“Continuations” and US Patent Law

 

When crafting a patent strategy in the United States, one of the most powerful tools available to inventors and businesses is the continuation application. Continuation practice can dramatically extend the value and scope of patent protection. This post will provide an overview of U.S. patent continuation practice, discuss why many patent owners keep an “open” continuation on file, and explain the role and strategic advantages (and disadvantages) of a Continuation-in-Part (CIP) application.

This article was originally published at https://innovationcafe.us/continuations-and-us-patent-law

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1. What Is a Continuation Application?

In the U.S. patent system, a continuation application is a follow-on patent application that:

1. Is filed before the parent patent application issues or is abandoned;
2. Contains the same disclosure as the parent (i.e., no new subject matter);
3. Presents different claims from the original or parent application.

By filing a continuation, an applicant can continue to prosecute claims based on the original disclosure, even after a parent application has been allowed or issued. Continuations serve as an invaluable tool for refining or expanding the scope of claims as new markets develop, new competitor products come to light, or as the applicant refines the commercial focus of the invention.

Why Continuations Are Useful

• Flexible Claim Strategy: By changing or refocusing claims in a continuation, applicants can strategically capture additional aspects of the invention that might not have been fully covered in the initial application’s claims.
• Ongoing Protection: Continuations maintain the original application’s priority date for the subject matter disclosed in the parent, which is critical if competitors release competing technology after the earliest filing date and before the filing date of the continuation.
• Response to Evolving Technology and Market Conditions: Especially in fast-moving industries (e.g., software, electronics, biotech), an invention may have several market applications not apparent — or not commercially viable — at the time of filing. A continuation keeps open the option to seek protections on evolving iterations of that invention.

Use Case: Imagine that you’ve developed a new drug class that improves outcomes in certain viral infections. The class includes ninety different variations on the molecule that fits into the drug class. Initial research shows each of the variations have different levels of efficacy against different viruses. If you could not file a continuation, you would have to seek patent protection for ninety different molecules at the same time — an incredibly expensive proposition, and one that may largely be a waste of money if clinical testing in over the next ten years shows that only a handful of the molecules are the most effective. If molecule 1 and molecule 2 treat the same infections, but molecule 2 is only 95% as effective as molecule 1, you may choose to develop (and go through the FDA process) molecule 1 as a commercial product. You patent only molecule 1. A competitor starts selling molecule 2 as a cheaper alternative to molecule 1 — even though you invented both. If you have an open continuation, you could file a new continuation claiming molecule 2. If you get the patent issued only on molecule 1 with no continuation filed, you would have no way to stop the competitor from using your invention.

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2. The Benefits of Keeping an “Open” Continuation

One particularly powerful strategy is to keep at least one continuation application pending at the U.S. Patent and Trademark Office (USPTO). This is often referred to colloquially as maintaining an “open” continuation.

2.1. Adjust Claims for Unforeseen Infringers

Even after a patent has issued, situations arise in which the patent owner uncovers an infringing product or process. However, sometimes the issued claims do not line up perfectly with the infringing embodiment, making enforcement uncertain or difficult. If there is an open continuation still under examination, the owner can:

• Amend the claims in the pending continuation to better capture the alleged infringing features, provided that those features are supported by the original specification.
• Potentially secure stronger, more targeted coverage against the competitor’s products.

2.2. Extend Patent Coverage

If your invention has multiple facets or improvements, you can sequentially file continuations to protect these different aspects. Each continuation that matures into a patent can confer additional layers of protection, potentially hindering competitors from designing around your initial claims. Note that in the past, patents lasted some number of years (usually 17) from the date they issued. This is no longer the case. The Lemelson patent continuation strategy locked up bar code technology for many decades, and served as a cautionary tale against measuring patent life in this manner. Lemelson was indeed known for “submarine patents,” which took advantage of the old rule that gave a 17-year term from issue, and he kept applications pending a very long time.

2.3. Avoiding Premature Narrowing

Often during prosecution, claim amendments are made to appease the patent examiner’s requirements for allowance. While this can result in a narrower scope in the issued patent, having an open continuation lets you claim broader or alternative features that you could not secure in the parent. This keeps your protection dynamic and potentially broader overall. Although beyond the scope of this post, you should be aware that the patent prosecution history (the file at the USPTO reflecting the back and forth with the patent examiner) may narrow claims in a way not reflected in the claim language.

