Teva Pharmaceuticals is buying Allergan’s generic drug business for $40.5 billion.
The Israeli pharmaceutical signed an agreement on 27 July for Allergan Generics and withdrew its plans to acquire Mylan’s business.
Under the new agreement, Teva will pay Allergan $33.75 billion in cash for the generics unit.
Dublin, Ireland-based Allergan announced it will acquire San Francisco-based Oculeve for a $125 million upfront payment plus milestone payments related to Oculeve’s lead development program OD-01, a device to treat dry eye disease. The agreement also includes the acquisition of an additional earlier-stage dry eye device development program.
Lombard & Geliebter partner, Mathew Lombard, will be speaking at this year’s annual PTMG meeting in Warsaw, Poland. He will be speaking on Thursday, 1 October 2015 on the topic of Business & Trade Secrets, from the U.S. perspective. For more information, please click here.
In Commil Usa, LLC v. Cisco Systems, Inc. (Supreme Court 2015), the Supreme Court held that, because induced infringement and validity are separate issues and have separate defenses under the Act, belief regarding validity cannot negate Section 271(b)’s scienter requirement of “actively induce[d] infringement.” “When infringement is the issue, the patent’s validity is not the question to be confronted.” The Court pointed out the practical rationale that if accused infringers believe a patent being asserted against them is invalid, they have other, more appropriate mechanisms at their disposal to secure a ruling of invalidity, such as seeking ex parte reexamination of the patent by the U.S. Patent & Trademark Office, something Defendant Cisco did in this case.
Commil USA v Cisco Systems – US S.Ct. 2014 – D’s Belief re Patent Validity not Defense to Inducement
In B&B Hardware Inc. v. Hargis Industries, Inc. (Supreme Court 2015), the Supreme Court held that Trademark Trial and Appeal Board (TTAB) decisions regarding likelihood of confusion have preclusive effect in subsequent district court infringement actions “[s]o long as the other ordinary elements of issue prelusion are met [and] when the issues adjudicated by the TTAB are materially the same as those before the district court.”
Generally, trademark owners have exclusive rights to use their mark to label or identify their goods and/or services. However, trademarks may overlap under either of the following circumstances:
1. In different industries; or
2. In different geographical locations.
The most frequently litigated of these exceptions has been the concurrent use of trademarks in different geographical locations, as courts have had to determine the appropriate geographical scope of territorial priority rights in a particular trademark.
Concurrent Use in Different Geographical Areas
Although two companies must typically use an entirely different mark in order to avoid confusing the public as to who makes what, courts have typically permitted concurrent use of the same or similar mark by restaurants in different parts of the country. The rationale behind permitting concurrent use of a mark in different geographical areas is that there is little likelihood of confusion.
For example, in Weiner King, Inc. v. Wiener King Corp., the federal district court permitted concurrent use of “Weiner King” as a mark for restaurants featuring hot dogs in New Jersey and “Wiener King” as a mark for restaurants in North Carolina. Similarly, in Pinocchio’s Pizza Inc. v. Sandra Inc., the court permitted concurrent use of “PINOCCHIO’S” as a mark for restaurants in Maryland and “PINOCCHIOS” as a mark for restaurants located elsewhere in the country.
Concurrent Use Application and Proceedings
The Trademark Trial and Appeal Board (the Board) holds a concurrent use proceeding to determine whether an applicant is entitled to concurrent registration of a trademark. In order to initiate a concurrent use proceeding, a concurrent user must submit a concurrent use application, in which the applicant meets the following criteria:
1. Concedes that its use is not exclusive
2. Specifies the goods and/or services and area or mode of use for which the applicant desires registration
3. Identifies one or more persons which concurrently use the same or similar mark for the same or similar goods or services
4. Provides certain information concerning use of the mark by each listed concurrent user
Under Section 1052(d) of the federal Lanham Act, the Board Director may issue concurrent registrations upon finding that “confusion, mistake, or deception is not likely to result from the continued use by more than one person of the same or similar marks.” Further, an applicant is only entitled to concurrent registration if they have used the mark in commerce prior to the applicable date specified in the provision.
Priority of Use Test to Determine Ownership
The generally accepted rule on how to determine ownership of trademark rights is by the “first use date.” Specifically, the priority of use standard dictates that the first to actually use a mark in the sale of goods or services gains exclusive rights to the mark in the geographic area in which the mark is actually used.
In addition to gaining ownership rights in a trademark by way of actual use of the mark in a specific geographical area, ownership rights may also come from “constructive use.” Under this theory, federal registration of a trademark with the U.S. Patent and Trademark Office (PTO) raises the presumption that the registrant owns the mark, and fixes the registrant’s nationwide priority rights in the mark. However, federal registration of a mark does not give the registrant priority over others who have previously used the mark in commerce. As such, federal registration by one mark user places the burden on a concurrent user to show their prior and continued use of the mark.
Geographical Range of Prior Use
The Lanham Act requires the Board Director to “prescribe conditions and limitations as to the mode or place of use of the mark” in issuing concurrent registrations. Typically, the Director will grant territorial priority in a mark to the “senior user” who has applied for federal registration (as discussed above). However, the territorial rights of a senior user are subject to the rights of a “junior user” who has used the mark prior to the senior user’s application for federal registration.
When actual use of a mark by a senior user has been limited, courts frequently consider four factors to determine territorial priority in a mark, including:
1. The volume of sales of the product in a particular geographical location
2. Growth trends in the area
3. The market penetration as a function of the total product market
4. The amount of advertising
If a senior user satisfies the aforementioned criteria, actual use of a mark in a territory is not necessary to establish priority in the mark. Because pre-existing federal registration gives a registrant nationwide priority in a mark, it is important to conduct a trademark search before becoming committed to a particular trademark and using it in a particular geographical location.
