Tag Archives: Enablement

Transocean v. Maersk: Speeding Up Deepsea Drilling

Enablement, Infringement, Obviousness, Patent, ,
By Jason Rantanen

Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc. (Fed. Cir. 2010)
Panel: Gajarsa, Mayer, Moore (author)

Drilling rigTransocean brought suit against Maersk for infringement of three patents relating to an improved apparatus for offshore drilling.  Offshore drilling involves lowering a variety of equipment, including the drill bit, a series of long pipes, and a blow-out-preventor, to the ocean floor in order to drill and stabilize a borehole that reaches a subterranean oil reservoir.  These components are moved by a derrick (the tower on the picture to the right), which is equipped with a station that raises and lowers them to the ocean floor.  To begin the drilling process, the rig lowers the drill bit to the ocean floor, adding sections of pipe until the bit reaches the floor.  Periodically as the drill descends into the seabed, it must be brought back up to the surface so that casings can be inserted into the borehole.  Conventional rigs utilized a derrick with only a single station for performing these steps, thus requiring that they be performed sequentially – a time consuming process. 

The patents-in-suit describe a derrick that includes two stations – a main advancing station and an auxiliary advancing station – that can each assemble the strings of drilling materials and lower them to the ocean floor.  According to the patent, this "dual-activity" rig can significantly decrease the time required to complete a borehole.  The accused infringer, Maersk, contracted with a U.S. company to build a rig with two stations for use in the Gulf of Mexico.  However, prior to delivery of the rig, Maersk implemented a modification that, it argued, precluded Transocean from claiming infringement.  It also argued that the claims were invalid.

The district court granted summary judgment in favor of Maersk, holding that the asserted claims were obvious and not enabled.  The court further ruled that Maersk's activities did not constitute either an offer for sale or a sale within the United States.  Transocean appealed these rulings, along with the district court's grant of summary judgment of collateral estoppel and no willful infringement.

Obviousness
The Federal Circuit's obviousness ruling is notable because, although it found that the references cited by Maersk created a prima facie case of obviousness, it concluded that the district court had erred by ignoring Transocean's significant objective evidence of nonobviousness.  This included evidence of industry skepticism about a dual drill string approach, industry praise for its dual activity rig, copying, and commercial success, in that its dual activity rigs commanded a higher licensing premium then standard rigs.  Although Maersk presented counter evidence, the Federal Circuit concluded that it was improper to resolve these disputes on summary judgment. 

Enablement
The Federal Circuit also reversed the grant of summary judgment of lack of enablement, finding that factual issues precluded such a ruling.  In particular, it noted that while the patent must enable one of ordinary skill in the art to practice the claimed invention without undue experimentation, it does not need to enable the most optimized configuration (unless it is an explicit part of the claims). 

Infringement
The district court's noninfringement ruling did not rest on a comparison of the accused device to the claim, but rather on a conclusion that there was no offer for sale or sale within the United States.  Although the contract at issue was between two U.S. companies, and specified an "Operating Area" for the rig that was in U.S. territorial waters, it was negotiated and signed outside of the United States.

The Federal Circuit disagreed that these activities fell outside the scope of 35 U.S.C. 271(a).  With respect to the "offer for sale" provision, after reviewing the legislative history of this language, analyzing its literal text, and considering the policy implications, the court concluded that it covered a contract between two U.S. companies for performance in the U.S., regardless of whether it was negotiated or signed within the U.S.  Likewise, the court concluded that, because the contract was for the sale of a patented invention with delivery and performance in the U.S., it constituted a sale for purposes of 271(a) as  a matter of law.

Note: Although the court used the term "patented invention," it was careful to note that there remained a dispute over whether the rig described in the contract actually infringed the patents-in-suit.

The Federal Circuit did, however, affirm the district court's ruling that Transocean was collaterally estopped from arguing that the rig Maersk ultimately delivered infringed the patents.  In another litigation, Transocean had obtained by an injunction requiring the defendant GlobalStantaFe Corp. ("GSF") to make a particular modification to its rig in order to avoid infringing the patents-in-suit.  Prior to delivering the rig to the United States, Maersk had learned about this injunction and made the relevant modification.  The Federal Circuit concluded that the ruling in the GSF litigation estopped Transocean from arguing that rigs with the modification infringed its patents.

The panel also affirmed the district court's ruling of no willful infringement, concluding that Maersk's activities were insufficient to create an objectively high risk of infringement.

Michel & Nothhaft: Inventing Our Way Out of Joblessness

Articles and Publications, Fees, Patent,

Judge Paul Michel and Hank Nothhaft (Tessera CEO) have written an important OP-ED for the New York Times. They argue that an important way for the US government to stimulate entrepreneurship and job growth is by giving the USPTO a large bolus of money ($1 billion) to put its affairs in order:

This would enable the agency to upgrade its outmoded computer systems and hire and train additional examiners to deal with the threefold increase in patent applications over the past 20 years. Congress should also pass pending legislation that would prohibit any more diverting of patent fees and give the office the authority to set its own fees.

. . . .

To be sure, not every patent creates a job or generates economic value. Some, however, are worth thousands of jobs — Jack Kilby’s 1959 patent for a semiconductor, for example, or Steve Wozniak’s 1979 patent for a personal computer. It’s impossible to predict how many new jobs or even new industries may lie buried within the patent office’s backlog. But according to our analysis of the data in the Berkeley Patent Survey, each issued patent is associated with 3 to 10 new jobs.

In addition, the pair suggests an “innovation tax credit” for each patent received by a small business:

To encourage still more entrepreneurship, Congress should also offer small businesses a tax credit of up to $19,000 for every patent they receive, enabling them to recoup half of the average $38,000 in patent office and lawyers’ fees spent to obtain a patent. Cost, after all, is the No. 1 deterrent to patent-seeking, the patent survey found.

For the average 30,000 patents issued to small businesses each year, a $19,000 innovation tax credit would mean a loss of about $570 million in tax revenue in a year. But if it led to the issuance of even one additional patent per small business, it would create 90,000 to 300,000 jobs.

Taken together, fully financing the patent office and creating an innovation tax credit could mean as many as 2.5 million new jobs over three years, and add up to 600,000 more jobs every year thereafter.