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3. Continuation-in-Part (CIP) Applications

A Continuation-in-Part (CIP) application is another powerful mechanism in U.S. patent law. A CIP differs from a standard continuation because it can include new subject matter in addition to the text carried forward from the parent application.

3.1. How CIPs Work

• Parent Material Retains Original Priority: The original subject matter from the parent application in a CIP retains the parent’s priority date.
• New Matter Has a Later Priority: Any newly added content introduced in a CIP receives a new priority date (the filing date of the CIP), which means it is not protected as early as the original content.
• Potential Risk: Because you partially rely on the new filing date for new matter, any third-party disclosures or publications that occur between the parent’s filing date and the CIP’s filing date could potentially act as prior art for the new matter.
• Real and Tangible Cost: The expiration of a patent arising from a CIP is on the 20 year anniversary of the original filing date of the first patent application that the CIP claims priority to. If you filed the first application in 2006 and the CIP with new material is filed in 2025, the patent will expire in 2026. If he new material can stand on its own as patentable, there is a very strong case for filing a separate application for the new material that, in this example, would not expire until 2045.

3.2. Strategic Uses of a CIP

1. Incremental Innovation: If an inventor refines or improves upon the technology disclosed in the parent application, a CIP can cover the incremental advances.
2. Continuing Development: Fast-paced industries can see rapid improvements. A CIP allows the inventor to capture these developments without losing the benefit of the original filing date for the material previously disclosed.
3. Optimizing Portfolio Coverage: While standard continuations focus solely on subject matter already disclosed, a CIP can expand your patent portfolio’s coverage to include newly invented aspects.

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4. Considerations and Best Practices

4.1. Timing and Deadlines

A continuation (including a CIP) must be filed while the parent application is still pending. If the parent issues as a patent or goes abandoned before the continuation is filed, you lose this strategic option. Make sure to monitor your application’s prosecution timeline closely. Filing too close to the expiration date of a patent may change the cost/benefit analysis.

4.2. Priority Date Nuances

• Continuations: Retain the original priority date for all claims fully supported by the original disclosure.
• CIPs: Claims supported entirely by the original disclosure keep the parent’s priority date; claims relying on new subject matter get the CIP’s filing date.

4.3. Costs and Resource Allocation

Keeping a continuation pending can be invaluable, but it also comes with additional USPTO fees and attorneys’ fees. Strategies differ by industry and competitive landscape, so it is essential to balance the potential advantages with the financial and administrative costs of ongoing prosecution.

4.4. Avoiding Double Patenting Issues

When you obtain multiple patents from a chain of continuations, you might have to address double patenting concerns. Typically, filing a terminal disclaimer (where you agree the patents will expire on the same date and are commonly owned) resolves this issue, but it can limit your patent term for the later applications.

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5. Concluding Thoughts

Continuation practice, when used strategically, enables patent owners to pivot, adapt, and strengthen their protection over the lifetime of an invention. By filing continuations, you can tailor claims to newly identified competitor products or refine your coverage if initial claims had to be narrowed during prosecution.

A CIP further allows you to add new subject matter while retaining priority for the original aspects of the invention, a powerful approach when improvements to an invention emerge during its development cycle.

Ultimately, the decision to keep an “open” continuation or file a CIP is highly context-dependent—factoring in budget, commercial goals, and the competitive environment. However, for many patent holders, the flexibility afforded by these strategies is more than worth the additional prosecution expenses.

If you are navigating the complex world of patent applications and would like to discuss how continuations or CIPs might fit into your IP strategy, feel free to reach out. Carefully planned continuation practice can be the key to securing robust, broad, and adaptable patent protection.

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Disclaimer: This article is for informational purposes only. It is not intended as legal advice, nor does it form an attorney-client relationship. For specific questions or personalized advice, consult with a qualified patent attorney or patent agent.

Actively manage your intellectual property portfolio

The primary kinds of intellectual property (IP) are:

1. Utility patents (these protect a device, a function, an artificial molecule, etc.)

2. Design patents (these protect an ornamental design)

3. Copyrights (these protect works of authorship, drawings, art, movies, songs)

4. Trademarks (these protect consumers from being sold items that mislead the consumer about who made the item; for example, you cannot have Coca-Cola Sneakers)

5. Trade secrets (these are protected against theft, but not other people coming up with the same idea)

There are several other varieties of IP (such as "moral rights" in certain countries, plant patents, state law trademarks), but they are less critical tools for a business -- particularly an early stage business.

