There are four basic requirements for patentability under the European Patent Convention (EPC): 1) there must be an “invention”; 2) the invention must be “susceptible of industrial application”; 3) the invention must be “new”; and 4) the invention must involve an “inventive step” (Article 52).

Many people who have confidence in their knowledge of U.S. patent law run into problems when applying for European patents because they disclose their invention before filing either a U.S. or European patent application. While this may be acceptable (with certain limitations) in the U.S., it can create insurmountable problems in many other countries.

In order to understand why, you must understand the third requirement of patentability under the EPC - the “new” requirement.

According to Article 54(1) of the EPC, an invention is considered to be new if it does not form part of the state of the art. Article 54(2) goes on to define “state of the art” as everything made available to the public, whether written, oral, in use, or any other way before the date of filing of the European patent application.

So, any public disclosure before the filing date of your invention, including writing about your invention on your blog, or using your invention as part of your newly launched website, can result in loss of international patent rights. The only situations where public disclosure is not taken into consideration is if the public disclosure was made within six months of the filing of the European patent application, and was the result of some sort of abuse, such as a breach of confidence, or if it was made at a recognized international exhibition (Article 55).

Since the EPO only searches printed publications during examination, an oral disclosure is unlikely to affect the grant of a patent. However, the oral disclosure could be used by others after grant, for example, during an EPO opposition proceeding or national revocation proceeding.

Therefore, those considering filing international patent applications should be extremely careful about any public disclosure and, preferably, seek the advice of qualified patent counsel.

Links: European Patent Convention, Article 54, Article 55, Guidelines for Examination in the European Patent Office (Patentability: General, Non-prejudicial disclosures; Guidelines for opposition procedure), EPC Part V - Opposition Procedure.

Senior officials of the United States Patent and Trademark Office, as well as a representative from the Patent and Trademark Depository Library Program, will be available live on-line on Thursday, November 16 , from 2 to 3 pm (ET). They will be answering questions and offering tips for independent inventors. Instructions for taking part in the chat will be posted on the home page of the USPTO website at 10:30 am (ET) on Thursday. Inventors can begin logging on at 1:30 pm.

Links: transcripts and index from previous on-line chats.

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.

Senior officials of the United States Patent and Trademark Office will be available live on-line on Wednesday, February 22, from 2 to 3 pm (ET). They will be answering questions and offering tips for independent inventors. Instructions for taking part in the on-line chat will be posted on the home page of the USPTO website at 10:30 am (ET) on Wednesday. Inventors can begin logging on at 1:30 pm.

Links: transcripts and index from previous on-line chats.

Q: Can I patent features of a new version of an existing product? The new product performs the same function as the original product, but it looks and operates completely differently.

A: Improvements to existing products may be patentable if they are new, useful, and non-obvious. This is true even if the improved product retains the same basic function as the original, but the way it accomplishes that function has changed.

For example, an electronic device such as an mp3 player, or an iPod, may be improved so that it has a longer battery life, uses memory more efficiently, or can be manufactured more economically. The same basic function is the same - the device plays music - but the improvements provide advantages over the original design.

If the look of a product has changed, a patent can be filed that covers the appearance of the product; this is called a design patent.
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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 US Patent and Trademark Office occasionally conducts live on-line chats to answer questions and offer tips to independent inventors. Inventors may also find useful information on the USPTO Inventor Resources page.

Links: transcripts of chats, index of chat topics.

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.