The document provides advice for in-house counsel to prepare for potential patent litigation under the Hatch-Waxman Act. It recommends that counsel: 1) research potential generic drug company challengers by monitoring their patent applications, clinical trials, and regulatory filings; 2) re-evaluate which patents are listed in the Orange Book and assess potential invalidity arguments in advance; and 3) identify key witnesses, documents, and experts that will be important for proving infringement and responding to validity challenges. Thorough preparation is important to enforce pharmaceutical patents and defend against challenges that could determine the fate of a product.
SKGF_Presentation_Antibodies, Patents and Freedom to Operate: The Monoclonal ...SterneKessler
This document discusses the importance of freedom to operate (FTO) analysis for companies developing therapeutic antibody technologies. It notes that the patent landscape for antibody technologies has become more complex, making a thorough FTO analysis essential to avoid infringing the patents of others. The document outlines key concepts of patentability and dominance, describes strategies for clearing FTO such as design-arounds, invalidity arguments, and licensing. It provides examples of important patents in antibody humanization, expression, display, and other areas, as well as emerging antibody technologies that may create new patenting opportunities and risks.
Methods to improve Freedom to Operate analysisDauverC
This document discusses improving freedom to operate (FTO) analysis through comprehensive risk assessment and targeted patent searching. It provides an overview of patent filing trends, litigation statistics in key regions like the US and Europe, and a business case study on conducting an FTO analysis for a proposed fuel tank product. New semantic search technologies available in tools like PatentOptimizer can help enable more precise and recall patent searches to better inform FTO evaluations.
The document discusses freedom to operate (FTO) in intellectual property. It defines FTO as the ability to capitalize on an invention without challenges from other patent holders. The author cautions that during research and development, one must carefully record all materials, tools, and processes used and identify any existing exclusivity claims. Several strategies are discussed for circumventing or removing obstacles to FTO, such as paying to license a patent, exchanging technologies, inventing around a patent, or sharing patents or confidential information. The document provides an example of FTO considerations for biopharmaceutical research and development and discusses a technology using deuterium to extend drug effects. It concludes with discussing concepts and strategies for searching patents.
It is focused to provide basic knowledge on prior art search for new intellectuals in the field of IPR. It includes Basic knowledge of Prior art, File wrapper analysis, not list preparation, and one of the important law of Prior Art.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
World Intellectual Property Organization (WIPO), Standing Committee on the Law of Patents (SCP) 14th Session, January 25-29, 2010 (Geneva, Switzerland)
1) Post-grant reviews like inter partes reviews and post-grant reviews allow third parties to challenge patent validity, but Section 101 subject matter eligibility challenges can only be brought in post-grant reviews, not inter partes reviews.
2) Recent Supreme Court cases have increased the use of Section 101 challenges in district courts, which have invalidated patents around 70% of the time post-Alice. However, post-grant reviews have limitations for Section 101 challenges including timing restrictions and estoppel risks.
3) It remains uncertain how the Patent Trial and Appeal Board will handle Section 101 challenges compared to district courts, and whether success rates will differ across technologies like molecular diagnostics. The increasing use of Section 101 in
Dr. Priti Aggarwal has 9 years of experience in intellectual property management in the pharmaceutical sector. She has a PhD in synthetic organic chemistry and has worked at reputable law firms and pharmaceutical companies like Teva and Ranbaxy managing patent portfolios. Her expertise includes patent prosecution, drafting, landscaping, infringement analysis, and litigation support. She has strong technical skills in chemistry, patents, and drug regulatory processes.
SKGF_Presentation_Antibodies, Patents and Freedom to Operate: The Monoclonal ...SterneKessler
This document discusses the importance of freedom to operate (FTO) analysis for companies developing therapeutic antibody technologies. It notes that the patent landscape for antibody technologies has become more complex, making a thorough FTO analysis essential to avoid infringing the patents of others. The document outlines key concepts of patentability and dominance, describes strategies for clearing FTO such as design-arounds, invalidity arguments, and licensing. It provides examples of important patents in antibody humanization, expression, display, and other areas, as well as emerging antibody technologies that may create new patenting opportunities and risks.
