Biotech Buzz, February 2013

Webinars Subcommittee

FREE CLE: Reprise of the “Issues in Novel Venture Capital Financing for Biopharmaceutical Development” Panel from the 2012 Annual Meeting, March 26, 12:30 PM-2:00 PM EST

The Biotech Committee in partnership with the Chemical Practice Committee will present a free CLE-qualifying webinar reprising the well-attended (150+ people) and popular program from the 2012 AIPLA Annual Meeting titled “IP Issues in Novel Venture Financing of Biopharmaceutical Development.” The webinar will be held on March 26, 2013 from 12:30 pm to 2:00 pm EST.  The panel consists of Cindy Fuchs and Lili Portilla of the National Institute of Health and Translational Research Resources, Joel Nied of LeClairRyan, Mike Warner of Pfizer, and Greg Sieczkiewicz of Flagship Ventures.  They will discuss issues and opportunities in novel venture capital arrangements that are increasingly being used to fund clinical development of biopharmaceuticals.  Invitations to this program will be sent soon. Keep an eye on your inbox.

FREE: Doctrine of Equivalents, AIPLA Patent Law Committee Teleconference, March 5, 12:00 PM-1:00 PM EST

AIPLA’s Patent Law Committee invites you to a teleconference on recent Federal Circuit decisions on the Doctrine of Equivalents in Deere v. Bush Hog and Sandisk v. Kingston Technology.  The presentations should be no longer than 5 minutes per opinion to optimize opportunity for discussion.  You may use the following dial-in to participate in the teleconference:

Toll-Free call-in:                   1-(877) 219-6790 International call-in:            1-719-867-4954 Participant passcode:          610-993-4222

Case Law Reports Subcommittee

Case Law Report Link

Bowman v. Monsanto Co., et al., Brief for the United States as Amicus Curiae Supporting Affirmance, reported byCathy Kodroff, Howson & Howson, Fort Washington, Pennsylvania.

 

No. 11-796 (U.S. Sup. Crt.) (whether a patentee’s rights are exhausted as to subsequent generations of seeds after patented seeds have been purchased in an authorized sale for planting). 

Biosimilars Subcommittee

State Biosimilars Legislation Gains Foothold

Citing safety and regulatory concerns, legislatures in several states have introduced or planned bills designed to control or prevent substitution of biosimilar products – i.e., products approved under the new abbreviated pathway in 42 U.S.C. §262(k) – for biological products approved under 42 U.S.C. § 262(a).  The Alliance for Safe Biologic Medicines, which includes several biotech industry members and BIO, has also interjected concerns that the substitution of biosimilars will cause confusion in pharmacovigiliance studies.

The state bills propose varying degrees of control over substitution.  Each would prevent pharmacists from substituting a biosimilar for a pioneer biologic unless that FDA has already deemed the biosimilar “interchangeable.”  There appears to be little debate over that requirement. 

Most of the bills, however, further require pharmacists to notify doctors of substitution, acquire written consent from patients, and keep records of substitutions for a number of years in order to track adverse events.  For example, Illinois House Bill 5581 provides in part:

c) A pharmacy may substitute a prescription biosimilar product for a prescribed product only if:

(1) the biosimilar product has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use;

2) the prescribing physician does not designate in writing on the prescription that substitution is prohibited;

(3) the patient (or patient’s authorized representative) provides written consent for the substitution;

(4) the pharmacist notifies the prescriber in writing within 24 hours after the substitution; and

(5) the pharmacy and the prescribing physician retain a written record of the biosimilar substitution for a period of no less than 5 years.

Pending bills in Indiana and North Dakota appear to be identical to the Illinois bill.

                As another example, Virginia House Bill 1422, which has passed the House, provides in part:

§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted.

A. A pharmacist may dispense a biosimilar that has been licensed by the U.S. Food and Drug Administration as interchangeable with the prescribed product unless (i) the prescriber indicates such substitute is not authorized by specifying on the prescription “brand medically necessary” or (ii) the patient insists on the dispensing of the prescribed biological product…. No pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the U.S. Food and Drug Administration for the specific use.

B. When a pharmacist dispenses an interchangeable biosimilar in the place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar and shall provide electronic, written, or telephonic notification of the substitution to the prescriber or his staff within five business days of dispensing the interchangeable biosimilar or as set forth in a collaborative agreement as defined in § 54.1-3300. Such notification shall be documented on the record of dispensing. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the brand name or, in the case of an interchangeable biosimilar, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words “Substituted for” and the name of the biological product for which the prescription was written. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.

