is remanded. 

What were the particular USPTO rules at issue in this case?

Final Rule 78: This rule provided that an applicant is entitled to file two continuation applications, but to file any additional applications, the applicant is required to make a showing as to why the amendment, argument, or evidence could not have been submitted in a prior continuation application.

Final Rule 114: This rule provided than an applicant is entitled to file on request for continued examination per application family, but to file any additional requests, the applicant is required to make a showing as to why the amendment, argument, or evidence could not have been submitted prior to the close of prosecution in the application.

Final Rule 75: This rule provided an applicant who submits either more than five independent claims or twenty-five total claims must provide the examiner with an examination support document.

Final Rule 265: This rule set forth the requirements for the examination support document, which were as follows: (i) conducting a preexamination prior art search, (ii) providing a list of the most relevant references, (iii) identifying which limitations are disclosed by each reference, (iv) explaining how each independent claim is patentable over the references, and (v) showing where in the specification each limitation is disclosed. 

The decision focused on an analysis by the Federal Circuit on whether the rulemaking exercised by the USPTO was substantive or procedural.  The Federal Circuit found that Congress did not intend to give the USPTO substantive rulemaking authority, but that procedural rulemaking was in the scope of the USPTO’s delegated authority, stating:

While we do not purport to set forth a definitive rule for distinguishing between substance and procedure in this case, we conclude that the Final Rules challenged in this case are procedural.  In essence, they govern the timing of and materials that must be submitted with patent applications.  The Final Rules may "alter the manner in which the parties present . . .  their viewpoints" to the USPTO, but they do not, on their face, " foreclose effective opportunity" to present patent applications for examination.  JEM, 22 F.3d at 326, 328.

As for why Rule 78 was held to be invalid, the Federal Circuit stated:

Rule 78 is invalid because it attempts to add an additional requirement–that the application not contain amendments, arguments, or evidence that could have been submitted earlier–that is foreclosed by the statute. . . .[T]he statute is clear and unambiguous with respect to this issue.

The commentary on this case has been mixed, but there seems to be an overall feeling among commentators that a more definitive decision on the issue would be desirable. 

The Patent Baristas expressed some exasperation at the result, stating:

Apparently, the U.S. Court of Appeals for the Federal Circuit could not bear to see an end to the drama between the U.S. Patent and Trademark Office and its customers over proposed patent application rules. . . . .Expect everyone to find something to dislike about this ruling. . . .Will Congress ever step up and fix this mess?

Peter Zura of The 271 Patent Blog wrote:

While many are hopeful for en banc review, the odds don’t seem in favor of it right now. 

Since I do not personally prosecute patents, I must admit that my reaction to this decision is a bit muted.  As a patent and copyright licensing attorney, my practice is only tangentially affected by USPTO rulemaking, so I just do not have a strong opinion on the issue. 

Having said this, I must say that if you read over the rules that were at the heart of this case, it is easy to see why the USPTO set off a controversy when it enacted these rules.  Should the USPTO be able to enact this type of rule, which certainly puts some serious constraints on patent filing?  I think that the Patent Baristas are right: perhaps Congress needs to take a look at this issue as it revisits the patent reform issue this session.

Congress is examining backlog issues at the United States Patent and Trademark Office ("USPTO"), according to a report by Peter Zura’s 271 patent blog.   The report indicated that Howard Berman, Chairman, Subcommittee on Courts, the Internet, and Intellectual Property recently sent a letter to USPTO Director Jon Dudas asking a number of questions relating to these issues.

Peter Zura’s 271 patent blog reported on the highlights of the letter as follows:

• According to the recent GAO report titled "Hiring Efforts Are Not Sufficient to Reduce the Patent Application Backlog, " the GAO found that the USPTO cannot hire enough patent examiners to reduce patent pendency in the next five years. It seems, however, that this projection is based on estimates provided by the USPTO. . . . Please provide all data related to these "USPTO estimates, " including mathematical models, and underlying statistics and assumptions such as examiner retention and productivity. Under these same assumptions, hypothetically, how many patent examiners would have to be hired in the next five years in order to reduce the patent backlog?
• After release of the above mentioned GAO report, the USPTO issued"a press release on October 4, 2007 that stated the USPTO would"review assumptions the agency uses to establish production goals for patent examiners." Then, before the Subcommittee, Director Dudas confirmed that the USPTO has begun to study patent examiner production goals. Please provide details on the methodology of the study and personnel conducting it. What is the current progress of the study and when can Congress expect the study to be completed? To what extent is the Patent Office Professional Organization and the Patent Public Advisory Committee involved in this study. . . . .
• Examination on Request (or, as the USPTO called it, Deferred Examination) is used in many countries such as Canada and Japan. Under such a system, applications are not examined automatically, as in the U.S., but only upon a specific Request for Examination within a set time period, say 3 years. If no request is filed within that period, the application is deemed abandoned and is never examined. From experience of other patent offices, 10% to 40% of applications are never examined under Examination on Request systems, resulting in substantial workload reduction. This is due to applicants’ voluntary abandonment of obsolete applications prior to the Request for Examination deadline. Under current USPTO practice, applications that become obsolete, but receive examination by the USPTO, are the worst investment the USPTO can make because their obsolescence means that the patents are unlikely to fetch any renewal fees.
• Why did the USPTO reject such a method that has the potential to reduce its workload and increase efficiency?

There is no word yet on the USPTO’s response to this inquiry.  We will keep you posted of any developments that arise.  To review the full text of the letter, please see attached.

A petition has been filed with the U.S. Supreme Court, which challenges the constitutionality of the appointments of more than two-thirds of the USPTO’s board of patent appeals and interferences ("BPAI") judges, reported The National Law Journal.

The National Law Journal reported on the filing of the petition as follows:

The company’s petition, drafted by veteran high court litigator Robert Long of Washington’s Covington & Burling, contends that one of the three panel judges in its case was named to the board in violation of the Constitution’s appointments clause. Translogic Technology v. Dudas, No. 07-1303. . . .

Such a constitutional flaw, if legitimate, could call into question the hundreds of decisions worth billions of dollars in the past eight years. The flaw, discovered by highly regarded intellectual property scholar John Duffy of George Washington University Law School, could also afflict the appointment of nearly half of the agency’s trademark appeals judges.

According to The National Law Journal, forty of the sixty-one of the BPAI judges were appointed after March 29, 2000, which was the date when a law changing the appointment process came into effect.

The National Law Journal reported:

The Intellectual Property and Communications Reform Act of 1999, according to Duffy, was intended to give more authority and status to the director of the PTO, but also to keep the agency firmly within the Department of Commerce. A provision of the act transferred the power to appoint BPAI judges from the secretary of Commerce to the PTO director.

BPAI judges exercise "significant authority," argue Duffy, Long and others, and qualify as "inferior officers" under the appointments clause. The clause requires that inferior officers be appointed either by the president, the courts of law or heads of departments. The PTO director is not a head of a department.

Given the large number of judges appointed after March 2000, Duffy said, the odds are that the vast bulk of appeals since then had at least one invalidly appointed judge sitting on the panel.

With respect to the current petition, Long has is arguing that the Supreme Court should vacate the BPAI decision in the Translogic case; however, he denies that such an action by the Supreme Court would call into question all of the decisions by the BPAI since 2000. 

The National Law Journal states as follows:

[Long] contends that the de facto officer doctrine does not apply, and that the PTO’s claim — that failure to apply it would cast a cloud over "many thousands of Board decisions" — is inaccurate.

"Our position is this affects only decisions that are still subject to a direct appeal — those pending in the Federal Circuit or in the Supreme Court — a much smaller group. . . . "

We will continue to follow this matter as it develops, and keep you posted here at the California Biotech Law Blog.

The Patent Office is considering whether or not to appeal a recent ruling by a U.S. District Court in Virginia, which voided the new rules limiting how many times companies could submit patent applications, according to a report by the San Francisco Business Journal.

The ruling was viewed as a victory for the biotech industry, since the industry had opposed the new rule changes. 