The first thing to understand is that there are bright lines defining the legal status of the various types of IP, but the underlying IP itself can cross multiple categories. A fun example -- one that wouldn't be possible today because recent cases have clarified that games are almost never patentable -- is the game Monopoly.  At one point, it was covered by a utility patent, a copyright, and a trademark -- all three of which granted a monopoly on Monopoly. Software is covered by copyright, but can also be patent-eligible (note that software patents are currently very complicated in the US). A design eligible for design patent protection can also have a related copyright. A trademarked logo is also protected by copyright. In other words, overlap between IP types is very common.

Get a patent lawyer who understands the big picture (or teach the lawyer the big picture):

The problem with many IP lawyers is that they lack the big picture that the client has. Patent lawyers often think the pinnacle of success is calling the client and saying "we got a notice of allowance!" What they don't say -- because they don't know the client's business well enough -- is "we got claims allowed that cover X, Y and Z".  As Judge Giles Rich (former Chief Judge of the Federal Circuit Court of Appeals) famously observed, "the name of the game is the claim".  In other words, you can have the greatest invention supported by the greatest patent application and still get nothing of value if the issued claims have limitations to them. 

For example, if I invented the internal combustion engine and prototyped its use for transportation on motorcycle, a patent lawyer might assume that I want to patent my primary use case only -- motorcycles. The claim might read (translated to non-lawyer English) "An apparatus, comprising an internal combustion engine operably connected to a two-wheeled bicycle".  As far as the patent lawyer is concerned, mission accomplished. The client came to the firm with an invention and the firm obtained a patent for the client. As far as the client is concerned, though, they have paper-thin protection. What happens if the best use of the engine is four or more wheeled vehicles? What about using the engine to turn a turbine and make electricity? Patent lawyers typically think of their job as "getting the patent issued" with the assumption that the client's business will benefit from any patent. They are wrong. In order to infringe a patent claim, one must infringe every element of the claim. If I use an internal combustion engine to power a sea plane, the patent claim would not provide any protection.

Define your strategy based on your end goals:

Your attorneys do not know your business plans better than you do. In fact, they might not understand the business side of your innovation at all. They aren't operating an entity in any field other than law (typically), so they don't have the experience of actually using an IP portfolio in a business setting. By contrast, entrepreneurs knows what they have, have an excellent idea of what they plan to do in the near term, have a pretty good idea of mid-term goals, and have a firm idea about their exit strategy.

There are several common exit strategies, each with different IP requirements.

Investment: One exit strategy isn't a true exit: It is bringing in investors and monetizing (i.e. selling an interest in your company or product). This can range from venture capital to crowd funding to going public. In this case, your IP strategy needs to show investors a few things.

(1) "We're Innovators": We have good, innovative technology (so good that the patent office thinks we deserve a patent!);

(2) "We own our innovations": We have taken steps to protect our technology (i.e. patents and trademarks);

(3) "We understand copyright": To the extent we rely on software or other works of authorship in a tangible form including literary, dramatic, musical, and artistic works, such as poetry, novels, movies, songs, computer software, and architecture, we recognize their value and have registered copyrights to protect them.

(3)(a) Software audit: Be prepared for a "software audit" that will confirm you own the software you use. This means you need to be able to identify which portions of code you or your employees wrote (you should have a copyright assignment in your employment agreements, but normally you will own the copyright of works done by employees as part of their job); you need to be able to identify which portions of code were written for you by third parties, such as independent contractors -- and you need to show a contract assigning those copyrights to you; and you need to be able to identify which portions of your code use software with open licenses and to show that you are in compliance with those license terms (beware that some open licenses can "infect" other portions of your code with copyright (or "copyleft") issues, so you would be wise to check with a lawyer before using that code).  

(4) "We understand branding and trademarks": A pending or registered trademark shows that we know the importance of branding, and signals to investors that they are buying into a company with valuable branding and goodwill.

Sale of the Company: This is probably the most frequently desired exit -- a clean exit for cash or stock. Sometimes the buyer will want to hire on the creators of the company. All of the same factors in the "Investment" section apply here.

