Abbot Laboratories fought for 14 years (receiving 12 rejections) to get a patent allowed, only to have the patent found unenforceable because Abbot’s patent attorney withheld key information in connection with the patent filing. Lesson: disclose information which may be material to the patentability of any of your claims, as required under 37 CFR 1.56.

Links: Law.com article.

U.S. District Judge James Cacheris granted GlaxoSmithKline’s motion for a preliminary injunction blocking the U.S. Patent and Trademark Office from implementing the rules set to go into effect today. Glaxo filed its suit against the U.S. Patent and Trademark Office and its director, Jon Dudas, earlier this month. The company plans to seek a permanent injunction.

Link: Law.com article.

Effective November 1, 2007, and applicable to pending applications in various ways, there are some major changes in the number of claims permitted in an application, and in the number of continuations permitted. A few highlights (with many details left out):

* No more than 5 independent and 25 total claims per application (5/25 rule). For applications exceeding the 5/25 rule, an examination support document (ESD) must be filed before the first office action, or the application must be amended to comply with the 5/25 rule.

* An ESD must include: a preexamination search statement, a listing of references deemed most closely related to the subject matter of each claim, an identification of claim limitations disclosed by each reference, a detailed explanation of patentability, and a showing of support under 35 USC 112 paragraph 1.

* For applications that exceed the 5/25 rule and have claims directed to more than one patently distinct invention, the applicant may submit a suggested restriction requirement (SRR) and elect an invention complying with the 5/25 rule before a first office action or restriction requirement.

* The USPTO will give notice to applicants whose applications exceed the 5/25 rule.

* The new claim rules are in effect for all pending applications for which an office action has not been received before November 1, 2007.

* An application or chain of continuation applications may have only two continuation applications and one request for continued examination (RCE). More than this number of continuations or RCEs must include a petition and showing.

* Divisional applications to non-elected inventions may be filed only if the USPTO issues a restriction requirement.

* The applicant must identify the claims in a continuation-in-part application that are supported by the prior-filed application.

* Applicants may file “one more” continuing application after August 21, 2007, regardless of the number of continuing applications filed before November 1, 2007.

* Applicants must identify other commonly owned pending applications or patents that have an inventor in common, and a claimed filing or priority date within two months of the claimed filing or priority date of the application.

* Applicants must file a terminal disclaimer or explain how the applications (or application and patent) contain only patentably distinct claims if the applications also have the same claimed filing or priority date and contain substantial overlapping disclosure.

* Applicants may be required to put all patentably indistinct claims in a single application unless there is good reason for multiple co-pending applications having patentably indistinct claims. The single application would then be subject to the 5/25 rule.

* Applicants may request a refund of any excess claims fees paid on or after December 8, 2004 for a claim if the amendment canceling the claim is filed before an examination on the merits has been made of the application.

Links: USPTO Claims and Continuation Practice page, Federal Register - Final Rule (72 Fed. Reg. 46716 - 21Aug2007), Claims and Continuations Final Rule powerpoint slides.

Biomedino v. Waters Technology (Fed. Cir. 2007)

(via Patently-O)

If you haven’t heard already, the Supreme Court’s recent decision makes it easier to invalidate already issued patents, and will likely make it more difficult to obtain patents. More to come later.

Links: KSR v. Teleflex decision, Transcript of oral arguments.

Q: Does FDA approval of a drug for a new use forestall the expiration of the drug’s patent for an old use? Wellbutrin XL has been approved for major depression for a while. Its patent is up some time this year. It has recently been approved so that it can be marketed for seasonal affective disorder (SAD). Does that mean that a new patent is issued?

A: New patents are not automatically issued. In order to receive a patent you must file a patent application. A patent is only issued after a lengthy and in-depth examination, during which time you have the opportunity to respond to rejections from the patent office.

A patent’s term is unaffected by FDA approval allowing an already existing drug to be marketed for a different illness. The patent term for a drug is 20 years from filing or 17 years from grant, depending on when it was filed (with few exceptions, see 21 CFR 60, 35 USC 156).

There are many different ways to patent drugs. Without getting into specifics of the Wellbutrin patents, let’s assume they claim a composition of matter (the makeup of the drug) as well as a novel use of the drug.

A new use for an old composition of matter is patentable, however the new use must be non-obvious and actually new. A method of administering the same drug, in substantially the same way, but for a different but somewhat related condition would be unlikely to satisfy the non-obvious requirement.

Furthermore, in this specific case, doctors have probably been widely prescribing Wellbutrin for SAD for many years (without FDA approval). If that is the case, then the prior SAD use should itself bar the issuance of any patent claiming the use of Wellbutrin for SAD.

So, for the maker of Wellbutrin to have a chance of getting a new patent, they would have to create a new, improved, and non-obvious formulation of the drug, and/or find a truly new and non-obvious use. They could also file a patent on a new and non-obvious method of manufacturing the drug, but many companies prefer to keep their manufacturing process a trade secret.

According to the Generic Pharmaceutical Association, brand-name drugs for which patents will expire in the next few years include Wellbutrin XL for depression and smoking cessation (this year), Imitrex for migraines (next year), Advair for asthma (2008), Zyrtec and Clarinex for allergies, and Valtrex for herpes (2009).