It only makes sense to help innovative small businesses make their way to the patent office and, once there, find it ready to issue the patents that lead to new jobs.

I have quibbles with the numbers used by the authors. However, I do think that they are on the right track in a few respects — especially with the idea that investing in incentives to innovate is a much more cost-effective and stable policy approach as compared with hiring folks to do government work.

Notes:

  • As academic quibbles: 
    • The statement that “each issued patent is associated with 3 to 10 new jobs” cannot be derived from the Berkeley Patent Survey.  However, I don’t see that figure as unreasonable or unlikely. It would be helpful to see how the authors calculated this figure.
    • In addition, it is important to recognize that patents are just one step along the road toward job creation. The idea is that patents can provide confidence and stability in business potential ventures.  That confidence and stability leads to investment and job creation.

Prometheus v. Mayo: En Banc Petition on Patentability of Medical Methods

En Banc, Patent,

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)(on petition en banc)

by Dennis Crouch

In the wake of the Supreme Court ruling in Bilski v. Kappos, Mayo has petitioned the Court of Appeals for the Federal Circuit to sit en banc to re-hear its statutory subject matter challenge to the Prometheus  patents. (U.S. Patents 6,355,623 and 6,680,302).

The Prometheus Claims are directed toward an iterative approach of dosing an active drug ingredient (6-thioguanine).  Most of the claims are centered around three ordered-steps of:

  1. administering a dose of the drug to the subject;
  2. determining the amount of the drug in the subject’s blood; and
  3. re-calibrating the drug dosage.

A broader claim (claim 46 of the ‘632 patent) does not require the administering step of claim 1 above.

In its 2006 decision, The district court held the Prometheus patents invalid under Section 101 — holding that the claims preempt all practical uses of a natural phenomenon.  On appeal, the Federal Circuit reversed that decision — that the claims satisfied the Machine-or-Transformation test. Namely, the Federal Circuit panel held that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”

The transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined. Because the claimed methods meet the transformation prong under Bilski, we do not consider whether they also meet the machine prong. . . . [C]laims to methods of treatment . . . are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition. . . .

[T]he determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.

Preemption: The original appellate panel addressed preemption issue somewhat indirectly — holding that the claims could not preempt a fundamental principle because they passed the machine-or-transformation test: “Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.”

Following its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus holding and remanded for further proceedings. 

Not Concentric: Some have described the Supreme Court’s Bilski v. Kappos holding as situated somewhere between the broad State Street decision and the narrow machine-or-transformation test. (See Joe Mullin’s article quoting Mark Lemley as saying “Now we're halfway in between.”).  However, Supreme Court’s vacatur in Prometheus suggests that there are cases that would have been patentable under the strict machine-or-transformation test but that are no longer patentable.  (Otherwise, the court could have simply denied Mayo’s petition for a writ of certiorari as it did in Fergusun.) 

Roadmap: The machine-or-transformation test offers a clue to the existence of Section 101 qualifying subject matter. However, Prometheus may well present a situation where the claims satisfy MoT, but fail because of their preemptive nature. In its brief, Mayo argues that the three-justice opinion dissenting from the dismissal (DIG) provides a “roadmap” for this case.

Provisional Patent Applications

Patent, Provisional Patent Application

The number of provisional patent application filings continue to rise.  Well over 100,000 provisional patent applications have been filed each of the past five years.

For many, provisional applications are seen as a low-cost mechanism for claiming a priority date and for delaying the eventual higher cost of drafting and filing a non-provisional application. (A Google search for “provisional patent” resulted in ads for “$99 provisional patent”, “$139 provisional patent”, etc.) Others (especially those in the pharmaceutical industry) use provisional applications as a way to claim an additional year of at the end of the patent term.

Many patent attorneys criticize the use of provisional applications as a low-cost pathway — arguing that approach leads to a false sense of security because the low-quality applications will be insufficient to satisfy the disclosure requirements for later priority claims.

I am working on a project that looks at how patent applicants are using provisional patent applications.  The heart of the project attempts to determine whether the provisional disclosure properly enables and describes the invention as eventually claimed. Those results are still pending. However, I thought I would present some preliminary information about the provisionals in our study.

Results: One of the low-cost benefits of provisional applications is that they have no formal requirements. Thus, a printed PowerPoint presentation, whitepaper, or circuit diagram could each serve as a provisional application.  Patent claims are not required. However, we’re finding that about 60-70% of provisional applications are filed with at least one claim.  About 50–60% really look like non-provisional patent applications.  Around 15% of the provisional applications are essentially a stack of presentation materials. Almost all of the provisional applications are computer generated (rather than handwritten).

 

 

Judge Plager: “The Walls Surrounding the Claimed Invention [Should] be Made of Something Other than Quicksand”

Patent, , ,

Enzo Biochem and Yale University v. Applera Corp. (Fed. Cir. 2010)

The district court initially held Enzo’s patent claims invalid as indefinite because of the ill-defined term “not interfering substantially.” On appeal, the Federal Circuit reversed — finding that the someone of skill in the art “would understand what is claimed.”

Applera requested a panel rehearing and rehearing en banc which the Federal Circuit recently denied. However, as part of that denial, Judge Plager penned an important dissent — arguing that indefiniteness law should be given more teeth and that claim construction commands too large of a role in the litigation process.

“In my view, this court’s definiteness doctrine could go considerably further in promoting that objective than it currently does, with the not inconsequential benefit of shifting the focus from litigation over claim construction to clarity in claim drafting. . . . The court now spends a substantial amount of judicial resources trying to make sense of unclear, over-broad, and sometimes incoherent claim terms. It is time for us to move beyond sticking our fingers in the never-ending leaks in the dike that supposedly defines and figuratively surrounds a claimed invention. Instead, we might spend some time figuring out how to support the PTO in requiring that the walls surrounding the claimed invention be made of something other than quicksand.”

PatentLawPic990Read the full dissent here:

Judge Plager: I respectfully dissent from the denial of the petition for panel rehearing on the question of indefiniteness.

