Examination of Patent Applications in Biotechnology and Organic Chemistry: Determining Obviousness and Sufficiency of Disclosure
To obtain a patent in the United States, an invention must be disclosed in a manner that adequately describes the invention and teaches a person skilled in the art how to both make and use the invention (enablement). Additionally, the invention must be both novel and not obvious to a person of ordinary skill in the art. A number of factors have been defined by the Courts in the United States to help determine the sufficiency of the invention disclosure and to aid in the consideration of whether the invention as claimed is obvious in light of the prior art and the level of the skill in the art. How these factors are considered in determining the adequate enablement and non-obviousness of a claimed invention during examination of an application for patent in the U.S. Patent and Trademark Office will be discussed, with particular attention paid to biotechnology and pharmaceutical inventions.
Overview of the grant procedure and patentability standards at the EPO
The presentation will give an overview of the patent grant procedure including opposition at the EPO. With focus on pharmaceuticals the patentability standards of novelty and in particular inventive step in the EPO will be addressed, as well as the requirements for data disclosure for enablement (sufficiency of disclosure) and inventive step.
Patent Examination for Pharmaceutical Invention at the JPO
At the JPO, patent applications are examined according to the Examination Guideline. The brief outline of the examination practice for medicinal invention at the JPO according to the Guideline will be explained especially on description requirements (requirements for claims and description;"clarity requirement", "enablement requirement" and "support requirement") and novelty / inventive step.
Legal Certainty and Business Investment
This presentation will discuss the relationship between the predictability of a Nation’s IP procurement and enforcement jurisprudence, and the willingness of business leaders to invest in developing new, innovative products in that Nation. While IP protection is just one aspect analyzed by business leaders when making a financial assessment of new product development, ambiguity in IP protection may create sufficient uncertainty in market and financial models that the feasibility of the entire development project becomes unclear. Indeed, in certain scenarios, the lack of predictability of IP protection can be more damaging to a project than knowing with certainty there will be no IP protection at all.
Intellectual Property Challenges Facing the Innovative Biotech Industry
In its more than 30 years of existence, the biotechnology industry has delivered on the promise of developing new, innovative products that have provided treatments for previously unmet medical needs and changed the treatment of disease in various therapeutic areas. Biotechnology continues to hold the potential of delivering products that will address the most grievous diseases of our time. However, due to the high costs, high risks and long product development timelines in obtaining regulatory approval, the biotech industry faces significant challenges in bringing these new treatments to the patients who need them. Now, more than ever, intellectual property protection is critical to allow innovative biotech companies sufficient market exclusivity on the successful products to recoup their development costs, make a meaningful profit and pay for continued R&D investments.
In this presentation, we will discuss the new challenges that have arisen in the United States and in other countries to obtaining patent protection on biotech inventions and in enforcing those patents against competitors. We will review the issue of patentable subject matter and what biotech inventions should be patented, the proper standard for determining obviousness of biotech inventions, the need for sufficient patent term given the long product development timelines, and the need for effective relief in enforcing patents. As an introduction to the two presentations to follow, we will discuss briefly the challenges to obtaining meaningful patent protection for biotech inventions in China and the challenges presented by the new patent and biosimilar laws in the United States.
Overview of Recent Developments in Patent Litigation in the United States
This presentation will discuss recent developments in patent law in the United States. Specifically, it will discuss important new caselaw developments from the United States Court of Appeals for the Federal Circuit and the United States Supreme Court and their intersection with the pharmaceutical industry. Topics will include the patentability of method claims and ways to prove infringement of such claims during litigation in the federal courts.
Legal watch areas in external R&D collaboration
The presentation will look at special legal topics that are often overlooked when entering into collaboration agreements with external R&D partners. It will analyse how specific rights of the inventors (e.g. remuneration) as well as rights of the public (government funding) need consideration. Concern areas are identified and potential solutions discussed based on experience in other law systems (e.g. Germany). Knowing of these areas, it will be explained that early attention to them is crucial.
Biologic drug patents in China: Obtaining meaningful and enforceable protection
The focus of research and development efforts within pharmaceutical companies seems to be shifting away from small molecule therapeutics to biologics and vaccines. In China, government policies also encourage innovations in biologic drugs including antibodies, vaccines, recombinant proteins and stem cells.
Due to the unique features of researching and developing biologic drugs, including the high cost, the extensive clinical testing required, and the high risk of failure, obtaining meaningful patent protection for biologics is critical if the biopharmaceutical industry is to grow and advance.
However, the examination criteria adopted by the SIPO for biotech inventions are rather strict. In prosecution, support and enablement issues are very commonly raised to reject broad claims. It is often the position of the patent office that the scope claimed is too broad to be supported by the description. Consequently, many patents have been granted with very narrow scope. Do such narrow patents provide sufficient protection to encourage development of innovative products in China? Are these patents enforceable to protect against biosimilars competition? As there has not been any actual case so far, we are waiting to see if effective relief can be obtained. It is a challenge for both in-house and outside IP counsels to draft and get meaningful and enforceable patents that are resistant to design around. It is time for the patent office to adopt a smarter policy so as to effectively protect the innovations and investment of the biotech industry.
In this presentation, the lecturer will review the patent practice of China in this particular area and compare it with the US and EU practice. Meanwhile, some advice for drafting and prosecution will be provided.
New Laws, New Challenges: How will the BPCIA and AIA impact the Biotech Industry?
The United States Congress has enacted two major changes in the laws affecting intellectual property rights for biologic drugs: the Biological Price Competition and Innovation Act, (BPCIA) and the Leahy-Smith America Invents Act (AIA). The BPCIA, enacted in March 2010, provides the FDA with authority to establish a regulatory approval pathway for follow-on biologic drugs, establishes periods of regulatory exclusivity that complement patent rights, and provides the framework for the resolution of patent disputes surrounding the development of follow-on biologics. The AIA was enacted in September 2011 and makes the most significant changes to the U.S. patent code since the 1952 Act was signed into law. With the AIA, Congress sought to harmonize US patent law with international law and improve the quality of US patents.
The recent enactment of these two laws means that the legal landscape surrounding biologic drugs is evolving. We will cover important aspects of both laws, including recent PTO proposed rules and draft FDA guidance, and discuss their potential impact on the Biotech Industry.
European Pharmaceutical Patent Litigation
Generic companies usually want to sell their products in most of the 27 member countries of the European Union (EU). There is no single patent or patent court that is effective in all EU countries. This presentation explains how patent owners enforce their rights in Europe. The discussion will review the typical strategies used by generic pharmaceutical companies, and reactions by innovator pharmaceutical companies.
Life Science and Pharma Patents – Pitfalls and Tips
There have been many interesting developments in the last few years that affect the way life science and pharma patents should be prepared and prosecuted. It is becoming more and more difficult to obtain broad claims in certain technologies due to new case law. The lecture will provide suggestions that should be helpful to companies involved in research in pharmaceutical, biotech and other related life science fields.
Pharmaceutical Patent Litigation in the United States Under the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act)
The US has enacted legislation that seeks to balance the rights of innovator pharmaceutical companies to the benefits of their inventions with the desire for lower cost pharmaceuticals through increased competition from generic manufacturers. The Hatch-Waxman Act has generated numerous lawsuits as innovator and generic companies compete for pharmaceutical business. This presentation will describe the Hatch-Waxman Act and recent rulings affecting the value of patents and innovation.