Don’t get tripped up when calculating the deadline within which to respond to an Office action issued in connection a Section 66(a) application at the U.S. Patent & Trademark Office. A response to an Office action issued by the USPTO is due within six months of the date on which the USPTO sent the action to the International Bureau (IB), not the date on which the refusal was processed by the IB.
You can find and confirm the date on which the USPTO sent the action to the International Bureau on the USPTO’s TARR database record for the subject application. It will likely look something like this:
2011-05-29 – Non-Final Action Mailed – Refusal Sent To IB
To be clear, the six-month deadline within which to respond to the Office action must be calculated from this date (using our example, from March 29, 2011). Not from the date the Office action was written, which is also typically noted in the TARR Prosecution History, looking like this:
2011-05-28 – Non-Final Action Written
I suppose that it’s not the worst thing in the world to mistakenly rely on the earlier date on which the Office action was written, as submitting a response within that time period will not result in a late filing. Things can get a little more confusing when you receive official notification of the provisional refusal of protection from WIPO. In this notification, you will see the following dates set forth:
Date on which the notification was sent to WIPO (mailing date): 29/05/2011
Date of receipt by WIPO: 29/05/2011
Date of notification by WIPO to the holder: 31/05/2011
This is where a little sloppiness or simple lack of sophisticated knowledge of the intricacies of the Madrid Protocol rules can really cause trouble. If an unsuspecting docketing clerk calculates the response deadline using the “Date of notification by WIPO to the holder” date (which is also the date indicated at the top of the letter on which the notification is sent), then there is a real danger that the applicable deadline will be missed.
In summary, be aware that a response to an Office action issued by the USPTO in connection with a Section 66(a) application is due within six months of the date on which the USPTO sent the action to the International Bureau (IB), not the date on which the refusal was processed by the IB, and not on the date of notification by WIPO to the holder (the applicant).
Public Disclosure- The Novelty Requirement
Most countries are “first to file” countries- in other words, you have to file a patent application to establish rights. The U.S. has historically been a “first to invent” system;; but as of March 16, 2013, the U.S. officially changes to a first-to-file patent system pursuant to The Leahy-Smith America Invents Act (AIA). Furthermore, if you do not file first in these countries, but publicly disclose the invention before filing, you are usually precluded from filing the patent in that country. Each country’s law’s definition of “public disclosure” is different and would need to be assessed on a country-by-country basis as applicable to the situation. For example, some countries require absolute novelty (which, in practical terms, means that a patent application must be filed before any public disclosure), while other countries give inventors or applicants grace periods, following disclosure, for filing patent applications.
Major exception to the general rule: If you filed a U.S. patent application prior to public disclosure (but have subsequently disclosed the invention), you will probably have a 12-month window within which to file a corresponding patent application in a foreign country. See more below on this.
Paris Convention One-Year Grace Period
The U.S. has entered into treaties with almost every industrialized country such as the Paris Convention, which allow U.S. applicants to file patent applications with the party nations within 12 months of the earliest U.S. filing date and get the benefit of the U.S. filing date. When filing an international application that relies on the Paris Convention one-year grace period for a priority date, the time period for filing the foreign application is calculated from the date of the first-filed national application. For most U.S. applicants, the first-filed national application is a regular nonprovisional U.S. application. Please note that if a U.S. provisional application is filed as the first-filed application, the one-year grace period begins with the filing of this provisional application and not with the filing of the “conversion” regular non-provisional U.S. application that claims priority over the provisional application. Thus, if a provisional application is filed, the conversion date for the nonprovisional U.S. application and the Paris Convention bar date for the filing of international applications fall on the same day. Therefore, the international application and the U.S. regular application need to be filed on the same date.
Patent Cooperation Treaty (PCT)
In addition, the U.S. is a party to the Patent Cooperation Treaty (PCT), which allows applicants to file a single international application within 12 months of the earliest U.S. filing date and also get the benefit from an U.S. filing date. The applicant, however, will have to file the international or PCT application nationally in select countries within 30 or 31 months from the earliest filing date. Therefore, PCT filings preserve future foreign patent rights and permit an applicant to delay national entry into PCT member countries for up to 30 or 31 months from the priority date. This delay period may provide opportunities for further market analysis, obtaining a licensee or business partner for the invention, etc.
Although PCT applications are examined and applicants are able to amend the application before entering the national stage, PCT applications do not grant. Rather, each national patent application must be prosecuted individually. The European Patent Convention (EPC) similarly allows applicants to file a single patent application within 12 months or 31 months when entering with the PCT application of the earliest filing date. Unlike the PCT application, however, the European patent application is prosecuted at the European level and later registered in the elected countries after the grant. The most important thing to remember about foreign filing is that missing a filing deadline likely results in a loss of foreign patent rights.
Cost Estimates
The costs associated with foreign patents vary, but as a rule of thumb expect the PCT application to cost at least $5,000 and each national filing will be approximately $5,000 each for English speaking countries and $10,000 for non-English speaking countries. The EU is an additional $10,000. Applicants will likely pay at least the same amount to prosecute applications in each country or region. The cost for filing foreign patent applications consists mostly of patent office fees. Therefore, there is little that can be saved by shopping around for the least expensive agent. Bigger savings can be realized in prosecution by using strategies similar to those for the U.S. Of course the most prudent strategy is to limit foreign filing to only those countries where it makes good business sense to do so.
Darren Geliebter
Mathew Lombard
THE PRINCIPAL REGISTER 