Sale or License of IP: This is where many companies hit a speed bump on their way to the exit and need IP counsel. Let's take ExampleSearch, Inc. as an example. ExampleSearch has developed a new search technology that uses a pulse oximeter and a webcam to read biofeedback for search results and feeds that data into an AI engine that is able to identify how a user feels about the search results and modify the algorithm to return search results users feel good about more often.  Leaving aside the mess that is United States patent eligibility (read this brief to learn about the mess), we assume that ExampleSearch is able to get a patent in the biggest ten global economies. ExampleSearch intends to keep operating, but needs to raise money and does not want to give up equity. ExampleSearch uses a patent broker to monetize the IP. ExampleSearch will need a "license back" to be able to keep using their technology if they do sell it (a license back can save you a lot of headache -- or even a trip to the Supreme Court. All the purchaser really cares about are the "We're Innovators" and "We own our innovations" elements discussed above. ExampleSearch needs to use a lawyer to make sure that they can continue to practice their own invention after selling it, or to limit licenses in a way that allows it to continue to operate.  It is not uncommon to sell geographically or area of practice limited licenses.

We Want to be Huge: Many entrepreneurs (particularly those in the age range where brain circuity for risk analysis is still developing) want to own their company and ride it to gigantic Google/Facebook-like success. While "defensive IP" is of some importance in a company sale situation, it is critical in a "I'm building my company into a monster" situation. Companies looking for this non-exit will want to get legal advice about the impact of joining patent risk mitigation groups, such as RPX, Unified Patents, or LOTNETWORK. It is inevitable that a big enough company will eventually infringe somebody's IP. If that IP owner is a non-practicing entity, patent risk mitigation groups might help. If that IP owner is a competitor, having an IP portfolio that can be traded (i.e. cross-licensed) is crucial. If your company is sued for infringement, a common out for both parties is to cross-license their IP (and sometimes exchange money if one party's portfolio is more valuable than the other party's portfolio).

We Want Insurance Against Failure:  A well known cautionary tale about how the superior technology can fail is the competition between VHS and Beta video tape. Beta was the superior format, yet VHS eventually dominated the market and put Beta under. Even if your company has the best product, marketed in the best way, your company could fail. However, your patents and other IP can make that failure less painful by allowing you to recover some of, all of, or more than your initial investment. Consider the ExampleSearch example above. If Google decides to simply outcompete ExampleSearch, they could literally devote billions of dollars to a rapid development cycle and be on the market and competing with you in days. Sometimes this kind of thing happens under a theory called efficient infringement. However it comes about, having issued (or even pending) patents allows you to approach the infringer (probably after partnering with an entity with enough money to be able to sue the tech giants without being destroyed by the legal fees) and seek (preferably through negotiation, but frequently through litigation) recovery for infringement of your patents. This provides a parachute in the event that a giant company tries to push you out of the plane this way.

Grow Your IP Consistently With Your Exit Strategy: 

Exit strategies change, so the safest path is to follow all of the IP protection pathways. However, IP protection doesn't come cheaply for small companies and independent inventors (spending $100,000 to get a patent issued in the major economies may be no big deal to a trillion dollar company, but catastrophic for a small company). In this case, you need to speak with an IP strategist to help you prioritize how to spend your IP budget.

Get an IP Strategist: 

An IP strategist is somebody who can help you determine how much money to spend and what to spend it on when it comes to efficiently and effectively obtaining IP protection. An IP strategist needs to understand what can be protected (a determination that is a heavy lift requiring legal training for US patents), the cost of that protection, and the business value of that protection. In addition to understanding the legal side of IP, the strategist needs to understand your business needs, your cash flow and projections, your exit strategy, your competitors, and the existing IP landscape (you don't want to crash into a wall of patents a competitor holds).

Those who read this blog regularly will know that we don't use it to expressly direct people to us. Of course we hope that customers come to Coleman & Horowitt because they like the content, but this is the first time I am expressly suggesting talking to us. I'm breaking my "no express self-promotion" rule because there are very few people who have the expertise to provide IP strategy advice.

As an inventor (closing in on 250 issued patents), an entrepreneur (sold companies and patents, licensed patents -- many times but all subject to non-disclosure agreements) and a lawyer, I am one of the few people with the expertise in all of the requisite areas. You want an advisor who has walked in your shoes, who has the hard experience that comes with IP entrepreneurship, and who understands how IP fits your goals.

I'm sure there are others out there with the requisite expertise, but they are few and far between. 

