What is Intellectual Property Law?

Intellectual Property law deals with the rules for securing and enforcing legal rights to inventions, designs and artistic works. Just as the law protects ownership of personal property and real estate, so too does it protect the exclusive control of intangible assets. The purpose of these laws is to give an incentive for people to develop creative works that benefit society, by ensuring they can profit from their works without fear of misappropriation by others.

Why secure Intellectual Property?

Intellectual property rights are your most important and valuable assets. Companies of all sizes are at risk of having their unique ideas, products or services infringed upon, even if they are on the other side of the world, making intellectual property protection more important than ever. You need to protect assets that may be integral to the core services of the business and overall long-term viability of your enterprise.

How can we help you secure and benefit from your Intellectual Property?

We have twenty years of experience in every aspect of Intellectual Property Law including, biotechnology, chemical, electrical, hardware and software technologies, information technology, materials and polymer science, pharmaceuticals, telecommunications, trademarks and copyright laws, which gives us an edge in protecting your intellectual property.

What are the types of Intellectual Property Law?

Intellectual Property Law covers a wide range of novel ideas, processes and intangible rights of the idea creator or team. They can be grouped under different categories as mentioned below, for example:

• • Copyright
• • Patents
• • Trademarks
• • Industrial Designs
• • Geographical Indications

Pharmaceutical Law

Pharmaceutical laws relate to the creation, sale, distribution, and use of pharmaceutical drugs. These laws include intellectual property rights to protect drug manufacturers’ research, safety standards to protect the public from harmful side effects, restrictions on marketing drugs to the public, and rules regarding how drugs may be prescribed and distributed.

Intellectual Property Protection in the Pharmaceutical Industry

Pharmaceutical industries invest millions of dollars in research in the development of new drugs. It is important for companies to have the ability to protect their investments. This is typically done through the use of patents. Patents can apply to the method of synthesizing a drug, the chemical makeup of a new molecule, or possibly even to certain genetic discoveries. There are also many other potential uses for patents in the field of pharmaceutical law.

How can we help?

We can help protect your investment by providing valuable services in all aspects of intellectual property law and practice using our vast, in-depth expertise in the pharmaceutical industry.

Trademark and Copyright

Trademark and copyright registrations are both issued by the federal government and protect two distinct types of intellectual property. Here are some key differences:

Trademark

• A trademark protects names, terms and symbols that are used to identify the source of goods and/or services on the market. In other words, a trademark lets the consumer distinguish one company's offering from another's.

• A trademark can be a name, word, slogan, design, symbol or other unique device that identifies a product or organization.

• Trademarks are registered at a national or territory level with an appointed government body and may take anywhere between 6 and 18 months to be processed.

• Trademarks, for example, include brand names such as "Coca-Cola" and images such as Nike's famous "swoosh." As the owner of a federally registered trademark, you can sue for trademark infringement in federal court and prevent the importation of foreign goods that display your trademark.

Copyright

• A copyright protects original creative works such as books, movies, songs, paintings, photographs, web content and choreography. As the owner of a federally registered copyright, you can control how your work is reproduced, distributed and presented publicly, and you can sue infringers in federal court and prevent others from importing infringing goods.

IP Counseling

Our intellectual property counseling practice assesses and analyzes clients’ technologies and their intellectual property portfolios to identify both opportunities and roadblocks.

Building an IP Portfolio

Patents are tangible assets which, if properly managed and utilized, create increased value in a company. Patents provide tangible value in that they are often a means for attracting investors or providing a source of revenue through the patent licensing. Moreover, patents inspire confidence in shareholders for a company’s competitive position in the marketplace since patents protect specific products and create a barrier to competition in the marketplace.

Patents are a very effective means of protection for the assets of any technology-based business. A patent portfolio provides sufficient coverage to practice a technology, and deterrence of competitors. An ideal patent portfolio provides a sufficient defensive and optimal offensive position regarding the product, in order to provide a competitive advantage in a highly competitive and lucrative environment.

Patent Searches

What is a pre-patentability patent search?

A pre-patentability patent search is a search of issued patents and published patent applications for inventions that might be considered important “prior art” references when applying for a patent. Prior art is anything in the public domain, patented or not patented, that may determine whether an invention is novel or not.