Methods to improve Freedom to Operate analysisDauverC
This document discusses improving freedom to operate (FTO) analysis through comprehensive risk assessment and targeted patent searching. It provides an overview of patent filing trends, litigation statistics in key regions like the US and Europe, and a business case study on conducting an FTO analysis for a proposed fuel tank product. New semantic search technologies available in tools like PatentOptimizer can help enable more precise and recall patent searches to better inform FTO evaluations.
The document discusses freedom to operate (FTO) in intellectual property. It defines FTO as the ability to capitalize on an invention without challenges from other patent holders. The author cautions that during research and development, one must carefully record all materials, tools, and processes used and identify any existing exclusivity claims. Several strategies are discussed for circumventing or removing obstacles to FTO, such as paying to license a patent, exchanging technologies, inventing around a patent, or sharing patents or confidential information. The document provides an example of FTO considerations for biopharmaceutical research and development and discusses a technology using deuterium to extend drug effects. It concludes with discussing concepts and strategies for searching patents.
It is focused to provide basic knowledge on prior art search for new intellectuals in the field of IPR. It includes Basic knowledge of Prior art, File wrapper analysis, not list preparation, and one of the important law of Prior Art.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
World Intellectual Property Organization (WIPO), Standing Committee on the Law of Patents (SCP) 14th Session, January 25-29, 2010 (Geneva, Switzerland)
1) Post-grant reviews like inter partes reviews and post-grant reviews allow third parties to challenge patent validity, but Section 101 subject matter eligibility challenges can only be brought in post-grant reviews, not inter partes reviews.
2) Recent Supreme Court cases have increased the use of Section 101 challenges in district courts, which have invalidated patents around 70% of the time post-Alice. However, post-grant reviews have limitations for Section 101 challenges including timing restrictions and estoppel risks.
3) It remains uncertain how the Patent Trial and Appeal Board will handle Section 101 challenges compared to district courts, and whether success rates will differ across technologies like molecular diagnostics. The increasing use of Section 101 in
Dr. Priti Aggarwal has 9 years of experience in intellectual property management in the pharmaceutical sector. She has a PhD in synthetic organic chemistry and has worked at reputable law firms and pharmaceutical companies like Teva and Ranbaxy managing patent portfolios. Her expertise includes patent prosecution, drafting, landscaping, infringement analysis, and litigation support. She has strong technical skills in chemistry, patents, and drug regulatory processes.
This document summarizes best practices for brand name and generic drug companies in navigating Paragraph IV patent challenges and IPR proceedings at the PTO. It recommends that companies 1) identify and prepare experts early, 2) develop claim construction positions, 3) investigate and develop evidence of non-obviousness, and 4) investigate prior art of record. It also discusses considerations for addressing parallel IPR and litigation proceedings, such as potential estoppel effects and prosecution bars. Additionally, it covers unsettled issues in damages law for at-risk generic launches and antitrust risks of product switching strategies for brand name drugs.
i2b Conference Patents Presentation May 28 2013Jim Francis
This document provides an overview of patent law concepts for entrepreneurs. It discusses the challenges of commercializing an idea, including the need for funding, intellectual property identification and protection, and risk management. The document outlines the patent process, including different types of patent searches and patents. It provides examples of intellectual property issues entrepreneurs may face and best practices for patenting an invention and beginning commercialization. Key steps include performing due diligence, identifying the market and distribution channels, and finding an experienced patent attorney.