Despite the varying formulations that this court has used over the years in describing its “indefiniteness” jurisprudence . . . , the general conclusion from our law seems to be this: if a person of ordinary skill in the art can come up with a plausible meaning for a disputed claim term in a patent, that term, and therefore the claim, is not indefinite. At least not so indefinite as to run afoul of the statutory requirement that claims shall “particularly point[ ] out and distinctly claim[ ] the subject matter which the applicant regards as his invention.” 35 U.S.C. § 112, second paragraph.

The corollary derived from this understanding is that if several persons of ordinary skill come up with competing but plausible interpretations of a disputed terms is typically the case with competing “expert witnesses” in patent infringement litigation—the problem is not one of an inherently ambiguous and potentially indefinite claim term, but rather the problem becomes simply one of picking the “right” interpretation for that term. Since picking the “right” interpretation—claim construction—is a matter of law over which this court rules, and since the view of the trial judge hearing the case is given little weight, so that the trial judge’s view on appeal becomes just a part of the cacophony before this court, it is not until three court of appeals judges randomly selected for that purpose pick the “right” interpretation that the public, not to mention the patentee and its competitors, know what the patent actually claims. The inefficiencies of this system, and its potential inequities, are well known in the trade.

The United States Patent and Trademark Office (“PTO”), by contrast, appears to be taking steps to give the statutory requirement real meaning. In 2008, the patent examining corps was given a five-page instruction on “Indefiniteness rejections under 35 U.S.C. 112, second paragraph.” The memo initially observes that “[t]he primary purpose of the definiteness requirement for claim language is to ensure that the scope of the claims is clear so that the public is informed of the boundaries of what constitutes infringement of the patent.” The memo reviews in detail a recent opinion of this court, following which the memo states the position of the PTO: “If the language of a claim, considered as a whole in light of the specification and given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpre-tation then a rejection of the claim under 35 U.S.C. 112, second paragraph, is appropriate.”

This memo was followed later in the year by a rare precedential opinion issued by the Board of Patent Appeals and Interferences (“Board”) in Ex parte Miyazaki. The Board noted that this court has in post-issuance patent infringement cases held “that the definiteness requirement ‘does not compel absolute clarity’ and ‘[o]nly claims “not amenable to construction” or “insolubly am-biguous” are indefinite.’” Recognizing that this court has never set forth a different standard of review for indefiniteness under 35 U.S.C. § 112, second paragraph, for pre-issuance pending claims as compared with post-issuance patent claims, the Board concluded that the Federal Circuit’s reading of the indefiniteness requirement was counter to the PTO’s broader standard for claim construction during prosecution. Accordingly, the Board announced that, “rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.”

The Board is clearly right in recognizing that the circumstances are different between pre-issuance and post-issuance application of the definiteness standard with regard to claim terms. At the same time, the PTO and the Board are clearly right in insisting that, if the public notice function of the patent law is to be honored, claim terms must particularly point out and distinctly claim the subject matter of the invention. In my view, this court’s definiteness doctrine could go considerably further in promoting that objective than it currently does, with the not inconsequential benefit of shifting the focus from litigation over claim construction to clarity in claim drafting.

To begin the discussion of how this court could move in that direction, I would grant the petition for panel rehearing. The court now spends a substantial amount of judicial resources trying to make sense of unclear, over-broad, and sometimes incoherent claim terms. It is time for us to move beyond sticking our fingers in the never-ending leaks in the dike that supposedly defines and figuratively surrounds a claimed invention. Instead, we might spend some time figuring out how to support the PTO in requiring that the walls surrounding the claimed invention be made of something other than quicksand.

I respectfully dissent from the loss of that opportunity through the panel’s denial of rehearing.

Substantially: As a claim limitation, “substantially” is being used less frequently than ever before. The chart below shows the percentage of issued patents that include “substantially” as a claim limitation. The data is grouped accourding to the patent issue year. (For the 1980’s and 1990’s, I grouped the data by decade.)

PatentLawPic991

PatentLawPic992

 

 

 

Donald Chisum: Ariad (2010) and the Overlooked Invention Priority Principle

Patent, , ,

In a new essay for the Patently-O Patent Law Journal, Donald Chisum considers the "invention priority principle" and its role in the written description analysis. 

There may be a solution: application of an established patent law priority principle. The principle focuses on a specific embodiment of a generically claimed invention as a constructive reduction to practice, that is, as a completion of the inventive process. Adopting this solution would preserve the written description of the invention's (WDIs) independence and applicability to original claims but would remove WDI as a standard for assessing the scope of a patent claim. WDI would continue to govern whether, at the time an applicant files an application, he or she has completed the inventive process, that is, "possesses" the invention. But only enablement would govern how broadly the applicant is entitled to claim that invention. It may be possible to implement this priority principle interpretation of Ariad without contradicting its clear holdings.

Cite as Donald S. Chisum, Written Description of the Invention: Ariad (2010) and the Overlooked Invention Priority Principle, 2010 Patently-O Patent L.J. 72.

Other Patently-O Patent Law Journal publications: 

Donald Chisum: Ariad (2010) and the Overlooked Invention Priority Principle

Patent, , ,

In a new essay for the Patently-O Patent Law Journal, Donald Chisum considers the "invention priority principle" and its role in the written description analysis. 

There may be a solution: application of an established patent law priority principle. The principle focuses on a specific embodiment of a generically claimed invention as a constructive reduction to practice, that is, as a completion of the inventive process. Adopting this solution would preserve the written description of the invention's (WDIs) independence and applicability to original claims but would remove WDI as a standard for assessing the scope of a patent claim. WDI would continue to govern whether, at the time an applicant files an application, he or she has completed the inventive process, that is, "possesses" the invention. But only enablement would govern how broadly the applicant is entitled to claim that invention. It may be possible to implement this priority principle interpretation of Ariad without contradicting its clear holdings.

Cite as Donald S. Chisum, Written Description of the Invention: Ariad (2010) and the Overlooked Invention Priority Principle, 2010 Patently-O Patent L.J. 72.

Other Patently-O Patent Law Journal publications: 

Donald Chisum: Ariad (2010) and the Overlooked Invention Priority Principle

Journal,

In a new essay for the Patently-O Patent Law Journal, Donald Chisum considers the "invention priority principle" and its role in the written description analysis. 

