BIOSIMILARS
Te biosimilar legislation outlines a fascinating process for managing patent disputes:
• The biosimilar applicant must provide to the company selling the approved reference medicine (and to patent owners of the approved medicine) a copy of the biosimilar FDA application, including a description of the method by which the biosimilar medicine will be manufactured
• The approved company must then share a list of all patents it believes are infringed, along with a statement of which patents it is willing to license to the biosimilar company
• The biosimilar company may share its own list of patents that the approved company could assert, along with a statement of either why it does not infringe any valid and enforceable claim or an assurance that the patent will expire before commercialisation
• The approved company must respond with its own statement pointing out how the biosimilar company would infringe
• The approved company and the biosimilar company must then negotiate which patents will be litigated
• If the parties cannot agree, the biosimilar company provides to the approved company the number of patents it wants to have litigated
• After the number is shared with the approved company, the parties simultaneously share the list of patents each wants to have litigated. Te number of patents on each list cannot exceed the number provided to the approved company by the biosimilar company. Te patents on the list are then eligible to be litigated under the biosimilar legislation. As an example, if the biosimilar company provides the number ‘five’, each company selects up to five patents. If the patents match, five patents are litigated. If three patents match, seven patents are litigated (the three matching patents and the two unmatched from each list). If the biosimilar company selects zero patents, the approved company may only litigate a single patent under this statutory scheme.
In addition to the framework outlined above, the law gives exclusivity to the approved medicine company for a period of 12 years. Tis helps give comfort that a company will not go through clinical trials only to have a biosimilar product get into the dance for free. Unlike the ANDA framework, process patents are not excluded from the biosimilars statute.
Issues to consider when litigating
A successful manufacturer of generic drugs has built into its business model the prospect of
patent litigation. In fact, a sophisticated company that desires to make generic pharmaceuticals understands that it may lose some of its patent challenges on its way to manufacturing generic products. A company wishing to make a generic version of a drug must undertake an extensive patent analysis to determine which drugs to pursue.
One strategy used by generics companies is to first identify the drugs that are commercially successful. In the case of a small molecule drug (covered by Hatch-Waxman), this step is followed by hiring a patent analysis team to find a way to certify that the patents listed in the Orange Book are either invalid or not infringed. Taken to its worst extreme, this strategy is akin to the relationship between a drunk and a lamppost; the drunk is looking for support, not for illumination.
A defence of non-infringement is oſten unavailable when a company wants to take advantage of the accelerated drug approval procedures outlined above. Aſter all, in many cases, it is the similarity between the generic product and the original that allows the FDA to grant approval. Te problem with invalidity is that it must be proved by clear and convincing evidence.
Although neither a Hatch-Waxman nor a biosimilars case is tried before a jury, judges are reluctant to invalidate a patent that has survived the scrutiny of the patent office. Courts do not always appreciate that patent examiners have perhaps 20 hours for the entire process of allowing a patent—from searching to responding to analysing the prospective patentee’s arguments. Tese cases are technical and do not lend themselves to second-guessing by the judge.
Te best strategy for a generics company is to work closely with its patent litigation counsel to identify the drugs worth pursuing. Tis analysis is not merely looking at the size of the market but also the vulnerability of the relevant patents. Companies that engage in a systematic methodology for finding the flaws in patents are most likely to find fatal problems in a cost- effective way.
In generic drug patent litigation, the defendant has a hidden weapon. It is the defendant who is picking the fight and therefore has the advantage of engaging the best experts before the patent owner knows a fight is brewing. Even if the expert never testifies, having the insight of the world’s top minds will help a defendant if it has the foresight to hire the expert early in the process.
Just because a patent lawyer is willing to write an opinion that says a patent is invalid does not
28 World Intellectual Property Review November/December 2010
www.worldipreview.com
David Cornwell specialises in patent litigation in the fields of consumer product protection, clean technology, biotechnology, computers and related technologies. He has numerous offensive and defensive litigation to his credit in the fields of utility patents, design patents, trade dress, unfair competition and trade secret law, and is known for his creative litigation strategies.
make it so. It is critical that the lawyer not only assesses the validity of a patent but also assesses the likelihood of winning both at the District Court and on appeal. Winning at trial means having a great story to tell, a great expert to teach and executives who can explain the goals of providing reasonably priced healthcare.
David K.S. Cornwell heads the cleantech industry group and is a director in the mechanical group at Sterne, Kessler, Goldstein & Fox. He can be contacted at:
davidc@skgf.com
Kevin W. McCabe is a director in the biotech group at Sterne, Kessler, Goldstein & Fox. He can be contacted at:
kmccabe@skgf.com
Kevin McCabe represents companies in complex multi-jurisdiction, multi-party and multi-patent litigations, including Paragraph IV ANDA litigations. He has argued interference cases before the Board of Patent Appeals and Interferences and has participated in appeals to the Court of Appeals for the Federal Circuit. McCabe also has extensive experience in re-examinations, especially those concurrently involved in litigation.
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