Why Strengthen Your Medical Device Patent Portfolio For Infringement Litigati...SHIMOKAJI IP
A 2013 PricewaterhouseCoopers survey indicates that for about the last dozen years the medical device industry represents 9% of all patent infringement cases. This puts the medical device industry in the top 10% of all industries for patent infringement cases, and with a ranking of 5th out of a total of 20 ranked industries. In that same period, the median damages award in the medical device industry was $53M.
We often hear that the vast majority of patent infringement cases settle. But what we usually do not hear is why they settled and on what terms did they settled.
Strengthening your patent portfolio has the obvious benefit of strengthening your ability to assert patent infringement claims. But it can also minimize the potential of being the recipient of patent infringement claims. Here’s how.
Frequently, patent infringement lawsuits follow a cease and desist letter. What follows a cease and desist letter but before the filing of suit can be lengthy discussions about the infringement and invalidity of the patent at issue. What may also be the subject of these pre-lawsuit discussions is potential counterclaims of patent infringement – infringement claims being made against the party who sent the initial cease and desist letter.
The document summarizes a panel discussion on the evolving landscape of molecular diagnostics in light of recent changes in patent law. The panelists, who represented both public and private sector organizations, discussed how Supreme Court rulings have narrowed the scope of patentable subject matter. This has made it more difficult to patent diagnostic methods, natural products, and isolated genomic sequences. The panelists outlined strategies for companies to diversify their patent portfolios and pursue more creative claiming approaches in response to the changing legal environment. They also emphasized the importance of demonstrating clinical utility rather than relying solely on patent protection. While the full impacts of the new case law remain uncertain, the consensus was that clarity around patent eligibility is needed for continued innovation in molecular diagnostics
Patent Due Diligence in the Sale-Acquisition of a Medical Device Company, by ...SHIMOKAJI IP
One of the most important assets of a medical device company is often its patent portfolio. The portfolio can include issued patents, patent applications, and patentable inventions that are not the subject of issued patents or pending patent applications. Whether the seller or buyer of a medical device company, it is imperative to know what assets are in the company’s patent portfolio and factors that affect their value.
Commercially available, off the shelf patent databases do not often exist to hold the company’s patent portfolio information – at least for many medical device companies of a small to moderate size. Instead, the patent information might be in an excel spreadsheet kept by someone internally in the company. The information might be in the form of paper files kept in a file cabinet.
So, where do you look for patent information?
This document discusses the benefits of retaining FDA consultants as part of a legal team for litigation. Consultants can help navigate complex FDA regulations and understand how the agency applies and interprets them. Their expertise in areas like GMPs and scientific protocols provides crucial insight. Consultants assist with developing strategy, reviewing evidence during discovery, identifying critical issues, and serving as expert witnesses who can help explain FDA's perspective and expectations to a jury. Properly selecting a consultant with relevant qualifications and strong communication skills is important to support a case.
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
The document discusses various strategies and considerations for knowledge management during pretrial patent litigation. It covers searching internal and external information sources, organizing documents obtained through discovery, and using legal and factual research to strengthen a patent case. Key areas discussed include validity searches, selecting expert witnesses, determining royalty rates, and pre-suit investigations.
The document provides guidance on devising international patent litigation strategies. It discusses defining goals for litigation, understanding the tools available, where to deploy those tools based on jurisdictional factors, and executing a coordinated global campaign. Specifically, it emphasizes the importance of thoroughly understanding local laws and customs in different jurisdictions, developing a comprehensive budget, maintaining a consistent narrative, and knowing when objectives have been achieved or when to change strategies. Managing litigation across multiple countries introduces challenges from legal differences, cultural factors, time zones, and ensuring consistent coordination.
The document provides guidance on devising international patent litigation strategies. It discusses defining goals for litigation, understanding the tools available, where to deploy those tools based on jurisdictional factors, and executing a coordinated global campaign. Specifically, it emphasizes the importance of thoroughly understanding local laws and customs in different jurisdictions, developing a comprehensive budget and timeline, and knowing when objectives have been achieved or when to change strategies. Managing litigation across multiple countries introduces challenges from legal and cultural differences that require careful planning and flexibility.