The San Francisco Business Journal explained the industry’s position as follows:

The problem is that, for competitive reasons, the biotech industry often has to submit patent applications before it has completed clinical trials. New drug technology only gets patent approval if it has been proven to help cure disease, but as clinical trials take years, companies might loose out if they wait to file until the benefits have been demonstrated in humans. Instead, applications are usually based on lab data that show a drug is likely to impact the molecular processes involved in disease. Sometimes patent reviewers find this data to be insufficient, especially if a new, little-understood class of therapies are featured in the application.

This is why the biotech industry disliked the changes. They only allowed companies two chances to resubmit if the patent reviewer rejected an initial application. The patent applications would also have to be more narrowly focused, forcing companies to limit the scope of their drug therapies early on.

In contrast, the opposing view by patent rule change supporters was that the "changes would help prevent abuses of the system," and that the biotech industry had been guilty of those abuses.  The San Francisco Business Journal reported on the position of supporters as follows:

[Many biotech companies submit patent] applications before new drug candidates have been thoroughly investigated. In these cases the patent application is used to curtail competitors while the research process continues. This goes against the fundamental nature of the patent process, which has never allowed a patent application to serve as a "hunting license."

The new rules were scheduled to go into effect on November 1, 2007, according to The Recorder.  However, Triantafyllos Tafas, founder of Ikonisys, and GlaxoSmithKline filed suit against the Patent and Trademark Office and its director Jon Dudas, to block this from happening.  Eastern Virginia U.S. District Judge James Cacheris granted a preliminary injunction on Oct. 31, 2007 and GlaxoSmithKline and Tafas filed for summary judgment on Dec. 20, 2007.

According to The Recorder, Cacheris granted summary judgment to the plantiffs earlier this month, ruling that the patent office can’t make "substantive" changes to the rules, only "procedural" ones. 

Ultimately, the Patent and Trademark Office’s decision on whether or not to appeal this ruling could be irrelevant.  The San Francisco Business Journal reported:

If a patent reform act passes over the next few years, the debate may become a mute point. A patent reform bill was proposed in early 2007 that would grant the USPTO more rule making autonomy.

Of course, patent reform legislation has not to date been passed, and so life sciences companies, including biotech companies, are likely to continue their challenge of this exercise of Patent and Trademark Office rulemaking.

According to a Patent Baristas report, the U.S. Patent and Trademark Offics ("USPTO") is proposing a rule change to require deposits when the invention involves biological material. 

Patent Baristas wrote of the proposed rule change:

The proposed rules would require:

(1) that any deposit of biological material be made before publication of a patent application; and

(2) that all restrictions on access to the deposited material imposed by the depositor be removed upon publication.

The proposed changes will provide that the public has access to biological materials referenced in the disclosure of a patent application to the same extent that access to the remainder of the disclosure is available. The public policy basis for allowing access to a referenced item is the same whether the item is another patent application or a deposited biological material.

The USPTO is currently accepting written comments to this proposed rule change through April 21, 2008.  The full text of the notice is attached.

The United States Patent and Trademark Office (“USPTO”) has agreed to reconsider patents on Gilead’s HIV drug Viread, according to a report by The Mercury News.

The Mercury News reported:

The Public Patent Foundation, a consumer advocacy group, claimed in a petition filed with the agency in March that the patents shouldn’t have been issued because key facts about the makeup of Viread – generically dubbed tenofovir – had been made public previously. . . .

Invalidating the patents would let other companies seek federal permission to sell the same drug, which could make Viread more widely available and lower its price, said Daniel Ravicher, the foundation’s executive director. Retail prices for drugs vary, but a 30-day supply of Viread can easily cost more than $1,000.

Viread sales were nearly $690 million in 2006, so it goes without saying that the invalidation of these patents could potentially be very costly for Gilead.  Moreover, Viread is a key component of two other Gilead drugs, Truvada and Atripla.  Thus, the invalidation of the patents could potentially impact the sales of those drugs as well.

Should Gilead be concerned?  The USPTO agrees to reconsider a large number of patents each year and only a small percentage of those patents are actually invalidated, so the odds of these patents being invalidated are probably relatively small.  Still, Gilead has to have some concerns, since the invalidation of these patents is likely to have a very real impact on the company’s bottom line.