SCOTUS: Trademark Licensees Retain Their Rights To Use Debtors’ Trademarks Despite Rejection Of The License

            On May 20, 2019, the Supreme Court handed down an 8 -1 opinion in MissionProduct Holdings, Inc. v. Tempnology, LLC, holding that a debtor’s rejection of a trademark license under Bankruptcy Code § 365 does not revoke the licensee’s trademark license or deprive the licensee of its rights to use the trademark.  Instead, the Court concluded that the debtor’s rejection has the same effect as a breach of contract outside bankruptcy; it does not rescind the contract and all rights that would ordinarily survive a breach of contract remain in place. 

            This case arises from a licensing agreement between a debtor/licensor, Mission Product Holdings, Inc. (Mission) and Tempnology, LLC (Tempnology), for the use of Tempnology’s trademarks (logos and labels for “Coolcore”) on manufactured clothing and accessories.  The agreement provided Mission with an exclusive license to distribute Coolcore products in the United States and a non-exclusive license to use the trademarks in the United States and around the world.  The agreement was set to expire in July, 2016.  In September 2015, Tempnology filed for Chapter 11 bankruptcy and asked the court to allow it to reject the Mission licensing agreement under Section 365. 

            Section 365 of the Bankruptcy Code enables a debtor to “reject any executory contract” – meaning a contract that neither party has finished performing, thus allowing a debtor to decide whether a particular contract is a good deal for the estate going forward.  This is especially important when a debtor is reorganizing under Chapter 11.  Rejecting the contract constitutes a breach of contract, giving the licensee a pre-petition claim against the estate for damages as a result of the nonperformance. 

In this case, the Bankruptcy Court held that even though Section 365 allows, for example, a tenant to stay and pay rent for the duration of a property lease despite a bankrupt landlord rejecting the lease, or allows certain intellectual property (e.g. patent) licenses to remain in place despite rejection, Section 365 does not reference trademark licenses and, therefore, does not apply to the facts of this case.  The Bankruptcy Appellate Panel (BAP) reversed, noting that while a rejection can convert a debtor’s unfilled obligations to a pre-petition claim, it does not vaporize the counterparty’s rights.  The First Circuit Court of Appeals rejected the BAP’s reasoning and reinstated the Bankruptcy Court’s decision to terminate the license, finding that because special features of trademark law include licensors monitoring and exercising quality control over goods associated with their trademark, if a licensor is forced to carry on these monitoring activities, it would frustrate “Congress’s principal aim in providing for rejection,” which is to release the debtor’s estate from burdensome obligations. 

            Interestingly, the Supreme Court disagreed with the First Circuit and agreed with the BAP, concluding that Congress intended, except in very limited cases, for parties to retain rights after rejection of an executory contract, and trademark licenses should not be any different.  Thus, rejection of a trademark license in bankruptcy is treated as a breach, not a rescission.  As to the concerns about ongoing monitoring, the Supreme Court found that while Congress considered the burdens on the debtors when certain contracts are rejected, it also weighed the “legitimate interests and expectations of the debtor’s counterparties.” In the case of trademark licenses, the ruling clarifies that the legitimate interests and expectations of the trademark licensee outweigh the burdens on the debtor, and the licensees rights remain in place after rejection. 

Authored by:

Jennifer T. Poochigian

Q&A: How to use trademark to protect against cybersquatting

Cybersquatting is when a third party registers a domain name that really should be yours.  For example, if my company's name is "Fresno Widgets" and I register fresnowidgets.com, I would be very unhappy to learn that a competitor or a prankster (or, most likely, somebody who wants to sell the names back to you at 100 times their cost) has registered fresnowidgets.org and fresnowidgets.net.

This used to be a substantial problem.  However, two things have mitigated this problem, and they both require that you obtain a trademark on your company's name.

The first is 15 U.S.C. § 1125(d), which provides that in cases of bad faith cybersquatting on a trademarked name, damages can be obtained (up to $100,000 in statutory damages is available in the event that you cannot prove that much in actual damages).  Of course, the United States had strong free speech protection, and to the extent that the First Amendment continues to hold judicial sway, there is a free speech defense to such cases.  For example, if I register "NRApoliciesKILL.com" or "NRApoliciesRULE.com", and proceed to post a bunch of my opinions on gun control, no amount of trademark protection will overrule my right to express my opinions.  So fresnowidgetssucks.com is unlikely to trigger liability under the statute.

The second is the Uniform Domain Name Dispute Resolution Policy.   Under this policy, the owner of a trademark can strike back at cybersquatters without going to court.  There is an expedited administrative procedure that can give ownership of  domain names to a trademark holder in months.