There may be a solution: application of an established patent law priority principle. The principle focuses on a specific embodiment of a generically claimed invention as a constructive reduction to practice, that is, as a completion of the inventive process. Adopting this solution would preserve the written description of the invention's (WDIs) independence and applicability to original claims but would remove WDI as a standard for assessing the scope of a patent claim. WDI would continue to govern whether, at the time an applicant files an application, he or she has completed the inventive process, that is, "possesses" the invention. But only enablement would govern how broadly the applicant is entitled to claim that invention. It may be possible to implement this priority principle interpretation of Ariad without contradicting its clear holdings.

Cite as Donald S. Chisum, Written Description of the Invention: Ariad (2010) and the Overlooked Invention Priority Principle, 2010 Patently‐O Patent L.J. 72.

Gary Locke: Patent Office Needs Self-Control of Funding and Enhanced Post-Grant Review

Patent, , ,

PatentLawPic985The following essay was written by Secretary of Commerce Gary Locke and originally published in Politico. Locke is the former Governor of Washington and former partner at Davis Wright Tremaine. As you may know, the US Patent & Trademark Office operates as a branch of the Department of Commerce. 

* * * * *

As Congress hurtles toward the midterm elections, there are two things everyone agrees Washington needs to keep working on: spurring job creation and promoting continuing economic recovery.

Fortunately, there’s legislation now before Congress that has bipartisan support, can boost our economy and doesn’t add a cent to our federal debt. This bill aims to fix the outdated patent system, which has left the U.S. Patent and Trademark Office with a backlog of 750,000 applications — a backlog that’s threatening America’s ability to innovate. 

And that’s a big problem, because innovation is the lifeblood of the U.S. economy. The introduction of new products and services accounts for three-quarters of America’s annual growth rate since World War II. This innovation is fueled by businesses, inventors and entrepreneurs who depend on patent protection to attract capital investment and to promote and protect their products and services in the global marketplace. Today, America’s patent system – and by extension our entire innovation system – isn’t working. As a result, we are jeopardizing our edge in the global economy.

America may still be a world leader in key metrics of economic success – like levels of entrepreneurship, R&D investment and IT infrastructure – but a report last year from the Information Technology and Innovation Foundation concluded that no advanced economy has done less than the United States to improve its competitive position over the past decade. President Barack Obama sees the urgency of this problem and has announced a formal National Innovation Strategy, which, among other things, calls for doubling the budgets of agencies like the National Science Foundation so they can better support the basic research that spawns new products and services.

But to unleash the full power of America’s innovators, we’ve got to repair an overloaded and inefficient patent system. The unacceptably long backlog at the patent office – in which the average time it takes to grant or deny a patent is more than 34 months – is a striking signal of the system’s dysfunction. Since taking over at the patent office last August, David Kappos has already made significant strides in reforming the workplace, improving productivity and boosting morale. These steps and others have been applauded by all sectors of the innovation community. But additional, desperately needed reforms require action by Congress. The Commerce Department just released a white paper that quantifies the effect America’s patent system has on the economy and job creation and describes the benefits of two key elements of pending patent reform legislation.

First, Congress will grant fee-setting authority to the patent office, which will enable it to adjust the actual costs of the services it provides. This could contribute significantly to the office’s ability to reduce the application backlog by 40 percent. Second, creating an enhanced post-grant review procedure within the office will provide an alternative to costly – and often lengthy – litigation. It could also provide greater marketplace certainty – at lower cost. This review procedure is expected to be 50-100 times less expensive than litigation.

The patent reform legislation being considered by both chambers will also improve patent quality, streamline the patent examination process, promote international harmonization of patent law and limit litigation expenses. All these provisions will foster innovation and contribute to long-term economic growth. As we move forward on reforming our patent laws, we need to remember that the ultimate goal is to create more American jobs that can provide dignity, security and a sense of hope for the future. After a decade fueled by speculation and short-term thinking, the United States needs to refocus on nurturing innovations that generate real value for society and spur sustainable job creation. It’s not the role of the federal government to predict or dictate exactly how this new economy will take shape. Our job is to create the right set of incentives, regulations and laws that allow innovators to experiment with new ideas, build new businesses and follow their dreams. Patent reform legislation is a key part of this strategy. To promote continued economic recovery, it is critical for Congress to create a business environment that fosters innovation and risk taking ‹ accelerating economic growth and job creation and expanding America’s ability to innovate. Now is the time to act. Congress should seize this opportunity and send patent reform legislation to the president’s desk. Gary Locke is the secretary of commerce.

Policing Priority: Nintendo Escapes Liability Based on Patentee’s Failure to Satisfy the Written Description Requirement

Patent,

PatentLawPic968Anascape v. Nintendo (Fed. Cir. 2010)

A jury found that the Nintendo Wii and GameCube infringe Anascape’s U.S. patent No. 6,906,700.  The ‘700 patent claims priority to a parent application and, as it turns out, needed that priority to avoid intervening prior art.  On appeal, the Federal Circuit found the asserted claims invalid — holding that parent application could not serve as a priority document because it did not describe the invention as claimed in the ‘700 patent.

In my recent article on antedating prior art, I suggest that the prevalent practice of quickly filing provisional and other patent applications has largely supplanted patentee’s need to prove a prior invention date.  In order to claim priority to an earlier-filed patent document, that document “must meet the requirements of 35 U.S.C. 112 p1, as to that claimed subject matter.”  These requirements include enablement, written description, and best mode.

Here, the focus was on whether the priority disclosure satisfied written description requirement for the newly added claims of the ‘700 patent. Anascape’s specific problem was that the priority document identified a single “input member” that could measure movement along six degrees of freedom while the ‘700 patent claims were directed toward a controller with multiple input members that each measured fewer than six degrees of freedom.

Written Description of the Invention: The ‘700 patent’s priority document discussed prior art game controllers that were operable with fewer than six-degrees of freedom.  In its analysis, the Federal Circuit refused to consider that disclosure as applicable to the written description requirement because that disclosure “is not a description of the [claimed] invention; [rather,] it is a description of prior art joysticks as generally used in video games.”