• • This patent search can be used to determine whether the time and expense of moving forward with a patent application is a worthwhile endeavor. The patent process can be expensive, so the last thing you want to do is spend a lot of time and money preparing and filing an application when there is prior art that will likely prevent a patent from being issued.
• • Patent searches are excellent sources of information because they give you an opportunity to discover which aspects of your invention are most likely to contribute to patentability, thereby allowing the description in any filed patent application to focus on those aspects most likely to contribute to patentability.

What is a patent landscape analysis?

Patent landscaping is a detailed state-of-the-art search of patents in a particular technology field that provides an overview of IP market.

A landscape analysis report includes a competitive view of the industry and current and future trends in the technology domain which helps clients explore the ample business opportunities available.

What are invalidity searches?

An invalidity search is an exhaustive prior art search conducted after the issuance of the patent. The purpose of the search is either to validate the enforceability of a patent's claims, or to invalidate one or more claims of a patent. These two searches are identical, except for the desired outcome (valid or invalid patent claims) of the search. Alternative terminology for these searches includes Validity Patent Search or Invalidity Patent Search.

How can we help you with these searches?

We conduct an extensive search of patents, technical publications and any other publicly available materials, prior to the filing date/priority date of the patent application. We use a comprehensive set of search tools applied on multiple databases to extract the material that can be classified as prior-art.

Patent Drafting and Filing Services

The goal in a patent application is to provide a full, clear, exact description of the invention in a way that particularly points out and distinctly identifies what the inventor believes he or she has invented and wants protection to cover. Besides being the most important document in the entire patent registration process, it is also considered to be one of the most complex documents needing expertise in technical and legal fields. The patent drafting/writing specification contains the aspects of the invention such as field of invention, background, summary, detailed description, patent drawings, abstract and patent claims for which protection is sought.

Challenges in drafting a patent application

A very important aspect of patent drafting is knowing how best to describe the invention and all aspects of the invention so as to maximize the likelihood of obtaining a patent while minimizing roadblocks and pitfalls that lurk for nearly every invention.

When the PTO issues a patent, the patent is presumed to be valid. This presumption can be overcome. In fact, a patent’s validity can be challenged. Typically, these validity challenges allege:

• • an insufficient disclosure by the patent
• • preclusion of the claims by the prior art; or
• • some type of misconduct by the applicant during prosecution of the application before the PTO.

How can we help?

Our strong expertise in multiple technologies combined with an exceptional depth of experience in drafting will help you bring the largest possible coverage with the highest chance of obtaining a patent for your invention and ideas.

Patent Prosecution

Patent prosecution describes the interaction between applicants and their representatives, and a patent office with regard to a patent or an application for a patent. We have deep experience in applying for a patent and negotiating with patent offices to get the patent issued.

Why patent your invention?

Benefits of patenting an invention include:

• • A patent protects your inventions, designs and ideas.
• • Gives inventors the right to stop competitors from producing or selling inventions without authorization.
• • Allows inventors to generate money from their inventions by licensing other parties to manufacture the inventions per agreed terms.
• • Gives inventors an incentive to continue researching and developing new creations.
• • Once you receive a patent on your design or invention, you can prevent anyone from copying your patented work without your permission.

Patent Reexamination & Reissue:

The U.S. Patent & Trademark Office provides a venue for correcting or challenging issued patents. This can be part of a strategy to re-validate a patent prior to licensing or litigation or can help a patent owner or defendant determine whether a patent was granted in error.

We are experienced in these corrective and adversarial proceedings of USPTO:

• • Supplemental Examination
• • Reissue Patents
• • Ex-partes Patent Re-exam
• • Inter-parties Review
• • Patent Post Grant Review

IP Litigation

Patent litigation describes the legal process that unfolds when a patent holder for a particular invention enforces their right by suing another party for manufacturing or selling the invention without permission. Our patent attorneys can assist litigants in developing their cases and in securing aggressive litigation services.

Patent Litigation:

Patent litigation includes legal actions to protect patents against infringement and may result in monetary damages or an injunction against the infringement.

There are different ways another party may infringe on your patent, including:

• • Direct Infringement: This occurs when a product covered by a patent is manufactured without permission.
• • Indirect Infringement: An indirect infringer may induce infringement by encouraging or aiding another in infringing a patent.
• • Contributory Infringement: This occurs when a party supplies a direct infringer with a part that has no substantial non-infringing use.
• • Literal Infringement: This exists if there is a direct correspondence between the words in the patent claims and the infringing device.