Coleman & Horowitt attorneys have experience with domain name issues, and would be happy to help.  Perhaps more importantly, Coleman & Horowitt can help you get a registered trademark for your company's name, dramatically improving your chances of recovering domain name variants.  This way, if you own fresnowidgets.com, you can gain control of fresnowidgets.org and fresnowidgets.net from your non-trademark-protected competitor.
 

If a patent is expired, can it be used freely by everybody?

It is important to remember that a patent does not give anybody the right to do what the patent covers. For example, if I had a patent on a more effective delivery system for MDMA or LSD, having a patent doesn't change the fact that those drugs are considered Schedule 1 and illegal under almost every circumstance -- meaning that my delivery system couldn't be used even though I had a patent on it.

While a patent doesn't give the patentee the right to practice the invention, it does give them the right to sue people to stop them from using the invention (or to recover financial damages). The expiration of a patent simply means that the owner of that patent can no longer sue anybody for using the inventions claimed in the patent.

Those things together mean that the impact of expiration of a patent on the ability to freely copy what was patented is limited. Taking the game "monopoly" as an example, the game was initially covered by a patent, by copyright, and by trademark law (though it does seem likely that recent Supreme Court decisions may have rendered that game not patentable today). When the patent expired, the copyright and trademark in the game remained in place. So while a company could sell a game with the same game-play mechanics that were claimed in the patent without fear of being sued for infringing the patent, that company could still be sued if they violate the copyright to the game or call it "Monopoly".

The bottom line is that the expiration of a patent simply means that the patent is no longer in play (sometimes subject to revival for unintentional or unavoidable delay in paying maintenance fees). However, there are other intellectual property rights (copyright, trade secret, trademark, trade dress, state-level trademarks, rights of publicity, etc.) that can give rise to significant liability. The expiration of the patent will not impact those other rights. The mere expiration of a patent does not mean that anybody can freely practice everything in the patent until they are satisfied (preferably by a lawyer's opinion letter) that what they intend to do is (a) legal, and (b) does not violate any other IP rights.

The other thing about patents is that it is common for a single patent application to result in numerous patents. There is even a thing called a "terminal disclaimer" that is used when a second patent claims something not significantly different than the first patent. Because patent maintenance fees are expensive, infrequently a patent owner will allow one patent to go expired for non-payment of fees, counting on other patents in the family to cover the same material. You'll want to go to https://portal.uspto.gov/pair/PublicPair and look up the expired patent. First, make sure it is really expired. Second, check the "continuity" tab and see if there are other patents still in force (or pending applications) in that patent family.

Perhaps most importantly, you need to seek proper legal advice. A good IP lawyer should be able to walk you through it. It is tough to provide a firm answer in the abstract, and the facts specific to what you want to do will be critical in having a lawyer give you the right answer.

U.S. Supreme Court holds that a copyright claimant may not file infringement suit until the Copyright Office registers a copyright

Although an author automatically gains copyright protection for her work immediately upon the work’s creation, an author may not file an infringement action in court until “registration of the copyright has been made” in accordance with the Copyright Act. The Supreme Court was recently called upon to resolve a split amongst the circuit courts regarding when registration of a copyright is deemed made.

Some circuits held that a registration of a copyright is made as soon as the claimant delivers the required application, copies of the work, and fee to the Copyright Office; other circuits held that registration is made only after the Copyright Office reviews and registers the copyright. The Supreme Court in Fourth Estate v. Wall-Street.com,LLC resolved the split by holding that registration occurs, and a copyright claimant may commence an infringement suit, when the Copyright Office registers a copyright. The Court further held that, upon registration of the copyright, however, a copyright owner can recover for infringement that occurred both before and after registration.

Fourth Estate Public Benefit Corporation is an online news producer that licensed articles to Wall-Street.com, LLC, a news website. The license agreement required Wall-Street to remove from its website all content produced by Fourth Estate before canceling the agreement. Wall-Street canceled, but continued to display articles produced by Fourth Estate. Fourth Estate sued Wall-Street and its owner for copyright infringement. Because the Copyright Office had not yet acted on Fourth Estate’s registration applications, the District Court, on Wall-Street’s motion, dismissed the complaint. The Eleventh Circuit affirmed the dismissal.

The Supreme Court’s ruling of course has no effect on the statutory scheme that allows for preregistration infringement suits to be filed in limited circumstances. Claimants are still allowed to bring suits under those statutes, provided that they eventually make registration as required to maintain their suits.