Don’t Feed the Trolls_ Practicality in View of the FTC’s Report on Patent Ass...ravimohan2
The document summarizes and comments on recommendations from the FTC's report on patent assertion entities (PAEs, also known as "patent trolls"). It discusses three recommendations: 1) Addressing discovery burdens and costs asymmetries in PAE litigation through early disclosure of claims and contentions. 2) Broadening disclosure requirements under Rule 7.1 to reveal related entities. 3) Encouraging courts to stay PAE actions against customers/end-users where the manufacturer is also sued. The article analyzes the practical impacts and limitations of these recommendations, and argues that addressing patent quality is also needed to truly curb PAE activity. It concludes that multiple coordinated efforts are required to solve this complex issue.
There is nothing more important to a medtech company—nor more confusing and misunderstood—than its intellectual property. An effective patent counsel is essential to a company to help it clarify and protect its most valuable asset. Two medical device experts from the intellectual property law firm Knobbe Martens highlight what to look for in an IP attorney who understands and can negotiate the medtech patent jungle.
The Benefit of Early Case Assessment in Food CourtRonaldJLevine
Scores of food and beverage manufacturers have faced consumer fraud lawsuits challenging labeling claims like "all-natural" and "healthy". While many claims are frivolous, companies still face large legal costs from document collection and review that exceed budgets. Early case assessment uses technology to quickly evaluate the case and evidence to help determine liability and strategy early, allowing for better outcomes and lower costs through improved strategic decision making and discovery planning.
Leveraging Early Case Assessment for Food Industry LitigationRonaldJLevine
Scores of food and beverage manufacturers have faced consumer fraud lawsuits challenging labeling claims like "all-natural". While many claims are frivolous, companies still face large legal costs from document collection and review that cut into margins. Early case assessment uses technology to evaluate liability and promote strategic action early, allowing better outcomes at lower costs by revealing key evidence and documents.
Marketing managers can assist attorneys in intellectual property lawsuits in three ways:
1. By building inherent distinctiveness into products, names, logos and packaging to make them easier to protect from imitation.
2. By collecting and providing evidence of customer confusion between a company's products and imitative competitors' products.
3. By assisting litigation survey experts, with a light touch, in demonstrating the extent of confusion in the marketplace to strengthen intellectual property protection claims.
Financial Disclosure –Duties and Strategies for Clinical StudiesMichael Swit
Financial disclosure requirements for clinical studies are explored with a particular emphasis on how the requirement for tracking "Significant Payments of Other Sorts" -- or SPOOS -- present challenges in clinical study compliance.
This document provides litigation tips and strategies for attorneys. It discusses the importance of having a clear end goal and theme in mind from the start of a case. It offers tips for developing claims, using Rule 202 depositions to investigate potential claims, and document management strategies. The document also discusses case preparation, developing an effective theme and theory, avoiding distractions, crafting an impactful opening and closing argument, and using various presentation tools and exhibits to engage the jury throughout trial.
2001-07-09 Declatory Judgements in Patent CasesLawrence Kass
The document summarizes the evolving test used by the Federal Circuit Court to determine personal jurisdiction in declaratory judgment patent cases. The Federal Circuit applies a three-part test: 1) whether the patentee purposefully directed activities at forum residents, 2) whether the claim arises from or relates to those activities, and 3) whether exercising jurisdiction would be constitutionally unreasonable. Sending a cease-and-desist letter alone is insufficient contact, but adding an exclusive license with a forum resident satisfies the test. The test balances a patentee's ability to enforce patents against subjecting them to distant forums.
The Hatch-Waxman Act was passed in 1984 to balance incentives for developing new drugs with increasing availability of low-cost generic drugs. It allows generic companies to file abbreviated applications to gain expedited FDA approval of generic versions of approved drugs. Pioneer drug companies can extend their patent terms to compensate for delays in regulatory review. The Act is currently receiving heightened scrutiny around "improper" patent listings by brand companies to delay generics and potential anti-competitive agreements between brand and generic companies. Two ongoing court cases relate to patent listings for drug metabolites.