Writing in Concurrence, Judge Gajarsa writes that this particular use of the written description requirement is “best” and preferred use of the doctrine. Namely, written description should primarily be primarily used to police priority and new matter issues and other questions of inadequate disclosure should be handled by enablement.  In my recent study of the written description requirement, I found that the USPTO is largely following Judge Gajarsa’s guidance in asserting written description rejections primarily to police priority and new matter issues.

Notes:

  • This decision appears to eliminate what was likely a $100 million total payout for Anascape.  The decision also eliminates the permanent injunction that had been stayed pending appeal.
  • Anascape appears to be primarily owned by the inventor of the ‘700 patent, Brad Armstrong. Armstrong prosecuted the applications himself. Armstrong has several continuations pending. In addition, Anascape appears to have a still-pending (but stayed) litigation against Nintendo based on several more patents that are currently undergoing reexamination.
  • Microsoft was originally a defendant in this case, but settled in a confidential agreement.

Justifying the Decision in Ariad v. Lilly

Patent, ,

In Ariad v. Lilly, defenders of the written description requirement made two primary arguments: (1) that the text of the Patent Act and the accompanying jurisprudential history lead to the conclusion that the statute creates a separate written description requirement; and (2) that the written description requirement serves an important role in policing applicant behavior. An en banc Federal Circuit confirmed that the written description requirement is separate and distinct from enablement, but firmly based its decision on the first argument rather than the second. I believe that the Federal Circuit took the correct approach – especially in its substantial rejection of the second argument. In my recent essay, I wrote that – apart from its value in "new matter" rejections – the role of the written description requirement in ex parte prosecution is negligible. See An Empirical Study of the Role of the Written Description Requirement in Patent Prosecution, 104 NORTHWESTERN UNIV. L.R. Colloquy ___ (2010) (ssrn download). In that essay, I took no position on the larger issue of whether the written description doctrine is nevertheless required by the statute.

In his concurring opinion, Judge Gajarsa explicitly rejects the argument that the written description requirement is a necessary on policy grounds – writing that "[t]he empirical evidence confirms my belief that written description serves little practical purpose as an independent invalidity device [apart from policing priority]." Despite the lack of a policy justification, Judge Gajarsa concurred with the judgment "because the majority's opinion provides a reasonable interpretation of a less than clear statute."

Guest Post: Ariad v. Lily: Choosing to Not Disrupt the Settled Expectations of the Patent Community

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I asked Howard Skaist for his views on the recent decision in Ariad v. Eli Lilly. He wrote the following:

* * * * *

By Howard Skaist of Berkeley Law, LLC.

In an en banc case closely watched by the patent bar, the Federal Circuit made little change to the law regarding written description and provided little additional guidance, despite a majority opinion nearly 40 pages long, two concurrences, two dissents and having received 25 amicus briefs. At a high level, the case can probably be best understood as having been resolved on policy grounds in the face of an unclear statute and Supreme Court precedent that does not directly address the question at hand; however, policy is only a portion of the justification that the majority of the full court uses for the outcome. 

The fundamental question is whether or not a separate and independent written description requirement exists under 35 USC section 112, first paragraph.  The majority answers the question in the affirmative, relying on the language of the statute, Supreme Court precedent and policy considerations.  However, the concurrence and dissenting opinions demonstrate that this language of the statute is far from clear and that the Supreme Court precedent does not really address the question directly.  Therefore, the main division among the judges appears to rest on policy considerations.  In addition to the policy considerations regarding the advisability of a written description requirement, the majority apparently does not want to “disrupt the settled expectations of the inventing community….”  Majority Opinion at 16. 

The facts of this case suggest that it may have been a good one to test policy rationales since it was brought by a variety of academic and research institutions, including MIT and Harvard, against Eli Lilly.  The inventors had made a fundamental research discovery in biotechnology and hypothesized several possible ways to take advantage of it, but it took those working in the field several more years to successfully develop a product exploiting the discovery.  Therefore, at the core of this case, a legitimate question exists regarding the role or purpose of a patent system and how research or academic institutions should fare under existing legal standards.  Also telling is the citation by Gajarsa in his concurrence of work by Dennis Crouch and Chris Holman showing that few cases have invalidated claims based on written description.  Linn, in his dissent, also cites to Crouch’s work. 

Ariad and a variety of institutions sued Eli Lilly on US Patent 6,410,516 the day the patent issued.  The inventors were the first to identify NF-xB and uncover the mechanism by which it activates gene expression underlying the body’s immune response to infection.  Thus, the inventors recognized and suggested that artificially interfering with NF-xB activity could reduce harmful symptoms of certain diseases.  At the District Court level, a jury determined that Lily infringed the four claims asserted and determined the patent to not be invalid for anticipation, lack of enablement or lack of written description.  However, on appeal, the Federal Circuit reversed and held the patent invalid under 35 USC 112, first paragraph, for failing to provide an adequate written description.  Ariad petitioned for en banc review and the Federal Circuit granted the petition. 

In the en banc opinion, the majority does a good job clarifying the heart of the dispute by stating: “[A]lthough the parties take diametrically opposed positions on the existence of a written description requirement separate from enablement, both agree that the specification must contain a written description of the invention to establish what the invention is.  The dispute, therefore, centers on the standard to be applied and whether it applies to original claim language.”  The point of departure therefore appears to center more upon whether or not original claims can be held invalid for lack of written description or not.  The conventional view had been that a claim supports itself.  However, Federal Circuit decisions in the last few years have challenged that thinking, such as Fiers v. Revel, Enzo v. Gen-Probe and LizardTech v. Earth Res. Mapping.  Here, the Federal Circuit establishes that those decisions were correct. 

As alluded to above, the majority does not agree with Ariad’s arguments about the wording of the statute or its characterization of the relevant Supreme Court precedent.  However, Gajarsa, while concurring, states: “[T]he text of section 112, paragraph 1 is a model of legislative ambiguity.”  Likewise, even the majority, in discussing the Supreme Court precedent concedes: “Although the Court did not expressly state that it was applying a description of the invention requirement separate from enablement, that is exactly what the Court did.” Majority Opinion at 14. Therefore, Ariad’s points may have more substance than the majority concedes. Nonetheless, the Federal Circuit states that “[a]s a subsidiary federal court,” majority opinion at 15, it is obligated to follow such precedent.  The Federal Circuit, however, does directly address Ariad’s contention that original claims should be treated differently than amended claims saying that the distinction does not exist in the language of section 112 and that Ariad has not provided a principled basis for making the distinction being asserted.  Majority Opinion at 19. 