The Court’s ruling in Fourth Street means that many copyright suits currently in progress are not ripe for adjudication and can likely be dismissed on motion. It is also important to note that, while the Court’s ruling allows claimants to sue for infringement occurring prior to registration, nothing provides for the tolling of the statute of limitations while the Copyright Office processes registration. With a three-year statute of limitations for copyright infringement, and an average application processing time of seven months, parties should not delay in getting their applications on file. 

Authored by:
Brandon Hamparzoomian

SCOTUS Finds An Inventor's Sale of Product to Third Party can Qualify as Prior Art 35 U.S.C. § 102(a)

In Helsinn Healthcare v. Teva Pharmaceuticals USA, the Court affirmed a Federal Circuit decision invalidating the patent for Helsinn=s nausea drug Aloxi, based on patent law=s Aon sale@ bar.  In short, the Court found that the sale of an invention to a third party who is obligated to keep the invention confidential by agreement may place the invention “on sale” for purposes of the Leahy‑Smith America Invents Act (AAIA@), which bars a person from obtaining a patent on an invention that was Ain public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.@  An exception to the on sale bar is made if a sale or offer to sell is made 1 year or less before the effective filing date of a claimed invention, and certain other conditions are met.  

The facts of the case are as follows.  While Helsinn was in development of a drug, which uses the active ingredient palonosetron to treat chemotherapy‑induced nausea and vomiting, it entered into two agreements with a third party, MGI Pharma, Inc., a license and supply and purchase agreement.  These agreements gave MGI the right to distribute, promote, market and sell two specific dosages of the palonosetron in the United States.  In exchange, MGI made up-front payments to Helsinn and agreed to future royalties on distribution.  Most importantly, the agreements required MGI to keep confidential any proprietary information regarding palonosetron.  The agreements were disclosed to the public in a joint press release and related filings with the SEC, but the specific dosage formulations covered by the agreements were not included in the disclosure.

On January 30, 2003, nearly two years later, Helsinn filed a patent application covering the two doses of palonosetron.  Over the next 10 years, it filed additional patent applications, all claiming priority to the January 30, 2003 date.  Years later, Teva Pharmaceuticals sought FDA approval to market a generic palonosetron at one of Helsinn=s dosages.  Helsinn brought suit claiming the product infringed its patent.  Teva argued that the fourth patent was invalid because the specific dose was Aon sale@ more than one year before Helsinn filed its initial patent application in 2003.  The District Court held that the “on sale” provision did not apply because the public disclosure of the agreements did not disclose the specific dosages.  The Federal Circuit court, however, reversed, and concluded that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the terms of the agreements.

            In a unanimous ruling, SCOTUS found that an inventor=s commercial sale of an invention to a third party invalidates the patent, even if the third party is obligated to keep the invention confidential due to the “on sale” bar.  The Court recognized that the pre-AIA statute included the “on sale” bar and noted the precedent that secret sales could invalidate a parent.  It then applied the presumption that Congress intended the same with the AIA, which includes the same “on sale” language.  Further, the Court found that the addition of the catchall phrase “or otherwise available to the public” is not enough of a change from the pre-AIA statute to conclude that Congress intended to alter the meaning of “on sale.”

The practical application and effect of this ruling is interesting to note.  On the one hand, a modest inventor can argue that upholding the Federal Circuit=s decision would discourage innovation in the biotech sector, particularly among small or start-up companies who lack resources to have their drugs developed and distributed in-house, as they frequently rely on third party investment and partnerships which can help with costs of further research and development. Third party investments and partnerships, however, subjects them to the “on sale” bar and can discourage them from engaging in time-consuming and costly research, because it causes them to lose the ability to receive patent protection.  Also, being forced to file costly patent applications for the sole purpose of avoiding future patentability issues will further discourage small businesses from entering the industry, especially when their invention has not been tested to be commercially viable.

On the other side, competitors can argue that the Aon sale@ bar is triggered only when the invention is at a stage when it is ready for patenting and sale, or when the inventor is ready to start making profits before patenting it, and thus, the Aon sale@ restriction is appropriate.  Further, a one-year grace period provided in the AIA is sufficient in which to assess commercial viability.

In any event, all inventors should be aware of the fact that this decision has vast implications for patent-holders in the United States as well as for investors intending to sell their invention pre-patent application.

Authored by:

Jennifer T. Poochigian