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A 2013 PricewaterhouseCoopers survey indicates that for about the last dozen years the medical device industry represents 9% of all patent infringement cases. This puts the medical device industry in the top 10% of all industries for patent infringement cases, and with a ranking of 5th out of a total of 20 ranked industries. In that same period, the median damages award in the medical device industry was $53M.
We often hear that the vast majority of patent infringement cases settle. But what we usually do not hear is why they settled and on what terms did they settled.
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Frequently, patent infringement lawsuits follow a cease and desist letter. What follows a cease and desist letter but before the filing of suit can be lengthy discussions about the infringement and invalidity of the patent at issue. What may also be the subject of these pre-lawsuit discussions is potential counterclaims of patent infringement – infringement claims being made against the party who sent the initial cease and desist letter.
The document summarizes a panel discussion on the evolving landscape of molecular diagnostics in light of recent changes in patent law. The panelists, who represented both public and private sector organizations, discussed how Supreme Court rulings have narrowed the scope of patentable subject matter. This has made it more difficult to patent diagnostic methods, natural products, and isolated genomic sequences. The panelists outlined strategies for companies to diversify their patent portfolios and pursue more creative claiming approaches in response to the changing legal environment. They also emphasized the importance of demonstrating clinical utility rather than relying solely on patent protection. While the full impacts of the new case law remain uncertain, the consensus was that clarity around patent eligibility is needed for continued innovation in molecular diagnostics
Patent Due Diligence in the Sale-Acquisition of a Medical Device Company, by ...SHIMOKAJI IP
One of the most important assets of a medical device company is often its patent portfolio. The portfolio can include issued patents, patent applications, and patentable inventions that are not the subject of issued patents or pending patent applications. Whether the seller or buyer of a medical device company, it is imperative to know what assets are in the company’s patent portfolio and factors that affect their value.
Commercially available, off the shelf patent databases do not often exist to hold the company’s patent portfolio information – at least for many medical device companies of a small to moderate size. Instead, the patent information might be in an excel spreadsheet kept by someone internally in the company. The information might be in the form of paper files kept in a file cabinet.
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This document discusses the benefits of retaining FDA consultants as part of a legal team for litigation. Consultants can help navigate complex FDA regulations and understand how the agency applies and interprets them. Their expertise in areas like GMPs and scientific protocols provides crucial insight. Consultants assist with developing strategy, reviewing evidence during discovery, identifying critical issues, and serving as expert witnesses who can help explain FDA's perspective and expectations to a jury. Properly selecting a consultant with relevant qualifications and strong communication skills is important to support a case.
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
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The US Court of Appeals for the Federal Circuit issued a decision regarding the utility requirement for patents of expressed sequence tags (ESTs). The court affirmed the Patent and Trademark Office's rejection of a patent application for ESTs from corn plants. The majority found that the ESTs lacked a specific, substantial utility as required, as the application disclosed no information about the corresponding genes' structure or function. The court determined the disclosed potential uses for the ESTs, such as gene markers, were too generic and did not demonstrate real-world utility for the particular claimed ESTs. The decision confirmed that the utility standard under US patent law requires disclosure of a specific, practical benefit to satisfy the usefulness requirement.
This document provides a summary of news articles from Milbank relating to various financing transactions and mergers and acquisitions that Milbank represented on, including representing Goldman Sachs in a financing for FullBeauty Brands, representing lead arrangers in Clayton, Dubilier and Rice's acquisition of Mauser Group, and representing Catalyst Health Solutions in its $4.4 billion merger with SXC Health Solutions Corp. The news articles span from June 2015 to December 2010 and cover a range of industries.