The court challenges directly the thinking that an original claim necessarily supports itself under written description: 

“Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”  Majority Opinion at 20. 

The majority does provide a few clarifying points regarding application of written description: 

“[The] hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”  Majority Opinion at 24 

The court also acknowledges the disadvantage that this law creates for basic research institutions: 

“[T]he patent law has always been directed to the ‘useful Arts,’ U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use, see Brenner v. Manson, 383 U.S. 519, 532-36 (1966). Much university research relates to basic research, including research into scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered. That is no failure of the law’s interpretation, but its intention.” 

Conceding that enablement and written description are similar, the court nonetheless maintains that in some fields they can be quite different, particularly in chemistry and biotech: 

“Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions. Thus, although written description and enablement often rise and fall together, requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.”

The Relevance of Invention Date in Patent Prosecution: Part III

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This is Part III of my series on the relevance of the invention date in patent prosecution. You may download my entire paper here. This part considers the role of provisional patent applications as an incomplete but functional substitute for invention-date rights. 

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With some caveats, I argue that provisional patent applications can serve as functional substitutes for reliance on the U.S. filing grace period. Provisional patent applications have become popular since being made available in 1995. The USPTO reports that applicants filed 143,030 provisional patent applications in fiscal year (“FY”) 2008, compared with 466,147 non-provisional utility applications that year. U.S. applicants file a great majority of these provisional applications Consequently, the provisional filings correspond to more than half of the annual total of utility applications filed by U.S. residents.

A provisional application is essentially a low-cost placeholder that allows an applicant to establish a priority date by filing a description of the invention along with paying an administrative fee to the USPTO. The applicant may later file a non-provisional application claiming the benefit of the provisional application’s filing date. The provisional patent application has a twelve-month non-extendable pendency. During that time-period, the application is kept secret and is not examined. Thus, to rely upon the provisional priority date, the applicant must submit a non-provisional application within one year of the provisional filing date. Professor Seymore notes several additional strategic advantages of filing provisional patent applications: “extending the patent term to twenty-one years, postponing the examination period, trolling for prior art, and avoiding an allegation of inequitable conduct.”

To explore the relevance of provisional patent applications as a tool for claiming priority, I created a dataset of 5000+ provisional patent applications filed between January 1, 2001 and October 1, 2007. Of those, over half (52%) were still secrete as not yet identified in the priority claim of any publicly available non-provisional application. Although some of these will eventually become public as associated with a non-provisional filing, in the end, close to 40% or more of the provisional application filings will never be linked to an issued patent or public non-provisional application.   Collectively, these figures indicate that a large number of provisional applications are themselves left floundering to be abandoned twelve months after filing. The large number of abandoned provisional applications suggests to me that provisional patent applications are likely being used as early place-holders to cheaply secure a priority date, rather than as a means of extending the patent term or postponing examination. In a separate study looking at the 620,000+ issued patents for which applications were filed between 2000 and 2005, I found that seventeen (17) percent of the patents in the data-set claim priority to at least one provisional application. On average, the patents claiming priority listed 1.4 provisional patent applications. In a separate study, I found that on average abandoned non-provisional applications tended to claim priority to 2.0 provisional patent applications. This combining of multiple provisional applications to support a single patent supports this theory that provisional applications as a substitute for filing date evidence. Notably, each provisional can serve as evidence of an incremental advance in place of a corroborated laboratory notebook. Anecdotal reports suggest that this practice has become especially prevalent among universities developing early stage innovations. However, the value of incremental provisional application filings is limited by the hard twelve-month deadline for filing a non-provisional application.

For an inventor who has conceived a new invention, the legal benefits of filing a provisional application, rather than relying on the invention date, are compelling. If the filing deadlines are met, a provisional patent application will serve as conclusive evidence of priority—without any need for any affidavits or declarations—so long as the provisional application discloses the invention claimed in the non-provisional application “in the manner provided by the first paragraph of section 112.” In other words, the specification of the provisional application must “contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable” an ordinarily skilled artisan to practice the invention claimed in the non-provisional application.

Unlike an applicant seeking to assert a prior invention date, an applicant claiming priority to a provisional application need not provide corroborated evidence—or indeed any evidence—of actual reduction to practice, conception date, or reasonable diligence in working toward reduction to practice. Rather, the USPTO and courts treat the filing of a provisional patent application as a constructive reduction to practice, thus allowing the applicant to rely on the simple evidence of the paper filing.

An oft-stated disadvantage of provisional application filings is that they may create a false sense of security among patent applicants. Certainly, a hastily-filed provisional patent application may fail to properly describe the invention to be claimed in a later-filed non-provisional application. However, the validity of this criticism does not suggest that applicants should merely rely upon the hope that they will possess sufficient evidence to antedate references based on a prior invention date. Rather, risk-averse applicants should quickly file a well supported application either in provisional or nonprovisional form.

Patently-O Bits and Bytes No. 327

Patent,
  • Supreme Court: My sense is that Ariad v. Eli Lilly has essentially no shot for Supreme Court review unless the Ariad can do a great job of convincing the court that the written description requirement as applied is (1) new and (2) is severely detrimental to the patenting of breakthrough inventions and discoveries.
  • Supreme Court: A decision in Bilski is expected in the next 6 weeks – perhaps as soon as March 30.

  • Upcoming events:

    • I am traveling the next 10 days or so, but have pre-written a set of interesting (in my view) blog posts.
    • On the 25th and 26th of March, I'll be speaking at the Miami-based IP Law Summit (then to Disney with the kids…).
    • April 27th, I'll be speaking in New York at the Corporate IP Counsel Summit
    • On April 30, I'll be speaking in Kansas City at a KCMBA IP law event.
    • On May 20, the Federal Circuit is hosting its annual conference with an all-star lineup.
    • Statute of Anne: Two competing conferences are being held on the 300th anniversary of the Statute of Anne (the first copyright statute). (If I were turning 300, I'd want at least two parties.) The first is on March 27 at Cardozo Law School in New York [Link] and the second is on April 9-10 at Berkeley Law School [Link]. Professors Peter Jaszi (American) and Daniel Gervais (Vanderbilt) will be speaking at both events.