More often than not, this claim is countered by the accused party who will argue that that particular patent should be deemed invalid. Comprehensive understanding of our clients' technologies and industries leads to litigation solutions.

Our patent litigation services include certified translation, live interpretation, document review, expert witness and more. We offer high-quality, turnkey solutions that lower costs, speed up review times, and work seamlessly with your current workflow.

Our opinions include:

• • Freedom to Operate: A freedom to operate (FTO) opinion is based on a search done on issued patents or on pending patent applications to determine if a product or process infringes any of the claims of the issued patents or pending patent applications.
• • Non-Infringement: A non-infringement opinion is based on a determination that a specified product is not infringing on specified claims of patents.
• • Invalidity: A patent invalidity opinion determines the validity of a patent held by a competitor.

Opinions enable conformance to the law, avoid and counter litigation, and limit liability risks.

ANDA Comprehensive Practice

What is ANDA?

• An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

• • An Abbreviated New Drug Application (ANDA) is submitted to the FDA for the review and ultimate approval of a generic drug product. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
• • Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). Using bioequivalence as the basis for approving generic copies was established by the “Drug price competition & Patent term restoration Act of 1984” (Hatch-Waxman Act). The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

Steps in ANDA review:

• • Filling Review
• • Coordination of Generic Drug Review Process
• • Bioequivalence Review Process
• • Chemistry Review Process
• • Labeling Review Process
• • Assembling all Reviews and Paperwork

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Patent Portfolio Analysis and Opinions

Paragraph IV Patent Certifications:

Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy. To seek this approval, a generic applicant must provide in its application a "certification" that a patent submitted to the FDA by the brand-name drug's sponsor and listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) is, in the generic applicant's opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product. This certification is called a "paragraph IV certification". The first company or companies to submit an application that (1) is determined by the agency to be "substantially complete" upon submission and (2) contains a paragraph IV certification to at least one of the patents listed in the Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.

In order to challenge a patent in court, the generic applicant that submitted a paragraph IV certification must notify the brand product sponsor and any patent holder of the submission of the ANDA and patent challenge. If the brand product sponsor or patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market of the generic drug is generally postponed for 30 months unless the patent expires or is judged to be invalid or not infringed before that time. This 30-month postponement, commonly referred to as the "30-month stay," gives the brand product sponsor and patent holder a prescribed amount of time to assert patent rights in court before a generic competitor is approved and can market the drug.

Licensing

Licensing lets you instantly tap the existing production, distribution, and marketing systems that other companies may have spent decades building. In return, you get a percentage of the revenue from products or services sold under your license.

What is Licensing?

A business arrangement in which one company gives another company permission to manufacture its product for a specified payment. Licensing is the practice of leasing a legally protected property (such as a trademarked or copyrighted name, logo, likeness, character, phrase, or design) to another party in conjunction with a product, service or promotion. It is based on a contractual agreement between the owner of the property (or its agent) known as the licensor; and a licensee – normally a manufacturer or retailer. It grants the licensee permission to use the property subject to specific terms and conditions, which may include the purpose of use, a defined territory, and a defined time period.

How can we help you with your licensing needs?

We have experts in diverse technologies and trademarks and copyright laws giving us an edge in negotiating the best value for your products.

Dispute Resolution

Dispute resolution processes fall into two major types: Adjudicative processes, such as litigation or arbitration, in which a judge, jury or arbitrator determines the outcome. Consensual processes, such as collaborative law, mediation, conciliation, or negotiation, in which the parties attempt to reach agreement.

Technology Transactions

We have deep knowledge in analyzing the transactions that are critical to any technology company, including: Customer, reseller, VAR and OEM agreements, inbound software and technology licenses and acquisitions, outsourcing and manufacturing agreements, patent licensing, University licensing, strategic alliances and joint ventures, standards bodies.

IP Mining and Enforcement

Patent portfolio mining is useful when focused and coupled with effective marketing methods to extract value from the portfolio. The process of portfolio mining begins with a review of the portfolio's patents to assess their strengths and fields of use; the technology involved; and their potential commercial uses.

A general mining program includes a search for:

• • New applications of the technology (not just the patents)
• • New markets for the technology
• • Extensions of the technology
• • Infringement candidates
• • Hot technology and/or divisions for spin-outs and joint ventures