Links: Wellbutrin extended release tablet patents 6,143,327, 6,096,341; GlaxoSmithKline Intellectual Property; US FDA Generic Drug Approvals; US FDA FAQ on Patents and Exclusivity; FDA Electronic Orange Book; Drug patents to expire; Uniform Trade Secrets Act; 21 CFR 60; 35 USC 156.

The USPTO has established procedures under which the examination of a patent application may be accelerated. More details can be found on the USPTO Accelerated Examination Page.

The United States Patent and Trademark Office (USPTO) is publishing procedures setting forth requirements for patent applicants who want a final decision by the examiner on whether their application for a patent will be granted or denied within twelve months.

Links: Press Release, Notice, Federal Register.

The Manual of Patent Examining Procedure (MPEP) Eighth Edition, Revision 4 has been released. The Manual is published to provide U.S. Patent and Trademark Office (USPTO) patent examiners, applicants, attorneys, agents, and representatives of applicants with a reference work on the practices and procedures relative to the prosecution of patent applications before the USPTO.

This revision incorporates the changes necessitated by the final rule “Changes To Implement the Cooperative Research and Technology Enhancement Act of 2004,” which became effective on September 14, 2005. Chapter 2300 has been rewritten to incorporate the new Board of Patent Appeals and Interferences rules that became effective on September 13, 2004. The rules directed to interferences are in Part 41, Subparts D and E of title 37, Code of Federal Regulations.

The USPTO has released interim guidelines for determining the eligibility of subject matter for patent applications. The guidelines were published after a recent appeal (Ex parte Lundgren, Appeal No. 2003-2088 (BPAI 2005)) in which the Board of Patent Appeals and Interferences issued a precedential opinion stating that “… there is currently no judicially recognized separate “technological arts” test to determine patent eligible subject matter under § 101.” This decision may have the effect of eliminating the requirement that business method inventions be tied to a computer or some other electronic device.

Links: Association of Patent Law Firms.

After your utility patent is granted, you must pay fees in order for the patent to remain in force. These “maintenance fees” must be paid 3.5 years, 7.5 years, and 11.5 years after the patent is granted. The patent office offers a six month grace period so fees may be paid, with a surcharge, by the 4th, 8th, or 12th year after grant. Failure to pay the fees will result in the patent expiring. After expiration, however, you may petition the Director of the United States Patent and Trademark Office to accept a late maintenance fee and reinstate your patent. This may be done at any time if the delay was unavoidable. If the delay was unintentional, the petition must be filed within two years of the expiration of the grace period. In either case, the petition must include the required maintenance fee, a surcharge, and an appropriate statement that the delay was unavoidable or unintentional. If the petition is refused, you may file another petition for reconsideration within two month of the refusal. There are no maintenance fees due for plant or design patents.

The Cooperative Research and Technology Enhancement Act amends 35 U.S.C. 103( c ) to provide that subject matter developed by another person shall be treated as owned by the same person or subject to an obligation of assignment to the same person for purposes of determining obviousness if three conditions are met: (1) The claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and (3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

Internationally, an industrial design is the ornamental or aesthetic aspect of an article. The design may consist of three-dimensional features, such as the shape or surface of an article, or of two-dimensional features, such as patterns, lines or color. In most countries, an industrial design must be registered in order to be protected under industrial design law. Design registrations are similar in some ways to design patents in the United States.

As a general rule, to be registrable, the design must be “new” or “original”. Once a design is registered, a registration certificate is issued. Following that, the term of protection is generally five years, with the possibility of further periods of renewal up to, in most cases, 15 years.

Depending on the particular national law and the kind of design, an industrial design may also be protected as a work of art under copyright law. Under certain circumstances an industrial design may also be protectable under unfair competition law.

A procedure for an international registration exists under the WIPO-administered treaty, the Hague Agreement Concerning the International Deposit of Industrial Designs. An applicant can file a single international deposit either with the WIPO or the national office of a country which is party to the treaty. The design will then be protected in as many member countries of the treaty as the applicant wishes.

(additional links: design registrations in the UK)

An international application must be an application for the protection of an invention. The PCT encompasses the filing of applications for patents for inventions, inventors’ certificates, utility certificates, utility models, and various kinds of patents and certificates of addition. An international application thus cannot validly be filed for certain other forms of industrial property rights which fall outside the scope of “inventions”, such as, for example, purely ornamental designs. (PCT Articles 2(i), 2(ii), 3(1); PCT Applicants Guide Vol. I)

The USPTO is offering applicants an optional procedure to review the examiner’s rejection prior to the actual filing of an appeal brief.

You can ask, but it is most often not necessary. Patent attorneys deal with confidential information all day long and must preserve the confidences and secrets of a client.

Sometimes, much of the value of a product lies in its appearance. For example, Apple Computer is well known for designing instantly recognizable and attractive products. If your product has novel visual characteristics, such as a unique configuration, shape, or surface ornamentation, you can file a design patent application. A design patent protects only the appearance of a product. A utility patent may be filed to protect the way a product is used or works. Apple Computer has many design patents on products such as the Powerbook, eMac, and iPod. Design patents may also be filed on computer generated icons, including user interfaces for computer displays. More information on design patents can be found in MPEP 1500.