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1) The document discusses the history of patents for clean energy technologies like wind power. It notes that the first US patent for a wind-powered electricity generation system was issued in 1891 to James M. Mitchell.
2) Currently, patents are playing an important role in clean energy industries like wind power through litigation and licensing. For example, GE is asserting patents against Mitsubishi in an infringement case at the International Trade Commission.
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110510-BNA-Article-J-Griem-and-L-Kass[2]
1. Reproduced with permission from BNA’s Patent,
Trademark & Copyright Journal, 81 PTCJ 36,
11/05/2010. Copyright 2010 by The Bureau of Na-
tional Affairs, Inc. (800-372-1033) http://www.bna.com
PAT E N T S
The authors provide advice to in-house counsel to prepare for patent litigation under
Hatch-Waxman.
The Challenger Is Prepared, Are You?
Strategies for Preparing to Enforce Patents Covering Pharmaceutical Products
BY JOHN M. GRIEM JR. AND LAWRENCE T. KASS
Y
our company’s new product is doing very well, and
sales are increasing. Management is looking to
you, the chief IP counsel, for guidance on how to
use the company’s patents to protect the market for this
important product. Data exclusivity may not exist or
may be ending soon. You are sure that someone will try
to sell a generic version and you want to be prepared to
enforce your company’s hard-won patents.
If your company’s product is a small molecule prod-
uct subject to a Hatch-Waxman Act challenge, your
company will have only 45 days to decide whether to
file a patent infringement action against the challenger
in order to obtain the 30-month stay of Food and Drug
Administration approval provided by the act. This dead-
line makes it especially important to be prepared if any
challenge can be anticipated.
How do you figure out what potential challengers are
doing? What issues are likely to come up in litigation?
Set out below are a few key steps you can take to pre-
pare management and key personnel for litigation that
may determine the fate of this product.
Whether the litigation is triggered by the challenger’s
patent notice required by the Hatch-Waxman Act, or by
potential competition from a similar biologic product in
the same class as your company’s product, one key to
long-term success is thorough and effective early prepa-
ration.
JOURNAL
COPYRIGHT 2010 BY THE BUREAU OF NATIONAL AFFAIRS, INC. ISSN 0148-7965
A
PATENT,TRADEMARK
©RIGHT !
BNA’s
2. Do Your Homework to Find and Assess Potential
Challengers
The first place to start is making sure you have good
information available on potential challengers. There
are many good sources of market intelligence. Patents,
published patent applications, and prosecution histories
can yield particularly useful information about the di-
rection a generic challenger is taking. You also can re-
search potential challengers using press releases, cor-
porate financial statements, and regulatory information
such as clinical trial reports and FDA reports on Drug
Master File, or DMF, applications.
Analyst reports are another fruitful source of infor-
mation. A structured program to monitor various
sources of publicly available information can be very ef-
fective in piecing together disparate bits of information
into a useful picture of the competitive landscape.
For example, bioequivalence clinical trial information
can reveal the status of efforts to show that a potential
competitor is ready for commercial sale. However, bio-
equivalence clinical trial information is often sketchy.
For example, a trial may be identified only by a drug
number code, without stating what the active pharma-
ceutical ingredient is. But this code may be mentioned
in corporate news reports, financial statements, or pub-
licly available articles and presentations. Drug codes
may also be mentioned in patent applications and/or
prosecution histories.
In addition, DMF applications will reveal which com-
panies are planning to introduce an active pharmaceu-
tical ingredient in the United States, long before a for-
mulation is finalized. DMFs are listed on the FDA’s
website and updated frequently. When combined with
information from private market research and sales
people in the field, it is possible to make good guesses
as to which competitors are planning to challenge your
patents, and when. Often, a competitor will begin sell-
ing a formulation outside the United States, perhaps in
India or Eastern Europe, which can signal a potential
U.S. challenge.