Proponents of biosimilars argue that these restrictions place unnecessary impediments on the distribution of otherwise interchangeable and more cost-effective medications. They also argue the these states are taking inconsistent positions by freely allowing substitution of regular small-molecule generics or even requiring substitution by pharmacists unless the physician or patient requests the brand-name.

Depending on particulars of state legislation, there could be conflict with the Biologics Price, Competition and Innovation Act provisions of the federal Patient Protection and Affordable Care Act.  The Act defines “interchangeability” to mean that “a biological product that is shown to meet the standards described in subsection [42 U.S.C. § 262] (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”  Presumably, no state could enact law stating that a biological product that FDA finds to meet the stringent requirements of interchangeability in 42 U.S.C. § 262(k)(4) may not be substituted for a reference product that a health care provider prescribed.

Earlier this month, legislation proposing substitution restrictions failed to move to a vote in the Mississippi state legislature.  Similar bills remain on the table in several other states–Arizona, Arkansas, Colorado, Florida, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, and Washington.  Thus, the debate over biosimilar substitution will continue as these bills move through state legislatures.

The potential impacts that restrictions on substitutability may have on the attractiveness of developing interchangeable biological products is uncertain at this time.

Submitted by Lynn Tyler and Michael Brunelle, Barnes & Thornburg LLP, Indianapolis, Indiana

Biosimilars Subcommittee: Updated Mission Statement and 2013-2014 Objectives

 

Kristin Connarn

Co-Chair

McDermott, Will & Emery LLP, Boston, Massachusetts US

Vicki Norton

Co-Chair

Duane Morris LLP, San Diego, California US

Lynn Tyler

Co-Chair

Barnes & Thornburg LLP, Indianapolis, Indiana US

 

The Biosimilars Subcommittee held an introductory call on Monday, February 4th at 1:00 PM EST to discuss objectives and plans for 2013.  The mission and objectives published in the January 2013 Biotech Buzz have been updated, as presented below, in view of that discussion.

Mission Statement 

The mission of the Biosimilars Subcommittee will be to monitor patent issues, litigation, and regulations pertinent to the development and commercialization of therapeutic and diagnostic biological products, including biosimilar and interchangeable products.  The Subcommittee will provide Committee leadership and membership with periodic reports, and play a role in advocacy considerations, when pertinent.  The Subcommittee will coordinate with AIPLA’s Food and Drug Committee in monitoring and reporting on regulatory issues relevant to biological products.

2013-2014 Objectives

The Biosimilars Subcommittee has the following objectives for 2013-2014:

  1. Work with AIPLA’s Food and Drug Committee to analyze and advise on Abbott’s citizen’s petition arguing that the BPCIA amounts to an unconstitutional taking, and comments submitted to FDA.
    1. Review the Citizen Petition and Comments submitted
    2. Consider whether to comment on the Citizen’s Petition

Estimated Event Date: First Quarter of 2013

 

  1. Reporting and Advising on FDA Guidances and Draft Guidances for the Regulation of Biosimilar and Interchangeable Products
    1. Report & Analyze Final Biosimilar Guidance(s) When Issued by FDA

1)       Once FDA issues Final Guidance(s) on Biosimilar Products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including any changes from the draft Guidances and the FDA’s rationale for those change

    1. Analyze and Advise on FDA Proposed Interchangeable Product Regulations

1)       Once FDA proposes Guidances on the regulation of interchangeable biological products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including the implications of the guidances on litigation strategy, in coordination with AIPLA’s Food and Drug Committee. 

2)       Consider whether to make any submissions during the FDA’s comment period.

Estimated Event Date: Soon After Issuance of Guidances or Draft Guidances

 

  1. Monitoring and Advocacy
    1. Analyze and report any possible impact from the Federal Circuit’s split decisions on the scope of the 271(e)(1) safe harbor on manufacturers of biologic drug products (CompareMomenta Pharm., Inc. v. Amphastar Pharm., Inc.. withClassen Immunotherapies, Inc. v. Biogen IDEC) 
    2. Monitor regulations and patent issues pertinent to the development of therapeutic and diagnostic biological products, including biosimilar products.
    3. Monitor litigation relating to the commercialization of biological products, including biosimilar products.
    4. Monitor for legislative proposals by Congress to shorten the biologic product regulatory exclusivity period of 12 years currently set forth in the Biologic Price Competition and Innovation Act (BPCIA).
    5. Monitor the impact of the BPCIA on state legislation.
    6. Coordinate with AIPLA’s Food and Drug Committee.
    7. Provide Committee leadership and membership with periodic reports.
    8. Play a role in advocacy considerations, when pertinent.