Patently-O Bits and Bytes No. 327

Patent,
  • Supreme Court: My sense is that Ariad v. Eli Lilly has essentially no shot for Supreme Court review unless the Ariad can do a great job of convincing the court that the written description requirement as applied is (1) new and (2) is severely detrimental to the patenting of breakthrough inventions and discoveries.
  • Supreme Court: A decision in Bilski is expected in the next 6 weeks – perhaps as soon as March 30.

  • Upcoming events:

    • I am traveling the next 10 days or so, but have pre-written a set of interesting (in my view) blog posts.
    • On the 25th and 26th of March, I'll be speaking at the Miami-based IP Law Summit (then to Disney with the kids…).
    • April 27th, I'll be speaking in New York at the Corporate IP Counsel Summit
    • On April 30, I'll be speaking in Kansas City at a KCMBA IP law event.
    • On May 20, the Federal Circuit is hosting its annual conference with an all-star lineup.
    • Statute of Anne: Two competing conferences are being held on the 300th anniversary of the Statute of Anne (the first copyright statute). (If I were turning 300, I'd want at least two parties.) The first is on March 27 at Cardozo Law School in New York [Link] and the second is on April 9-10 at Berkeley Law School [Link]. Professors Peter Jaszi (American) and Daniel Gervais (Vanderbilt) will be speaking at both events.

Federal Circuit Confirms that Patents Must Meet Both the Written Description and Enablement Requirements of Section 112.

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Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2010) (En Banc Decision).

In a 9-2 decision, an en banc Federal Circuit has confirmed that 35 USC § 112 ¶1 includes separate written description and enablement requirements. “If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.” The court also clearly confirmed the prospect that originally filed claims can violate the written description requirement:

Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.

Possession vs Disclosure: The court did step away from “possession” as the hallmark of the written description requirement. Rather, the court wrote that “the hallmark of written description is disclosure. . . . [T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”

General Principles: The court presented “a few broad principles that hold true across all cases”: “the written description requirement does not demand either examples or an actual reduction to practice”; however “actual ‘possession’ or reduction to practice outside of the specification is not enough; and a “description that merely renders the invention obvious does not satisfy the requirement.”

Basic Research – Tough Luck: The court recognized that the written description requirement makes it more difficult to patent “basic research” that has not yet been fully reduced to a practical implementation. The court’s reaction to that problem was tough luck. “That is no failure of the law’s interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.”

That research hypotheses do not qualify for patent protection possibly results in some loss of incentive, although Ariad presents no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities. But claims to research plans also impose costs on downstream research, discouraging later invention. The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not “attempt[s] to preempt the future before it has arrived.” Fiers, 984 F.2d at 1171.

Holding: For the foregoing reasons, we hold that the asserted claims of the ‘516 patent are invalid for lack of written description, and we do not address the other validity issues that were before the panel. We also reinstate Part II of the panel decision reported at 560 F.3d 1366 (Fed. Cir. 2009), affirming the district court’s finding of no inequitable conduct. The majority opinion was written by Judge LOURIE and joined by Chief Judge MICHEL and Circuit Judges NEWMAN, MAYER, BRYSON, GAJARSA, DYK, PROST, and MOORE. Judges NEWMAN and GAJARSA filed concurring opinions.

Judges RADER and LINN each filed opinions in dissent. [I will write more on this later]

An Empirical Study of the Role of The Written Description Requirement in Patent Prosecution

Academic Studies, Articles and Publications, En Banc, Enablement, Patent, ,

Table 3[Download the Draft Essay]

Essay Overview: In the pending case of Ariad v. Eli Lilly, an en banc Federal Circuit is considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curiae brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role of the written description requirement in patent office practice. It is narrowly focused on rebutting the USPTO’s claim that the separate written description requirement serves an important role in the patent examination process. To the contrary, my results support the conclusion suggested by Chief Judge Michel during oral arguments that it is indeed “exceedingly rare that the patent office hangs its case on written description.”

For the study, I analyzed 2858 Board of Patent Appeals and Interference (BPAI) patent opinions decided January-June 2009. Written description issues were decided in 123 (4.3%) of the decisions in my sample. Perhaps surprisingly, I found that none of the outcomes of those decisions would have been impacted by a legal change that entirely eliminated the written description requirement of Section 112 so long as the USPTO would still be allowed to reject claims based on the addition of “new matter” (perhaps under 35 U.S.C. Section 132). New-matter style written description requirement rejections were outcome-determinative in 20 of the 2858 cases – about 1.0% of the cases in my sample. (I am very confident that the PTO will retain its ability to make new matter rejections even if the separate written description requirement is eliminated.)

Although there may be valid reasons for retaining a separate written description requirement, this study safely leads to the conclusion that the government’s conclusory statements regarding the doctrine’s critical importance for patent examination lack a factual basis.

Continue reading the essay. [PDF]

These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO , 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).

The Timeliness of the En Banc Rehearing of Hyatt v. Kappos

Patent,

The pending en banc case of Hyatt v. Kappos is more important now than ever before because the Board of Patent Appeals and Interferences (BPAI or Board) is deciding more appeals than ever before.  The chart below reflects the number of applications with completed appellate briefing that are pending resolution at the BPAI. As active patent prosecutors are well aware, this chart only reveals a small portion of a complex problem.  Appeal briefing has largely become an ordinary part of patent prosecution practice. Most cases where appeal briefs are filed do not actually reach a BPAI decision.  Rather, in most cases the examiner withdraws the standing rejection rather than pursue the appeal.  In this system, appeal briefs have largely become a priced commodity rather than an all-out factual and legal effort.

PatentLawPic928

In Hyatt v. Kappos, the en banc Federal Circuit is focusing on the amount of new evidence that can be presented when challenging a BPAI decision in Federal District Court under 35 USC 145.  The panel decision held that the district court properly refused to allow Hyatt to submit additional expert testimony that went beyond the arguments presented to the BPAI.  Judge Moore dissented from that holding and instead argued that the right to a “civil action” under Section 145 includes a right for a de novo consideration of patentability.