If there are other brand drugs in the same class as
your company’s product, it would also make sense to
monitor public information about challenges to those
drugs, such as DMF filings, Abbreviated New Drug Ap-
plications, and associated FDA approvals, whether they
are tentative or final. Challenges to related brand drugs
are often made by the same generic company, and its
processes to make the related brand drugs may be very
similar. Consequently, a challenge to a related brand
drug may provide some insight into potential chal-
lenges to your company’s product.
Preparing to Defend Your Hard-Won Patents
From Infringement
Now that you’ve determined a challenge is likely, re-
searched potential challengers, and hopefully obtained
some information on likely generic formulations, the
next step is to consider the defenses and claims that are
likely to be raised. It may make sense at this point to
line up outside counsel, clear conflicts, and set a budget
to permit them to come up to speed on the key facts and
to assist in considering the legal issues.
If the Hatch-Waxman Act applies to your company’s
product, it would make sense at this time to reconsider
whether all of the right patents have been listed in the
Orange Book. Orange Book listing decisions are impor-
tant because under the Hatch-Waxman Act, a generic
challenger that wants to sell a competing product be-
fore the patents expire must certify that any listed
patent is either not infringed, invalid, or unenforceable.
The patent owner can then sue for infringement and, if
it declines to file suit, the challenger may be able to
seek a declaratory judgment.
In either case, litigation may be imminent. It is there-
fore better to consider listing decisions well in advance,
rather than after a litigation is imminent or has been in-
stituted. It is generally not necessary to list process pat-
ents but they can be asserted in litigation, so they
should be considered in any pre-suit analysis. Use pat-
ents can be listed in certain circumstances, and should
also be considered in analyzing which patents are listed
in the Orange Book, as well as any infringement analy-
sis.
There are many useful steps you can take in assess-
ing how a litigation is likely to proceed. You should
start by stepping back and considering what evidence
will be necessary to prove infringement, and what po-
tential validity challenges might be raised.
A first step might be to ensure a prior art search has
been performed on any applicable patents and think
about what related invalidity arguments are likely to be
made. You can look at the prosecution history of the
patents with a critical eye. What arguments would you
make if you were the challenger, trying to limit or in-
validate the patents? Consider whether you have doc-
trine of equivalents limitations, or whether you can as-
sert a broad scope of equivalents. If such exercises are
performed sufficiently in advance, they may reveal
flaws in patent protection that can be corrected before
litigation ultimately commences. For example, it may
be possible to seek and obtain a patent continuation, re-
examination, or reissue that can fix a gap in coverage
or a potential invalidity issue.
You should also begin at this stage to ascertain the in-
vention story and develop litigation themes supported
by internal information that ultimately may be disclosed
in discovery. While U.S. discovery can be very wide-
ranging, it is usually possible to make reasonable esti-
mates and forecasts about what documents and groups
of documents will likely be relevant to the issues in the
litigation and to start thinking about what documents
will be produced.
It may make sense to conduct an initial review of
those documents to anticipate particular issues that
might come up. Because of the wide scope of discovery
in U.S. cases, litigation and prosecution on related for-
eign patents often becomes evidence in a U.S. litigation.
For that reason, your preparation should include if pos-
sible reviewing foreign evidence for statements and ar-
guments that a challenger might assert against you in
the United States.
It is usually possible to identify some people who are
likely to be the subject of depositions. Certainly, inven-
tors of the patents at issue are likely to be witnesses, if
they are available. There may be people who are par-
ticularly important from a marketing or business per-
spective, and so you should consider making contact
with those people in order to evaluate them as a poten-
tial witnesses.
Often, inventors can be excellent witnesses for the
patent owner because they can provide a personal story
of invention. Talking with people who have personal
knowledge of the invention is also the best way to un-
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3. cover any potential challenges based on alleged incor-
rect inventorship or alleged prosecution disclosure mis-
statements or omissions.