Estimated Event Date: Ongoing

 

  1. Outreach
    1. Hold regularly scheduled telephonic meetings to coordinate with Subcommittee members and other interested AIPLA members, and to discuss new developments

 

The Biosimilars Subcommittee would like to invite all interested AIPLA Biotech Committee members to join and participate. 

Estimated Event Date (Recurring): February 4, 2013 (first meeting)

 

Members of the subcommittee volunteered to work on Objectives 1, 2(A) and 3(A):

  • ·         Lynn, Kristin, and Sonsy will review Abbott’s citizen’s petition and consider appropriate vehicle for reporting the results of the review.  Lynn will coordinate with the FDA committee. 
  • ·         Angie and Vicki will analyze and report on any possible impact from the Federal Circuit’s split decisions on the scope of 271(e)(1) safe harbor on manufacturers of biologic drug products.
  • ·         Ronita will take the lead on monitoring when the final FDA Biosimilars guidances come out, and the committee will take action at that point to report and analyze the final documents.

 

FDA’S CDER Announces Biosimilar Guidance Documents Planned for 2013

On January 31, 2013, FDA’s CDER published a list of draft guidance document it plans to publish during calendar year 2013. At least two appear to be relevant to biosimilars, “Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products” and “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” So far, there is no word on when the FDA may finalize the three draft guidance documents on biosimilars issued about this time last year or issue draft guidance on interchangeability.

 

Diagnostics and Gene Patenting and Public Education Subcommittees

AIPLA Comments Again to the USPTO About Genetic Diagnostic Testing

On February 8, AIPLA submitted additional written comments to the USPTO regarding genetic diagnostic testing.  AIPLA’s written comments reiterate the comments that AIPLA submitted in March 2012 and the oral testimony that Karen Canady gave on behalf of AIPLA during a Public Roundtable at the USPTO in early January 2013.  AIPLA continues to oppose modifying patent eligibility or enforcement provisions with respect to confirmatory diagnostic testing.  

 

Plant Biotechnology Subcommittee

The “Standard Material Transfer Agreement” and Access to Plant Genetic Resources: To What are you Agreeing? 

1st of a Series on the SMTA from Mark Pidkowich of Smart & Biggar/Fetherstonhaugh, Vancouver, British Columbia, Canada

The Standard Material Transfer Agreement (SMTA) for use in the Multilateral System was drafted with the intentions of: 1) avoiding the imposition of burdens on receiving parties that may hamper access to the plant genetic resources, while 2) sealing gaps that may lead to the ‘leakage’ of material from the Multilateral System and jeopardize benefit sharing.  The tension between these objectives is somewhat difficult to resolve, as demonstrated by various practical problems the document poses for corporate players.

First, if a Recipient conserves any material that it receives pursuant to an SMTA, which it presumably would, Article 6.3 obligates the Recipient to become a “Provider” and make that conserved material available to third parties.  Article 5(a) of the SMTA dictates that the material must also be provided expeditiously in response to a request.  Essentially, utilization of material obtained under an SMTA creates the risk that the Recipient may become a de facto stock centre, with no ability to recoup its costs beyond the minimum involved (see Article 5(a)).  Moreover, the Recipient-cum-Provider is obligated to inform the Governing Body of all transfers made. 

Second, the SMTA also appears to fetter a Recipient’s control over the distribution of products that it develops with the materials it receives.  While no obligation is placed upon the Recipient to make its products incorporating the transferred material available to third parties, any such transfers that it does make must be made under the SMTA.  Accordingly, a Recipient may not itself be obligated to make its products under development available, but downstream recipients of those products would be so obligated.  This should pose a particular concern for multinational organizations accustomed to transferring material between affiliates, especially given that the Ad Hoc Advisory Technical Committee on the SMTA and the Multilateral System has recently opined that any transfer between different legal persons must be made with the SMTA.  Unless all aspects of an organization’s business are performed by a single legal entity, there seems little room for a company to avoid a transaction which triggers the obligation to transfer a product under development to third parties upon request.

Finally, while the SMTA imposes a number of anticipated and unanticipated obligations on the Recipient, it provides no mechanism to offload liability for breaches of the SMTA by subsequent recipients. Moreover, the Ad Hoc Advisory Technical Committee has indicated that the Provider should exercise some degree of due diligence when evaluating whether or not a transfer should be made in the first place.  Should a Recipient find itself obligated to serve as a stock centre as suggested above, it may also be in the unfortunate position of accepting liability for any leakage of material from the Multilateral System by an indefinite number of downstream recipients, or use of the transferred material for non-food or non-feed purposes.   The due diligence required to ensure that the material does not move to third parties without an SMTA, or that material is not used for unauthorized purposes, would create an immense burden for the Provider.