The issues raised in Hyatt v. Kappos are now important for many patent applicants because of the cost-pressures of appeal briefs and the high-likelihood that rejections will be withdrawn based on the briefing.  Typical Applicants do not submit substantial additional evidence of patentability during the appeal process.  However, under Hyatt, the applicant would be barred from substantially adding to the record in a subsequent civil action.

Appealing a BPAI Rejection: Can the Applicant Present New Arguments and New Evidence to the District Court?

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Hyatt v. Kappos (Fed. Cir. 2010)

The Federal Circuit has ordered an en banc rehearing of its August 14 decision. The appeal focuses on evidentiary and procedural limits of an appeal of a BPAI decisions to a District Court under 35 USC 145. The Court framed the en banc issues as follows:

(a) Are there any limitations on the admissibility of evidence in section 145 proceedings? In particular—

(i) Does the Administrative Procedure Act require review on the agency record in proceedings pursuant to section 145?
(ii) Does section 145 provide for a de novo proceeding in the district court?
(iii) If section 145 does not provide for a de novo proceeding in the district court, what limitations exist on the presentation of new evidence before the district court?

(b) Did the district court properly exclude the Hyatt declaration?

Background: Hyatt's district court action was originally filed in 2003 as Hyatt v. Rogan after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued 45 separate rejections of Hyatt's claims based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." Complicating the case is the fact that the application's claimed priority date is 1975.

The issues in this appeal case arose when Hyatt filed a civil action in DC District Court to challenge the BPAI decision. In the civil action, Hyatt submitted a new declaration offering additional evidence of enablement and written description. However, the district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO.

Writing for the majority in the original panel opinion, Judge Michel affirmed the exclusion of evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. Judge Moore penned a compelling dissent in support of the patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.

Briefing: Hyatt's en banc brief will be due around March 31 and the USPTO's response due 28-days later. Briefs of amici curiae may be filed without leave of the court, but must otherwise comply with FRAP 29 and Fed Cir R 29.

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35 U.S.C. 145 Civil action to obtain patent.

An applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia if commenced within such time after such decision, not less than sixty days, as the Director appoints. The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims involved in the decision of the Board of Patent Appeals and Interferences, as the facts in the case may appear, and such adjudication shall authorize the Director to issue such patent on compliance with the requirements of law. All the expenses of the proceedings shall be paid by the applicant.

Viagra, Cialis, & Levitra: Board of Patent Appeals Affirms Rejection of Pfizer’s Broad Patent over ED Treatment

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Ex parte Pfizer (BPAI 2010)

Pfizer’s broadest patent covering its bestselling drug Viagra is in the midst of an ex parte reexamination. See Patent 6,469,012. The reexamination was separately requested by Lilly & ICOS (makers of Cialis) and Bayer (maker of Levitra). In addition, the PTO director (then James Rogan) independently ordered reexamination. These separate actions were all merged into one proceeding before the PTO. In parallel, Pfizer has sued Lilly & ICOS – asserting that Cialis infringes the Viagra patent. See Pfizer Inc., et al. v. Lilly ICOS LLC et al, Civil Action No. 02-1561 (D. Del. Oct. 22, 2002). The litigation has been stayed pending reexamination since 2003.

The broad claim (that is said to cover both Levitra and Cialis) is claim 24:

24. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, of a pharmaceutical composition containing either entity.

During the reexamination, the examiner rejected Claim 24 as anticipated by each of five different references and also issued an obviousness-type double patenting rejection based on three other Pfizer patents. In a 56-page opinion, the BPAI rejected some of the examiner’s reasoning, but affirmed the decision as a whole.

In particular, the Board agreed that prior art descriptions of oral administration of the herb Yin Yang Huo (AKA Horny Goat Weed) serve as anticipatory prior art:

It is undisputed that the herb is orally administered, that icariin is an active component of the herb and that icariin is a selective PDEv inhibitor. Thus, the issue is whether the Yin Yang Huo references describe oral administration of the selective PDEV inhibitor icariin in an amount effective to treat ED. . . .

Appellant argues that a single dosage of Yin Yang Huo fails to provide an amount of icariin sufficient to treat ED . . . However, the selective PDEv inhibitor of claim 24 is not required to have a minimum % inhibition. . . . or a maximum Ki or other enzyme kinetics inhibition value or other defined parameter that would exclude Yin Yang Huo from the claimed method. Moreover, Yin Yang Huo is not administered as a single daily dosage when treating ED. Yin expressly defines one course of treatment as comprising administering 2.5 grams Yin Yang Huo 3 times per day for 20 days (FF 51). Therefore, this rebuttal evidence is insufficient to establish by a preponderance of the evidence that the Yin Yang Huo references fail to disclose oral administration of icariin in an amount effective to treat ED, particularly in view of [the prior art’s] disclosed successful treatment of 50 cases of impotence.

Examiner Rejection Affirmed.

Notes

  • [Updated based on Jon’s comment below] Pfizer has the opportunity to request a re-hearing and may also appeal the BPAI decision. Regarding a further appeal, the pertinent portion of 35 U.S.C. § 141 reads as follows: A patent owner, or a third-party requester in an inter partes reexamination proceeding, who is in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences under section 134 may appeal the decision only to the United States Court of Appeals for the Federal Circuit. Although the language is amenable to multiple interpretations, the best interpretation of this is that a patent owner undergoing an ex parte reexamination may only appeal to the CAFC.
  • The re-examination file history is quite long and includes over seventy-three-thousand pages (this total does not include the USPTO patent-documents cited as prior art).
  • What is the expiration date of this patent? Its earliest priority date is a Great Britain from June 9, 1993. A European PCT was then filed on May 13, 1994 which was published on December 22, 1994. The US National Stage application was filed March 4, 1996 and the patent issued October 22, 2002. There is no terminal disclaimer apparent from the file history and the PTO does not indicate any patent term extension due to FDA regulatory delay. [Patent][Granted FDA Extensions][FDA Orange Book Listing]