If likely deponents are in another country, it may
make sense to think about what the legal requirements
are for either bringing them for a deposition in the
United States, or holding a deposition in their country
of residence. And, of course, likely witnesses may be
former employees. You can anticipate that the chal-
lenger will seek to contact former employees to deter-
mine whether or not they are willing to appear as a wit-
ness. It may make sense for you to find out what they
will say beforehand, so that you can think about how
that information is likely to play out.
In a pharmaceutical patent infringement action, one
of the most important aspects of the evidence is expert
testimony. Experts are almost always used in address-
ing validity issues like anticipation and obviousness un-
der 35 U.S.C. §§ 102 and 103. Their testimony will also
be necessary on any enablement or description issues
under 35 U.S.C. § 112. And of course, experts are also
critical for infringement.
Experts can also provide good advice on outside test-
ing laboratories and/or internal testing protocols. So,
where you know that a certain patent is likely going to
be in litigation, it often makes sense to try to identify
and retain relevant outside experts early, even before a
suit is filed. Every patent is situated in its own area of
technology, and cases can be won or lost based on the
quality and preparation of experts.
To check on how strong an expert will be in litiga-
tion, it may make sense to review relevant publications
authored by a proposed expert, because these will likely
be used in cross-examination. Likewise, other cases
where the expert has provided an opinion or testimony
may come up, and so it may make sense to obtain and
review an expert’s earlier opinions or testimony, if
available.
Infringement is usually proven in part through the
testing of samples of the challenger’s product. In a
Hatch-Waxman action, where the product is not yet on
the market, the product to be analyzed for infringement
is the product that is likely to be sold if the product is
approved.
So, being able to test samples obtained from the chal-
lenger which may have been submitted to the FDA is
very important. A challenger may provide these
samples after its notice letter but before the 45-day
deadline to secure a 30-month stay and, depending on
the circumstances, you may be expected to have evalu-
ated those samples before filing suit.
This leaves only a narrow window to complete any
pre-suit testing, so it may make sense to try and line up
relevant testing capability beforehand. That testing can
be done by outside experts, outside testing laboratories
or, with permission from the challenger, in-house tech-
nical experts.
In any event, it will be important to have experts and
testing capabilities ready to hit the ground running
when a notice letter and samples come in. In fact, it may
be possible and desirable to get a head start by obtain-
ing samples of products containing the same active in-
gredient being sold by the challenger in foreign mar-
kets. These foreign samples, while not necessarily the
same as U.S. samples, may provide some insight into
the issues that will be encountered in a U.S. litigation.
Another important issue to consider is where an ac-
tion is likely to be brought. Think about where potential
defendants are likely to be found, and then what courts
would be considered good ones to hear the case. For
pharmaceutical patent litigation, the U.S. District Court
for the District of New Jersey is a popular place to bring
cases because of the number of pharmaceutical compa-
nies in that state and the experience of the federal
judges in the district. There are other districts that are
known for having faster dockets, however, and the
speed of the court may be a concern. Other factors to
consider in deciding where to bring an action include
the location of the likely witnesses, and whether sub-
poenas will be necessary in order to obtain their testi-
mony at trial.
New Jersey has joined other districts and adopted
patent-specific rules that can accelerate Hatch-Waxman
patent litigation. These rules require that the generic
challenger’s Abbreviated New Drug Application be pro-
duced very promptly, before the initial scheduling con-
ference, and that infringement and validity contentions
be exchanged within two months of the initial schedul-
ing conference.
These rules are similar in that respect to rules in the
Eastern District of Texas and the Northern District of
California. Preparation is arguably even more impor-
tant in those courts, where the rules further require a
plaintiff to present its claim construction and other key
positions quite early in the case.
Conclusion
Even before a specific challenge is received, prudent
in-house counsel can do a lot to get ready for challenges
to the patents protecting their company’s key products.
Early research and consultation with outside counsel
will make the process smoother and lead to a more ef-
fective defense.
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