Accordingly, for-profit organizations comprising multiple legal entities would be wise to develop a strategy for the development and transfer of resources in advance of accepting any material pursuant to an SMTA.  The obligations flowing from the use of the SMTA may ultimately limit the participation in the Multilateral System.  Alternatively, recipients may choose to destroy received material after evaluating it, rather than maintaining it and invoking the obligation to provide it to third parties.  Regrettably, neither option seems to serve the larger goals of the treaty in terms of conservation of and access to plant genetic resources.

 

International Issues Subcommittee

Patentability of Plant Biotechnology Inventions in Argentina

Contributed by Cristian Bittel and Iván Alfredo Poli, Marval O’Farrell & Mairal, Buenos Aires, AR

Argentina is one of the world’s major agricultural producers, ranking third worldwide in production of soybeans and sunflower seeds and fifth in the production of maize. Argentina set forth a regulatory frame for genetically modified organisms (GMOs) in 1991, and 99% of the soybean cultivated at present are genetically modified.  Naturally, this has increased interest in protecting biotechnological inventions. What follows are the salient points of the legal situation for biotechnological inventions in Argentina.

a.             General principles

Like most jurisdictions, the general rule in Argentina is that all inventions are patentable, provided they are new, non-obvious, industrially applicable and lawful, and have been appropriately disclosed and claimed. The basic tenet provided by Article 17 of the Argentine Constitution is that “Every author or inventor is the exclusive owner of his work, invention or discovery for the term granted by law”. 

The specific rules on the patentability of biotechnology inventions are spread among various provisions of the Patent Law and its regulatory decree. The more relevant regulations are:

(a)           Section 6.g of the Patent Law (“For the purposes of this Law, the following items shall not be considered as inventions: […]  g) Any kind of living matter or substance already existing in nature”);

(b)           Section 6 of Regulatory Decree No. 260/96 (“Plants, animals, and essentially biological process for their reproduction shall not be considered to be patentable subject matter”);

(c)            Section 20 of the Patent Law and its regulating decree which set forth formal requirements of inventions involving microorganisms,

(d)           Section 7.b of the Patent Law (“The following are not patentable: […] b) The totality of biological and genetic material existing in nature or their replica in the biological processes implicit in animal, plant, and human reproduction, including genetic processes involving material capable of self-duplication in normal and free conditions, as occurs in nature”);

(e)           Article 27.3 of the TRIPS Agreement.

 

 

b.            Patentability of plants

Under the Guidelines of the Argentine Patent and Trademark Office (PTO), “product claims covering plants […] shall not be allowed, even when they are produced through a microbiological process”.  The basis for this position is the above-mentioned section 6 of the Regulatory Decree.

Legal commentators in Argentina have argued that the PTO’s view is unconstitutional as Section 6 of the Argentine Patent Law, to which section 6 of the Regulatory Decree is subordinate, only bars the patentability of plants existing in nature, but not all plants (such as GMOs).  Despite the questionable constitutionality of the PTO’s position, the limitations it places on claims directed to plants, and the importance of Argentina as an agricultural producer and exporter, no case law yet exists on this issue.  Accordingly, the time may be ripe for challenge in the courts.

c.             Patentability of proteins, genes and/or DNA sequences

Section 7 of the Patent Law provides that the “totality of biological and genetic material existing in nature or their replica” is not patentable, but then goes on to clarify “in the biological processes implicit in animal, plant, and human reproduction”.  Importantly, genetic material not used in processes implicit in animal, plant and human is not within the prohibition.

Consequently, protein and DNA sequences are protectable under the Argentine Patent Law, provided they comply with the patentability requirements (novelty, inventive step, industrial applicability).  The Argentine PTO considers that purification and/or isolation does not provide novelty to proteins or DNA sequences, and therefore only genetically modified DNA sequences or mutant proteins are patentable.

Although plants may not be patentable per se according to the Argentine PTO, a plant comprising a patented DNA sequence can be considered as infringing claims to the patented sequence.  Consequently, protection for a DNA sequence or a polypeptide may prove to be useful to obtain some protection on plants carrying them.

d.            Methods for obtaining plants

Section 7 clearly excludes only the biological and genetic material in the essentially biological processes. Thus, processes in which human intervention has a significant role in determining or controlling the desired result (such as genetic engineering) are acceptable. On the other hand, claims directed to classical cross and selection methods are not acceptable as they are considered to be essentially biological.

Usually, steps such as “growing a plant” are objected to as being essentially biological.  Including transformation steps or reference to molecular markers generally improves the chances of acceptance as this differentiates the method from an essentially biological method.

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